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.
Congress Rejects HIV Cuts, But Flat Funding Won't End the Epidemic
As of this writing, the FY2026 Labor, Health and Human Services appropriations bill awaits final passage. The Senate is expected to pass the package Friday night, with the House voting Monday evening. A brief partial shutdown through the weekend appears unavoidable. The following analysis assumes the legislation passes as currently written.
After a year of proposed cuts that created significant uncertainty for HIV programs and the communities they serve, Congress has negotiated a spending package that maintains current funding levels while falling short of what ending the epidemic requires. The bill, released January 20, 2026, rejects over $1.7 billion in proposed cuts and preserves funding for Ryan White, the Ending the HIV Epidemic initiative, and CDC prevention programs. It also includes the first major pharmacy benefit manager (PBM) reforms in Medicare Part D in nearly two decades, a development with significant implications for patient access to HIV and hepatitis C medications.
Yet flat funding cannot meet growing demands, particularly as long-acting therapeutics promise to transform HIV prevention and care for those who need them most. In an environment where maintaining the status quo requires extraordinary effort, advocates must reckon with an uncomfortable truth: the status quo is not enough to end the epidemic.
What Was at Stake
The path to this appropriations package has been fraught, to say the least. In May 2025, the Trump administration proposed $31.3 billion in cuts to the Department of Health and Human Services, including a 40% reduction to NIH and the consolidation of its 27 institutes into eight. The proposal called for eliminating HIV prevention programs entirely and restructuring HHS agencies, including folding SAMHSA (Substance Abuse and Mental Health Services Administration) into a new "Administration for a Healthy America."
The House Appropriations Committee's September 2025 bill embraced much of this vision. It provided zero funding for CDC HIV prevention programs, proposed cutting the Ryan White HIV/AIDS Program by 20%, and would have eliminated the Ending the HIV Epidemic initiative completely. CDC funding faced a nearly 20% reduction overall.
The final package represents a decisive rejection of these proposals. Congress preserved the Ryan White HIV/AIDS Program at $2.6 billion, maintained the Ending the HIV Epidemic initiative at $165 million, and funded CDC HIV/AIDS, Viral Hepatitis, STDs, and TB Prevention at $1.384 billion. The Minority HIV/AIDS Fund received $56 million. The bill closely tracks the bipartisan Senate proposal that advanced from committee in July 2025, a predictable outcome given the Senate's historical role as a moderating force on appropriations. The Administration's proposed cuts and the House bill were never likely to survive a bicameral process intact, but their existence created uncertainty that disrupted planning and strained already stretched public health infrastructure throughout the year.
Flat Funding Is Not Progress
Preserving current funding levels is not the same as meeting current needs. The American Academy of HIV Medicinedescribed the bill as presenting "a mixed picture for domestic HIV programs," noting that level funding will not achieve the goals set forth in the Ending the HIV Epidemic plan launched during the first Trump administration or address a rise in HIV transmission outbreaks as we’ve seen in Maine and New York.
The timing makes this particularly frustrating. Long-acting injectable treatments and prevention options are transforming what is possible in HIV care. Lenacapavir for PrEP offers twice-yearly dosing. Long-acting cabotegravir and rilpivirine provide monthly or bimonthly treatment options for people who struggle with daily pills or face adherence barriers. These innovations could reach people who have historically fallen through the cracks of our prevention and treatment infrastructure, but scaling them requires investment that flat funding cannot provide.
Prevention initiatives, workforce development, training programs, and the rollout of new innovations are particularly vulnerable under current funding levels. Without targeted investment, long-acting options will remain inaccessible to people in Medicaid-dependent, rural, and underserved areas. The tools exist to end HIV as a public health threat. The political will to fund their deployment does not.
Within the broader infectious disease category, the bill sends mixed signals. Viral hepatitis prevention received a $3 million increase to $46 million, one of the few areas to see any growth. STI prevention, by contrast, took a $10 million cut to $164 million. While provisional 2024 data shows overall STI cases declining for the third consecutive year, reported syphilis cases and congenital syphilis remain at historically high levels, with continued increases in some demographics. Cutting prevention funding while these disparities persist is shortsighted.
Harm Reduction: Evidence Ignored
The bill's approach to harm reduction reveals a troubling gap between public health evidence and legislative ideology. Section 525 maintains the longstanding prohibition on using federal funds to purchase sterile needles or syringes, with a narrow exception for jurisdictions experiencing or at risk for HIV or hepatitis outbreaks. This reactive approach undermines prevention and contradicts the government's own evidence base.
The VA, in a December 2025 analysis of its harm reduction programs, described syringe services programs as "one of the most effective public health interventions ever devised," noting they decrease new HIV and HCV infections by up to 67% and increase the likelihood of achieving abstinence five-fold. The VA further emphasized that these programs "do not enable or increase drug use, nor do they cause increases in crime."
