Lenacapavir’s Biggest Test Is Getting the HIV Prevention Shot to Patients

Trials show lenacapavir, made by Gilead Sciences, is almost 100% effective in preventing HIV infection. The drug is given as two shots a year, offering an alternative to daily PrEP pills for people at high risk of infection.

The central takeaway: the science is promising, but the public-health impact depends on whether patients can actually get the drug at affordable prices and in reliable supply.

Business Insider reports that lenacapavir costs $14,000 a dose in the United States, while Gilead has agreed to license generic versions at around $40 a dose in 120 low- and middle-income countries. Several Latin American countries, including Brazil, Mexico, Argentina, and Peru, do not qualify for that reduced-price pathway because they are classified as upper-middle income countries.

That has created a sharp access dispute: some of the countries involved in clinical trials that proved the drug works are now facing prices many people cannot afford. Activists protested at the International AIDS Society Conference in Rio De Janeiro, while Brazilian officials said negotiations with Gilead had stalled.

Brazil’s health minister, Dr. Alexandre Padilha, said Gilead wanted a price 10 times higher than what Indonesia and Thailand were paying, according to the article. He told the conference: “Innovation without access is not an innovation. It is an injustice.”

Gilead said it is negotiating directly with Latin American governments and said access discussions go beyond pricing, including regulatory pathways, implementation readiness, procurement mechanisms, and long-term sustainability. The company also said it understands the urgency of expanding access in Latin America and the Caribbean and already covers 24 countries in the region.

Other long-acting HIV prevention options could eventually affect pricing and access. Fiocruz signed a memorandum of understanding with MSD Brasil to explore manufacturing alimatravir, a once-monthly oral pill still in Phase 3 trials, while Brazil also plans to incorporate ViiV Healthcare’s long-acting cabotegravir into its PrEP program by the end of the year, pending final agreement and review.

Supply remains a major constraint because lenacapavir was first licensed in its twice-yearly form in 2025 and manufacturing capacity is still building. Fewer than 250,000 people across the developing world are currently accessing the product, while UNAIDS Executive Director Winnie Byanyima wants that scaled to 20 million within three years.