Gilead commits to HIV prevention rollout for low-income countries despite funding uncertainty
Gilead Sciences says it still plans to supply its twice-yearly injection for preventing HIV infection in low-income countries if it wins U.S. approval despite funding uncertainty over the Trump Administration’s pullback in aid spending.
Some AIDS experts, including activists and doctors, say the Gilead drug, lenacapavir, could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million.
An FDA approval decision is expected by June 19 for lenacapavir, which proved to be nearly 100% effective at preventing HIV in large trials.
If the Food and Drug Administration green lights the drug, and its view is seconded by the WHO, the shots could start to roll out early in 2026 to at least 2 million people in 18 low-income countries based on Gilead’s agreement with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, a worldwide partnership targeting HIV, tuberculosis and malaria.
Gilead agreed to provide lenacapavir at cost for two-to-three years while six generic drugmakers, which were granted licenses to make the medicine for low-income countries, ramp up production.
Experts said a successful launch of a long-acting HIV prevention drug could help stall the epidemic. Until recently, the only pre-exposure prophylaxis (PrEP) options for people at high risk of infection were daily pills, requiring careful adherence to be effective.
“You can foresee a day where there are no new HIV diagnoses. It doesn’t happen if we only do this in the U.S.,” Gilead Chief Commercial Officer Johanna Mercier said. “We need to make sure we have a global approach to this launch.”
PEPFAR being part of the effort is Gilead’s intent and goal, Mercier said. “Unfortunately, if they’re not part of that mix, our goal is still to meet that objective of 2 million people getting access.”
Wall Street has a close eye on lenacapavir, one of the highest-profile drugs to undergo FDA review since President Donald Trump named Robert F. Kennedy Jr. as health secretary and promised to upend the status quo.
Most of the drug’s profits are expected in the U.S., with annual sales reaching $1 billion by next year, according to analysts’ estimates compiled by LSEG.
