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.
The False Economy of Rationing Life
Across the country, states are making a choice. Faced with budget shortfalls driven by flat federal funding, the expiration of enhanced ACA premium tax credits, and the downstream wreckage of H.R. 1's nearly $800 billion in Medicaid cuts, they are choosing to solve their fiscal problems by restricting access to the medications that keep people living with HIV alive and stop the virus from spreading. Eighteen states have implemented cost-containment measureson their AIDS Drug Assistance Programs, with five more considering changes. Florida slashed ADAP eligibility from 400% to 130% of the federal poverty level on March 1, cutting off more than 12,000 people and removing Biktarvy, which accounts for 52% of the U.S. ARV market, from its formulary. Louisiana is considering HB927, legislation that would repeal the state's long-standing statutory protections against prior authorization and step therapy for antiretrovirals in Medicaid.
The pressures are real. ADAP enrollment surged 30% from 2022 to 2024 as states shed Medicaid enrollees after the pandemic. NASTAD's February 2026 ADAP Watch reports 19 ADAPs forecast deficits for the upcoming fiscal year. When adjusted for inflation, ADAP appropriations have declined 31% since 2005, with the FY2025 appropriation carrying roughly the same purchasing power as FY1999 levels. Nobody disputes the math. What we dispute, forcefully and on the evidence, is the response.
Utilization Management on ARVs Is Clinically Indefensible
Step therapy requires a patient to "fail" a medication before accessing the one their provider has already determined is best for them. In HIV treatment, failure means the virus has replicated in the presence of inadequate drug levels and potentially developed resistance, rendering the entire associated drug class less effective or ineffective. For someone on PrEP, "failing" a regimen means they have seroconverted and acquired HIV, possibly with resistance that limits their treatment options from day one. Prior authorization creates gaps in access while paperwork is processed. Drug resistance can develop within several weeks of stopping ART, as some components of a combination regimen remain in the body longer than others, leaving HIV exposed to one or two drugs instead of a full suppressive regimen. CD4+ cell counts can decline by up to 100 cells/mm³ within weeks of interruption. The SMART trial demonstrated that episodic ART interruption was associated with increased risk of opportunistic disease and death, findings so conclusive the strategy was abandoned entirely.
The CMS Medicare Part D Manual specifically notes that utilization management tools like PA and step therapy are generally not employed in best-practice formulary models for HIV/AIDS drugs. The American Academy of HIV Medicine issued a white paper with a single recommendation: HIV medications should be exempt from prior authorization requirements. As of 2019, 14 states had enacted laws prohibiting at least some UM techniques for ARVs. The broader health policy world is arriving at the same conclusion about PA generally: a January 2026 KFF Health Tracking Poll found that four in ten people with chronic conditions say prior authorization is their single biggest healthcare burden beyond costs, and KFF President Drew Altman has openly questioned whether its short-term cost control benefits are worth the costs to patients in an already overburdened system. If the mainstream is questioning PA broadly, the case for applying it to ARVs, where the clinical stakes include drug resistance, viral transmission, and death, does not exist.
The Math Doesn't Work, and the Motive Is Worse
Here is where we need to stop treating this conversation as though it is happening in good faith.
The stated rationale for stripping UM protections from ARVs is cost containment. But anyone who has watched private insurance markets operate over the past two decades recognizes what utilization management on high-cost drug classes actually produces: leverage. Private payers have used UM as a negotiating tool for years, threatening to restrict formulary access unless manufacturers offer deeper discounts. The people whose treatment gets disrupted in the process are the collateral damage that makes the threat credible.
CANN has been warning for years that as state Medicaid programs face mounting budget pressure, the temptation to adopt this same playbook would grow. That is exactly what is unfolding. When states impose PA and step therapy on antiretrovirals, the practical effect extends well beyond cost management. It creates a bargaining position where patient access to life-saving medication becomes a concession to be traded for supplemental rebates from manufacturers. This is the private payer model of healthcare as revenue generation imported into public health programs responsible for managing a communicable disease. It transforms the health of people living with HIV into a bargaining chip, and it represents a fundamental betrayal of what public health programs exist to do.
The people whose medications get delayed, whose viral loads rebound, whose resistance profiles narrow while prior authorizations are processed are not an unfortunate side effect of this model. They are the leverage. That is not healthcare. It is government treating public health as a profit center.
