A New Single-Tablet Option for HIV's "Forgotten Population" Could Change Lives. Will Policy Let It?
With contributions from David "Jax" Kelly, JD, MPH, MBA
Editor's Note: David "Jax" Kelly, JD, MPH, MBA, is the Founder, President, and CEO of the Aging and HIV Institute and President of Let's Kick ASS Palm Springs (AIDS Survivor Syndrome). The Aging and HIV Institute works at the intersection of aging policy, HIV, and health equity, focusing on strengthening how aging systems recognize and respond to people aging with HIV. The organization analyzes policy language, governance structures, and planning processes to ensure that people living with HIV are explicitly included in the frameworks that guide aging services. The kind of policy and systems work described in this article depends on organizations like the Aging and HIV Institute having the resources to stay at the table. If you believe older adults living with HIV deserve a seat in the rooms where aging policy is shaped, consider making a contribution at AgingandHIV.org.
For nearly two decades, single-tablet regimens have been the standard of care in HIV treatment. One pill, once a day, to maintain viral suppression. For most people living with HIV, that promise became reality years ago. But for tens of thousands of people in the United States and many more worldwide, it never did.
These are people whose treatment histories stretch back to the earliest years of the epidemic, when the drugs available were less effective and far harder on the body. Many developed resistance to multiple classes of antiretrovirals over the course of decades on treatment. Others cannot tolerate components of existing single-pill options, or face drug-drug interactions with the medications they take for conditions that come with aging. The result is a population still managing complex regimens of multiple pills, multiple times a day, while the rest of HIV treatment has moved on without them.
As Dr. Chloe Orkin, Clinical Professor of Infection and Inequities at Queen Mary University of London and lead investigator of the ARTISTRY-1 trial, told NPR in March 2026: "They're like a forgotten population."
Now, new data suggest that may be about to change. On February 25, 2026, The Lancet published the Phase 3 results of the ARTISTRY-1 trial, which tested a new once-daily single-tablet regimen combining bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor. The combination, made by Gilead Sciences, was presented as a late-breaker at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) 2026 in Denver. The results are strong. The question now is whether the people who need this pill the most will actually be able to get it.
The ARTISTRY-1 Trial: What the Data Show
The ARTISTRY-1 trial enrolled 557 people with HIV across 90 sites in 15 countries, all virologically suppressed on complex multi-tablet regimens, and randomized 2:1 to switch to the bictegravir/lenacapavir (BIC/LEN) single-tablet regimen or continue their existing complex regimen. The study population reflects exactly who this pill was designed for: the oldest cohort enrolled in a registrational HIV treatment program to date, with a median age of 60, a median of 28 years on antiretroviral therapy (ART), and 81% on complex regimens due to drug resistance. At baseline, participants were taking a median of three antiretroviral pills per day (range 2 to 11), 39% were dosing twice daily, and 54% had two or more comorbidities including dyslipidemia (68%), hypertension (50%), and hyperglycemia or diabetes (24%).
At Week 48, only 0.8% of participants on BIC/LEN had HIV-1 RNA at or above 50 copies/mL, compared to 1.1% on the complex regimen, meeting noninferiority. No emergent resistance was detected. Switching to BIC/LEN also improved fasting lipid parameters in a population where over half carried two or more cardiovascular risk factors, and participants reported a mean 7-point increase in treatment satisfaction while those on complex regimens reported no change. A separate Phase 3 trial, ARTISTRY-2, presented alongside at CROI 2026, showed BIC/LEN was also noninferior to Biktarvy, a guideline-recommended first-line single-tablet regimen. Gilead plans to file for U.S. Food and Drug Administration (FDA) approval "in the near future," with a potential launch in the second half of 2026. Bictegravir/lenacapavir in combination is investigational and not yet approved anywhere globally.
Who This Pill Is Really For: Long-Term Survivors Aging into Medicare
The clinical data are compelling. But this story requires context beyond the trial results.
