In roughly nine days I’ll be standing in the Poster Hall at AIDS 2026. It’s a fluorescent-lit purgatory of white foam boards and academic jargon, the exact spot where high-stakes science goes to die in public. The air is going to taste like lukewarm coffee and industrial-grade desperation. You’ve got Ph.D.s in polyester suits guarding their data like religious relics, waiting for a nod from the gods that never comes. Right now the federal government is incinerating millions of dollars to work out whether cannabis is the savior or the executioner of the HIV-ravaged brain, and you’d never know it from the coverage. The findings are heavy. The stakes are visceral. And the HIV media is face-down in a gutter, asleep at the wheel. Nobody’s writing it down, and that’s the goddamn scandal.

Scientific priorities don’t talk. They bleed cash. Enter SCORCH, the Single-Cell Opioid Responses in the Context of HIV. It sounds like a black-ops weapons program. It’s actually a bureaucratic leviathan built to map the brain one twitching cell at a time. The thing is steered out of NIDA’s Division of Neuroscience in Rockville by the high priests of the federal checkbook, Susan Wright and John Satterlee. Back in 2023 they cut an $11.6 million check to Shomi Ndhlovu’s crew at Weill Cornell to see how cannabis warps or welds infected tissue. Tens of millions poured into the void, and the output is a run of posters pinned to the back wall of a convention center. Twenty-three thousand people will swarm IAS/AIDS 2026 and not one of

On paper, NIDA and NIAID are shaking hands. In the trenches, the SCORCH findings are hitting a brick wall. They aren’t translating to the AIDS Clinical Trials Group, the ACTG, the heavy hitters who actually run the trials that decide whether you live or rot. The ACTG’s Neurology Collaborative Science Group, chaired by Felicia Chow of UCSF, sits on the far side of a bridge nobody has built yet. No one on the executive committee is forcing the connection. So we watch tens of millions of people march toward cognitive decline while the researchers refuse to read off the same map. It’s a clinical failure dressed up in the robes of “process.”

And don’t let anyone tell you the data isn’t there. It’s piled to the ceiling. It just never leaves the building. Out at UC San Diego, Ronald Ellis and his colleagues pulled spinal fluid from 263 people and found that the daily cannabis users living with HIV had the calmest brains on paper. Their inflammatory chemokines, MCP-1 and IP-10, dialed down toward the levels of people who never carried the virus at all, and the calmer the fluid, the better they learned. It’s a cohort study, not a randomized trial, so association is the asterisk the scientists will always wave at you. But the signal is loud, and Ellis’s own review lays out the mechanism: cannabinoids tamping down the smoldering, body-wide inflammation that drives heart attacks, dementia, and death in people aging with the virus.

Then there’s the pill problem. Amy Justice at Yale has spent a career quantifying what it costs to grow old with HIV, and her polypharmacy data is a quiet horror show. Stack six drugs in an aging HIV patient’s medicine cabinet and you get roughly seven documented interaction pairs, against about one you’d expect by chance. This is the population SCORCH is supposed to protect. People already drowning in prescriptions, already aging a decade ahead of schedule. And the one intervention half of them are already self-administering, cannabis, is the one nobody in the clinical networks will study with any urgency.

Here’s the true absurdity. The system treats “cannabis” like a single grey blob. Most studies, including the elegant UC San Diego work on CBD and the brain’s TREM2 repair signal, use sterile CBD isolate. It’s safe, it’s boring, and it’s nothing like what humans actually put in their bodies: CBN, CBG, THC, and terpene profiles that would make a chemist weep. Ndhlovu’s Cornell trial is our best shot at a real answer, but here’s the catch. Nobody knows which cultivar they’re actually using. Not the dispensaries, not the regulators, not the industry.

And that’s the part that should make you throw your coffee. The tools to answer “which cannabis” already exist. Germplasm banks and DNA-marker fingerprinting can pin a plant to its genetic identity and its chemical profile. We know in black and white that the folk names are a lie. What sells as “Blue Dream” at the dispensary counter is, genetically, a coin toss. “Which cultivar?” isn’t an unanswerable question. It’s an unasked one. Answering it is exactly the applied science that outfits like Buffalo’s Dent Neurologic Institute, and our own affiliated ventures at GEM and Compound Genetics, exist to force onto the record.

Dent is worth pausing on, because it’s proof the clinical signal survives contact with real patients. In a chart review of 204 of their neurology patients, average age 81, roughly seven in ten reported that medical cannabis helped, and a third of them cut their opioid dose. It’s a retrospective review, not a gold-standard trial, but it’s exactly the kind of grounded, human evidence that the SCORCH machine, for all its millions, still refuses to connect to the people who need it.

Understand the scale of what’s being ignored. HIV-associated neurocognitive disorder isn’t some rare complication. The largest meta-analysis on record puts it at 42.6% of people with HIV, some 16 million human beings. And the population is graying fast. By 2021 more than half of Americans living with diagnosed HIV had already crossed 50, and the CDC now projects the ranks of the 75-and-older could swell as much as sixfold by 2040. Every one of those people runs roughly $420,000 in lifetime care, a bill that climbs, not falls, the longer they live. A brain you can’t keep is a patient who can’t adhere, can’t work, can’t live alone. This isn’t a footnote to the epidemic. It’s the next front of it, the same convergence of frailty, inflammation, and neglect this publication mapped in When the Levy Breaks.

The shift of medical marijuana toward Schedule III has kicked the doors open, but that window won’t stay propped forever. Federal funding is a political knife fight, and anything touching drug use and HIV is always first onto the chopping block. In the spring of 2025 the administration terminated $1.8 billion in NIH grants in a single month, and more than 200 HIV-related grants were killed outright. Congress preserved the topline NIH budget for 2026, but hundreds of terminated grants were never restored. If this science doesn’t mature into real therapies, FDA-approved drugs that reach a human hand, it’ll get swept away in the next budget brawl. We have to drag these findings out of the poster hall and onto the podium before the machine pulls the plug. In nine days I'll be at the microphone in Rio asking why. Somebody has to.

For decades, achieving an “undetectable” viral load has been considered the gold standard of HIV treatment. Yet a small number of people living with HIV continue to show detectable levels of viral RNA in their blood despite strict adherence to antiretroviral therapy (ART), no evidence of drug resistance, and no signs of treatment failure.

New research from Johns Hopkins University may provide an important explanation—and considerable reassurance.

In a study published in Nature Communications, investigators found that the vast majority of these persistent viral signals are not caused by active, infectious HIV. Instead, they originate from defective copies of the virus that are incapable of causing new infections.

The phenomenon, known as non-suppressible viremia (NSV), has long puzzled clinicians and patients alike. Individuals with NSV maintain detectable HIV RNA levels even while taking effective ART and without evidence that the virus is actively replicating.

Researchers analyzed samples from more than 50 individuals receiving long-term HIV treatment. Their findings revealed that approximately 95% of the detectable viral RNA originated from highly defective viral genomes carrying abnormalities in a region known as the 5′ leader, a critical genetic segment involved in viral replication and packaging. These defects render the virus incapable of producing infectious particles.

The discovery has significant implications for both clinical care and patient peace of mind.

Many people living with HIV are taught that any detectable viral load could indicate treatment failure or increased risk of transmission. According to the study’s authors, that assumption may not apply in many NSV cases.

The defective viral copies identified in the study can still produce fragments of viral RNA that appear on laboratory tests, but they lack the ability to establish new infections. This means that detectable HIV RNA does not always equate to infectious virus.

For patients who experience persistent low-level viral detection despite excellent adherence, these findings may help reduce anxiety surrounding laboratory results and lessen concerns about viral rebound.

The researchers also developed a laboratory assay called CLAWS (Capturing 5′ Leader Anomalies Without Sequencing). The test can rapidly distinguish intact HIV RNA from defective HIV RNA without requiring extensive genetic sequencing.

The investigators believe this technology could help clinicians determine whether detectable viral RNA represents a true clinical concern or simply reflects harmless defective viral remnants. Such distinctions could become increasingly important in HIV cure research and in monitoring participants enrolled in experimental treatment interruption studies.

Implications for HIV Cure Research

The study also contributes to a growing understanding of HIV persistence

.

While ART effectively suppresses viral replication, HIV establishes long-lived reservoirs within infected immune cells. Most of these reservoirs contain defective proviruses that cannot generate infectious virus. The new findings suggest that these defective genomes may account for much of the residual viral material detected in blood during long-term therapy.

Researchers observed that defective viral RNA becomes increasingly dominant over time in individuals receiving long-term ART, further supporting the idea that residual detectable virus often reflects biological “noise” rather than active infection.

The findings do not change the importance of adherence to antiretroviral therapy, nor do they suggest that all detectable viral loads are benign. Genuine treatment failure, drug resistance, and viral rebound remain critical clinical concerns that require careful evaluation.

However, the study provides compelling evidence that many cases of persistent low-level viremia are driven by defective viral copies rather than infectious HIV. As diagnostic tools improve, clinicians may be better equipped to distinguish between harmless viral remnants and clinically significant viral activity.

For people living with HIV, that distinction could offer not only better medical guidance but also greater confidence in the effectiveness of modern treatment.

Global AIDS News Today will continue following developments in HIV reservoir research, cure strategies, and advances in viral load monitoring as they emerge.

By Robert Antonacci, M.D. and David Miller

Across the United States, state HIV programs are facing unprecedented financial pressures that threaten access to lifesaving treatment and care for thousands of Americans living with HIV. Recent developments within state AIDS Drug Assistance Programs (ADAPs)—the cornerstone of the Ryan White HIV/AIDS Program—signal a troubling shift toward service restrictions, tighter eligibility standards, and reduced access to medications that have long served as the foundation of effective HIV treatment.

For more than three decades, the Ryan White HIV/AIDS Program has functioned as the nation’s HIV safety net, ensuring that individuals living with HIV can obtain treatment regardless of their ability to pay. Today, however, stagnant federal funding, rising pharmaceutical costs, growing enrollment, and increasing insurance expenses are forcing states to make difficult decisions that could undermine decades of progress in HIV care.

A Return to Cost-Containment Measures

Historically, ADAP programs have relied on waiting lists and other cost-containment strategies during periods of financial strain. While federal emergency funding helped eliminate widespread waiting lists by 2013, states are once again implementing measures designed to control costs.

Florida has emerged as one of the most visible examples. The state recently announced plans to dramatically reduce income eligibility for its ADAP program—from 400% of the Federal Poverty Level (FPL) to 130% FPL. For an individual, this change would reduce the maximum qualifying annual income from approximately $63,840 to just $20,748.

In addition, Florida has proposed removing Biktarvy—the nation’s most widely prescribed HIV medication—from its formulary and scaling back insurance assistance programs that help individuals maintain comprehensive health coverage.

These changes have generated significant concern among patients, providers, and advocacy organizations because treatment interruptions can lead to poorer health outcomes, increased morbidity, and greater risk of HIV transmission.

A National Trend, Not an Isolated Event

Florida is not alone.

According to data from the National Alliance of State and Territorial AIDS Directors (NASTAD), nearly half of all state ADAP programs have either implemented or are actively considering cost-containment measures. Several states, including Pennsylvania, Kansas, Delaware, and Rhode Island, have already reduced eligibility thresholds.

Other states are exploring options such as:

• Limiting formularies and covered medications

• Restricting insurance assistance programs

• Reducing support services

• Tightening recertification requirements

• Establishing annual spending caps

• Considering future waiting lists

Although no state has yet reinstated formal waiting lists, several—including Arkansas, Louisiana, and New Jersey—have reportedly considered them as a potential future measure should financial pressures continue to worsen.

Why Are ADAP Programs Under Financial Stress?

Federal Funding Has Lost Purchasing Power

While congressional appropriations for ADAP have remained relatively stable in nominal dollars for many years, inflation has steadily eroded their real value. When adjusted for inflation, federal ADAP funding has declined substantially since its peak in the mid-2000s. In practical terms, today’s funding levels provide purchasing power comparable to those available more than two decades ago, despite significant increases in both enrollment and treatment costs.

This funding stagnation reflects a broader failure of federal leadership. Under both the Trump Administration and Republican-led Congresses, Ryan White appropriations largely failed to keep pace with inflation and rising healthcare costs. Although annual appropriations often appeared stable on paper, flat funding in the face of expanding demand effectively amounted to a reduction in federal support. The result has been a gradual transfer of financial responsibility to states already struggling with competing budget priorities.

Enrollment Has Grown Dramatically

The number of Americans relying on ADAP services has increased significantly over the past two decades. Expanded treatment recommendations now encourage immediate initiation of antiretroviral therapy following diagnosis, resulting in more individuals receiving treatment earlier and remaining in care longer.

As enrollment grows while funding remains relatively flat, available resources must be stretched further each year. The mismatch between growing need and stagnant federal investment has become increasingly unsustainable.

HIV Medication Costs Continue to Rise

Modern HIV therapies have transformed HIV from a fatal disease into a manageable chronic condition. However, these advances come with increasing costs.

Many recommended treatment regimens now exceed $60,000 annually at wholesale acquisition prices. Although ADAP programs receive discounts through federal pricing mechanisms and manufacturer rebate agreements, rising drug costs remain one of the most significant financial pressures facing state programs.

Biktarvy, currently the most prescribed HIV treatment regimen in the United States, exemplifies this challenge. Its effectiveness and convenience have made it the preferred therapy for many patients, yet its cost places additional strain on state budgets already operating under constrained funding.

Insurance Costs Are Escalating

Another major challenge is the rising cost of health insurance coverage.

ADAP programs frequently assist eligible clients with insurance premiums, allowing individuals to access broader healthcare services beyond HIV treatment alone. However, recent increases in marketplace premiums combined with the expiration of enhanced Affordable Care Act premium tax credits have significantly increased costs for both patients and state programs.

The expiration of these enhanced tax credits represents another policy decision with direct consequences for people living with HIV. Congressional Republicans declined to extend the subsidies that had dramatically improved affordability for low- and middle-income Americans. As a result, many individuals now face sharply higher insurance premiums, while ADAP programs must absorb additional costs to maintain coverage for eligible clients. The burden falls particularly hard on working Americans who earn too much to qualify for traditional assistance programs but cannot reasonably afford rising healthcare expenses.

Many individuals who previously benefited from enhanced subsidies are now facing substantially higher premiums. For ADAP programs that subsidize these plans, the financial impact is considerable.

The Fight to Protect Ryan White Funding

As states struggle with mounting HIV care costs and shrinking resources, national advocates have worked aggressively to protect the Ryan White HIV/AIDS Program from deeper federal cuts.

Among the most vocal advocates has been Carl Baloney, Jr., President and Chief Executive Officer of AIDS United, who has repeatedly warned Congress that decades of progress against HIV are at risk if federal investments fail to keep pace with growing need. In testimony regarding Fiscal Year 2026 appropriations, Baloney urged lawmakers to increase federal investments in HIV treatment and prevention programs and cautioned that recent progress in HIV care and prevention “is in grave danger.”

Those warnings proved well-founded. During budget negotiations, House Republicans proposed reducing federal HIV investments, including significant reductions affecting Ryan White services and other HIV-related programs. HIV advocates argued that such reductions would have undermined care systems relied upon by hundreds of thousands of Americans living with HIV.

Following congressional negotiations over the FY2026 budget, Baloney praised lawmakers for restoring funding that had been targeted for elimination. As he stated:

“Congress is demonstrating once more that there is bipartisan agreement on the basics: HIV prevention works, treatment saves lives, and stable housing and strong public health systems are non-negotiable if we’re serious about ending the HIV epidemic.”