The economics don't support it either. Every new infection from someone with a detectable viral load carries an estimated lifetime medical cost of $326,500, with the cost avoided by preventing that infection estimated at $229,800. More recent analyses from HIVMA put average lifetime expenditures between $500,000 and more than $1.2 million. A Precision Health Economics analysis estimated that allowing UM on Part D antiretrovirals alone could result in over 6,750 new HIV infections. Whatever supplemental rebate a state might extract by threatening formulary restrictions will be dwarfed by the downstream costs. And in a U.S. cohort studied between 2021 and 2023, 28% of people with HIV experienced a treatment interruption of 90 days or more, with those affected disproportionately women, Black, dealing with substance use, and less likely to have commercial insurance. These barriers concentrate harm on the people who are already most structurally vulnerable.
We Have Already Watched This Fail
We don't need to theorize. We watched it happen with Hepatitis C. For years, state Medicaid programs and MCOs imposed PA, step therapy, sobriety requirements, and prescriber restrictions on curative direct-acting agents for HCV. People were denied treatment while their disease progressed. By the end of 2025, 34 jurisdictions had removed PA requirements for most Medicaid HCV patients, reflecting the national consensus that those restrictions never served patients or budgets. Louisiana itself now receives an "A" grade for HCV Medicaid access. As CANN's letter to Vice Chair McMahen on HB927 notes, the bill proposes substantially similar risks to HIV medication access as those once imposed on HCV, in a state that passed model PrEP and PEP legislation in 2024 that these same UM tools would undermine.
What Must Happen
Florida's own legislature proved these cuts are not inevitable when it passed HB 697 in mid-March with $31 million to restore ADAP eligibility for over 11,000 people. Bipartisan, responsive, and proof that different choices are available when the political will exists.
States must fight for adequate federal ADAP funding, which has been flat-funded since FY2014 while program costs have grown relentlessly. They must leverage 340B rebates and supplemental funding rather than cutting the people the programs exist to serve. They must design Medicaid formularies to ensure access following federal HIV treatment guidelines, not undermine them. And their federal legislators should realize that if we can fund the Department of Defense at a trillion dollars a year, we can surely pay to keep people from dying from AIDS.
There is no clinical necessity for removing ARV protections. Doing so will not balance budgets. It will create drug resistance, increase transmission, push people into more expensive care settings, and compound the harms of H.R. 1's Medicaid budget cuts and work requirements, which threaten coverage for 42% of Medicaid enrollees with HIV. At every level of analysis, this approach fails. What it succeeds at is transferring the cost of federal policy failures onto the bodies of people living with HIV, and that is not fiscal responsibility. It is abandonment dressed in budget drag.
CROI 2026: The Tools Are Here. The Infrastructure Is Not.
The 33rd Conference on Retroviruses and Opportunistic Infections (CROI) convened February 22nd – 25th in Denver under extraordinary tension between a pipeline of HIV prevention, treatment, and potential cure tools that could reshape the epidemic's trajectory, and a global funding crisis actively dismantling the infrastructure required to deliver any of it. As Conference Chair Nicolas Chomont of the Université de Montréal stated in the Opening Session, "we share a responsibility to defend and sustain funding for international HIV programs and research." That charge framed every session that followed.
The Funding Crisis: New Data on the Damage
The consequences of disruptions to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the dissolution of the United States Agency for International Development (USAID), and National Institutes of Health (NIH) cuts are no longer hypothetical. The CROI session "Sleepless in Denver" presented the first systematic evidence of the damage. Ellen Brazier's survey data from the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium found that across 32 countries, 47% of clinics reported disruptions in HIV services, with similar rates of disruption to medication availability, laboratory services, and clinic operations. In KwaZulu-Natal, South Africa, Lindsey Filiatreau reported that 39% of clinics experienced disruptions affecting an estimated 830,000 people living with HIV.
The damage is not confined overseas. Aaron Richterman presented data from a rapid survey across three U.S. states showing that 47% of clinics reported HIV service disruptions, including medication shortages. He also demonstrated how cuts to the Supplemental Nutrition Assistance Program (SNAP), the country's largest targeted anti-poverty program serving more than 42 million Americans, directly undermine treatment outcomes. During the 2025 government shutdown, ART adherence among people living with HIV who receive SNAP benefits dropped to as low as 40%. The connection between food security and viral suppression is well established; cutting one predictably undermines the other. As Filiatreau put it, "These things [HIV services]… can be taken away overnight, but they can't be rebuilt overnight."