The people who stand to benefit most from BIC/LEN are disproportionately older adults now covered by Medicare. Over half of people living with HIV in the United States are now age 50 or older, according to the Centers for Disease Control and Prevention (CDC). The number of traditional Medicare beneficiaries with HIV has more than doubled since the mid-1990s, rising from roughly 42,500 in 1997 to over 103,000 in 2020, and this count does not include those enrolled in Medicare Advantage plans. Medicare is the second largest source of federal financing for HIV care, accounting for 39% of federal spending on HIV care and treatment.
For these older adults, treatment complexity carries consequences well beyond inconvenience. Research published in AIDS and Behavior found that among nearly 48,627 people with HIV in the Medicare program, only about 53% achieved optimal ART adherence. More than one in four had treatment gaps of at least 30 days, and 10% discontinued treatment entirely. A Health Affairsanalysis of Medicare claims data found that Medicare beneficiaries with HIV who were not receiving ART incurred 95.4% higher total spending than those without HIV, driven by higher rates of hospitalizations, emergency department visits, and spending on mental health and other chronic conditions. Beneficiaries who filled ART prescriptions consistently for 12 months, by contrast, had similar risk-adjusted Parts A and B spending to people without HIV. The data make a clear case: keeping people on treatment and adherent saves both lives and money. Treatment simplification is a direct lever for achieving that.
"Medicare provides essential coverage, but it was not originally designed with the long-term trajectory of HIV in mind," said Jax Kelly, JD, MPH, MBA, Founder, President, and CEO of the Aging and HIV Institute. "When I speak with long-term survivors, many tell me they feel grateful for Medicare coverage but still find the system difficult to navigate when it comes to specialized HIV care and medications." The day-to-day burden, Kelly noted, is logistical and financial as much as it is medical: "For someone on a fixed income, managing a complicated regimen alongside Medicare coverage rules can become stressful very quickly."
Kelly's perspective is shaped by years of work at the intersection of HIV and aging, including through the Aging and HIV Institute and Let's Kick ASS Palm Springs. "From my work, I see how important it is that scientific advances translate into real improvements in people's lives," he said. "As more people with HIV age into Medicare, we need policies that recognize the intersection of HIV, aging, and chronic disease management. Without that coordination, people can fall through gaps even when effective treatments exist."
Federal research from HRSA has echoed this concern, finding that older people with HIV have significantly higher rates of depression, chronic kidney disease, COPD, hypertension, diabetes, and other conditions compared to those without HIV, and calling for better coordination between HIV services and geriatric services, including training for medical professionals on the intersecting challenges of aging and HIV.
The Access Question: Will Formulary Barriers Block the Path?
If BIC/LEN receives FDA approval, the question of access will be immediate, especially for people on Medicare.
Medicare Part D plans are required to cover all approved antiretrovirals as one of the six protected drug classes. That is a meaningful safeguard. But coverage does not equal access. People with HIV on Medicare still face prior authorization requirements, specialty tier copays, and formulary placement decisions that vary from plan to plan. An IQVIA analysisof Medicare Part D formulary controls across five chronic therapeutic areas found that more than half of patients were initially denied coverage when trying to fill a new prescription. Among those who could not overcome a rejection within a year, 68% to 80% never started any treatment in that therapeutic area. While this study did not focus specifically on HIV, the pattern of formulary-driven treatment delays and abandonment should concern anyone watching how a new HIV therapy might move through the Medicare system.
"Historically, when new HIV medications enter the market, there can be a lag before Medicare Part D plans fully incorporate them into formularies," Kelly noted. "Sometimes they are placed on higher specialty tiers or require prior authorization before patients can access them."
The broader policy environment compounds this concern. Biktarvy, the most widely prescribed HIV medication in the U.S., was recently selected for the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA), the first HIV medication included. At the same time, we have watched Florida's ADAP crisis unfold, with thousands of people losing access to medications after the state slashed eligibility thresholds. These are reminders that even widely used and well-established HIV therapies can become subject to pricing pressures and funding instability. A new medication entering this environment will face the same forces, and advocates should be watching closely from day one.
Beyond the Pill Burden: What Treatment Simplification Really Means
There is an aspect of this conversation that the clinical trial data cannot fully capture. For long-term survivors who have spent decades on complex regimens because of drug resistance, treatment simplification is about more than reducing the number of pills. It touches questions of stigma, identity, and belonging that have defined the experience of aging with HIV.