Baloney specifically highlighted the restoration of hundreds of millions of dollars in Ryan White HIV/AIDS Program funding that had been removed from earlier House proposals.

Yet the fact that such funding had to be restored in the first place illustrates the fragility of the federal commitment to HIV care. While advocates successfully prevented some of the most damaging proposed cuts, Ryan White funding continues to lose purchasing power due to inflation, rising drug prices, and growing enrollment. As AIDS United and other advocates have argued, preserving funding is no longer enough. Without meaningful increases in federal investment, states will continue facing impossible choices that ultimately threaten access to lifesaving treatment.

The consequences of restricting HIV treatment access extend far beyond individual patients.

Consistent engagement in care and uninterrupted access to antiretroviral therapy are essential components of modern HIV prevention strategies. Effective treatment suppresses viral load, improves health outcomes, reduces mortality, and virtually eliminates the risk of sexual HIV transmission.

When individuals lose access to treatment due to financial barriers, the public health consequences can be profound. Reduced treatment adherence and interruptions in care increase the risk of disease progression while potentially contributing to new HIV infections.

In short, restricting access to HIV treatment may ultimately prove more costly—both financially and socially—than maintaining robust support systems.

The irony is difficult to ignore. National leaders continue to speak about ending the HIV epidemic, yet policy decisions at the federal level have weakened the very programs responsible for the nation’s success in HIV treatment and prevention. Ambitious public health goals cannot be achieved while simultaneously allowing the financial foundations of those efforts to erode.

The growing fiscal challenges confronting ADAP programs should serve as a warning to policymakers at every level of government.

State programs have attempted to bridge funding gaps through supplemental appropriations, pharmaceutical rebates, and emergency funding mechanisms. Yet these efforts are increasingly insufficient to offset rising enrollment, escalating drug prices, and higher insurance costs.

Without meaningful investments and long-term funding solutions, more states may follow the path of restricting eligibility, reducing benefits, or considering waiting lists. Such actions risk reversing decades of progress in HIV treatment and prevention.

The Ryan White HIV/AIDS Program has been one of the nation’s most successful public health initiatives. Preserving its ability to deliver comprehensive care is not simply a healthcare priority—it is a public health imperative.

Congress and the Administration must recognize that ending the HIV epidemic requires more than campaign promises and policy statements. It requires sustained federal investment, protection of affordable insurance coverage, and a renewed commitment to the Ryan White Program that has served as a lifeline for hundreds of thousands of Americans. Failure to act will leave states with increasingly impossible choices—and leave vulnerable patients paying the price.

This commentary is based on recent analyses of ADAP financing and state program trends reported by the Kaiser Family Foundation (KFF), the National Alliance of State and Territorial AIDS Directors (NASTAD), and advocacy materials from AIDS United.

AIDS 2026 – 26th International AIDS Conference July 26–31 2026 Rio de Janeiro, Brazil (hybrid) https://www.iasociety.org/conferences/aids2026

Conference on Retroviruses and Opportunistic Infections (CROI 2026) February 22–25 2026 Denver, Colorado, USA https://www.croiconference.org

International Workshop on HIV & Women 2026 April 10–11 2026 Prague, Czech Republic https://academicmedicaleducation.com

ACTHIV 2026 (American Conference for the Treatment of HIV)April 30 – May 2 2026 Atlanta, Georgia, USA https://www.acthiv.org

Continuum 2026 (International Association of Providers of AIDS Care)June 21–24 2026 San Juan, Puerto Ricohttps://www.iapac.org/conferences/continuum-2026/

National Ryan White Conference on HIV Care & Treatment August 4–7 2026 Washington, DC, USA https://ryanwhiteconference.hrsa.gov

Major Global TB Conference

The Union World Conference on Lung Health 2026 (world’s leading TB conference) November 17–20 2026Rio de Janeiro, Brazil https://worldlunghealth.org/

Getting myself to Rome and reporting on the conference was as much of a challenge as devouring the enormous amount of research shown. We could spend months reporting on all the innovative advances presented at IAS 2011 and, in a number of venues, much of this vital knowledge has and will be appearing in the HIV media, both on the Web and in print, for months to come.

The sifting out of hundreds of presentations to identify the most compelling issues that, as a community, we need to pay attention to, requires some insight into how advances in research will translate to changes in treatment. In four days, conference attendees were drowned by fifty sessions, nine plenaries, 3,552 abstracts, and thirty-one satellite meetings.

The 6th IAS Pathogenesis Conference was important enough that Rep. Alcee Hastings (D.-FL) issued House Resolution 360 on the conference, which noted the dangers we’re facing from emerging drug resistance, including the spread of XDR TB (extensively drug resistant tuberculosis). This resolution is a clear sign that some of our more intelligent, responsible legislators are paying closer attention to the translation of the science that can help end this plague.

One shuddering event, just days before the conference, was the announcement that the Italian government has no plans to continue the National AIDS Research Program at the Istituto Superiore di Sanità (ISS), the equivalent of the U.S. National Institutes of Health that, at its peak in the 1990s, received €25 million a year. Italy is the only G8 country that has not recently contributed to the Global Fund to Fight AIDS, Tuberculosis and Malaria. A lot of very important research is going to be lost, research we all need now.

How fast can you run?
On Saturday, July 16, a session called “The New Concepts in HIV Immunopathogenesis, Treatment and Vaccines” drew key international opinion leaders who presented their innovative views and stimulated debate to help advance four critical areas of research in HIV infection: immunopathogenesis, new concepts in vaccine strategies, eradication of virus reservoirs, and molecular mechanisms of viral control. The meeting prompted serious discussion between prominent vaccine and treatment specialists and basic scientists, providing a unique opportunity to cross-fertilize these different fields.

The SHE (Strong, HIV positive, Empowered Women) Programme European Launch spoke to how much patient advocates, despite our reduced numbers, are still very influential in driving the clinical agendas in our interests.

Another important event at IAS Pathogenesis was the launch of a community based study of women living with HIV/AIDS in Europe. The SHE (Strong, HIV positive, Empowered Women) program is developed and steered by an independent advisory board, comprising advocates, women living with HIV, and other HIV healthcare experts composed of forty women representing close to forty advocacy groups from across eight European countries including Belgium, France, Germany, Italy, Poland, Portugal, Spain, and the United Kingdom. The program provides support to women living with HIV, aiding them to empower themselves to improve the quality of their lives, including getting the most out of their healthcare services and to create an effective dialogue with healthcare professionals. This will be a groundbreaking study of the challenges that HIV-positive women in Europe are facing; it addresses the clinical disparities between clinical outcomes we see between men and women and aims to engage policymakers to consider the special issues confronting women living with HIV, thereby increasing awareness and understanding throughout Europe. The SHE programme is developed at the discretion of the faculty and is funded by Bristol-Myers Squibb.

Another incredibly important meeting, “Towards an HIV Cure” Global Scientific Strategy–International Working Group & Stakeholders’ Advisory Board meeting, was

held on Thursday, July 21. Following the success of the workshop “Towards a Cure: HIV Reservoirs and Strategies to Control Them,” held in conjunction with the XVIII International AIDS Conference (AIDS 2010) in Vienna in July 2010, IAS decided to continue to mobilize the scientific community and guide the development of a Global Scientific Strategy Towards an HIV Cure. An international scientific working group is developing a draft global scientific strategy in cooperation with a stakeholders’ advisory board. Those two groups will meet after IAS 2011 to define research priorities in the field of HIV cure research. You can find a full list of the stakeholders membership on-line at: www.iasociety.org.

The Fourth International Meeting on HIV Infection and the Central Nervous System–Treating the Brain in the HAART Era took the opportunity of so many HIV clinicians and scientists gathered together in Rome to bring the issues of neurological manifestations, including HIV-dementia to the forefront of the discussions. Among the most threatening complications of HIV infection, although the incidence of neurocognitive impairment associated with HIV brain infection and progressive multifocal leukoencephalopathy has dramatically decreased among people receiving combination antiretroviral treatments, these complications are among the most frequent and devastating complications of HIV currently observed.

Despite significant progress in understanding the pathogenesis of these complications and efforts to translate this knowledge into clinical practice, it was made clear at the meeting that optimal management tools in HIV neurology are still lacking. At this meeting, attendees began to address unsolved issues, discuss clinical strategies and the need to begin to examine studies and interventions PLWHA’s currently have available.

Part of my work at the conference was helping to put on the NAPWA Treatment Horizons: Pathways Towards a Functional Cure satellite symposium, which was produced in conjunction with staff from Health People, an AIDS service organization located in the South Bronx, the epicenter of the epidemic in North America and one of the poorest communities in the U.S. The satellite symposium showed data on therapeutic vaccines, gene therapy, new antiretrovirals in development, and advances in treatment that are backed by good clinical rationale and experience. Close to a dozen new developments in clinical research to change the course of the epidemic included:

• Sandy Pijaia, MD, presenting on TBR652, a Phase II chemokine antagonist and Julian Chick’s presentation on Avexa’s long-awaited third-generation nuke, ATC.
• Another very promising antiviral maturing in development, ATC, a Phase III NRTI, was presented by Susan Cox, PhD, at Avexa.
• Virxsys presented on VRX 496, a gene therapy in Phase II clinical development, Vacc4x, a therapeutic vaccine in Phase II being developed by Bionor Pharma along with FIT-06 (FIT Biotech), which is also in Phase II development.
• Aphios presented data on APH-0812, a therapy for treating HIV latency, a new approach involving histone deacetylases (HDACs) inhibitors and non-tumor promoter Protein Kinase C (PKC) agonists.

Gary Blick, MD, who heads World Health Clinicians, a nonprofit, presented on MuscleGel, a new whey protein supplement that is getting support for Medicaid approval from a number of advocacy groups because of its ease of use. BioK+, the makers of CL1285, a probiotic, joined in on a presentation on therapeutic nutritional supplements that are so often overlooked. Both protein supplementation and probiotics are very helpful in managing side effects of ARVs and can help with HIV-infection-related weight loss, which is supported by a lot of data.

Disappointing was the lack of new data on the viral decay accelerator from Koronus or Adaptimmune, Argos Therapeutics’ autologous cell therapy and the research from Mike McGrath, MD, at Pathologica. Again, we can presume the financial climate is having an impact on very promising research that can save our lives.

The trends in HIV research in this stunningly unstable economy are greatly affecting the continued future of important research that is critical for the future of further advances to end the AIDS pandemic. We’ve all seen how therapeutic success has driven research of a cure closer to reality but more basic understanding of how to control HIV has to become better focused and translate into studies. HIV vaccines continue to remain out of reach, but it’s clear that groundbreaking ideas are coming forward into further investigation that could also contribute to curing HIV.

So what do we do now?
• Join International Treatment Preparedness Coalition (ITPC), ATAC and other organizations, both global and local, to get ready for the 2012 Conference on Retroviruses and Opportunistic Infections (CROI 2012) and the upcoming HIV Persistence Workshop in St. Maarten, West Indies, from December 6–9, 2011.
• Join other AIDS treatment activists and continue to learn more and report on scientific and clinical advances presented on the IAS Pathogenesis Conference Web site. There’s so much more research that demands more of our attention.
• Tell our legislators to find support for new strategies that may lead to advancing our understanding of how HIV works.
• Have a great idea? Know a clinician who does? Check out the new program at the NIH at: www.cnihr.org, which sponsored an instructive meeting on grant application programs focused on HIV eradication.

As we watch the horn of Africa experience a very unnoticed apocalypse, while our national economy has begun to resemble the convolutions affecting much of Europe, it is important for people with HIV/AIDS to defend our hard-won gains, to increase our knowledge about what’s in the pipeline, and to advance the research that may save our own lives, as we see from the first actual cure that HIV can be wholly defeated. A cure seems just within reach. The question now is how far we can all extend ourselves.

David Miller is a member and former co-chair of Cornell ACTG Community Advisory Board, as well as a member of the Campaign to End AIDS, The AIDS Treatment Activist Coalition and GNP+, the Bronx HIV/AIDS Advocacy Network and a board member of The AIDS Institute. David works with NAPWA and the Health People HIV/AIDS Treatment/Policy Education Advocacy Demonstration Project in the Bronx. David was a member of ACT UP NY.

This article originally appeared in aumag.org

The butcher’s bill being served because of the global food crisis isn’t surprising. The World Food Program (WFP), UNICEF, and a legion of NGOs managing famines ranging from Venezuela to South Sudan all warned the world that the wolf was at the door months before Putin decided to add a new chapter to the encyclopedia of atrocities.

The intersection of COVID-19, HIV, TB, and malaria; international conflicts fueled by proxy fights leveling cities; as well as domestic political chasms continue to over-burden the world’s emergency response resources. The warnings were sounded as loud as the air raid sirens in Ukraine as far back as 2019, when it became clear that climate change, overpopulation, and the resurgence of the Cold War were going to be the genesis of a new round of global famine. Jeannie Wraight’s article in A&U magazine last October discussed the challenges addressed in international policies affecting access to RUTFs for acute malnutrition (SAM).

The World Health Organization’s (WHO) report in 2020 noted that 149 million children under five were estimated to be stunted, and an estimated 45 million were suffering from wasting. It is estimated that over eighteen million children under age five are affected by the most extreme form of malnutrition, SAM, and are 12 times more likely to die than well-nourished children.

“Despite the number of people needing aid having already risen by more than 1 million to 17.4 million this year and estimated to rise by more than 1 million by the end of 2022, the WFP identified a food aid funding gap of $900m (£686m). Only 11% of its funding target has been met,” stated David Beasley, Executive Director of the United Nations World Food Programme. “We’ve got now 45 million people in 38 countries that are knocking on famine’s door. And you may see a general price increase of food, let’s say 38 to 40%, but in some very tough places like Syria, it’s going to be 100% to 200%. In Yemen, we’ve already cut rations to eight million people, about 50%, in Chad, Niger, and Mali. We already see an incredible number of people talking about migrating from Central America into the United States … If we don’t get the food that we need to reach the people in need, whether it’s in the Middle East, Northern Africa, or Central America, you’re going to have famine and you will have destabilization of nations and then mass migration. And this will cost a thousand times more than if we can get the food before they either die or create political unrest.”

The Biden administration has implemented plans to increase international aid beyond the previous administration’s efforts. That includes $58.5 billion for the State Department and U.S. Agency for International Development for bilateral economic assistance, which the administration proposes to spend $28.1 billion in fiscal 2022.

Also included in enhanced planning is funding for multilateral aid programs, such as the Global Health Program managed by the U.S. Agency for International Development, rising from $1.45 billion to $3.5 billion, and contributions such as the International Development Corporation and the African Development Fund, to $3.1 billion. The announcement of the Biden Administration in March, to defend global food security and provide more than $1 billion in new funding towards humanitarian assistance for those affected by Russia’s war in Ukraine, over the coming months.”

The limited tools for addressing famine are too familiar to the legions of international disaster organizations addressing generations of turmoil in low- and middle-income countries. One of the leading ways to cauterize clinical manifestations of acute malnutrition is Ready-to-Use Therapeutic Food (RUTF). The hundreds of organizations involved in famine relief — Partners in Health, World Vision, Doctors Without Borders, UNICEF, the International Rescue Committee, Red Cross, and many others — are all at a crossroads in this cornucopia of catastrophe. And while a new generation of NGOs has helped during the current crisis, World Central Kitchen (WCK) has emerged as the leader in addressing famine in Ukraine. To date, WCK has delivered over 25 million meals, including increased kitchen response and presence during the conflict in Ukraine. Team Rubicon, an international disaster response organization also on the front lines of the crisis in Ukraine, is providing medical teams who will be amongst the first to encounter widespread SAM in Europe for the first time in decades.