Prevention: An Expanding Toolkit, a Widening Access Gap
Against this backdrop, CROI delivered a prevention portfolio that is broader and stronger than at any previous conference. Final results from the PURPOSE 1 and PURPOSE 2 trials confirmed the efficacy of twice-yearly injectable lenacapavir for pre-exposure prophylaxis (PrEP). In PURPOSE 1, which enrolled cisgender adolescent and young women in sub-Saharan Africa, HIV incidence among lenacapavir recipients was 0.07 per 100 person-years, compared to 1.98 for oral emtricitabine/tenofovir alafenamide (F/TAF) and 1.94 for emtricitabine/tenofovir disoproxil fumarate (F/TDF), with only two seroconversions among more than 2,000 participants. PURPOSE 2, enrolling men who have sex with men and gender diverse people, showed HIV incidence of 0.11 per 100 person-years for lenacapavir versus 0.92 for F/TDF, with three seroconversions among 2,179 participants.
The five total seroconversions across both studies received considerable attention, with four showing lenacapavir-associated resistance mutations that researchers believe developed during PrEP rather than being transmitted. Research into why these breakthroughs occurred is ongoing. As Gilead's Stephanie Cox stated, "We don't know why these occurred… I think the efficacy is very high." San Francisco AIDS Foundation (SFAF) Medical Director Hyman Scott, MD, MPH, added context: "The breakthrough infections are important to evaluate but are extremely rare among the thousands of study participants."
The Prévenir study's final eight-year results from France reinforced that both daily and on-demand oral PrEP are safe and effective, with overall HIV incidence of 0.11 per 100 person-years across more than 3,200 users and 13,000 person-years of follow-up. Switching between daily and on-demand use was the norm rather than the exception, with 59% of daily users changing to on-demand at least once, and 52% doing the reverse. This carries a clear message for implementation: people need flexibility, and rigid one-size prescribing undermines persistence.
The prevention pipeline continues to expand. Merck's once-monthly oral PrEP candidate MK-8527 selected an 11 mg dose maintaining protective drug levels in at least 95% of participants, with Phase 3 EXPrESSIVE trials now enrolling. Gilead's PURPOSE 365 study, testing once-yearly lenacapavir for PrEP, is being designed. The SEARCH study showed that community health workers paired with digital tools reduced HIV incidence by 70% in rural populations, a reminder that prevention tools work best when embedded in community-driven delivery.
The problem is reach. Andrew Hill highlighted that only 2.3 million people are currently on oral PrEP, far below UNAIDS targets, and that injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of total PrEP use, respectively. We have a growing menu of prevention tools. Getting them to the people who need them is where the system breaks down.
Treatment: More Options, Longer Intervals, Patient Choice
The treatment pipeline at CROI 2026 moved toward a central goal: giving people living with HIV more choices that fit their lives. Merck presented late-breaking data from three Phase 3 trials of doravirine/islatravir (DOR/ISL), the first ever once-daily, non-INSTI two-drug regimen. In treatment-naive adults, DOR/ISL demonstrated non-inferiority to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), with 91.8% achieving viral suppression at Week 48 compared to 90.6%, including participants with high viral loads and low CD4 counts. The U.S. Food and Drug Administration (FDA) has set an action date of April 28, 2026 for the DOR/ISL application. For people aging with HIV who manage multiple comorbidities, a two-drug, non-INSTI regimen addresses a real clinical gap. Research presented at this same conference linked the widely used INSTI dolutegravir to neuropsychiatric effects, including blocking a brain enzyme essential for memory and emotional regulation, with one study halted for ethical reasons after participants experienced worsening symptoms. For people navigating tolerability concerns, toxicity issues, or polypharmacy, having a non-INSTI alternative with fewer active agents matters.
Gilead's ARTISTRY-1 and ARTISTRY-2 trials demonstrated that a bictegravir/lenacapavir (BIC/LEN) single-tablet regimen can maintain viral suppression for people switching from complex multi-tablet regimens (96% at 48 weeks in ARTISTRY-1) or from Biktarvy (93.5% in ARTISTRY-2). For people who have been on complex regimens for years due to resistance histories, this potential simplification addresses a real quality-of-life gap. Gilead plans to submit these results to regulatory authorities.
