FDA approves $40 generic HIV shot to expand access

The U.S. Food and Drug Administration tentatively approved a generic version of the HIV-prevention drug lenacapavir on Monday. The move is intended to accelerate distribution to 120 low-income nations at a cost of approximately $40 per year. This price point is a fraction of the $28,218 list price currently charged in the United States.

Lenacapavir, developed by Gilead Sciences, provides protection against HIV with two injections per year. While daily pills and other injectable options like cabotegravir remain effective and available, experts argue that lenacapavir’s long duration could help shift the global epidemic curve. Andrew Hill, a senior visiting research fellow at the University of Liverpool, stated that the current rollout pace is insufficient. He said the goal is to reach millions of patients soon.

In Mbarara, Uganda, a city in the country's west with an estimated 10% adult HIV infection rate, the shortage is acute. Lisa Mutoni, a sex worker, relies on the drug for protection. She noted that the six-month protection window offers peace of mind compared to the risk of forgetting daily pills. However, she frequently encounters empty shelves at local clinics.

Local health officials confirm the demand outstrips supply. Tarsisio Biryeija, a nursing officer at Mbarara Health Centre IV, reported that a batch of 70 doses delivered in June was used within 10 days. An earlier batch of 40 doses in April was initially restricted to pregnant mothers before guidelines expanded to include couples and sex workers. Julius Bampe, a local builder, sought the injection for himself after his wife tested positive for HIV. He was turned away because the facility lacked enough doses for all eligible patients.

Organizations are pressing for faster access. Doctors Without Borders, known as MSF, criticized Gilead’s current strategy. Melissa Barber, an MSF USA global health advocacy adviser, said the company’s actions contradict its stated mission to end the epidemic everywhere. The group is urging Gilead to sell doses directly to MSF to protect more people quickly.

The Global Fund expects to provide the drug to three million people by the end of 2028. In Mbarara, Immaculate Nyamwija, founder of Action for Improved Health and Wealth, continues to provide support services to women facing discrimination. She described the current situation as a challenge where high demand meets few available doses.

Uganda has reduced its overall HIV rates over the past 30 years, but health authorities say transactional sexual encounters remain a primary driver of new infections. The new generic approval aims to address the gap in protection for high-risk groups in these regions.