The specter of the war in Europe on the nightly news echoes Dublin in 1847, Berlin in 1918 during the Blockage, and the Dutch Hunger Winter. The common denominator of all these war-related famines: civilians, and especially children, starve. Mothers starve while entire families are eviscerated by the lack of nutrition and accompanying disease. Aid often arrives too late to save the most vulnerable. With all its bloodshed and trauma, Ukraine’s conflict is unraveling what’s left of the fabric of global food security. Ukraine’s Ministry of Agriculture has indicated that 30% of the country’s farmland is occupied or unsafe. The war’s disruptions have led to surging prices and raised fears of food shortages in parts of the developing world. Before the Russian invasion, the country was responsible for 12% of global wheat exports, 16% of global corn exports, and 46% of global sunflower oil production. Economists are looking at the immediate numbers — countries like Indonesia, Bangladesh, and Egypt, which import significant amounts of wheat from Ukraine, are realizing stark realities about their food supplies. It will take years, even decades, for the commodities market to normalize.

Before the war in Ukraine, Congress had introduced the Global Malnutrition Prevention and Treatment Act (HR 4693) sponsored (S.2956/H.R.4693). The effort was led by Senator Christopher Coons (D-DE) and Representative Gregory Meeks (D-NY), Chair of the House Committee for Foreign Affairs, who had a long record of working with the United States International Development Agency (USAID) to support countries in addressing global famine.

A relatively new source of funding to incentivize the private sector to address gaps in the delivery and improvement of RUTFs and to develop other tools for treating and preventing malnutrition is the U.S. International Development Finance Corporation (DFC) — through Samantha Power, Administrator of the United States Agency for International Development (USAID) — which is increasing coverage for high impact, proven and affordable interventions. Those efforts include research on next-generation therapeutic foods to treat severe acute malnutrition (SAM), which is the leading cause of death of children worldwide, accounting for more than three million deaths annually. Child death from malnutrition and starvation are expected to increase exponentially in 2022.

RUTFs are essential public health commodities for resource-poor settings to clinically address multiple disease states exacerbated by the physiological effects of famine. In addition to RUTFs, Humanitarian Daily Rations (HDR) are a critical part of humanitarian nutrition to feed large populations of displaced persons or refugees under emergency conditions. A single HDR is designed to provide a full day’s sustenance to a moderately malnourished individual. Current supply chain and transport challenges further prohibit the distribution of HDRs.

Implications of global food insecurity for national defense posture at the time of writing this article:

• ETHIOPIA – 25.9 million estimated people in need of humanitarian assistance in Ethiopia, 844,589 estimated refugees in Ethiopia, 4.5 million acutely malnourished (source: USAID Fact Sheet https://www.usaid.gov/sites/default/files/documents/Ethiopia_Fact-Sheet_Nutrition_Oct-2020.pdf)

• UKRAINE – Ukraine has the second largest HIV epidemic in the region, with nearly 250,000 people living with HIV (PLHIV) – many of whom do not know their HIV status. As of July 2022, 12 million Ukrainians have been displaced, with five million going to neighboring countries and seven million people thought to be displaced within Ukraine (source: USAID Fact Sheet https://www.usaid.gov/ukraine/fact-sheets/health)

• AFGHANISTAN – 2.5 million Afghans displaced to different countries, 2.2 million Afghans are severely food insecure, with over 700,000 Afghans internally displaced (source: USAID Fact Sheet https://www.usaid.gov/sites/default/files/documents/1866/afghanistan_ce_fs04_09-30-2014.pdf)

RUTFs are part of the overarching approach to meeting the millennium development goals (MDGs) developed by the United Nations. A study by Verified Market Research in 2021 identified the worldwide revenues for RUTFs at $363.72 million in 2019 and growing to $807.89 million by 2027, expanding at a CAGR of 10.5% for the forecast period. According to the UN report on Implications of Ready to Use Therapeutic Food for Children in Low-Income Countries, “One thousand metric tons of RUTF treats approximately 76,500 children for about 3.6 million USD (based on an average price of $50 per 150-sachet carton at approximately 13.8 kg per carton).”

The most commonly recognized RUTF being distributed, Plumpy’Nut, a peanut-based paste for treatment of severe acute malnutrition by French company Nutriset, had set the standard for other commercially available products in the field before new generations of RUTFs began coming to market. MANA is a RUTF composed of peanut paste, milk, and a special mix of vitamins and minerals designed to meet a child’s basic nutritional needs and provide nutrition and calories. The third leading RUTF on the market was developed with funding from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and technical support from the Food and Nutrition Technical Assistance III Project (FANTA), the Institut de Recherche pour le Development (IRD), Vietnam’s National Institute of Nutrition (NIN), and UNICEF. This rice/soy/mung bean-based RUTF is produced in Vietnam and offered as an alternative to the peanut-based Plumpy’Nut. The product is known as “High-Energy Bar for Integrated Management of Acute Malnutrition” (HEBI). Another RUTF, BP100, manufactured by GC Reiber, is delivered as a biscuit that can be made into a porridge. It serves as a fortified food rehabilitation diet for the malnourished but with a higher energy density with a four-year lifespan.

SUSTAINN (Superior Utility Supplementation Therapeutic Agent for Indicated Nutritional Needs) is being developed by AREV Life Sciences, based in Vancouver. This initiative aims to demonstrate the delivery of measurable therapeutic effect in forthcoming inferiority/superiority studies through a unique next-generation RUTF composition. SUSTAINN is intended to treat inanition, the complex disease state that is currently the culprit in the deaths of nine million people worldwide annually, according to the international relief agency Mercy Corps; more than the death toll of AIDS, malaria, and tuberculosis combined. Inanition is clinically characterized by dysbiosis, environmental enteropathy, neurodegenerative disease, organ failure, scurvy, beriberi, Kwashiorkor, and anemia due to SAM.

Innovations in RUTFs have demonstrated significant clinical benefits. Supporting neurological growth and function through the provision of essential fatty acids (“EFA”) in SAM patients was studied in a randomized, triple-blinded, controlled clinical trial by Wiley and published in the British Journal of Nutrition. This trial demonstrated that DHA Omega-3 supplements boost cognition in malnourished Malawian children. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition.

Another initiative by Evolve BioSystems, in collaboration with the International Centre for Diarrheal Disease Research, Bangladesh, announced a study of Evivo® in infants recovering from SAM, an activated form of the beneficial bacteria Bifidobacterium to restore essential bacteria to the gut microbiome. The study conducted at Dhaka Hospital in Bangladesh of infants under six months diagnosed with SAM, as well as non-malnourished infants under six months of age who are hospitalized for infections, is supported by the Bill & Melinda Gates Foundation.

Since 2015 the global community has established specific measurements of improvement greatly needed in nutrition. The World Health Assembly, with 194 countries representing, committed to ending “all forms of malnutrition” by 2030 as part of the Sustainable Development Goals (SDGs). SDGs are a focus at the Global Nutrition for Growth (N4G) conference. As of December 2020, more than $3B in financial commitments were verified from various stakeholders, including the Government of Canada, Pakistan, World Vision International, and UNICEF. The World Bank Guidelines within the Codex Alimentarius addressed using RUTFs this past year. The Codex Committee on Nutrition and Foods for Special Dietary Uses agreed on a new guideline on RUTFs to serve as a reference for governments in best practices for treating childhood wasting. The Codex ensures that RUTFs are effective and enable recovery and growth of children with wasting.

Data presented in peer-reviewed publications demonstrate the limited clinical utility of current RUTF formulas. The data suggest these are more accurately categorized as Ready to Use Supplemental Foods (RUSFs) rather than RUTFs. Despite Community-Based Management of Acute Malnutrition (CMAM) being World Vision’s core project model in nutrition, it’s not without complications. CMAM is a methodology for treating SAM using a triage approach. Further driving the challenges facing access to RUTFs are aflatoxins, currently present in the primary peanut-based RUTFs on the market. The Global Action Plan on Child Wasting (GAP report), created November 2021 by UNICEF and commissioned by the UN Secretary-General, outlines a key priority to support efforts to prevent and reduce aflatoxin and other toxins in therapeutic foods.

The COVID-19 pandemic and the supply chain disruption would have been horrific enough to shake the fragile foundations of global food security. Afghanistan has experienced unprecedented famine; the siege of Tigray left numerous people starving to death and displaced; and Yemen has become a hole in the collective soul of the 21st century that may never heal. Not since World War II has Europe faced the kinds of brutality that are now part of our daily diet as if the war in Bosnia had not happened. The center cannot hold without more resources and bold action necessary to change the course of malnutrition and its comorbidities. RUTFs, along with every other tool in the international public health toolbox, are our best hope.

Special thanks to Sateesh Apte, MD, and Frank Moresca for contributing to this article.

This article originally appeared in healthhiv.org

There are about a dozen therapeutic vaccines for HIV in various stages of development. However, the puzzling fact is that there’s no measurable emphasis to support their development to get to market.

AIDS 2022 is taking place July 29^th to August 2^nd in Montreal after unprecedented efforts to establish universal COVID-19 therapeutic vaccination became the dominant paradigm for controlling our latest pandemic. Funding HIV vaccines — such as VaccC5, AELIX, IAVI G003, or any of the preclinical constructs in the literature — with same resources allocated for Operation Warp Speed could help bring the end to the AIDS crisis.

The different vaccine models have historically been studied for HIV prophylactic vaccines — given to uninfected, healthy people to prevent HIV infection — and therapeutic vaccines — intended for people already infected with HIV to boost their immune system to fight HIV infection.

HIV’s replication cycle, which causes its pathogenicity, has been studied for five decades. While the antibodies generated in response to the presence of HIV do not slow disease progression, therapeutic HIV vaccines produce HIV-specific cell-mediated immune responses that can control the virus after the interruption of antiretroviral treatment. They are being investigated as a treatment strategy approach designed to bring about a ‘functional cure’ to HIV – indefinite HIV suppression without antiretroviral treatment. Structured treatment interruptions (STI) in chronic unsuppressed HIV infection in adults represent one of the most compelling promises of HIV therapeutic vaccine research.

A growing number of HIV therapeutic vaccines have been part of human studies to boost pre-existing immune responses by using multiple constructs — such as direct-DNA and viral vectors containing HIV protein expressing genes with and without adjuvants, DC-based vaccines, or a combination of these. Therapeutic vaccines for HIV infection should aim to elicit anti-viral CD8 T cells (CTLs), CD4 T cells, and neutralizing antibodies since these immune responses work in concert to control viral replication.

Unfortunately, approaches tested to date have used a piecemeal approach, often targeting only a few regions of HIV. They have not produced a significant salubrious result, primarily because they mitigate HIV’s primary strength of evading a CTL mediated response by interfering with immune signaling.

Live-attenuated vaccines administer a controllable dose of the live vaccine to build immunity against it. This approach has successfully controlled smallpox, polio, and measles. Whole-killed or attenuated virus vaccines are weakened or killed by using one or more of either heat or chemicals (e.g. glutaraldehyde and gamma radiation) to eliminate replication. A therapeutic vaccine that uses live attenuated HIV as opposed to vectors, VLPs, or only a few of the HIV proteins is likely to be successful in generating a kind of response that would counter HIV.

The question at AIDS 2022 is whether the leadership of the National Institute of Allergy and Infectious Disease (NIAID) and other globally recognized research institutions have given up on therapeutic vaccines for HIV. Do none of these demonstrate enough scientific utility to justify further dedication of resources by the AIDS clinical trials groups, the military HIV Research Program and the HIV Research Collaboratories, or is the status quo of the current paradigm of treatment considered adequate?

Inside the Pipeline-A Background on Recent HIV Therapeutic Vaccine Studies at AIDS 2022
Therapeutic vaccines demonstrate the ability to induce specific immune responses with better viral control, as well as a limited ability to contain viral replication once antiretroviral therapy is interrupted.

In March 2021, AELIX Therapeutics reported a single-center trial of a three-drug therapeutic vaccine (AELIX-002). The therapy was given to patients within six months of HIV acquisition who had been virologically suppressed for a year or more, designating those patients as having been treated with an early start. The efficacy of the AELIX-002 results was considered a step forward by the International AIDS Society (IAS), and considered “…an exciting step forward to HIV cure research” by IAS President Adeeba Kamarulzaman.

In May 2021, ImmunityBio set out to enroll 46 participants for a Phase I “HIV Cure Study” (A5386). With sponsorship from NIAID and the AIDS Clinical Trials Group (ACTG), this study is assessing the safety, level of acceptance, and efficacy of the Anktiva plus anti-HIV vaccine, featuring IL-15 superagonist N-803, in neutralizing antibodies. Thus far, the vaccine’s Anktiva molecule’s “kick and kill” approach induced viral transcription in CD4+T cells, while strongly activating CD8+ effector memory T cells and NK cells emitting them to viral reservoirs.

Immunity Bio’s Phase 2 study, reducing HIV persistence in lymph nodes by IL-15 receptor super-agonist (N-803) in acute HIV infection, is designed to test immunostimulatory effects of Anktiva administration in May of 2021. The study was conducted by the Walter Reed Army Institute of Research’s U.S. Military HIV Research Program (MHRP) at the Thai Red Cross AIDS Research Centre in Bangkok.

Bionor Holding, AS is currently in Phase II trials of its therapeutic vaccine Vacc-4x. It is a vaccine comprising of four synthetic proteins resembling HIV’s Gag proteins. This vaccine has shown encouraging results in Phase I and Phase II trials being conducted specifically to assist for structured therapeutic interruptions.

In March 2022, Moderna, with Excision BioTherpeutics, reached a breakthrough in HIV therapy, testing a second mRNA HIV therapeutic vaccine, MRNA-1574.The vaccine is designed to target HIV envelope trimers through mRNA rather than using broad antibodies. The trial took place collaboratively between Moderna and the National Institutes of Health (NIH), which at the time was in partnership with the Division of AIDS. The expected outcome, built on research by William Schief, Ph.D. at Scripps University is that B-cell response will evolve into more broad and efficient neutralizing antibodies over time.

In March 2018, NIAID, in collaboration with Auro Vaccines LLC, posted the combination antiretroviral therapy (cART) clinical trial. cART trial results indicated sustained reduction in viral replication, while also making it clear that cART cannot completely eradicate HIV in tissue compartments on its own. As a result, continued research is underway to develop strategies to eliminate persistent viral reservoirs, while boosting host immunity to control viral replication once cART is discontinued. With those additional elements, therapeutic HIV vaccines could augment immunologic control of HIV infection.

In May 2022, the clinical trial for the therapeutic HIV vaccine IAVI G003 took place, led by a collaboration known as the Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) program comprised of IAVI-ADAVANCE Partner Clinical Research Center (CRC) Network and Moderna. This Phase 1 trial was executed in Rwanda and South Africa to evaluate the mRNA HIV vaccine antigen. The trial built on the progress from Phase I clinical trial in the U.S. of IAVI G001, which demonstrated that vaccination with the HIV immunogen eOD-GT86omer (recombinant protein) safely induced the targeted immune responses in 97% of healthy adults in the study. The process created an induction of broadly neutralizing antibodies (bnAbs), objectively the first-step of establishing an efficacious HIV vaccine.

Funding for this trial was provided through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), United States Agency for International Development (USAID), with additional support provided by the Bill and Melinda Gates Foundation through grants to Moderna and the Collaboration for AIDS Vaccine Discovery (CAVD) Vaccine Immunology Statistical Center (VISC).

