The U.S. Food and Drug Administration has tentatively approved a generic version of lenacapavir, an HIV prevention drug that studies indicate can provide near-complete protection with two injections per year, according to PBS. The approval, announced Monday, is intended to speed manufacturing and distribution of the drug to 120 low-income countries at a price of roughly $40 annually, compared with a U.S. list price of $28,218.
The drug is made by Gilead Sciences, and the Global Fund hopes to reach 3 million people with it by the end of 2028. Whether that goal is realistic depends on how quickly production and delivery can scale up.
Why it matters
Lenacapavir, often called "lena," belongs to a class of medicines known as PrEP, or preexposure prophylaxis. Existing options — daily pills and an every-other-month injection of cabotegravir — are already highly effective and widely available. Health experts told PBS that lenacapavir's advantage is its dosing schedule: two shots a year, which removes the need for daily adherence and could make protection practical for people whose circumstances make regular pill-taking difficult.
That difference could matter not only for individuals but potentially for the global epidemic, experts said. Yet the drug has been extremely hard to obtain in the places where need is greatest.
"The rate of growth (of lenacapavir rollout) isn't fast enough. We need to be getting to the millions pretty soon," Andrew Hill, an HIV treatment expert and senior visiting research fellow at the University of Liverpool in England, told PBS.
Shortages in Uganda
PBS reported from Mbarara, a city in western Uganda known in part for sex tourism, where an estimated 10% of adults have HIV — twice the national rate. Health authorities there say infections are driven largely by transactional sex, the kind of transmission lenacapavir is designed to prevent.
Lisa Mutoni, a sex worker in the city's red light district, told PBS she insists on condoms with clients but that some men try to remove or tear them during sex. She takes PrEP and said a six-month injection would give her confidence and remove the risk of forgetting a daily pill. But each time she has tried to obtain lenacapavir, she said, she has been told it is out of stock.
Julius Bampe, a polygamous builder whose younger wife tested positive for HIV earlier this year, also sought the injection. His wife was immediately started on treatment to suppress the infection, but when Bampe went for his own dose, none was available. He told PBS that staff said the drug was what they would have given him but that supplies were insufficient for everyone.
Tarsisio Biryeija, a nursing officer and counselor at Mbarara Health Centre IV, told PBS the facility received 40 doses in April, initially restricted to pregnant women at risk of acquiring HIV. Guidelines were later broadened to include couples like the Bampe family and sex workers. That batch was used quickly, and a further 70 doses sent in June were gone within 10 days, he said.
Immaculate Nyamwija, founder of a Mbarara organization called Action for Improved Health and Wealth, provides counseling, condoms and other support to women who face discrimination elsewhere. She told PBS the gap between demand and supply is the central problem. "Who would not wish to take (lenacapavir) for six months? Who would wish to be on drugs every day?" she said.
Pressure on Gilead
Doctors Without Borders, known by its French initials MSF, has argued that the generic approval and the planned rollout do not go far enough. The group is asking Gilead to make low-cost doses available in more countries and to sell directly to MSF so it can protect more people sooner.
"Gilead says it wants to end the HIV epidemic 'for everyone, everywhere,' but its actions say otherwise," Melissa Barber, MSF USA's global health advocacy and policy adviser, said in a statement cited by PBS.
Uganda has cut its HIV rate substantially over the past three decades, and its burden is lower than that of some southern African nations. Even so, officials there say transactional sex remains a major driver of new infections — precisely the pattern that a long-acting injection could interrupt.
What to watch: whether generic manufacturing ramps up fast enough to meet the Global Fund's 2028 target, and whether Gilead widens the list of countries and buyers eligible for discounted pricing.
