Gilead Faces Pressure After FDA Clears Cheaper HIV Drug for Global Rollout

The U.S. Food and Drug Administration announced on Monday the tentative approval of a generic version of lenacapavir. This move is expected to accelerate the production and distribution of the HIV-prevention drug to 120 low-income countries. The generic formulation is projected to cost roughly $40 per year, a sharp decrease from the U.S. list price of $28,218.

Lenacapavir is developed by Gilead Sciences and offers nearly complete protection against HIV with just two injections per year. Health experts argue the drug could shift the global trajectory of the epidemic due to its long-lasting effects. Andrew Hill, a senior visiting research fellow at the University of Liverpool, stated that the current rollout pace is too slow. He said, “The rate of growth (of lenacapavir rollout) isn’t fast enough. We need to be getting to the millions pretty soon.”

The Global Fund aims to distribute the drug to 3 million people by the end of 2028. Melissa Barber, an MSF USA global health advocacy and policy adviser, told a statement that this target is insufficient. She said, “Gilead says it wants to end the HIV epidemic ‘for everyone, everywhere,’ but its actions say otherwise.” MSF is urging Gilead to sell cheaper doses directly to the organization to protect more people faster.

In Mbarara, Uganda, a city in the west with an estimated 10% adult HIV infection rate, residents struggle to access the medication. Lisa Mutoni, a sex worker, takes daily preexposure prophylaxis but says lenacapavir is often unavailable. She noted, “If you know that you have that injection for six months, you feel like you are safe.” Mutoni added that the pill format allows patients to forget doses, whereas the injection provides a reliable window of protection.

Julius Bampe, a builder in Mbarara, sought the injection after his younger wife tested positive for HIV earlier this year. He was told that doses were finished. Bampe said, “When I got here, they said that is what they would have given me, but they said they didn’t have enough doses for everyone.” His facility received 40 doses in April and another 70 in June. Tarsisio Biryeija, a nursing officer at Mbarara Health Centre IV, reported that the June batch was used up within 10 days.

Ugandan health authorities indicate that transactional sexual encounters drive a large portion of new infections. Immaculate Nyamwija, founder of Action for Improved Health and Wealth, provides support to women in the city. She said, “It is a challenge, because the demand is high and the doses are few.” She asked who would prefer daily drugs over a six-month injection.

The generic approval could alleviate these supply constraints in the coming months. The FDA’s decision allows manufacturers outside Gilead to produce the drug, potentially lowering costs and increasing availability in regions like Mbarara where current options are limited.