Lenacapavir Shortage Limits HIV Protection in Mbarara Despite FDA Generic Approval

The U.S. Food and Drug Administration announced a tentative approval on Monday for a generic version of lenacapavir, a drug that provides nearly complete protection against HIV with only two injections per year. The move is designed to accelerate distribution to 120 low-income countries at a cost of roughly $40 per person annually, a sharp drop from the U.S. list price of $28,218.

Health experts say the drug could shift the global fight against HIV because of its long duration, but current supply levels are insufficient to meet demand. Andrew Hill, a senior visiting research fellow at the University of Liverpool, stated that the rollout growth rate is not fast enough and that the world needs to reach millions of people soon. The Global Fund targets 3 million recipients by the end of 2028, though Doctors Without Borders argues that goal falls short of the need.

In Mbarara, Uganda, where an estimated 10% of the adult population has HIV, the shortage is already affecting care. Lisa Mutoni, a sex worker in the city, takes daily preexposure prophylaxis but seeks the biannual shot because it reduces the risk of forgetting doses. She reported that providers often tell her the stock is finished. "If you know that you have that injection for six months, you feel like you are safe," Mutoni said.

Julius Bampe, a builder who recently learned his younger wife had HIV, also found himself without treatment. He sought the injection to protect himself but was told there were not enough doses for everyone. His facility, Mbarara Health Centre IV, received 40 doses in April and 70 more in June. Tarsisio Biryeija, a nursing officer there, confirmed the June batch was used up within 10 days. Initial guidelines limited the drug to pregnant mothers at risk, but rules later expanded to include couples and sex workers.

Melissa Barber, an MSF USA global health advocacy adviser, criticized the manufacturer Gilead Sciences for not making cheap doses available to more countries. "Gilead says it wants to end the HIV epidemic ‘for everyone, everywhere,’ but its actions say otherwise," Barber said in a recent statement. The group is urging Gilead to sell directly to MSF to protect more people faster.

Local organizations continue to provide support while waiting for better supply. Immaculate Nyamwija, founder of Action for Improved Health and Wealth, provides counseling and condoms to women facing discrimination. She noted that demand is high while doses remain few. "Who would not wish to take (lenacapavir) for six months? Who would wish to be on drugs every day?" she asked. Uganda has lowered its infection rates over the last three decades, but authorities say transactional encounters in places like Mbarara remain a primary driver of new cases.