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.

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.

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).

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).