When the Undetectable = Untransmittable (U=U) message gained traction, it was a turning point for many people living with HIV. The science was clear: people who achieve and maintain viral suppression cannot sexually transmit the virus. But some long-term survivors could not fully participate in that promise because their complex regimens, while keeping them alive, did not always achieve stable suppression, or because decades of earlier treatment had left them with resistance profiles that made sustained undetectability harder to reach.
"When the U=U message took hold several years ago, it transformed how people think about HIV and transmission," Kelly said. "But some long-term survivors told me they felt left behind because they had never been able to reach an undetectable viral load after decades on earlier generations of treatment. A therapy that helps more people achieve viral suppression could mean more than convenience. It could help erase a stigma that some long-term survivors have lived with for much of their lives."
Research among older adults living with HIV in South Carolina published in the Journal of the Association of Nurses in AIDS Care found mixed views on U=U, with some participants expressing outright skepticism. For older adults already facing the double stigma of HIV-related stigma and ageism, the psychological weight of being on a complex regimen while others take a single pill is real. An effective new single-tablet option, if accessible, could begin to close that gap.
What Needs to Happen Now
The ARTISTRY-1 and ARTISTRY-2 data make a clear case for BIC/LEN as a treatment option. Gilead plans to seek FDA approval. Now the work shifts from the lab to the systems that determine whether people can actually get what the science has produced.
The Centers for Medicare & Medicaid Services (CMS) must ensure rapid and equitable formulary inclusion upon FDA approval. The agency should monitor Part D plan placement of BIC/LEN and act to prevent specialty tier assignment or excessive prior authorization requirements that would delay access for Medicare beneficiaries with HIV. Protected drug class status means nothing if the practical barriers to filling a prescription make access unworkable for people on fixed incomes managing multiple chronic conditions.
Federal and state policymakers must invest in integrating HIV care with aging services. HIV care and aging services operate in separate policy silos, with the Ryan White program, Medicare, and the Older Americans Act aging network each governed by different rules and funding streams. HRSA has called for increased integration, including training for medical professionals on multi-morbidity and polypharmacy in aging HIV populations. Older adults with HIV should not have to serve as their own case managers across fragmented systems. We need concrete movement on bridging them.
Advocates and community organizations must center older adults and long-term survivors in the conversation about treatment access. Too often, the voices of people who have been living with HIV the longest are absent from policy discussions about the medications they depend on. Community-based organizations, peer networks, and aging services providers should work together to ensure that this population is visible and heard, both in formal comment processes and in the broader public discourse around HIV treatment. The American Society on Aging's practical guide for making the aging network HIV-inclusive, published in December 2025, offers a concrete framework for this kind of cross-sector engagement.
We need to treat stigma as a policy issue, not a footnote. The work of education, outreach, and community building for older adults living with HIV has to accompany any new treatment advance. A pill that could bring more people to viral suppression has the potential to reduce the stigma that long-term survivors have carried for decades, but that potential only materializes if we pair it with targeted U=U education for older adults, provider training on the psychosocial dimensions of aging with HIV, and sustained investment in peer support networks. Science alone does not erase stigma. People do.
The long-term survivors who lived through the worst of the epidemic have been on treatment for close to three decades. They took the drugs that didn't work well, weathered the side effects of regimens that were the best available at the time, and developed the resistance profiles that locked them out of the simpler options that followed. As Kelly said: "New treatments are incredibly important, but they must be paired with policies that ensure older adults living with HIV can actually access them and benefit from them."
The science is closing the treatment gap for this overlooked population. Our policy systems and our communities must do the same.
Why Mental Health is Central to Ending the HIV Epidemic
Have you ever felt like you were living two lives—one presented to the world, while the other is buried under secrecy and shame? For many people living with or at risk of HIV, this dual reality is painfully familiar. World Suicide Prevention Day might trend on social media, but hashtags rarely touch on the quiet, insidious epidemic where HIV meets a mental health crisis that too often remains in the shadows.