Counting the Dollars: NIH NIAID HVTN Funding and L’institute Pasteur’s Investment

In August 2021, the NIH announced it was being awarded $53 million annually from L’Institut Pasteur, over the next five years, to find a cure for HIV. This initiative expands a 2016 initiative, increasing funding by 75% and the number institutions supported from six to ten annually.

The Activists in the Corner: IAVI, AVAC, and TAG

Advocacy leaders like Seth Berkley, at IAVI; Mitch Warren, Executive Director at The AIDS Vaccine Advocacy Coalition; and Mark Harrington, of Treatment Action Group haven’t been at the forefront of therapeutic vaccine development, despite the potential of this research to radically change the course of the AIDS crisis. It would be a legitimate question to ask whether the powers that be will now emphasize therapeutic vaccines, considering the lack of results with prophylactic vaccines and ongoing issues related to neurological side effects and drug resistance that can occur with antiretroviral treatment. IAVI has developed partnerships in 25 countries with a staff of more than 200, yet AmFAR’s initiatives to advance the cure agenda has yet to focusing on HIV remission studies using therapeutic vaccines to facilitate strategic therapeutic interruptions. Both IAVI and AVAC played a critical role in forming The Global AIDS Vaccine Initiative, which brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry in both industrialized and developing countries, research and technical agencies, civil society organizations, the Bill and Melinda Gates Foundation, and other private philanthropists. (No specific data on HIV-specific research or outcomes.)

We’ve seen tens of billions generated by the development of the COVID-19 therapeutic vaccines rushed into commercial development and facilitated by public funds in response to the pandemic. Would a therapeutic vaccine for HIV be any less rewarding financially to investors, to the governments supporting the Global Fund, PEPFAR, and other international health commodity procurement programs? Science writer Jon Cohen’s book Shots in the Dark, The Wayward Search for an AIDS Vaccine, demonstrates how directed, organized, goal-oriented research barely exists for new paradigms in the HIV therapeutic vaccine arena.

Without a robust, bold effort to secure a new initiative in the AIDS Clinical Trials Groups and the HIV Vaccine Trials Network for therapeutic vaccines, the race for remission studies may slow to a crawl at AIDS 2022.

Special thanks and recognition to David Miller and Frank Maresca for their considerable contributions to this article.

This article originally appeared in healthhiv.org

“Let’s be honest,” I said early this morning on my first call to one of my collaborators. “There’s not a solitary person heading to Montreal this July who’s not absolutely convinced all hell is coming at us at AIDS 2022.” We’re dealing with the most significant European HIV diaspora in the history of the epidemic, compounded by the intersections of COVID-19, the war that’s consuming the European illusion of stability, and the subsequent famines, all conspiring to undermine the hard-won gains that antiretroviral therapy and the evolution of programs taking precision aim at key populations affected, infected and disproportionately representative of the disparities driving new infections.

COVID-19 and the war in Europe will be at the forefront of AIDS 2022. I’d been at far too many conferences over the past three decades to take anything for granted. However, the fact that thousands of people from around the world are still coming to Montreal to present and discuss advances in AIDS research and treatment leaves me awestruck — even while the dimensions of my carry on defy my best efforts to not be left facing the inevitable horror that international travel has become.

Before the war, Ukraine was the epicenter of HIV in Europe. Today, Ukraine still has one of the highest rates of HIV in the world. With the war continuing and millions of refugees fleeing Ukraine to be housed in refugee camps where disease is spreading, the co-intersections of COVID-19 and AIDS as a result of this war mean severe increases in HIV in Eastern Europe. Add food insecurity to that horror — meaning refugees are not getting proper nutrition — and we have a devastating scenario at hand.

In sub-Saharan Africa, where the burden of HIV disease is also greatest, a consistent rise in food insecurity has left an estimated 258 million people facing famine, with an additional 605 million moderately or severely food insecure. The Intergovernmental Panel on Climate Change recently issued a report highlighting how climate change is already adversely affecting food security regarding food availability, access, and nutrition.

Every program that has served as a cornerstone of the global response to the AIDS crisis is being challenged. PEPFAR, The Global Fund for AIDS, Tuberculosis, and Malaria, and even the Ryan White CARE Act all face unprecedented pressure to maintain programs, innovate, and increase their reach while competing for resources against an unprecedented number of spending initiatives. Meanwhile, the integration of food security interventions into HIV treatment programs is essential to curtail the HIV epidemic and improve the health and quality of life of those infected.

It’s in the interest of people with AIDS and in the interest of the greater good to shift some of our attention to the global famine at AIDS 2022, preserving the UN Sustainable Development Goals (SDGs) of ending hunger by addressing the data demonstrating that antiretroviral therapy is being undermined by the malnutrition that’s at the forefront in the Sahel region — as well as the South Bronx.

Food security is now at the forefront of the lives of people with HIV as food prices have risen 12.6%, exacerbating global hunger. In contrast, Russia has weaponized global food supply chains. Conflict always goes hand in hand with food insecurity. Still, the supply, and frankly the contemporary composition of Humanitarian Daily Rations, currently deployed by the Defense Logistics Agency and the NATO Support and Procurement Agency (NSPA), have limited utility in the war in Ukraine. They are predictably inadequate to address the explosive patient populations now becoming refugees because of Russian shellfire, regional conflicts, climate change, and global inflation.

Next-generation enteral formulas and Ready to Use Therapeutic Foods to treat Serious Acute Malnutrition (SAM) are somehow making their way to market, despite the supply chain crisis. New enteral formulas like ACERT, ENU, and Peptide 1.5 are demonstrating superior clinical efficacy to past interventions to guard against involuntary weight loss by delivering nutrition that encourages immune reconstitution, sparing patients’ further exacerbation of cardiovascular disease and insulin intolerance-non-communicable diseases that HIV key populations are already at high risk for. As food prices continue to rise, previous studies on managing HIV nutrition enteral formulas will be critical. Studies have shown that food insecurity — a significant barrier to ART adherence and retention associated with adverse clinical outcomes, including incomplete HIV RNA suppression, CD4 declines — increased opportunistic infections, hospitalizations, and mortality.

Innovations
As stated in a 2014 paper written by the Food and Nutrition Technical Assistance III Project (with support from the Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health, and USAID), “weight loss and malnutrition are associated with HIV, and low body mass index at diagnosis of HIV infection significantly increases the risk of mortality. Chronic weight loss occurs in around 20 percent of patients with HIV, and severe weight loss is one of the strongest indicators associated with morbidity and reduced survival, even with antiretroviral therapy. Evidence has shown that macronutrient supplementation positively affects weight gain and adherence to medication in people living with HIV.” Eight years later, this remains a life-threatening issue globally.

Further evidence that proper base nutrition supplementation given to patient populations can reduce or eliminate malnutrition — and result in healthy weight gain — is provided by a clinical study conducted by the Plant-Based Enteral Formula (PBEF) pioneering company, Kate Farms.

The study, Weight Gain in Oncology Patients using a Plant-Based Oral Nutrition Supplement, included thirteen cancer patients. Of the thirteen patients, nine had at least one follow-up assessment from a dietitian after adding PBEF to their nutrition regimen. Of the nine, all either gained or maintained weight. Six gained, and four showed an increase in BMI. Of those with documented weight gain, the average was 3.5 kilograms. Of those with a documented increase in BMI, the average was 1.53 points over an average of 3.5 months. The nine patients received an average of 44.6% of their daily calories from PBEF. One of the nine was on PBEF for a 12-month period and experienced a 9.09-kilogram weight gain and a 2.8-point increase in BMI during this time. Significantly, nutritional status changed from “severely malnourished” to “no clinical signs of malnutrition.”

Conclusion: Weight maintenance, weight gain, and tolerance using a plant-based enteral formula were demonstrated in this small cohort of adult oncology patients.

Since medical treatment can be interrupted when patients experience significant weight loss, dehydration, or clinical malnourishment, the results of this study have important ramifications. Without proper supplementation, these patients would have continued to decline nutritionally. [The small sample size is a limitation to this study and supports the need for a larger trial.]

One immediate reform activists are hoping for is greater recognition and support of HIV nutrition among the American Society for Nutrition & ASPEN with the HIV Medical Association, IAPAC, The American Academy of HIV Medicine, and the IAS.

AIDS 2022 is going to be pulled in a dozen directions, between monkeypox, COVID-19, the advance of long-acting antiretrovirals, the Ukraine HIV+ refugee diaspora, the continued pursuit of a cure in the HIV Research Collaboratories, the AIDS Clinical Trials Groups, the Military HIV Research Program (MHRP), and other publicly sponsored research programs. We’re going to be awash in new data. The 24^th International AIDS Conference in Montreal this July is going to be the location where we affirm the resilience of the science and advocacy that’s characterized the AIDS crisis by demanding more advances, more improvements to HAART, more access to treatment… and for millions of people with HIV and their families, demands for more calories and more micronutrients as T-cell counts are going to be proportionate to access to clinical nutrition. Global food security becomes a dominant predictor of our continued collective community’s survival.

This article originally appeared in healthhiv.org

When thousands of scientists, activists, policymakers, healthcare workers, and people living with HIV/AIDS (PLWHA) gather in Rio de Janeiro this July for AIDS 2026, the 26th International AIDS Conference, they will do so against the backdrop of one of the most uncertain periods in the modern history of the HIV response.

The conference theme—Rethink. Rebuild. Rise.—captures a growing concern shared by researchers and advocates worldwide: progress against HIV is no longer guaranteed. Funding pressures, political polarization, healthcare inequities, and threats to public health infrastructure are forcing governments and communities to confront difficult questions about the future of prevention, treatment, and care.

The global HIV movement spent four decades transforming what was once a near-certain death sentence into a manageable chronic condition for millions. Yet the benefits of scientific progress remain unevenly distributed. As delegates arrive in Rio, the central question will not be whether the science exists to end the epidemic, but whether political systems are willing to deliver that science equitably.

One of the most pressing concerns heading into the conference is the growing instability of HIV funding worldwide.

Advocates and public health leaders have raised alarms about reductions in HIV program funding and uncertainty surrounding future commitments from major donors. These concerns are especially acute in low- and middle-income countries where treatment programs often depend on a combination of domestic spending and international assistance.

The consequences are not theoretical. Interruptions in prevention services, testing programs, outreach efforts, and medication access can quickly reverse years of progress. HIV remains a disease deeply tied to social determinants of health, meaning that cuts to housing support, mental health services, transportation assistance, and community-based care often have a direct impact on treatment outcomes.

Beyond concerns about treatment access and prevention programs,researchers at AIDS 2026 will be focused on a less visible but equally consequential issue: the future of HIV research itself.

Recent reductions and proposed constraints on federal biomedical research funding have raised alarms throughout the HIV scientific community. Funding pressures affecting the National Institutes of Health (NIH), which has long served as the cornerstone of HIV research in the United States and a major driver of global HIV scientific progress.

For decades, NIH investigators produced the breakthroughs that transformed HIV from a fatal disease into a manageable chronic condition. These investments have supportedl ART drug development and viral load monitoring to advances in prevention,vaccine research, and cure strategies.

Researchers warned funding instability threatens both basic science and clinical research infrastructure. Basic HIV research often requires years of sustained investment before practical applications emerge. Discoveries involving viral replication, immune function, viral reservoirs, and drug resistance have formed the foundation of modern HIV treatment.

Among the most significant concerns is the future of the AIDS Clinical Trials Group (ACTG), one of the world’s premier HIV clinical research networks. For nearly four decades, ACTG investigators have conducted many of the landmark studies that established today’s standards of HIV care. The network has been instrumental in evaluating new therapies, optimizing treatment strategies, addressing HIV-associated comorbidities, and improving care for women, children, and the aged with PLWHA..

Scientists argue that weakening support for networks such as ACTG could slow innovation precisely when new opportunities are emerging. Long-acting injectable therapies, broadly neutralizing antibodies, HIV cure research, and next-generation prevention technologies all depend upon robust clinical trial infrastructure and sustained federal investment.

The implications extend beyond HIV. The research platforms developed through decades of HIV funding have repeatedly been leveraged to address other infectious disease threats, including COVID-19, mpox, tuberculosis, hpv, syphilis, and emerging pathogens. Many experts view HIV research funding not simply as an investment in one disease, but as a cornerstone of the broader biomedical research ecosystem

The history of HIV has always been inseparable from questions of human rights and social justice. From the earliest years of the epidemic, marginalized communities carried a disproportionate burden of infection while simultaneously facing discrimination, stigma, and inadequate access to healthcare. Those inequities persist today.

Globally, gay and bisexual men, transgender individuals, sex workers, people who use drugs, incarcerated populations, veterans, migrants, and racial and ethnic minorities continue to experience higher rates of HIV infection and barriers to care. In many countries, criminalization and discriminatory policies discourage people from seeking testing or treatment.

Advocates attending the conference are expected to emphasize that ending HIV requires more than biomedical innovation. It requires dismantling structural barriers that prevent people from accessing care in the first place.

Housing instability, food insecurity, poverty, and lack of insurance coverage remain powerful predictors of HIV outcomes. Even the most effective medications cannot achieve their full impact when patients are unable to maintain stable housing, obtain transportation, or access culturally competent healthcare.

Although the conference is international in scope, domestic policy debates in the United States are likely to receive significant attention.

For PLWHA in the US, Medicaid is the nation’s most important source of healthcare. Medicaid finances physician visits, laboratory monitoring, mental health services, prescription drugs, and supportive services that help patients remain engaged in care. Among the most consequential is the ongoing discussion surrounding Medicaideligibility formulas, enrollment requirements, or funding mechanisms.Even modest barriers to enrollment can lead to treatment interruptions, delayed diagnoses, and reduced access to preventive services.

Beyond PLWHA. Medicaid also supports access to pre-exposure prophylaxis (PrEP), one of the most effective HIV prevention tools available. Consistent PrEP access requires regular physician visits, laboratory testing, and prescription coverage. Reductions in coverage could disproportionately affect low-income communities already facing elevated HIV risk.

Access to ARV’s is also affected. ARV’s have transformed life expectancy and quality of life for millions, but uninterrupted access remains essential. Coverage disruptions can lead to viral rebound, increased transmission risk, and the emergence of drug resistance.

Although the conference is international in scope, domestic policy debates in the United States are also likely to receive significant attention.

For the approximately 1.2 million Americans living with HIV, Medicaid remains one of the nation’s most important sources of healthcare coverage. Medicaid finances physician visits, laboratory monitoring, mental health services, prescription drugs, and supportive services that help patients remain engaged in care. Proposed changes involving Medicaid eligibility formulas, enrollment requirements, or funding mechanisms have generated concern among HIV advocates, who note that even modest barriers to enrollment can lead to treatment interruptions, delayed diagnoses, and reduced access to preventive services.

Beyond people living with HIV, Medicaid also supports access to pre-exposure prophylaxis (PrEP), one of the most effective HIV prevention tools available. Consistent PrEP access requires regular physician visits, laboratory testing, and prescription coverage. Reductions in coverage could disproportionately affect low-income communities already facing elevated HIV risk.

Advocates are also closely monitoring the future of the Ryan White HIV/AIDS Program, which serves as the nation’s safety net for people living with HIV who are uninsured or underinsured. Established in 1990, the program currently receives approximately $2.6 billion in federal funding and provides medical care, medications, case management, and support services to more than half of Americans diagnosed with HIV each year. Ryan White-funded programs frequently work alongside Medicaid and local healthcare providers to help patients remain engaged in treatment and achieve viral suppression.

While no specific reductions have been enacted, public health organizations warn that broader efforts to reduce domestic discretionary spending could place Ryan White funding under pressure. Depending on the scope of future federal budget reductions, cuts ranging from 5% to 20% could translate into losses of roughly $130 million to more than $500 million annually. Advocates argue that reductions of that magnitude could weaken AIDS Drug Assistance Programs (ADAP), medical case management, and support services that help vulnerable patients remain connected to care.