The appropriations bill ignores this evidence. Report language frames harm reduction through an abstinence-first lens, elevating the administration's efforts to "prioritize prevention, treatment, and long-term recovery." This framing treats harm reduction and recovery as opposing forces when the evidence shows they are complementary. Meeting people where they are is essential to eventually connecting them with treatment. Restricting proven interventions on ideological grounds costs lives.
The bill does maintain substance use disorder treatment funding, with SAMHSA receiving $7.44 billion (a $65 million increase), State Opioid Response Grants at $1.6 billion, and CARA First Responder Training at $59 million. These investments matter. But they would matter more if paired with evidence-based harm reduction that keeps people alive long enough to access treatment.
PBM Reform: A Genuine Win With Implementation Risks
The inclusion of pharmacy benefit manager reforms represents a genuine policy achievement and the first major PBM reform in Medicare Part D in nearly 20 years. For people living with HIV and hepatitis C who depend on specialty medications, these provisions could meaningfully improve access and reduce costs.
The reforms target the opaque practices that have allowed PBMs to profit at the expense of patients and plan sponsors. Beginning in 2028, PBM compensation in Medicare Part D will be delinked from drug list prices, eliminating the perverse incentive to favor higher-priced medications. PBMs will be required to pass through 100% of manufacturer rebates and fees to plan sponsors. The bill bans spread pricing in Medicaid, where PBMs have profited by charging plans more than they reimburse pharmacies. CMS receives $188 million for implementation and new authority to define and enforce "reasonable and relevant" contract terms between Part D plans and pharmacies.
The transparency provisions are equally significant. PBMs must report pricing information, including all rebates negotiated with manufacturers, directly to plan sponsors and HHS. For PBMs with affiliated mail-order or specialty pharmacies, the bill requires disclosure of any benefit design parameters that steer prescriptions to those pharmacies. This addresses a core concern: vertically integrated PBMs using formulary placement and prior authorization requirements to drive volume to their own pharmacies at the expense of patient choice and community pharmacy access.
For people living with HIV, the stakes are concrete. Specialty HIV medications flow through PBM-controlled channels that have historically lacked transparency around rebates, formulary decisions, and pharmacy reimbursement. The reforms create mechanisms to challenge contract terms that effectively exclude community pharmacies or impose unreasonable administrative burdens. The appeals process for pharmacies to dispute terms that fail the "reasonable and relevant" standard could prove particularly important for independent and specialty pharmacies serving HIV populations.
The risk, as always, lies in implementation and industry adaptation. PBMs have proven adept at restructuring their business practices to maintain margins when regulations target specific revenue streams. The provisions take effect in 2028 for Medicare and 2029 for pharmacy contract standards, giving industry ample time to identify workarounds. Advocates should watch for attempts to shift costs to patients through benefit design changes, or to game the "reasonable and relevant" standard through contract terms that are technically compliant but practically exclusionary. The history of PBM regulation is a history of regulatory arbitrage, and vigilance will be required to ensure these reforms deliver their intended benefits.
Structural Protections and Access Provisions
Beyond funding levels, the bill includes important structural provisions. It rejects the administration's proposed HHS restructuring and requires the Secretary to provide detailed justification to Congress at least 60 days before any reorganization affecting CDC functions. Grant terminations now require three days' advance notice to appropriations committees. These guardrails matter in an environment where administrative action has disrupted programs faster than legislative oversight can respond.
The package extends Medicare telehealth waivers through December 31, 2027, maintains community health center funding at $4.6 billion plus bridge funding, and delays Medicaid disproportionate share hospital cuts until September 2028. These provisions support healthcare access in underserved communities where HIV and viral hepatitis programs depend on functioning safety-net infrastructure.
The Work Ahead
Assuming the bill passes as expected, funding appropriated is not funding effectively deployed. The same administration that proposed eliminating these programs will now oversee their implementation. How HHS manages grant administration, staffing, and program guidance will determine whether level funding translates into maintained services or quiet erosion. The bill's requirements for advance notice on grant terminations and reorganization plans provide some guardrails, but vigilance will be required.
The United States has the tools to end HIV as a public health threat. Long-acting prevention and treatment options could reach people who daily pills cannot. Harm reduction keeps people alive and connected to care. Ryan White and the EHE initiative provide the programmatic infrastructure. What we lack is the political will to fund these efforts at the scale required and the moral clarity to implement evidence-based policy over ideological preference.
Flat funding is not progress. It is a holding pattern in an environment where holding ground required effort. The work ahead is ensuring these programs are implemented effectively while continuing to push for the investment these programs actually need. The fight for adequate funding, evidence-based policy, and equitable access continues.