We’ve made significant strides in treating HIV, but the virus isn’t the only battle. There’s another battle just as critical: the mental toll—the invisible wounds and lingering trauma often overlooked despite medical advances. And all the progress in the world won’t matter if we ignore the mental and emotional realities of those living with HIV. We need more than medicine—we need a mindset shift that sees mental health as equally important and valid as physical health.
It’s time to confront the deeper issues directly: the stigma, the trauma, the daily fears. We need a mental healthcare system that understands, listens, and treats the whole person—not just the virus. Until we address these challenges head-on, we aren’t truly ending the HIV epidemic.
Navigating Mental Health Challenges with HIV
Living with HIV is not solely a medical challenge; it is a continuous mental marathon. The numbers show that we’re dealing with more than just a virus. People living with HIV are 100 times more likely to die by suicide than other populations. Anxiety disorders affect 15.5% of people living with HIV, compared to 3.6% in the general population, and depression is 2 to 5 times more common. Even more concerning, up to 70% have experienced trauma—20 times the rate of the general population.
These numbers represent real people navigating complex challenges. While not every person living with HIV faces mental health issues, for many, these struggles are a significant part of their experience. As one researcher notes, "The significantly higher prevalence compared to the general population suggests that anxiety disorders are a critical global public health concern among people living with HIV, requiring urgent prevention and treatment efforts."
To fully understand the scope of these challenges, we must consider "weathering"—the cumulative wear and tear on the body and mind from chronic stress and adversity. Dr. Sannisha K. Dale explains that for people living with HIV, this process is worsened by relentless stigma, discrimination, limited access to resources, systemic inequities, and other enduring social barriers. Weathering isn’t just about feeling worn down; it accelerates aging in a very real, biological way, leading to more chronic illnesses, cognitive decline, and other issues that hit harder and sooner for people with HIV. Research in iScience shows this accelerated aging can start almost immediately—within three years of acquiring HIV—due to cellular changes that affect overall health.
And it’s not just biology. Behavior plays a significant role too. A study in Translational Psychiatry reveals that maladaptive coping mechanisms like smoking or substance use, often developed in response to constant adversity, can accelerate aging and complicate HIV management. This highlights the importance of addressing both psychological and behavioral factors in HIV care, not just the virus itself.
Take Malcolm, a 66-year-old who’s been living with HIV for 28 years. Despite his resilience, he faces daily struggles: managing not only his HIV but also high blood pressure, Type 2 diabetes, and the mental toll of juggling multiple health conditions. As he puts it, "I'm just happy to be here," but that statement carries the weight of a lifetime of survival amid a complex landscape of healthcare challenges, stigma, and aging with HIV. Malcolm’s experience highlights the compounded difficulties faced by many older adults with HIV, where trauma is often a chronic companion rather than a singular event.
His story reflects a broader pattern: trauma, whether from the loss of friends to the epidemic, ongoing health challenges, or societal discrimination, often persists and manifests as PTSD, depression, substance use, and other mental health struggles. As such, the need for comprehensive care that addresses both the psychological scars and the physical realities of living with HIV has never been more urgent.
As Dr. Dale puts it, "Systemic oppression and mental health struggles faced by people living with HIV throughout their lives may accelerate the aging process and continue to negatively impact their physical health and wellbeing as they age." This isn’t just a health crisis—it’s a call to fundamentally rethink how we approach care and compassion for those most affected, demanding action that is both immediate and transformative.
Understanding weathering in the context of HIV is critical to developing effective care strategies. Research from the HIV Vaccine Trials Network makes it clear: it’s not just about treating the virus; it’s about recognizing the full scope of what people are up against—mental health challenges, trauma, and social determinants of health. Only by addressing all these factors can we create interventions that truly support healthier aging and improve the quality of life for people living with HIV.
Why Mental Health is Key to Effective HIV Care
Mental health and HIV care are inextricably linked, with research showing that untreated mental health conditions can significantly undermine adherence to antiretroviral therapy (ART), complicating efforts to achieve viral suppression and maintain overall health. The Substance Abuse and Mental Health Services Administration (SAMHSA) highlights this connection, stating, "Untreated behavioral health conditions can significantly hinder HIV care engagement, medication adherence, and overall health outcomes."