Access to antiretroviral therapy (ART) is similarly dependent on stable healthcare coverage. ART has transformed life expectancy and quality of life for millions, but uninterrupted access remains essential. Coverage disruptions can lead to viral rebound, increased transmission risk, and the emergence of drug-resistant virus. As policymakers debate healthcare spending priorities, advocates are expected to emphasize that maintaining continuous access to treatment remains one of the most cost-effective and successful public health interventions ever developed.

Despite the policy concerns dominating headlines, AIDS 2026 will also highlight remarkable scientific achievements.

Another current federal policy changes include rescheduling of medical cannabis in the US which has renewed conversations about cannabis access for PLWHA. While medical cannabis is not a treatment for HIV itself, some patients use cannabis-based products to help manage chronic pain, nausea, appetite loss, sleep disturbances, and anxiety.

Advocates argue that rescheduling will facilitate rigorous research and create a more consistent regulatory framework for evaluating therapeutic uses. For many patients living with chronic illness, the issue is less about politics than about access to evidence-based options that may improve quality of life.

Despite the policy concerns dominating headlines, AIDS 2026 will also highlight remarkable scientific achievements.

Long-acting injectable therapies continue to reshape HIV treatment and prevention. Researchers are advancing studies involving broadly neutralizing antibodies andnext-generation prevention tools, vaccine candidates, and potential cure strategies.

Yet conference participants are likely to return repeatedly to a familiar lesson: scientific breakthroughs matter only when people can access them. The gap between discovery and delivery remains one of the defining challenges of global health.

The choice of Rio de Janeiro as host city is resonating in the public health sector

Brazil has long been recognized as a global leader in HIV policy, particularly for its commitment to broad access to ART. Its public health system has frequently been cited as an example of how political commitment can expand access even in resource-constrained settings.

Hosting the conference in Brazil highlights the growing importance of perspectives from the Global South. HIV advocates argue that contemporary HIV challenges must increasingly emerge from communities directly affected by the epidemic rather than being dictated solely by wealthier nations.

Every major breakthrough in prevention, treatment, and care emerged because scientists, activists, patients, and communities refused to accept the status quo. AIDS 2026 arrives at a moment when innovation is once again required.

The challenge facing the global HIV movement is not merely scientific. It is political, economic, and moral. Clinicians possess tools capable of dramatically reducing new infections. What remains uncertain is whether governments and institutions will commit the resources necessary to ensure those tools reach everyone who needs them.

As delegates gather in Rio, they will confront a question that has echoed throughout the history of the epidemic: who gets access to care, and when?

The answer will shape not only the future of HIV policy but also the broader global conversation about health equity, human rights, and social justice in the years ahead.

About the Authors

Robert Antonacci, M.D. is a physician, healthcare executive, and public health advocate whose work focuses on healthcare innovation, population health, and improving access to care. He has written extensively on health policy, infectious diseases, and strategies to advance equitable healthcare delivery in the United States and globally.

David A. Miller is an AIDS treatment activist and journalist focused on HIV aging, coinfections, emerging therapies, and policy issues affecting people living with HIV (PLWH). He is the former Co-Chair of the Cornell AIDS Clinical Trials Group Community Advisory Board and has served as Co-Chair of the New York City HIV Planning Council Community Advocacy Group. Miller has also served on the Board of the AIDS Institute and the Bronx HIV CARE Network. A veteran of ACT UP New York, his work emphasizes the intersection of science, access to care, and quality of life for PLWH. He is a member of the International AIDS Society, the American Public Health Association, the International Association of Providers of AIDS Care, the National Minority AIDS Council, the HIV Medicine Association, and the American College of Epidemiology.

Felipe Recalde is a global health advocate and communications strategist whose work centers on health equity, international healthcare policy, patient engagement, and expanding access to evidence-based healthcare. His writing and advocacy focus on strengthening healthcare systems and advancing equitable health outcomes worldwide.

By David Miller and Noreen Griffin.

At IAS 2017 in Paris last July, delivering treatment, medicines, and other HIV-related services to the most vulnerable patient populations in resource-poor, distressed, and unstable nations should have been a matter of urgency. But there were no declarations, no condemnations, and no calls for immediate action.

More than a decade ago, Venezuela was lauded for its treatment program. Now, more than a decade into its political and economic crisis, Venezuela’s oil revenues account for 95% of the country’s export earnings and the precipitous decline in oil prices has helped plunge Venezuela ever deeper into crisis. The corrupt and increasingly dictatorial regime of President Nicolás Maduro Moros, has only accelerated the country’s decline.

Venezuela’s economic crisis is a tragic example of impact of domestic instability on the testing, treatment, and care of people living with HIV and on the worsening global HIV pandemic. Venezuela’s entire healthcare system is critically short of medication, including life-saving anti-HIV drugs. Despite pleas for immediate assistance from the Global Fund to Fight AIDS, Tuberculosis and Malaria, no measurable degree of help has arrived. The World Bank continues to classify Venezuela as a high-income nation and the Global Fund “is not in a position to grant any exceptions from its rules,” according to its Executive Director Mark Dybul and Norbert Hauser.

An estimated 110,000 people in 2015 were living with HIV in Venezuela, and at least 63,000 of them had started antiretroviral (ARV) treatment, says Feliciano Reyna Ganteaume, whose Caracas-based nonprofit Acción Solidaria supplies HIV-infected people with ARVs. “[The situation] is much worse than one can describe,” he says. “When the government does take action, drug orders are placed late and not paid for on time, causing interruptions that have lasted more than months… There is not even 1 month without our receiving complaints of lack of one or more ARVs from one or more Venezuelan states,” he says. In addition, reagents for the tests needed to monitor people on treatment are in short supply.

Economic instability has greatly affected basic HIV treatment and care for people living with HIV in Venezuela. Diagnostics such as CD4 and drug resistance testing have become all but non-existent and stocks experience a lack of resupply, lasting a month or two, approximately every two to three months. Basic laboratory services and drugs such as antibiotics have become unavailable. HIV testing for mothers and ARVs to prevent mother to child transmission are in inadequate supply, resulting in late-stage diagnosis and contributing to an increased rate of mother to child transmission. Maria Eugenia Landaeta, the chief of infectious disease at the teaching hospital who oversees the HIV program for 5,600 patients, reports that a small group of AIDS physicians has been scrambling to hold it together for years. “The HIV and TB programs were the last to deteriorate,” she said. “We have tried to defend the program in all possible ways.” (https://www.theglobeandmail.com/news/world/in-venezuela-a-once-leading-aids-program-lies-inruins/article35417359/)

At IAS 2017, while the refugee crisis in Europe was a key issue of reference, with numerous posters and presentations featuring the challenges of internally displaced persons, the Venezuelan crisis went virtually unmentioned, despite the knowledge that tens of thousands were going without life-saving medications. The Venezuelan Society of Infectious Diseases (SIV) issued a statement back in November of 2016 announcing that supplies of key drugs used for the treatment of HIV were dangerously low and in danger of stock-out. These drug shortages mean that there are currently no treatment options considered first-rate under international guidelines. “The shortage of antiretroviral drugs and reagents makes it impossible to control the HIV/AIDS epidemic in the country, making it difficult to control the transmission of the virus from the mother to her children and in the general population,” Maritza Landaeta, a senior member of SIV, said. “We are seeing a collapse in the public health system. Venezuela is witnessing a miracle, a miracle of destruction.”

Vulnerabilities continue to mount for displaced persons, who are increasingly exposed to the social drivers of HIV, Hep C, and co-infections. In addition, instability in countries throughout Africa and South America also contributes to an unsteady state of universal access to HIV testing and treatment which drive the continued spread of HIV.

We have learned the hard way the consequences of complacency in the response to global pandemics. The epidemiological dimensions of Venezuela’s current descent into chaos should concern all researchers, activists, and policy makers in the Americas. HIV and its co-morbidities thrive on poverty, instability, and displacement. Several presentations at IAS 2017 focused on the impact of specific instabilities and policies on the treatment and care of its citizens, in particular, at-risk populations such as refugees, migrants and asylum seekers.

One study found a wide range of disparities negatively affecting access to testing and treatment of key at risk and populations. The disparities centered mainly on migrants, asylum seekers, and refugees. The study resulted in a website called “Barring the Way To Health” (https://www.gnpplus.net/our-solutions/barring-the-way-to-health/)

Another study at IAS 2017 analyzed a pilot program initiated by Medecins Sans Frontiere in rural areas of Yambio South, Sudan, to test the feasibility of providing HIV testing and counselling and ARV initiation in regions of chronic conflict. Five mobile teams offered testing and counselling and same day ART initiation to those who tested positive and data over a 17- month period was analyzed. Counseling sessions were provided which included instructions on what to do during times of active conflict including a constituency plan that provided access to ‘go bags’ containing a three-month supply of ARVs. During the study, there were several episodes of instability where the contingency plan was activated.

Results of this study found that levels of ARV retention (86% at 6 months and 81% at 12 months) and viral load suppression (85% below 1000 copies) were comparable to clinic settings. Throughout the study, 13,872 people were tested for HIV, of which 442 (3.2%) tested positive. Of the 442 positive individuals, 344 (77.8%) were started on ART.

A third study assessed the feasibility of providing home-based HIV testing in sub- Saharan refugee camps. Visits were made to 319 homes that reported a total of 566 individuals living in the homes, during a one- month period of time in the Nakivale Refugee Settlement. During a total of three visits per home, researchers were able to reach 507 individuals in 292 homes. Of these, 378 (75%) agreed to be home-tested and received their results. There were 7 (1.9%) individuals who tested positive for HIV. Researchers found that people were more likely to agree to be tested if there were others present. The authors concluded that home-based HIV testing is feasible in refugee camp settings.

There is robust data demonstrating that effective service delivery can be conducted for large HIV patient populations struggling in distressed economic and political circumstances. Global Fund’s ban on HIV-related assistance to ostensibly high-income countries is contributing to several regions of risk. The policy has previously led to cuts in HIV/AIDS funding to several Eastern European countries, a move heavily criticized by advocates in those countries. As international assistance for HIV/AIDS has steadily dropped over the past few years, the Global Fund has pushed harder on governments to foot their own bills. The unfolding crisis in Venezuela, and its dire implications for the diagnosis, treatment, and prevention of HIV, should shake the complacency of the Global Fund and other international aid organizations. In an ever more global community, Venezuela’s humanitarian crisis will not long stay Venezuela’s alone. We will help ease Venezuela’s pain, or we will eventually feel it ourselves.

This article originally appeared in Panaware panaware.wordpress.com/

The International AIDS Society (IAS) held the world’s largest scientific gathering on HIV science in Paris, France this year, a country where 37% of patients with AIDS have evidence of toxoplasmic encephalitis.

Toxo has been reported as the most common opportunistic infection in HIV/AIDS in developed countries and the most common cause of focal brain lesions, coma and death. It commonly causes encephalitis in HIV-postive patients and increases the risk of HIV Associated Neurological Disorders (HAND) by 60%.

HAND is becoming increasingly prevalent as Anti-Retroviral Therapy (ART) allows HIV patients to live longer lives. Several poster sessions at IAS 2017 discussed the issue of HAND.

Ei Kinai from the National Center for Global Health and Medicine in Tokyo, Japan presented on The Impact of Age and Time of Disease on HAND. The study concluded that, “Older patients are more likely to have neurocognitive decline at early stages of HIV infections.” It is also known that the prevalence of Toxo increases with age, an aspect that was not addressed in the study.

Galia Manuelle Aurora Santos from Lausanne University Hospital Center in Lausanne, Switzerland presented on the link between depressive symptoms and HAND. This study suggests that addressing depressive symptoms, especially in HIV positive-women, might potentially improve the neurocognitive outcome of HIV-positive patients. Toxo has been linked to depression in numerous studies.Vincent Senecal of the Centre de Recherche du CHU de Quebec, Centre de Recherche en Infectiologie, Quebec, Canada shed light on HAND pathogenesis by studying the interactions of HIV with the anti-inflammatory chemokine, fractalkine (FKN). The results indicated that HIV reduced FKN receptor expression in microglia/macrophages which could have important implications in chronic inflammation and immune activation for HAND. It has been found in separate studies that Toxo also down-regulates FKN after 24 hours of infection.

HAND continues to be a major concern in HIV patients and the connection between HAND and toxo is an understudied issue that may help to better understand and potentially treat HAND. New studies to determine if toxo has a causative effect contributing to neurocognitive decline in people living with HIV are essential.

Toxo infects approximately 1.1 million people each year in the United States. The global prevalence is estimated between 2 and 3 billion and there is no cure. Acute infection in the immune compromised is often deadly if not aggressively treated with Pyrimethamine (Daraprim). In 2014, the CDC designated Toxo a Neglected Parasitic Infection (NPI), targeting it for public health action based on the number of people infected and the severity of the disease. Less than a year later, Martin Shkreli, then CEO of Turing Pharmaceuticals, acquired the rights to Daraprim and raised the price of the now 64 year old drug 5000%, a notorious move that increased an annual prescription to $634,500 for patients weighing more than 60 kilograms (132 pounds).

Without an available cure and considering the unfavorable treatment options at hand, our only immediate hope to alleviate the burden of toxo is to prevent human exposure to the offending pathogen causing the initial disease.

Toxo can only complete its life cycle and produce infectious spores on cat feces. Most people and animals become infected by unknowingly ingesting or inhaling these spores which makes cleaning a cat’s litter box a high-risk activity, particularly to those who are immune- compromised. Simple precautions should be taken that can eliminate the risk of toxo infection.

Toxo is also transmitted by consuming the raw or rare meat of previously infected animals and is a leading cause of death from foodborne illness in the United States. The general public is warned of toxo risk by the mandated menu advisory, “Consuming raw or undercooked meats, poultry, seafood, shellfish, eggs or unpasteurized milk may increase your risk of foodborne illness,” But public awareness on how to prevent toxo infections is otherwise extremely limited.

With more than one third of the U.S population sharing their homes with pet cats, the responsibility to provide the warnings and resources necessary to protect the general public from the burdens of toxo and create a safer environment for both humans and cats, should be a high priority of our public health d healthcare systems.

viable solutions to reducing the risk of toxo are essential. One such alternative to using masks and gloves when changing kitty litter is a self-contained cat waste disposal system (created by Toxoplasmosis Solutions, an enterprise of BetterBox) which allows cat owners to safely contain and dispose of domestic cat waste without exposing themselves or their environment to toxo’s infectious spores. Additional tools that the public can utilize including public service announcements on how to properly handle and prepare raw meet, are needed.

Toxo’s life cycle is dependent on cat waste contaminating the environment of its future hosts. Considering that the majority of cats in the U.S. are domesticated and living in human homes, mechanically blocking the life cycle of this devastating disease by implementing responsible cat waste disposal procedures is an effective option.

Legislators in the U.S. need to be encouraged to develop a national toxoplasmosis bill supporting the additional research, education, prevention, and treatment efforts. The latest scientific findings regarding “latent” toxo along with the compelling epidemiology to inform legislators, public health officials, and health insurance providers that an investment towards designing public awareness has great potential to reduce healthcare costs and disease burden in the United States and globally.