Long-acting injectables continued their forward march. In ViiV Healthcare's EMBRACE study, lotivibart (a broadly neutralizing antibody, or bNAb) given as an IV infusion every four months plus monthly cabotegravir maintained viral suppression in 94% of participants at 12 months. Part 2 of EMBRACE, testing lotivibart infusions every six months, is now fully enrolled. ViiV also presented early data on VH-184, a third-generation integrase inhibitor with potential twice-yearly dosing, and VH-499, a capsid inhibitor supporting twice-yearly intervals. The VOLITION study showed that 85% of treatment-naive adults opted to switch from daily pills to bimonthly long-acting cabotegravir/rilpivirine (CAB+RPV LA), with 95% maintaining suppression. Data like VOLITION's 85% opt-in rate reinforce what the HIV community has long argued: when people living with HIV are offered options that fit their lives, they take them. Payers, formulary committees, and ADAP programs should take note. Treatment is not one-size-fits-all, and coverage shouldn’t treat it as such.
Community activist Shari Margolese put it plainly at CROI's final Community Breakfast Club: "As a community we need to get much angrier about the fact that we can't get access to the drugs." Francois Venter of Ezintsha in South Africa warned that without action, "we might be sitting here again in 10 years' time" celebrating breakthroughs that never reach communities.
Cure, Comorbidities, and the Equity Question
On the cure front, the RIO trial's Phase B results offered genuine encouragement. Among the 28 people who received a placebo in Phase A and were then given bNAbs teropavimab and zinlirvimab, 54% had prolonged viral remission after stopping antiretroviral therapy (ART), with two still off treatment after more than a year. Because ART was stopped six months after the bNAb infusions, these results point to an immunological "vaccinal effect" rather than direct viral suppression. A cure remains distant, but these are the kinds of incremental, well-designed steps that build the evidence base forward.
CROI also highlighted the growing urgency of managing comorbidities in aging populations living with HIV. The POPPY study found that depression affects 32.4% of people living with HIV over 50, linked to inflammatory markers rather than psychosocial factors alone. A study of over 1,500 men showed that the combination of age 65 and over, HIV, and metabolic syndrome produced significantly worse cognitive impairment than any factor alone. Metabolic syndrome is the modifiable factor in that triad, which means clinicians and patients can act on it now. CROI data on GLP-1 receptor agonists like semaglutide point toward a potential tool for doing so: in a study of people living with HIV-associated lipohypertrophy, semaglutide produced a 19% reduction in total body fat, a 31% decrease in visceral adipose tissue, and a nearly 50% drop in C-reactive protein, a key inflammatory marker. Separate data presented at the conference found that semaglutide did not worsen depression in people living with HIV, and that people with moderate or severe depression at baseline actually showed improvements. These findings warrant dedicated research into how GLP-1 therapies can address the long-term health consequences of chronic inflammation and aging with HIV. If the evidence continues to support their role, GLP-1 receptor agonists should be evaluated for inclusion in the HIV standard of care, with appropriate insurance and program coverage to match.
The equity question came into sharp focus with data from the ENCORE cohort. Black trans women in the U.S. had an HIV incidence of 15.5 per 1,000 person-years, compared to 1.4 for White trans women. Poverty, houselessness, and lack of insurance were significant drivers, and only 4% of trans women in the cohort used long-acting injectable PrEP. Dr. Sari Reisner of the University of Michigan warned that the current administration's erasure of gender identity data from federally funded datasets will make it harder to monitor disparities and determine what works. We cannot close gaps we refuse to measure, and they know that.
What Comes Next
CROI 2026 produced a clear picture: we have tools that can change the course of the HIV epidemic, and the systems required to deliver them are being actively undermined. The path forward requires specific action. We must defend and restore funding for PEPFAR, NIH, and the global HIV infrastructure that makes science reach people. State ADAP programs and payers must expand coverage for long-acting prevention and treatment options and remove administrative barriers that delay access. To do that, they need to be adequately funded. PrEP implementation must embrace the full range of validated modalities, from daily oral to on-demand to injectable to monthly oral, with flexibility built into delivery. Care for people aging with HIV must shift toward whole-person approaches that integrate cognitive screening, metabolic risk management, and mental health support alongside viral suppression. And we must protect the community-led surveillance and data collection that allows us to see and respond to disparities, especially for trans and gender-diverse communities.