Yet, accessing mental healthcare while living with HIV is often a challenge. Limited services, cultural gaps among providers, and pervasive stigma are just some of the hurdles. This is compounded by a fragmented healthcare system that treats HIV care and mental health services separately. To address these gaps, we need to urgently improve provider education and competency in addressing both HIV and mental health needs. The World Health Organization and UNAIDS advocate for integrating mental health and HIV care. Their call for a holistic approach goes beyond just medical checklists—it’s about addressing psychological and social factors too. Integrated care models have shown promise, improving both mental health outcomes and adherence to HIV treatment.
Studies have shown that integrating mental health services into HIV care can significantly improve outcomes. This approach has been shown to reduce depressive symptoms by 25-50%, enhance adherence to antiretroviral therapy (ART), and increase the rates of viral suppression up to 95%. Collaborative care models, where mental health professionals and HIV providers work together, have proven effective in reducing hospitalizations, improving patient engagement, and promoting overall better health for people living with HIV.
However, getting there isn’t easy. SAMHSA's Center for Integrated Health Solutions identifies big hurdles, like funding limitations, workforce shortages, and resistance to organizational change. Despite these challenges, integrated care remains a critical goal—one that could significantly improve the health and well-being of people living with HIV.
And we can't ignore the impact of stigma. The Well Project notes that stigma in healthcare settings can worsen trauma and deter people from seeking care. Training providers in trauma-informed care and cultural competency is essential to creating safe, inclusive spaces for people living with HIV.
How Politics and Society Shape the HIV Experience
The mental health of people living with HIV is profoundly influenced by the broader social and cultural context in which they live. Systemic stigma, discrimination, and social exclusion intersect with issues like racism, homophobia, transphobia, and economic inequality, creating significant barriers to care and support. Research published in the American Journal of Public Health illustrates how these overlapping forms of discrimination increase stress, social isolation, and complicate access to healthcare. The study presents a framework demonstrating how HIV-related stigma, when combined with other forms of social marginalization, can negatively impact treatment adherence and overall health outcomes for people living with HIV.
HIV criminalization laws are another piece of this complex puzzle. As highlighted by Xtra Magazine, Canada and the U.S. still lead the world in criminalizing HIV, perpetuating stigma and further alienating those affected. Furthermore, the World Health Organization notes that discriminatory policies in employment, housing, and education create additional barriers, directly impacting mental well-being. Media and entertainment also plays a critical role. Sensationalized coverage and inaccurate portrayals continue to fuel harmful stereotypes, adding to the stigma people living with HIV experience.
Cultural and religious beliefs in certain communities can further exacerbate HIV-related stigma, leading to isolation, rejection, or even violence. UNAIDS emphasizes the importance of addressing these deeply ingrained attitudes.
However, positive messaging also has the power to reshape perceptions. The Undetectable = Untransmittable (U=U) campaign is a key example. HIV.gov explains that effective ART leading to undetectable viral loads prevents transmission, challenging outdated misconceptions and empowering those living with HIV.
This messaging has made a significant impact. Research has shown that U=U reduces anxiety and changes perceptions, helping people with HIV feel less like a threat. Similarly, PrEP (pre-exposure prophylaxis) offers another powerful tool, proving highly effective in preventing HIV transmission and fostering open, honest conversations about sexual health.
Building Resilience: Strategies for Mental Wellness
Supporting the mental health of people living with or at risk of HIV means thinking beyond a one-size-fits-all approach. We need to tackle this from multiple angles. Integrated care models that combine mental health and HIV services are proving to be effective. Programs like the Collaborative Care Model and the Mental Health Integration Programme show how treating the whole person—not just the virus—leads to better outcomes.
Trauma-informed care is crucial for creating environments where people feel truly safe and supported. This means training healthcare workers in sensitive communication, empowering patients in their care, and recognizing how trauma affects health behaviors and outcomes.