This article originally appeared in panaware.wordpress.com

By David Miller and Chad S. Johnson Esq

Many AIDS 2017 attendees in Paris were disappointed by the neglect of a timely, critical focus on the HIV challenges in Venezuela caused by the abject failure of governance, human rights, and the rule of law in Caracas. With the country falling apart and people unable to obtain essential HIV medications and basic medical supplies, the lack of a concerted effort to address this urgent human tragedy at AIDS 2017 seemed like an astounding failure by the most powerful stakeholders in the epidemic. However, an equally pressing dynamic has existed for years without mainstream media coverage in many countries in Eastern Europe and Central Asia (EECA). While not making the daily headlines, the EECA region has the highest new HIV infection rate in the world at 57% between 2010 and 2015 according to AVERT, a statistic highlighted at the AIDS 2017 teaser session on the upcoming 22^nd International AIDS Conference in Amsterdam, Netherlands underway during the next days in July 2018 (AIDS 2018).

The AIDS 2017 session emphasized that one of Amsterdam’s top five objectives is to change the dynamic in the EECA where governments, institutions, orthodox religions, society, law enforcement and criminality, and international organizations fail vulnerable populations. Session participants noted that this EECA problem was on the agenda during the 19^th IAC in Vienna in 2010, a conference now deemed a failure in this regard. Leading up to AIDS 2010, the WHO reported that the epidemic in Eastern Europe “… can be ascribed to government intransigence, public ignorance and the criminalization of risky behaviors, compounded by poverty, social exclusion and political and economic turmoil.” These conditions have not significantly changed in Eastern Europe and continued to be mirrored in Central Asia.

Consequently, AIDS 2018 Local Co-Chair Dr. Peter Reiss of Amsterdam and International Co-Chair Dr. Linda Gail-Bekker of Cape Town, South Africa, committed to shine a spotlight on people left behind in the international response to the AIDS epidemic and to prompt a vigorous discussion about the reasons that the EECA region is an outlier in the progress seen around the world. The theme of AIDS 2018, “Breaking Barriers, Building Bridges,” speaks to some of the unique contributing factors beyond unsafe sexual practices, including language, culture, lack of human rights and freedom of information, and “relative” prosperity (and with it, non-qualification for various international assistance programs for middle-income nations). Additional factors on the rise in the EECA region include IV drug use in countries disapproving of needle-exchange programs, migration of female sex workers who are shamed into the shadows by conservative societies, and the refugee crisis and its health consequence.

The organizer of the session, the Dutch Ministry of Foreign Affairs, represented by Mr. Lambert Grijus, the Dutch Ambassador for Sexual and Reproductive Health & Rights and HIV/AIDS, articulated rights- and community-based approaches to more effectively reach key populations in the EECA region, along with putting mechanisms in place to hold politicians accountable in regional and international diplomatic settings for shortcomings in HIV-related awareness, funding and policy. Dr. Michel Kazatchkine, former Director of the Global Fund and currently the UN Secretary-General Special Envoy on HIV/AIDS in Eastern Europe and Central Asia, also underscored the importance of aggressive work with top-level politicians as key to breaking the log jam in the region. Unless governments acknowledge and take ownership of the growing HIV problem, outside efforts will continue to fail. In some EECA nations, leaders are in denial that HIV/AIDS even exist in their countries – typifying the difficulties that stand between an increasing epidemic and effective solutions.

On top of government inaction and denial, several avenues of international support are not available as policy enticements since median incomes disqualify funding and assistant for many EECA countries – incomes that are by no means truly prosperous. Traditional and orthodox populations in rights-limited societies add to the slow demand for and pace of change. Communication and the free flow of HIV-related information are limited, and a lack of historical commitment to Russian language-based prevention and treatment programs is recognized as a problem for much of the EECA region.

The eastern view from Amsterdam is gloomy but there are glimmers of light. AIDS 2018 will lead to critical analysis of potential solutions for the epidemic in the EECA. Having hit the ground running on this 19^th Day of July, 2018, we hope for an effective conference. If the welcome provided at Amsterdam’s Schiphol Airport to conference participants is any sign, maybe this IAC will come closer to meeting its goals than previous conferences. The response to this epidemic is constrained by resources and shaped by priorities, funding and discrimination and always will be. It is disappointing, for example, that there are no sessions on the impact of HIV on war veterans around the world who suffer disproportionately. The IAS community does not even recognize HIV veterans as a key population group for study and focus. While different, this is reminiscent of AIDS 2017’s lack of programmatic flexibility and basic resolve to act on the dire circumstances in Venezuela, discussed above, when we assembled in Paris.

AIDS 2018 in Amsterdam has an opportunity for real success. The next week will test us all, and we remain cautiously hopeful.

This article originally appeared in

David Miller

It’s been more than a decade since, in 2007, a German oncologist named Dr. Gero Hütter performed a risky surgical procedure on a willing patient with both HIV and leukaemia that would result in the first and only person to date cured of HIV. In the years since, the details of the procedure have been well documented, publicized, and scrutinized, leaving little doubt that Timothy Ray Brown (formerly known as the “Berlin Patient”) has indeed been cured of HIV (and leukaemia).

Although successful, Timothy Ray Brown’s treatment may provide proof of concept but not a functional way to generalize the cure to a widespread population of people living with HIV. It remains unclear whether Brown’s cure methodology could be replicated at all, given similar circumstances and unlimited funds. To date, it sadly has not.

The procedure is relatively simple to understand. The immune system is destroyed by using chemotherapy and radiation, killing the HIV, and the cancer along with it. Blood cord cells (transplanted bone marrow cells) from a compatible donor are then used to rebuild the immune system. In Brown’s case, these cells were donated by a man with a genetic mutation that confers resistance to HIV, as the mutation of the CCR5 “doorway” that HIV typically uses to enter and infect a cell is physically incompatible with the virus.

This procedure is not without risk; one in every five people who undergo a regular blood cord transplant do not survive. Brown received his HIV cure because his leukaemia was life threatening, necessitating radical intervention. Dr. Hütter struck upon the idea of using stem cells resistant to HIV, as well as matched for blood-type, for the transplant

It is astounding that more than a decade after the successful cure of one person, it has neither been replicated nor inspired a precise medical breakthrough for curing other people infected, if not hundreds, thousands, or millions. Brown continues to live as the only person granted a new and hopeful future. He has become iconic as a symbol of hope in this pandemic.

With thousands of clinicians, scientists, researchers, doctors, bureaucrats, and activists working hard to advance an HIV cure strategy, will AIDS 2018 go down in history as a turning point in the struggle for the cure? We can only hope. Timothy Ray Brown often speaks of feeling lonely as the singular cured person; many would love to stand with him – and give him company.

This article originally appeared in PanAware

By Roberto Antonacci, M.D., Alexandra Bridget Perkins M.D., Felipe Recalde, Frank Maresca, and David Miller

Antiretroviral therapy (ART) is transforming HIV from a fatal diagnosis into a chronic, manageable condition. Millions of people living with HIV/AIDS (PLWHA’s) are surviving into older age. By 2030, 65% of PLWHA will be 50 years or older. But this success comes with an urgent challenge- frailty.

As the global HIV community prepares to gather for AIDS 2026 this July, discussions about long-term survivorship are evolving beyond viral suppression alone. The April/May 2026 edition of POZ addressed the growing burden of frailty among older PLWHA, emphasizing that frailty is not a geriatric abstraction but a measurable driver of disability, healthcare costs, and declining quality of life.

Frailty is defined by diminished physiologic function, reduced resilience, exhaustion, loss of muscle mass, weight loss, and increased vulnerability. In HIV-positive populations, frailty often develops earlier and appears even in individuals whose viral loads are fully suppressed. This reality represents an important unanswered question in HIV medicine: how to prevent frailty in people with HIV/AIDS.

HIV frailty research is inseparable from international funding stability. Public health experts and global HIV advocates have criticized efforts to reduce U.S. contributions to international health programs, including the Global Fund for AIDS, TB and Malaria and foreign aid infrastructure, warning that instability in the Global South threatens continuity of HIV treatment in regions carrying disproportionate HIV burdens.

The Biology of Accelerated Aging:

For decades, HIV has been characterized by immune dysfunction and devastation.Today, the HIV treatment cascade is more complex. Despite antiretroviral therapy effectively suppressing viral replication, chronic immune activation and systemic inflammation persist. Research established that persistent inflammation results in accelerated aging.

The Women’s Interagency HIV Study and the HIV Veterans Aging Cohort Study Index show that frailty does not exist in isolation. It occurs with depression, multimorbidity, pain, cognitive vulnerability, and social instability. Research shows frailty among PLWHA being intertwined with malnutrition, cognitive impairment, polypharmacy, and geriatric syndromes that HIV clinics were not originally designed to detect.

PLWHA’s experience cardiovascular disease, osteoporosis, sarcopenia, cognitive decline, metabolic disorders, polypharmacy complications, and mobility impairment, leading to frailty years earlier than expected.

Several mechanisms are contributing to frailty including chronic immune activation despite viral suppression. persistent viral reservoirs in tissues, coexisting infections, metabolic dysfunction, excessive viscera fat accumulation and chronic inflammation. Social determinants of health, including isolation, poverty, stigma, food insecurity, and housing instability, also play a role. HIV frailty is not accelerated chronological aging: it’s biologically distinct, socially mediated, and often multidimensional.

From Survival to Function: HIV at AIDS 2026

HIV medicine has historically been focused on viral suppression, prevention of opportunistic infections, and immune recovery. Now, clinicians and activists are focusing on preserving function mobility, cognition, independence, metabolic health, and quality of life. Frailty is not a biological fate; It’s a warning sign.

Frailty research suggests that functional decline in HIV is dynamic rather than inevitable. Investigators with the NIH’s AIDS Clinical Trials Group (ACTG) reported that frailty fluctuates over time. Emerging studies such as Improving Physical Ability and Cellular Senescence Elimination in HIV (IPACE-HIV 2026), an ACTG phase 2 study, explored whether senolytic approaches improve frailty-related outcomes in PLWHA’s aged 50 and older.

“For decades we measured success in HIV almost exclusively through virologic suppression,” said Dr. Linda-Gail Bekker, former President of the International AIDS Society. “But viral suppression alone is no longer enough. The next generation of HIV care must address how people age, function, move, think, and live over time. Frailty is rapidly emerging as one of the defining challenges of long-term survivorship.”

Researchers are exploring senolytic therapies to interrupt inflammatory and degenerative pathways associated with HIV frailty. Recent studies identified senolytic therapies to eliminate senescent cells, which accumulate with chronic inflammation and contribute to organ dysfunction, immune dysregulation, frailty, and multimorbidity. PLWHA’s exhibits persistent immune activation and accelerated biological aging, increasing the burden of cellular senescence even in the setting of long-term viral suppression. Early studies of dasatinib and quercetin are examining whether senolytics improve physical function, inflammation, mitochondrial health, and markers of biological aging in PLWHA.

While the science is still early, the concept represents a transformative shift in HIV treatment: moving beyond viral control toward interventions targeting accelerated aging to preserve healthspan, mobility, cognition, and resilience.

Metformin, HIV, and the Search for Geroprotection

Metformin has become one of the most closely watched drugs in aging research because of its effects on metabolism, inflammation, insulin signaling, mitochondrial function, and cellular nutrient-sensing pathways. Studies have examined whether metformin can affect HIV reservoirs and systemic inflammation and influences monocyte epigenetic aging and immune pathways in virologically suppressed PLWHA, Metformin’s effects on immune activation and biological aging in PLWHA’s. Research has examined metformin’s effects on epigenetic age in people with well-controlled HIV, reflecting a broader effort to evaluate whether an inexpensive and familiar medication has geroprotective effects.

GLP-1 Drugs, HIV, Metabolism and Muscle

GLP-1 receptor agonists, including semaglutide, have opened another area of HIV aging research. These drugs are already transforming obesity, diabetes, cardiovascular risk, sleep apnea, and fatty liver disease care. For HIV patients, their relevance extends to lipohypertrophy, visceral adiposity, metabolic dysfunction-associated steatotic liver disease (MASLD), cardiovascular risk, chronic inflammation, oncogenicity, and frailty.

Recent analyses show that semaglutide improves metabolic parameters and reduces inflammatory markers in PLWHA. A randomized placebo-controlled trial reported reductions in markers of inflammation and immune activation, findings directly relevant to the biology of frailty.

Yet GLP-1 therapy also raises a frailty-specific caution. Weight loss can involve not only fat loss but also lean muscle loss. The ACTG reporting on SLIM LIVER noted that muscle volume decreased with weight loss. That nuance matters. For PLWHA demonstrating frailty, the goal must be metabolically healthy weight management that preserves strength, mobility, and function. GLP-1 drugs may become quintessential in HIV care, but in patients at risk for frailty nutrition, resistance exercise, functional monitoring, and careful attention to involuntary muscle loss has to be emphasized.

Cannabis and HIV Frailty

Cannabis is attracting attention from clinicians for treating frailty, after the recent federal rescheduling of medical cannabis by the Trump Administration. More than 60% of HIV patients reportedly use cannabis to address chronic pain, neuropathy, appetite loss, insomnia, anxiety, and nausea, which intersect with frailty and declining quality of life. Research has shown that cannabinoids influence inflammation, immune activation, and symptom burden.

Rescheduling has expanded research opportunities previously limited by regulatory barriers. But significant obstacles remain. Access to medical cannabis remains inconsistent nationwide, insurance coverage is generally nonexistent, and out-of-pocket costs are substantial for patients already burdened by chronic illness

The REPRIEVE trial...a phase 3 trial of 7,769 PLWHA’s receiving ART with low-to-moderate cardiovascular risk randomized participants to pitavastatin,showed that pitavastatin significantly reduced major cardiovascular events and modified inflammatory pathways preserving long-term function.

The implications extend beyond cardiology. PLWHA have elevated cardiovascular risk because immune hyperactivation, metabolic changes, and vascular injury are not captured by conventional models. REPRIEVE validated that HIV-associated chronic inflammation has clinical consequences.

Recent follow-up analyses continue to examine how pitavastatin’s benefits relate to lipid lowering and other pathways. A 2026 Lancet HIV analysis reported that REPRIEVE found a 36% reduction in adverse cardiovascular events with pitavastatin in HIV patients.

“The biology of chronic inflammation connects many conditions we are now seeing in aging people with HIV,” noted Dr. Steven Deeks of the University of California San Francisco. “Cardiovascular disease, frailty, sarcopenia, cognitive decline, and metabolic dysfunction are not isolated problems. They are interconnected manifestations of persistent immune dysregulation that we are only beginning to fully understand.”

Developing Early Clinical Recognition of Frailty

Frailty is still underrecognized and HIV guidelines continues to emphasize laboratory values- viral load, CD4 counts, and resistance profiles,markers that remain critically important, but fail to capture declining functional status. Routine frailty screening in HIV clinics remains inconsistent despite mounting evidence supporting its evaluation.

And these shifts will require significant funding. AIDS treatment activists are demanding biomarkers for HIV-associated frailty because the lack of uniform clinical endpoints is slowing progress across studies. AIDS 2026 is a platform to begin establishing consensus frameworks that guide international research.

At the same time, NIH funding cuts and political attacks on federally supported biomedical research threaten progress in HIV frailty research precisely when HIV frailty studies require expanded investment. Critics of the Trump administration’s public health agenda warn that cuts to HIV-related research infrastructure, prevention programs and grant funding are undermining long-term advances including frailty research among PLWHA’s.

Nutrition also remains a critically underappreciated component of HIV frailty management. Frailty is frequently accompanied by sarcopenia, unintentional weight loss, protein-calorie malnutrition, gastrointestinal disorders, and reduced oral intake, particularly among long-term survivors with multiple comorbidities. Enteral nutritional formulas have become increasingly important tools in HIV aging care to help preserve lean body mass and support physical resilience in patients at risk for functional decline.

