FDA approves generic HIV drug as Uganda struggles with supply shortages
The new authorization aims to cut costs for 120 low-income countries, but local clinics report that current stockpiles are depleted within days.
By Rafael Collins ·
The U.S. Food and Drug Administration announced Monday that it has tentatively approved a generic version of lenacapavir. This decision is expected to lower the annual cost of the HIV prevention injection to approximately $40 in 120 low-income countries. That figure stands in contrast to the $28,218 list price currently seen in the United States.
Lenacapavir is developed by Gilead Sciences and requires only two injections per year to provide near-complete protection against HIV. Health experts argue that the drug’s long duration could shift the global trajectory of the epidemic more effectively than daily pills or monthly shots. The Global Fund projects that this generic approval will help reach 3 million people by the end of 2028.
In Mbarara, a city in western Uganda, the supply of the drug has not kept pace with demand. An estimated 10% of the adult population there lives with HIV, double the national average for the country. Tarsisio Biryeija, a nursing officer at Mbarara Health Centre IV, noted that a batch of 40 doses received in April was used quickly. A subsequent shipment of 70 doses in June was exhausted within 10 days.
Local patients often find that their preferred treatment is unavailable. Lisa Mutoni, a sex worker in Mbarara, takes daily PrEP pills but seeks the biannual injection for its convenience. She reported that clinic staff frequently tell her the stock is finished. Mutoni said the six-month protection provides a sense of safety, particularly for workers who may travel for months at a time.
Julius Bampe, an itinerant builder, also faced a shortage when seeking the drug for himself after his younger wife tested positive for HIV earlier this year. Bampe said he was told there were not enough doses for everyone. His clinic initially received instructions to reserve the 40 April doses for pregnant mothers at risk, a guideline later expanded to include couples and sex workers.
Doctors Without Borders, known as MSF, argues that the current rollout is too slow. Melissa Barber, an MSF USA global health advocacy adviser, criticized Gilead for its actions not matching its goal of ending the epidemic for everyone. The organization is urging the company to sell cheap doses directly to MSF to accelerate distribution.
Immaculate Nyamwija, who runs a support organization in Mbarara, noted that high demand meets low supply. She observed that many women prefer the biannual injection over daily medication to avoid the burden of daily adherence.