Monte Ephraim, a clinical social worker, sums it up: “Everyone has the possibility of living a satisfying and meaningful life, regardless of what happened to them or what health challenges they are living with.” Their approach centers on acknowledging trauma, promoting healing through relationships, and building resilience.
Community-based organizations are also vital. They offer support groups, peer counseling, and advocacy, using the power of shared experiences to reduce isolation and build resilience. For people living with HIV, resilience isn’t just a buzzword—it’s a lifeline. Research highlights that engaging in helpful coping mechanisms, like relying on social support, spirituality, creative expression, and activism can improve resilience. Practices like mindfulness, stress reduction, and positive psychology can also help. Each person’s way of coping will differ, and that’s perfectly fine. What’s important is finding what brings peace and comfort, in whatever form that takes.
Moving Forward: A Call to Action
If we’re serious about ending the HIV epidemic, we have to face the reality that mental health isn’t just part of the equation—it’s central to it. This isn’t a side issue or an optional extra. It's a fundamental piece of the puzzle that must be integrated into every aspect of HIV care and prevention.
To make progress, we need a strong commitment from all fronts—policymakers, healthcare providers, and communities:
Policymakers: Fund mental health services, integrate mental health care into all HIV programs, mandate trauma-informed training, and address social determinants of health.
Healthcare Providers: Implement trauma-informed approaches, conduct routine mental health screenings, and build strong referral networks.
Communities: Challenge stigma, support local organizations, and advocate for policy changes that promote mental health and HIV care.
We’re not just fighting a virus; we’re fighting for the dignity, health, and well-being of people living with HIV. This battle calls for a holistic, compassionate approach that treats the whole person—mind and body. It’s about creating a healthcare system that goes beyond the virus to address the real, lived experiences of those affected.
By integrating mental health care, tackling stigma, and fostering supportive communities, we can help ensure a future where people living with HIV not only survive but thrive. Let’s not just aim for zero new transmissions or deaths; let’s strive for a world where every person living with HIV is valued, empowered, and has the chance to live their fullest life.
Are Cancer Risks Higher for People Living with HIV/AIDS
For many years, scientists have been exploring the relationship between HIV/AIDS and various cancers. This complex connection stems from how the virus weakens the immune system, leaving folks more vulnerable. While there has been evidence of higher prevalence of certain cancers amongst people living with HIV/AIDS (PLWHA), the actual mechanisms have thus far remained unclear.
Recently, a team from Hospital 12 de Octubre (H12O) and the National Cancer Research Centre (CNIO) in Madrid, Spain found that Hepatitis B and C viral infections can cause multiple myeloma and its pathological precursors, monoclonal gammopathies. Additionally, they found that early detection of viral hepatitis and the use of antiretrovirals resulted in better health outcomes in general – taking care of the hepatitis and the monoclonal gammopathies/multiple myeloma at the same time.
This groundbreaking discovery comes shortly after the data was made available from the HIV/AIDS Cancer Match Study, which links United States’ HIV surveillance and cancer registry data from 2000 to 2019. Haas et al. examined this data and created a population-based linkage study which garnered the largest cohort to date for estimating anal cancer among PLWHA in the United States, with a cohort of 3,444 anal cancers diagnosed in patients with HIV. Of these 3,444 cases, 2,678 occurred in patients with a prior AIDS diagnosis.
Additionally, several cancers have been identified as AIDS-defining illnesses. The presence of these conditions indicates that the patient has reached the advanced stage of HIV infection known as AIDS. These include invasive cervical cancer, Kaposi’s sarcoma, and some iterations of lymphoma (e.g. diffuse large B-cell lymphoma and Burkitt or Burkitt-like lymphoma). A 2021 meta-analysis of twenty-four studies found that women with HIV are six times more likely to have cervical cancer than their counterparts without HIV. This is likely due to the inability to clear human papillomavirus (HPV) infection, which can cause cervical cell changes if left untreated in some cases. According to Lymphoma Action, diffuse large B-cell lymphoma is around fifteen times more common in PLWHA, while PLWHA are around 30 times more likely to develop Burkitt lymphoma.