But barriers remain significant. Reimbursement policies vary widely, and patients face substantial out-of-pocket costs for medically necessary nutritional support. As HIV populations age, frailty prevention strategies are beginning to include nutrition science alongside pharmacology, rehabilitation, and social support interventions.

Getting HIV frailty into Ryan White CARE Act during the Trump Administration

In the U.S. and Europe, more than half of PLWHA are now older than 50, a demographic shift reshaping the epidemic. Reviews of frailty in PLWHA’s emphasize that antiretroviral therapy has created a new clinical landscape in which geriatric syndromes must become part of routine HIV care.

Without proactive intervention, healthcare costs will continue to rise while disability rates increase and demands for long-term care expand. Existing health disparities worsen among key populations — Black and Latino communities, veterans, rural populations, women aging with HIV, and long-term survivors who have already endured decades of clinical and social adversity.

The Ryan White CARE Act (RWCA) and The End the Epidemic initiatives determine much of the U.S. response to HIV frailty. Designed during an era when HIV care centered primarily on survival, medication access, and treatment infrastructure, the RWCA now faces an aging HIV-positive population with increasingly complex medical, nutritional, functional, and psychosocial needs.

The future of HIV frailty research is increasingly vulnerable to political hostility toward federal biomedical research. The Trump administration repeatedly proposed cuts to NIH budgets, weakened public health infrastructure, and fostered a political climate that many researchers viewed as openly dismissive of scientific expertise. Those concerns have intensified with the growing influence of figures such as HHS Secretary Robert F. Kennedy Jr., whose long history of vaccine skepticism and promotion of medical misinformation has alarmed HIV researchers and infectious disease specialists. Activists warn that public health agencies are undermining decades of progress in HIV science precisely when frailty research requires sustained long-term investment.

Researchers are also worried that the leadership associated with NIH Director Jay Bhattacharya, whose emphasis on reducing what he describes as institutional orthodoxy within public health agencies has generated anxiety among HIV advocates about the future stability of federally funded prevention, frailty and disparities research. Scientists working in HIV and gerontology fear that ideological battles over public health priorities is inhibiting critical work on frailty biomarkers, inflammation, and interventions targeting long-term survivorship. The era of mass demonstrations by ACT UP in Bethesda at the sprawling campus of the NIH and the FDA in Rockville, demanding critical research and accelerating drug development are long gone…this fight is destined for the auditoriums in Rio this July.

These changes are unfolding amid renewed uncertainty surrounding federal HIV policy. During the Trump administration, efforts to weaken the Affordable Care Act, reduce Medicaid spending, and shrink federal health programs policies HIV advocates consider

threats to the healthcare safety net supporting PLWHA’s, arguing that the administration treats public health funding as politically expendable despite the disproportionate impact such cuts have on HIV patients, vulnerable populations and rural communities.

The policies of Robert Kennedy at DHHS further intensified fears among HIV organizations that evidence-based public health policy have become subordinated to ideological agendas and distrust of scientific institutions. For PLWHA’s already facing housing insecurity, nutritional instability, and complex chronic illness, instability in federal HIV policy carries potentially devastating consequences

Long-term survivors are now confronting sarcopenia, cognitive decline, mobility impairment, polypharmacy, social isolation, food insecurity, and housing instability simultaneously. Ryan White programs have excelled at coordinating HIV treatment access and supportive services, but frailty requires expanded integration of geriatric medicine, rehabilitation services, nutritional support, mental health care, transportation assistance, homecare, and multidisciplinary functional assessments.

HIV frailty is a healthcare infrastructure issue, demanding public health reimbursement policy and influencing the quality of life of aging PLWHA. RWCA transformed HIV in the U.S. from a fatal disease into a manageable chronic condition over four decades. Addressing HIV frailty i ensures long-term survivors are able to age with dignity, mobility, support, and functional independence. Without prioritization, frailty research remains fragmented across geriatrics, oncology, infectious disease, endocrinology, cardiology, rehabilitation medicine, and behavioral health.

HIV Frailty: A New Priority for Ending the Epidemic:

Managing HIV frailty effectively requires interdisciplinary collaboration among infectious disease specialists, geriatricians, physical therapists, nutritionists, neurologists, mental health professionals, rehabilitation experts, pharmacists, and social workers. HIV care systems proved extraordinarily effective at responding to opportunistic infections and viral management.

The research on metformin, GLP-1 receptor agonists, pitavastatin, senolytics, inflammation, epigenetic aging, and HIV reservoirs demonstrates that frailty may be approached from multiple angles. Interventions targeting metabolism, inflammation, cardiovascular risk, cellular aging, and muscle preservation are emerging.

The increasingly nationalist and anti-institutional approach to global public health under Trump-aligned leadership — amplified by Kennedy’s skepticism toward international health initiatives and Bhattacharya’s critiques of federal scientific institutions — is weakening international HIV collaboration at the very moment HIV frailty complications are becoming a universal concern while HIV researchers argue that frailty research requires greater international coordination, not political retrenchment or reduced investment in global public health systems.

HIV Frailty at AIDS 2026

“We are entering an era where preserving healthspan may become just as important as extending lifespan,” said Jules Levin, founder of the National AIDS Treatment Advocacy Project. “The HIV community must aggressively pursue research into frailty, nutrition, muscle preservation, cognition, inflammation, and aging biology. Otherwise we risk creating a generation of long-term survivors who are living longer but struggling with preventable disability and loss of independence.”

HIV-related frailty is not inevitable. It is measurable, modifiable, and increasingly treatable. At AIDS 2026 activists and clinicians hope the next era of HIV medicine will not be defined solely by suppressing the virus but toward the active development of multicenter studies, prevention frameworks, therapeutic trials, functional outcome measures, and implementation strategies to facilitate

Frailty is becoming the most neglected story at AIDS 2026, at the very moment when this evolution converges around a unified goal: extending both lifespan and healthspan for PLWHA’s. AIDS 2026 is an opportunity — and arguably an obligation — to help lead that transformation and elevate HIV frailty research from an emerging subspecialty concern to a central pillar of HIV agendas

About the Authors

Roberto Antonacci, M.D. is a Board Certified Radiation Oncologist, a member of the International AIDS Society and VOCAL-NY, an HIV advocate, and a recognized public health leader whose work has focused on advancing care models, social justice prevention strategies, and long-term survivorship for PLWHA. Dr. Antonacci is the Co-Chair of the New York Medical Cannabis Industry Association (MCIA) and a member of VOCAL NY, The NY Public Health Association and the International AIDS Society.

Alexandra B. Perkins, M.D. is a physician with dual Board Certification in Diagnostic Radiology and Integrative Medicine. She is an experienced clinical leader in women’s health, population based screening, and development and implementation of integrative therapeutic protocols to address chronic complex disease.

Felipe Recalde is a global health advocate whose work centers on health equity, international healthcare policy, patient engagement, and expanding access to evidence-based healthcare. His writing and advocacy focus on strengthening healthcare systems and advancing equitable health outcomes worldwide.

Frank Maresca is a board member of Health People, a leading AIDS Service Organization in the Bronx, NY and a longtime AIDS advocate, focused on the economic dynamics of contemporary health disparities.

David Miller is an AIDS treatment activist and journalist focused on HIV aging, coinfections, emerging therapies, and policy issues affecting PLWH. He is the former Co-Chair of the Cornell AIDS Clinical Trials Group Community Advisory Board and has served as the Co-Chair of the New York City HIV Planning Council Community Advocacy Group. David has served on the Board of the AIDS Institute and the Bronx HIV CARE Network. A veteran of ACT UP New York, his work emphasizes the intersection of science, access to care, and quality of life for PLWH.He is a member of the International AIDS Society, the American Public Health Association, The International Association of providers in AIDS Care, The National Minority AIDS Coalition, The HIV Medicine Association, the American College of Epidemiology,

An HIV preventative vaccine is making its way through the clinical trial system with a new study beginning enrollment later this year. Mosaico is the latest in a string of primate and then human studies stretching over the past fifteen years, testing vaccine candidate Ad26.Mos4.HIV. The Phase III clinical trial will evaluate the Janssen Pharmaceutical vaccine in men who have sex with men (MSMs) and transgender women and men. Mosaico is a collaboration between Janssen, the NIH, the HVTN and the U.S. HIV Military Research Program (MHRP.)

“We’re very excited because it’s an exciting product that has been extensively tested in earlier-stage trials. People appear to not only develop a strong immune response but a lasting immune response, which is important in a vaccine,” stated Dr. Susan Buchbinder, MD, Protocol Chair of the Mosaico Trial and Director of Bridge HIV at the San Francisco Department of Public Health.

Mosaico (HPX3002/HVTN 706) will be enrolling 3,800 transgender individuals and men who have sex with men at fifty-five sites throughout the United States, Latin America, and Europe. In the U.S., twenty-two sites throughout sixteen cities will enroll HIV negative, at risk participants. Sites in Argentina, Brazil, Italy, Mexico, Peru, Poland and Spain will also participate in the study.

Mosaico is the largest clinical trial to date evaluating the promising “Mosaic’” vaccine candidate, that, if successful, will be able to be used globally against all strains of HIV. This is due to its genetic inserts, which contain various HIV strains. Producing an effective vaccine that would maintain protection against the numerous strains of HIV found around the world has been a major challenge in vaccine research and development. The establishment of one vaccine that can be used in every population and against all clades of HIV is essential to the eventual eradication of HIV.

According to Dr. Buchbinder, the vaccine used is “designed to be a global vaccine. It takes information from multiples clades around the world. If effective, we hope people could be protected against multiple strains of HIV so we don’t need to recreate a vaccine for each region of the world.”

Mosaico is a complementary study to Imbokodo, a separate clinical trial of a near identical vaccine which has already completed enrollment.

The one difference between the vaccines being studied is that, in the Mosaico trial, a mosaic insert is added to the third and fourth injections (four total injections) and for Imbokodo a Clade C insert is used. Clade B is included in this mosaic insert, and is the prominent clade of HIV seen in North America and Europe. Clade C is the most common strain in Southern Africa. As well as examining different regions, the two studies will examine the vaccine in different populations of people.

Studies have shown that men and women can elicit different immune responses to a vaccine. When asked if a vaccine might behave differently in transgender people on hormone therapy, Dr. Buchbinder stated that this is why they are testing it specifically in transgender men and women because they don’t know how the hormones some transgender people take will affect their immune response.

A 2019 systematic review and meta-analysis published in the American Journal of Public Health found that an estimated 14% of all transgender women are living with HIV and 44% of black/African American transgender women are currently living with HIV. The CDC recognizes transgender men and women as being at a high risk for HIV. Many transgender individuals experience stigma, social rejection, workplace discrimination, difficulty obtaining employment and social isolation. This can contribute to risky behaviors and prevent them from fully integrating into society, building healthy support systems and accessing HIV testing and medical care.

Imbokodo enrolled 2,600 sexually-active women ages eighteen through thirty-five from five African countries (South Africa, Malawi, Mozambique, Zambia, and Zimbabwe). These countries were chosen due to the extremely high risk of HIV in young women. In the regions being studied there are 3,500 new HIV infections per week in young girls and women. In South Africa, the hardest hit area of Southern Africa, although HIV rates are very high in men who have sex with men at 26.8% and a rate reported in transgender women to be double that of MSMs; young cisgender women are at an even higher risk. Young cisgender women between the ages of fifteen and twenty-four alone, make up 37% of new infections. The large Phase II clinical trial is expected to be completed in 2021.

Results from Mosaico are expected in 2023, with researchers hoping to achieve at least a 65% protective rate against HIV. Stay tuned….

Originally published in Destination: Cure, A&U Magazine — https://aumag.org/2019/10/21/mosaico-trial-testing-hiv-preventative-vaccine/

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Originally published on PanAware on Wordpress.com on November 1, 2019. By Jeannie Wraight.

Large multi-colored pharmaceutical posters line the hallways like soldiers while federal researchers proclaim the second coming of one drug as a cure “to End the Epidemic” as hundreds flock to grab free samples – not of the drugs – but a variety of knickknacks and expensive to print and colorful marketing materials that use the language of the old civil rights movement and proclaim “sensitivity” to diverse communities.

Welcome to the new age of AIDS and HIV community “activism” where big pharma tries to by access to non-profit executives and big government sponsors the research. This is now a time when researchers tell a story about how “effective” the drugs are in the short run without mentioning the possibility – or probability – of co-morbidities like heart disease, stroke, gut problems and more – particularly in African American and Latino communities in the longer run.

Doesn’t this sound like a much bigger version of the “Tuskegee Experiment, “officially known in research circles as “The Tuskegee Experiment of Syphilis in the Negro Male.” This kind of language has not been entirely lost and may sound somewhat familiar to those who peruse the current research involving African Americans and HIV. The Tuskegee Experiment began in 1932 when 399 African American men who had latent syphilis were all given placebos though penicillin was available. Public health researchers wanted to track the course of the disease and its consequences. Not until 40 years later was this story revealed by a conscientious Associated Press reporter. Of course the disease, the times and therapeutics are different but are the intentions and the greed that different?

The real intentions of big government and its collusion with big pharma was in evidence at the conference. This columnist was verbally assaulted by a researcher during a session of the 19th USCA and told to “step out of the room I am from the South Chicago” – for what seemed like a prelude to a physical confrontation – when I asked a question about the long term effects of a certain drug treatment and the consequences of big pharma and big government funding research, marketing that research and packaging the idea that one therapeutics was a major part of ending the epidemic without any consequences whatsoever.

There is a massive marketing assault on the community by big pharma and big government. These non-profit leaders provide large forums at USCA to tell their story of “Ending the Epidemic” by taking their drugs alleging their safety.

This is NOT an attack on the current crop of antiretroviral therapies. They work and keep people alive. No one should stop taking them. They are what is available right now and they are essential to keeping people alive. However, there are serious complications associated with ARVs that are quietly swept under the rug so people don’t demand better. You can sit in scientific and research meetings and listen to Big Pharma presenting itself as a caring, sensitive protector of the lives of those with HIV and AIDS. Believe that all you want. But the truth is that there are seriously downplaying the side effects and long-term effects of ARVs.

Who can you trust? Turn out the lights, the parties over if individuals in the HIV/ AIDS community and those at risk don’t learn the science of the disease, how to really protect themselves and how not to take easier “solutions” marketed to them in collusion between Big Government and Big Pharma. What happened to research on condom use, microbicide research and using next generation therapeutics? This funding has been set aside largely for a concentration on one drug package that a big pharma brochure proclaims is “Standing Side-By-Side with the HIV Community.” Objective research needs to be performed on the effects of PrEP on the HIV-negative population.

The Old Guard like Act Up knew the truth. They paid for it with their lives. Big Pharma and Big Government stood side by side as thousands died in the early days of the disease. Unfortunately few of the old guard remain – those who became treatment activists and learned the science of drug development have largely died out. Their ranks have dwindled from disease, isolation or disgust thrust aside by the collusion between big pharma and big government. Their victory in May 1990 at Storm the NIH largely forgotten. For those too young to remember, ACT UP chapters from across the country occupied the National Institutes of Health (NIH) to demand AIDS drug treatments. And they succeeded, but paid for their success in blood.

What’s left is similar to the Tuskegee Experiment. Sure there is a difference. Drugs are being used instead of placebos in a package called “Ending the Epidemic.” But the point is that those poor black farmers who were experimented on during the Tuskegee Experiment died over the years when a better treatment was available that could have prevented adverse and deadly effects and that is the point. Now however, we are talking about thousands of HIV positive people in diverse communities. Is their a parallel here? If not, Big Pharma and Big Government should be willing to engage in real discussions and meaningful plans with the diverse communities that have been the targets of their drugs. Especially when it comes to PrEP.