Wes Sundquist of the University of Utah, who helped develop the science behind lenacapavir, reflected at CROI on the decades-long journey that produced this tool. He warned that while the field now has "a really powerful new tool in the arsenal," forces are blocking its use. "It will be a human tragedy," he said, "if we don't overcome those." The science has done its part. The rest is a question of political will, policy design, and whether we as a community can sustain the pressure long enough for these tools to reach the people who need them.
Mapping Injustice: Redlining's Legacy in HIV Treatment Delays
A new study from Tulane University reveals how discriminatory housing policies from decades ago continue to shape HIV care outcomes today. Published in JAMA Internal Medicine, the research shows that people living with HIV (PLWH) in historically redlined neighborhoods face 15% longer delays in achieving viral suppression compared to counterparts in non-redlined areas—193 days versus 164 days. These delays impact both patient health outcomes and broader public health efforts to prevent HIV transmission.
The Lasting Legacy of Redlining
Redlining—the practice where mortgage lenders marked certain areas with red lines to deny loans based on race or ethnicity—was officially abolished in 1968. Yet its consequences persist in the built environment, healthcare infrastructure, and social conditions that determine health outcomes.
The Tulane study analyzed 1,132 newly diagnosed patients in New Orleans between 2011 and 2019. Of these patients, 62% resided in formerly redlined neighborhoods. Most were men between ages 25-44 years, and despite New Orleans having a majority Black population, the study found a higher concentration of Black residents in redlined areas than in non-redlined ones.
The findings validate what many healthcare advocates have long observed: geography profoundly influences health. As senior author Scott Batey noted, "The association between redlining and health outcomes is not a new concept, but applying this lens specifically to HIV was novel." Even where gentrification has occurred, treatment delays remain—indicating that historical marginalization creates barriers that investment alone cannot remove.
Interconnected Barriers to HIV Care
What explains these persistent treatment delays? The answer lies in multiple overlapping structural barriers that create a healthcare access quagmire for PLWH in redlined communities.
Pharmacy Deserts
One-third of neighborhoods in major U.S. cities qualify as pharmacy deserts, with predominantly Black and Latino neighborhoods disproportionately affected. In Los Angeles, for example, one-third of all Black and Latino neighborhoods were pharmacy deserts, particularly concentrated in South Central LA neighborhoods.
For PLWH, this means not just longer travel times for medication but reduced access to HIV prevention resources and testing services. Pharmacies serve as crucial health access points—they provide HIV prevention tools like PrEP, conduct HIV testing, and offer medication counseling essential for treatment adherence. When pharmacies close or never open in certain neighborhoods, these services disappear too.
Medicare Part D and Medicaid plans often exclude independent pharmacies serving these communities, forcing PLWH to travel even farther for care. These policies function as a form of structural racism that requires historically marginalized populations to overcome additional barriers to access life-saving medications.
Provider Network Inadequacy
Healthcare provider shortages plague formerly redlined areas. Current federal network adequacy standards fail to ensure sufficient HIV care providers in these communities. Provider directories frequently overstate physician availability, and narrow insurance networks often include less than one-fourth of available providers.
Studies show that adults with Medicaid or Marketplace coverage are more likely than those with Medicare or employer-sponsored insurance to report network problems. This is especially concerning as approximately 40% of people living with HIV (PLWH) rely on Medicaid for their healthcare coverage. For PLWH, this translates to longer wait times, fewer options for culturally competent care, and reduced provider continuity—all factors that influence treatment adherence and viral suppression rates.
Time/distance standards for network adequacy ignore the reality that residents often rely on limited public transportation, making even "acceptable" distances functionally unreachable. A mile can feel like thirty when bus service is limited, transfers are required, or service ends before evening clinic hours conclude.
Hospital Consolidation
The acceleration of hospital consolidation has further eroded healthcare infrastructure in vulnerable communities. When acquiring systems take over local hospitals, they frequently close specialized services, forcing patients to travel further for care.
"The unfortunate reality is that more than 25 years of market-driven health facility consolidation has really left too many communities across the U.S. without timely access to needed care," experts note. This especially impacts residents of redlined neighborhoods, who often must navigate complex transportation systems to reach consolidated healthcare facilities.
Research shows hospitals without nearby competitors charge prices 12.5% higher than those in competitive markets—a financial burden that falls heavily on communities already struggling with economic disadvantage. As of 2017, 19% of markets—representing 11.2 million U.S. residents—were served by only one hospital system, creating healthcare monopolies that exacerbate access disparities.
