Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

Gilead, one of the few drugmakers in the HIV field, has ended a Phase 2/3 trial of two long-acting HIV pills that had been on hold for safety reasons, Endpoints News has learned. The California biopharma ended one of two late-stage studies of the pills “following consultation with the FDA,” a Gilead spokesperson told Endpoints on Wednesday. The study, called WONDERS-2 , appears to have been ended recently, according to an update this week to the federal trial registry. The drugs are GS-1720, an oral integrase inhibitor, and GS-4182, a prodrug of lenacapavir, the main ingredient in the company’s landmark twice-yearly HIV prevention tool. Lenacapavir is also being studied in combination with other approaches . Most study of the drugs — in WONDERS-2 and another Phase 2/3 study called WONDERS-1 — was placed on hold last year after some patients had decreases in their immune cell counts, a sign of a weakening immune system. WONDERS-2 had enrolled 73 participants, well short of initial plans for 675 people. Certain Phase 1 trials of the experimental pills were also placed on hold at the time. The Gilead spokesperson said that patients’ immune cell counts in the now-ended trial “have returned to baseline or are within normal ranges.” The studies were comparing the treatment combination to Biktarvy, Gilead’s cornerstone HIV drug that brought in $14 billion last year and serves as a standard of care for the disease. The drugmaker has a number of programs it is developing to succeed Biktarvy when it eventually loses exclusivity. “We continue to work closely with study investigators to ensure a smooth transition for participants to standard of care HIV treatment options,” the spokesperson said. Gilead had backups for both drugs in preclinical and Phase 1 development at the time of the hold, Leerink Partners analysts said in July, but the clinical setback “could compromise the likelihood Gilead meets their targeted launch goal of 2029 for their first wholly-owned, once-weekly oral regimen for virologically suppressed patients and treatment-naïve patients.” HIV makes up the bulk of Gilead’s business, comprising 72% of its 2025 product sales. But the company has written large checks to boost its blood cancer and autoimmune work, including a $7.8 billion deal for Arcellx and a $1.67 billion agreement with Ouro Medicines.

TUESDAY, March, 3, 2026 — A growing number of states are rolling back financial help for HIV medications. An analysis released March 2 by the health research group KFF found that 18 states have adopted cost-cutting changes to their AIDS Drug Assistance Programs, known as ADAPs. Five more states are considering similar steps. ADAP programs are funded through the federal Ryan White Federal HIV Program. They help pay for HIV medications, provide drugs at no cost to some patients and cover insurance premiums for others. When taken daily, the medications suppress the virus to undetectable levels, which means a person cannot pass HIV to others. Experts warn that stopping this treatment can increase new infections and cause the virus to become resistant to medication. The largest change took effect over the weekend in Florida. The state ended benefits for at least 16,000 residents living with HIV and stopped covering Biktarvy , the most widely prescribed HIV medication. Florida’s ADAP program serves more than 32,000 clients, making it the nation’s largest. In January, the state lowered income eligibility from 400% of the federal poverty level to 130%. That means an individual must now earn no more than $20,748 per year to qualify. The previous limit was $63,840. The Florida Department of Health cited a projected $120 million budget shortfall but has not released any more information. But the change is already causing fear in patients. “We’re seeing patients across the state full of anxiety and fear rationing their lifesaving medication,” Esteban Wood , director of advocacy and legislative affairs at the AIDS Healthcare Foundation, told The New York Times . “These are people who have no other safety net,” he added. “ADAP is the safety net.” The foundation has filed a legal injunction to block Florida’s restrictions. To help residents who lose premium support, the Centers for Medicare & Medicaid Services opened a special enrollment period for Floridians. Those affected can choose a new health plan through April 30. ADAP programs support about 25% of the 1.2 million people living with HIV in the United States. Enrollment increased by 30% from 2022 to 2024, in part because states began removing people from Medicaid after the pandemic. At the same time, federal funding has remained flat for more than a decade, even as drug prices and insurance premiums have increased. “Effectively, programs are being asked to do more with less federal funding,” Lindsey Dawson , associate director of HIV policy at KFF, told The Times . Other states have reduced income eligibility limits or cut back on the number of medications they cover. Pennsylvania, for example, lowered its eligibility criteria for income from 500% of the federal poverty level to 350%. Experts warn that more states may follow, especially as work requirements push some folks off Medicaid. “We’re expecting to see more states anticipating or contending with budget deficits, and we do anticipate a growing number of states having to implement cost-containment measures," Tim Horn , director of medication access at the National Alliance of State and Territorial AIDS Directors, told The Times. Wood of the AIDS Healthcare Foundation summed up the situation succinctly. “This is really an economic disaster, a public health disaster, a moral disaster,” he said. Sources The New York Times, March 2, 2026