There was a ray of hope at USCA 2019. In a loud, but serious demonstration of community dissension with the Big Pharma and the Federal government’s collusion to expand a drug treatment with possibly lethal long range effects, demonstrators took over stage at the Opening Plenary of 19th USCA to question the Director of Centers for Disease Control and Prevention “misleading” description of the presidential plan to end the HIV epidemic. The demonstrators took over the stage from Joy Reid, an MSNBC news host, to chants of “You cannot end the epidemic without us.” Reid did not know how right she was when she introduced the plenary session by saying, “We are here at a very important point in history.”

More than a dozen demonstrators took over the stage and continued the chants. “All progress has been by in HIV by activism and now we demand our seat at the table,” said one demonstrator on stage. “We demand immediate involvement in the negotiations” with pharma another said. Still another demonstrators called for an end to racism in the collusion between Big Pharma and the Trump Administration’s HIV and AIDS drug plan. Another said, “We cannot end this epidemic while your Administration continues to put people in concentration camps,” referring to the Trump Administration’s jailing of Latino immigrants and their children attempt to cross the U.S. and Mexico border. A group of the demonstrators left with a member of the Administration for a private meeting. We don’t know what the results will be, if any.

The demonstrators pointed out that the CDC could have prevented the spread of HIV, but did not because of the use of the lethal version of the drug packaged as “Ending the Epidemic.” The Federal government hold s the patents on a number of the therapeutics including one that is the foundation for the treatment now being touted as “Ending the Epidemic.” The HIV/ AIDS communities may be oblivious to history. But that history has echoes here in the present. The fact that there was a safer drug available at the very same time the more damaging drug was marketed shows that the Tuskegee experiment remains template for the present. This time though, all of the HIV and AIDS community regardless of race or gender definitions are the poor, southern black farmers left to die on the alter of Big Pharma and Big Government. Isn’t it time for HIV organizations to actively intervene so that a new generation of HIV drugs can really “End the Epidemic”?

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Originally published on PanAware on Wordpress.com on September 12, 2019. By Jeannie Wraight (column by Rick Blake, Washington-based Columnist).

In order to keep their virus suppressed, most people living with HIV must take antiretrovirals (ARVs) daily. If ARVs are stopped, an increase in viral load to detectable levels is usually seen after three to four weeks. However, a small group of HIV-positive people are able to discontinue therapy without viral rebound for an extended period of time. These people are referred to as post-treatment controllers.

At one time, HIV antiretroviral therapy consisted of many pills taken several times a day. Despite a massive reduction in the number of pills, current HIV regimens—even one-pill-a-day regimens—can be difficult to maintain on a daily basis due to side effects, co-morbidities, high cost, stigma and/or difficulty remembering to take one’s pill(s). Also for some, having to take ARVs every day is a constant reminder that they’re living with HIV and makes adherence more difficult.

Researchers are developing ARVs that can be taken less often then the daily medications that people living with HIV currently must contend with. Long-acting ARVs are in development and they may allow for weekly or even monthly injections in lieu of daily dosing.

In addition to long-acting ARVs, researchers are also looking at a small group of individuals with HIV who are able to maintain an undetectable viral load after discontinuing therapy. Post-treatment controllers may offer clues to develop strategies and new drugs that could help others to better control HIV and allow for less frequent use of ARVs.

Descriptions vary, but one definition of post-treatment controllers is those who are able to maintain viral loads of 400 or fewer copies per milliliter of blood for at least twenty-four weeks after stopping HIV therapy. An exact percentage of people who are able to control their virus is unknown, but researchers estimate the number to be between five and fifteen percent of people living with HIV. However, as most people on ARVs don’t interrupt their therapy, it is difficult to know exactly who or how many actually belong to this group.

Post-treatment controllers are different from “HIV controllers” who are able to maintain undetectable viral loads without ARVs. Less than one percent of people living with HIV are thought to be HIV controllers.

There are several well known cases of post-treatment control. Most notably, the VISCONTI cohort. VISCONTI stands for Viro-Immunologic Sustained Control After Treatment Interruption. The VISCONTI cohort was a group of fourteen Italian people living with HIV who began ARVs within ten weeks of HIV infection. They remained on ARVs for a minimum of three years and, after discontinuing treatment, were able to suppress HIV to undectable levels for an average of seven and a half years.

The “French teenager” is another well documented case. The girl was born with HIV and received prophylactic ARVs shortly after birth (though the exact time frame is unclear). She remained on treatment for six years. At the time of the most recent report in 2016, she had remained off therapy with an undectable viral load for twelve years.

Very early treatment after HIV infection as in the VISCONTI cohort and the French teenager is thought to possibly limit the establishment of viral reservoirs . However, a very small handful of cases differ greatly from the others in as they were positive for some time before initiating antiretroviral therapy.

In 2011 a (then) fifty-one year old Argentinian woman was reported to have discontinued ARVs in 2007 after eleven years of treatment. In addition to having started ART a substantial period of time after HIV infection, the Argentinian woman had been defined as having AIDS before she began taking ARVs. In fact, she was quite sick before initiating therapy, unlike nearly all other cases of post-treatment controllers who began ARVs very early on after their initial infection with HIV.

A study in 2018 described three individuals who were also considered “chronically infected” and were able to control their virus after stopping ARVs. It’s unclear whether the Argentinian woman is among the three people studied.

As it’s now standard of care to begin ART immediately following diagnosis and remain on treatment indefinitely, how would we be able to tell who is a post–treatment controller? One study published last year examined post-treatment controllers in hopes of determining characteristics that may help to identify who may belong to this group. They found that post-treatment controllers had smaller viral reservoirs and that reservoir size may be a useful biomarker in determining who may be a post-treatment controller.

More studies on post-treatment controllers could help to establish if a person needs to be on lifelong ARVs or if they belong to the small group of people living with HIV who are able to stop HIV treatment and remain undectable. Further studies could potentially also offer clues for the development of drugs and strategies to help others maintain temporary viral suppression after discontinuing ART.

Originally published in Destination: Cure, A&U Magazine — https://aumag.org/2019/07/31/post-treatment-controllers-hiv-treatment/

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Originally published on PanAware on Wordpress.com on August 22, 2019. By Jeannie Wraight.

The Trump Administration is considering issuing an Executive Order “to prioritize the funding, facilitation, development and commercialization of therapies focused on HIV/AIDS comorbidities for the U.S. HIV population that experience insulin intolerance, stroke, heart, disease, inflammation, diarrhea, gastrointestinal intestinal diseases. diarrhea and other HIV comorbidities.” This aims to be a part of the Administration’s effort to end the epidemic by 2030. There have been similar legislative proposals in the U.S. House of Representatives. Can there be a meeting of the minds?

Fifteen to 30 percent of U.S. HIV patients currently experience one or more comorbidities. Currently, People Living with HIV and AIDS (PLWHA) have higher co-morbidity rates that HIV-negative people. People living with HIV on Medicaid generally have more health problems than those with commercial health coverage. In addition, nearly half of people living with HIV in the US are age 50 or older and are more susceptible to HIV comorbidities that lead to sub-optimal immune responses.

As more live due to ARV therapies, an aging HIV population are beginning to die from conditions other than those that are HIV-related. Antiretroviral therapy (ARV) has for a generation prolonged the lives of U.S. citizens infected by the HIV retrovirus. While ARVs prolongs the life of those infected, it does not fully restore health. Long-term patients on ARVs remain at higher risk for a wide range of comorbidities. In addition, scientific studies have attributed ARV-associated diarrhea and other comorbidities as drivers of non-adherence to ARV therapies, thus lessening their effectiveness. Addressing chronic inflammation in HIV is particularly critical because inflammation is strongly associated with the development of morbidity and mortality in the HIV population.

Research studies in the Journal of Infectious Diseases Comorbidities Among US Patients With Prevalent HIV Infection—A Trend Analysis Gallang, Hsue, et al, those from the last Conference on Retroviruses and Opportunistic Infections (CROI 2019) Increased Prevalence of Prolonged QTC in Persons Living With HIV Compared to Controls D. Knudsen, Jonas B. Nielsen; Sudden Cardiac Death Among HIV-Infected and Uninfected Veterans Freiberg, Meredith S. Duncan, et al; HIV Post SCD Study: 80 Percent of Autopsy-Defined Sudden Arrhthmic Death in HIV Tseng, Ellen Moffat, et al; Elsevier’s published study, Comorbidity is more common and occurs earlier in persons living with HIV than in HIV-uninfected matched controls, aged 50 years and older: A cross-sectional study Maciela, Moreira, et al and many others show a much higher prevalence for heart disease, stroke and many other comorbidities for those with HIV and AIDS.

Drs. Anthony Fauci, Bob Redfield et al have generally responded to Trump’s State of the Union statement concerning ending the epidemic in 10 years. This means an emphasis on more treatment, diagnosis and rapid testing. However, those long term HIV and AIDS salvage patients need diagnosis and treatment for HIV co-morbidities, particularly those that experience insulin intolerance, stroke, heart, disease, inflammation, diarrhea, gastrointestinal intestinal diseases and diarrhea. They cannot wait any longer.

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Originally published on PanAware on Wordpress.com on August 20, 2019. By Jeannie Wraight (column by Rick Blake, Washington Correspondent).

HIV organizations and Democrats were highly skeptical about the actual funding of this initiative, which was announced in a paragraph during the speech. The funding has yet to be included in the Administration’s actual budget but maybe spelled out into next year’s budget requests.

HIV activists have been highly skeptical concerning regarding Trump’s HIV proposals because formal budgets from the White House included $1.35 billion in cuts to the President’s Emergency Plan for AIDS Relief and $392 million in cuts to the Global Fund to Fight AIDS, Tuberculosis and Malaria. The proposed budget also contained rollbacks to important domestic programs such as cuts to the Housing Opportunities for Persons With AIDS (HOPWA) program and cuts to the Supportive Housing Program for Persons with Disabilities.

In order to advance this budgetary process, activists, biotechnology companies and others will have to work in a bipartisan way to ensure the authorization and appropriation for 2020-21. Trump’s consideration of funding for HIV comorbidities comes at a time when Republicans in the Senate may well ask for “pay-fors” from other parts of domestic spending.

The Trump Administration’s proposal did stimulate a promise to expand access to Gilead’s Truvada by the company promising to supply 2.4 million “free” bottles of the drug annually to an estimated 200,000 at risk people. The Administration will be responsible for distributing the drug and the cost of this distribution is not clear nor is it in the current budget. It is also unclear when this distribution will begin and whether it will be solely targeted to rural areas, a focal point of the Trump Administration’s HIV proposal and a target of the President’s re-election campaign.

As the 2018 U.S. Conference on AIDS approaches, the Trump Administration has yet to establish a consistent budget and policies that fund and support the extension of health and well-being for either long-term HIV survivors or a new generation of those infected with the disease. Those policy advocates and HIV activists will have to maintain a close eye on changes in the Administration’s budget proposals and policies in order to determine their effectiveness for the HIV and AIDS communities.

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Originally published on PanAware on Wordpress.com on July 30, 2019. By Jeannie Wraight (column by Rick Blake, Washington, D.C. Correspondent).

For the past two presidential Administrations, NIAID has remained a silent partner as tenofovir disoproxil fumarate (TDF) drug prices almost doubled, the company generated $3 billion a year and NIAID brokered the myth of “Undetectable equals Untransmittable.”

Thanks to the work of Chairman Cong. Elijah Cummings and the House Oversight Committee, Gilead is being challenged. But what about NIAID and the mythology of U=U?

NIAID once had a tool box for HIV prevention that cost the American taxpayer millions to develop. This toolbox included microbicides, a plethora of vaccines and condom research. These were dumped in favor of Truvada (TDF) and PrEP as the King of the Hill. Why? Has NIAID been in collusion with Gilead? The Oversight Committee is examining Gilead’s practices, patents and pricing. Shouldn’t it examine NIAID’s actions, policies and practices as relates to Gilead and TDF as well?

At the Committee’s last hearing (May 2019), the Committee requested a substantial number of documents to backup its high pricing for TDF. Gilead has furiously rebutted as it tries, and probably ultimately fails, to use the Trump U.S. Patent Office to justify its rip-off pricing in the U.S. market. Why does the drug cost less than a quarter of its U.S. pricing in overseas markets?

What about NIAID’s role in “marketing” the drug through its pronouncements like “…an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others.”

Many advocates and activists in the HIV community have bought this hook, line and ultimately sinker without any challenges to what it really means. The AIDS Healthcare Foundation (AHF) has pioneered the fight against the harmful side effects of Gilead’s TDF-based (tenofovir disoproxil fumarate) drugs as part of its treatment for HIV/AIDS or as a part of the HIV prevention strategy pre-exposure prophylaxis or PrEP. AHF’s has called for a victim compensation fund from Gilead that comes as its attorneys announced a filing in the Superior Court of California County of Alameda of a lawsuit seeking compensation and accountability for Gilead’s actions for failure to publicly communicate defects in TDF’s drug formulation. The lawsuit alleges Gilead knew almost a decade in advance that a safer version of tenofovir existed. The Company kept silent publicly on the availability of tenofovir alafenamide (TAF) “to retain its profits from and monopoly of the harmful version of TDF.” This lawsuit alleges that Gilead failed to warn patients of the damaging side effects of TDF and actively misrepresented TDF’s efficacy and risks knowing that TAF, the safer alternative, existed in its own laboratories. But where was NIAID?

This justifiable confrontation between AHF representing HIV patients and Gilead brings to the forefront the question, “Where was NIAID in communicating the dangers of TDF and why does it continue to market “U = U” when the foundation for PrEP is TDF, the same drug that has potentially harmed a great number of HIV and AIDS patients?

NIAID should be further scrutinized for potential collusion with the drugmaker because it is the foundation for what Trump called for during a paragraph in his second State of the Union, the Ending of the AIDS Epidemic by 2030 plan. If TDF, and by extension PrEP, are the basis for ending of the epidemic, not only are the prices for the drug another means for the company to expand its profits, but the drug itself will put even more HIV and AIDS patients at risk thanks to NIAIDs silence about its dangers.

Gildead’s has announced that it will provide 200,000 individuals, or 2.4 million bottles of PrEP to those who are uninsured and at high risk of HIV with free or low cost access to the drug. That should be chilling news to the Oversight Committee. Instead, the Committee has said that this insufficient access to the drug and has pointed out that Gilead could provide an additional 1.1 million people with the drug. That is frightening.

While well intentioned, the Oversight Committee does not have the scientific expertise to review this drug without an impartial NIAID’s analysis of what Gilead is doing and has done. And NIAID impartiality itself could be called into question. While Gilead is now attempting to market a less harmful version of tenofovir, tenofovir alafenamide (TAF) – potentially making billions more in profit at the expense of U.S. HIV and AIDS patients, the House Oversight Committee and the Trump Administration need to hold the National Institute of Allergy and Infectious Diseases accountable for its Rip Van Winkle act for nearly a decade. Plain and simple, Gilead needs more competition in the marketplace with additional tools in the HIV and AIDS drug development tool box and it needs a change of direction when it comes to drug development and the denial of other avenues of funding drug development research for the epidemic. Without this competition, the Company – with covert help from NIAID – can continue to expand its marketplace for a drug that potentially has and can continue to harm thousands of HIV patients and displace other therapeutics that may have better results with appropriate Federal assistance.

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Originally published on PanAware on Wordpress.com on July 20, 2019. By Jeannie Wraight (column by Rick Blake, Washington Correspondent).