Political Context: New Threats to Health Equity Research
Political attacks on health equity initiatives now compound these structural barriers. Recent executive orders targeting Diversity, Equity, and Inclusion (DEI) programs across federal agencies threaten vital HIV research and services.
The U.S Department of Health and Human Services (HHS) faces proposed budget cuts from $121 billion to $80 billion in discretionary funding, cutting precisely the prevention-focused health initiatives designed to address disparities. Healthcare researchers report increasing censorship pressures around health disparity research, particularly when using terminology associated with equity.
One cancer researcher noted the chilling effect: "We aren't sure what we can say in our grants. I very freely — before — wrote about disparities and equity in my grants." This uncertainty threatens the very research needed to understand and address HIV treatment delays in historically redlined communities.
Federal agencies have removed HIV-related content from websites, especially materials serving transgender populations. Reports indicate hundreds of HIV-related web pages were removed following executive orders targeting "gender ideology" and "DEI." When pages were restored, they often lacked reference to transgender people, creating significant gaps in data and care recommendations for key populations.
The threat extends to global HIV prevention efforts, with pauses on foreign aid affecting PEPFAR implementation and leaving vital medication and services in limbo. These disruptions threaten to reverse hard-won progress in controlling the HIV epidemic both domestically and globally.
From Analysis to Action
Understanding redlining's impact on HIV treatment access demands more than recognition—it requires targeted policy responses:
Strengthen pharmacy access in underserved areas by incentivizing pharmacy establishment and requiring Medicaid and Medicare Part D plans to include independent pharmacies serving marginalized communities. State pharmacy boards should consider pharmacy access when reviewing new applications and closures.
Reform PBM practices to eliminate patient steering by prohibiting PBM-owned specialty pharmacies from exclusively dispensing HIV medications. Research shows that patient steering to mail-order or specific chain pharmacies disrupts established care relationships and reduces medication adherence, particularly affecting PLWH in historically redlined areas who rely on community pharmacies for wrap-around services.
Reform network adequacy standards to ensure sufficient culturally-competent providers in historically redlined neighborhoods. Standards must account for transportation realities and penalize narrow networks that exclude critical HIV care providers. Secret shopper surveys should validate actual appointment availability beyond paper compliance.
Mandate PBM transparency and fair reimbursement to prevent discriminatory practices forcing community pharmacies in redlined neighborhoods to close. State legislation should require PBMs to disclose all revenue streams, prohibit retroactive fee clawbacks, and establish minimum reimbursement rates based on acquisition cost plus a fair dispensing fee.
Enhance antitrust enforcement to prevent further hospital consolidation, reducing access points in vulnerable communities. When mergers occur, mandate maintenance of essential services in historically underserved areas and require community benefits agreements that address historical inequities.
Protect and expand community-based HIV programs that provide testing, prevention education, and linkage to care services directly within affected neighborhoods. This includes mobile testing units, community health worker programs, and faith-based outreach initiatives.
Prioritize long-acting injectable antiretrovirals as a solution for areas with limited pharmacy access, reducing adherence challenges for people facing transportation barriers. Delivery models should include provision through mobile clinics and community-based organizations.
Defend health equity research funding against political attacks that threaten to undermine our understanding of how structural racism impacts health outcomes. Ensure that Institutional Review Boards (IRBs) and research institutions protect researchers examining health disparities.
Moving Forward
The link between historical redlining and HIV treatment delays reveals how structural inequities become embodied in health outcomes. This connection demands that policymakers, healthcare systems, and advocates recognize that achieving HIV treatment equity requires addressing the legacy of discriminatory housing policies.
As Dr. Batey notes, "If we can make services more accessible and get people virally suppressed sooner, the impact on the HIV epidemic can be quite significant." This requires defending existing health equity initiatives and developing new approaches that confront the structural barriers in historically redlined communities.
The one-month treatment delay identified in the Tulane study translates to real health consequences for PLWH and increased transmission risk within communities. Moving from awareness to action means investing in healthcare infrastructure that overcomes geography as destiny, creating systems where treatment access doesn't depend on neighborhood history.
In an era of political attacks on health equity initiatives, this research underscores why structural analysis matters. Without understanding how policies like redlining continue to shape healthcare access, we risk addressing symptoms while ignoring causes. Achieving HIV treatment equity demands both acknowledging historical injustice and implementing structural change—starting with the communities where barriers remain highest.