As is often the case when living with HIV/AIDS and co-occurring conditions, early detection, open and frequent communication with healthcare providers, and HIV/AIDS treatment regimen adherence can make a significant difference in the duration and intensity of these conditions, so patients should be encouraged to be vigilant self-advocates when it comes to their health and wellness, and, when needed, identify resources among caregivers and community who might be able to assist in care advocacy.
Eddie Hamilton (left), Bill Arnold (right)
CANN would like to recognize the fierce advocacy of our colleague, friend, and former board member, Edward “Eddie” Hamilton (pictured). Eddie served on CANN’s Board of Directors from 2014 to 2022 and was the Founder and Executive Director of the ADAP Educational Initiative, which assisted clients enrolled under the AIDS Drug Assistance Program (ADAP). In 2012, Eddie was honored as the ADAP Champion of the Year by ADAP Advocacy for fighting the Ohio Department of Health’s attempts to implement medical eligibility criteria to qualify for ADAP services. Eddie passed away on July 12, 2022, having had cancer twice. CANN continues to honor Eddie’s legacy as well as that of the late Bill Arnold (pictured right), who served as CANN’s founding President & CEO, by championing patient-centric action toward health equity and access.
Feds Launch National HIV/AIDS Strategy Implementation Plan
On August 26th, the White House Office of National AIDS Policy (ONAP) director, Harold Phillips, announced publication of the Federal Implementation Plan for the National HIV/AIDS Strategy. A “dear Colleague” letter was circulated among advocates shortly before the announcement and Mr. Phillips discussed the release of the implementation plan via recorded video, published to the federal government’s HIV.gov blog.
Significantly, the implementation plan details more than 380 action items from 10 different federal agencies and specifically adds focus issues of quality of living among people living with HIV/AIDS (PLWHA) which will be added to the Medical Monitoring Project’s data tables in 2023. Many of the action items detailed include education and outreach and coordination of efforts between affected federal agencies and state partners. Much of this work intersects with the Biden Administration’s efforts to address health equity and disparities, given the disproportionate representation of marginalized communities affected by HIV.
For most advocates, the announcement was a “mixed-bag” of good news and frustration at planning that primarily highlights assessments and monitoring where data may already exist or where advocates have already outlined more concrete steps they wish the federal government to take. For example, advocates and the federal government is well-aware that thanks to the advancements in quality of medications to treat HIV and being able to keep more patients engaged in care, the population of PLWHA is generally much older than they were in say…2000. However, our planning and supports for this aging population is not sufficiently strong. Medicare integration and coverage of support services specific to PLWHA is lacking and the federal government has had to engage in repeated enforcement actions against skilled nursing facilities and assisted living facilities, both regarding the refusal to provide services to PLWHA and the failure to have adequate services for PLWHA in the facility’s care.
The new quality of life metrics focus on issues of mental health, behavioral health support, food insecurity, unemployment, and unstable housing for PLWHA, with the last 3 items being considered “structural/subsistence” issues for patients. These items are arguably significantly intertwined and success or failure in any may implicate success or failure in all of these items.
In order for the federal government’s efforts to meaningfully move forward, these plans should be treated as a roadmap, rather than actions themselves. One of the things we are very good at in HIV is planning and processing. Where efforts tend to fall short is in implementation and in order to improve implementation, we need to identify if those failures to implement are due to lack of appropriate resources, expertise, or conflicting federal and state policies and priorities. Advocates should seek to hold our friends at ONAP and other agencies accountable to proactive action in defending the rights of PLWHA as patients and acting on appropriate integration of care for our aging colleagues and friends – both in terms of ensuring existing entities serving an aging population are aware of how to care for PLWHA and in ensuring entities serving PLWHA are adequately supported to care for an aging population.
In assessing effective uses of limited resources and the plan’s goals toward meeting these quality of life metrics, advocates and the federal government should consider how to leverage the Ryan White program as a workforce development and employment opportunity in order to help lift patients and highly affected communities out of poverty and, in so doing, addressing the other listed quality of life metrics. The 2021 (fiscal year) budget for the Ryan White program is $2.4 billion (not including AIDS Drug Assistance Programs). Those dollars, when focused on employing people living with and at risk for HIV, those who would otherwise be or are already Ryan White clients, would provide a significant opportunity to address these quality of life concerns and meaningfully put these dollars to use in the community the funds are meant to serve.
Rising Morbidity: Viral Hepatitis Co-Infection with HIV and Age All Associated with Increased Rates of Liver Cancer
In February, researchers associated with numerous universities across Canada and the United States published one of the most comprehensive data reviews thus far conducted on the incidence rates of the most common type of liver cancer among people living with HIV/AIDS (PLWHA) and PLWHA co-infected with viral hepatitis. The study reviewed data collected as part of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), conducted between 1996 and 2015, with clinical data from 109,283 participants. Conclusions from the study were fairly straight-forward: the combination of HIV status (mono-infection), co-infection with viral hepatitis (HBV and/or HCV) and age all correlated with an increased chance of developing liver cancer (hepatocellular carcinoma [HCC]). The hope of researchers, as evidenced in the study’s introduction was to “inform expectations for other regions with a substantial burden of HIV and HBV-HCV coinfection but with delayed cART [combination antiretroviral therapy] scale-up and limited access to viral hepatitis treatment”.
While most research papers wait to include study limitations at the end, I prefer to open with them as prefacing allows for contextualizing data. The first and primary limitation on the review is clinical information reviewed was necessarily from those people linked to care and correlations provided by the data in the study cannot be applied to the diagnosed-but-not-in-care or undiagnosed population. Second, researchers note, information on relevant, individual health factors were missing from significant portions of participants data (example: smoking and drinking habits, natural clearance of HCV, fibrosis score, and HIV exposure risk). Additionally, data collection was not uniform across all participating entities at the time of linkage to care, though a quality analysis was used to help even things out and ensure the integrity of data comparisons. This lack of uniform protocol also included certain sites not administering or participants not receiving HCV or HBV screening. The last, though likely most significant limitation of the study is the data were collected prior to the advent of curative direct acting agents (DAAs) for HCV, and conclusions cannot be made on the potential positive impacts of readily available DAAs.
A limitation not mentioned and data unassessed is any reference between older ART regimens and newer ones, in which toxicity and tolerability is commonly known to be considerably improved with newer regimens. Liver health monitoring is fairly standard, among other relevant patient labs, for PLWHA because of a relationship between ART and liver health. While it’s understandable researchers who generally enjoy significant funding from manufacturers may wish to avoid broaching this topic, not mentioning the issue, even to say “we can’t make any conclusions on cART tolerability and toxicity as an indicator for adherence or risk of developing HCC” misses an incredibly important elephant in the room for researchers, providers, and patients alike.
Instead, researchers chose to focus on cART “eras” (1996-2000 [A], 2001-2005[B], and 2006-2015[C]), in which there’s a positive correlation between age and era; or those aging with HIV were more likely to be diagnosed with HCC. Highest rates of HCC diagnosis by cART area are as follows: A – between 50 and 60 years-old (HBV co-infection with HIV), B – lower end 70-80 (HCV co-infection with HIV), and C – upper end 70-80 (HCV and HBV co-infection with HIV). This data is particularly valuable on its own, however, as the associated risk cohort shift appears to be very closely related to age (ie. those in the upper end of the C “era” are also those to first receive effective cART and the 20-year age gap between the C and A cART eras).
Ultimately, PLWHA were more than 3 times as likely as the general population to develop HCC and more than 20 times more likely to develop HCC if co-infected with viral hepatitis. HCC incidence among study participants fell along rather predictable lines in terms of HIV related clinical monitoring metrics; those with higher viral loads and lower CD4 counts were more likely to develop HCC.
The study’s finding highlight the need for ensuring access to DAAs and HBV vaccines, ready ART uptake upon linkage to care, and strengthening the integrity of AIDS Drug Assistance Programs, Medicaid Programs, and care provided to incarcerated persons – specifically, ensuring the inclusion of coverage of DAAs in these.
Advocates, providers, and patients can review DAA coverage inclusion in ADAPs and Medicaid and harm reduction policies impacting HIV and HCV with Community Access National Network’s quarterly HIV-HCV Co-Infection Watch report.