Twice-Yearly HIV Prevention Shot Lenacapavir Expands to More Countries in 2026

February 16, 2026

The United States and the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an expanded commitment in April 2026 to scale up access to lenacapavir, a twice-yearly injectable HIV prevention drug, aiming to reach an additional 1 million people over the next three years.

The expanded commitment brings the joint goal to 3 million people reached with lenacapavir for pre-exposure prophylaxis (PrEP) through 2028, according to a Global Fund announcement. Initial doses have already been delivered to nine African countries, including Eswatini, Kenya, Lesotho, Nigeria, Zambia, and Zimbabwe, with rollout continuing across additional early-adopter nations.

Lenacapavir was approved by the FDA in June 2025 as the first twice-yearly injectable option for HIV PrEP. Clinical trials known as PURPOSE 1 and PURPOSE 2 found the drug provided near-complete protection against HIV acquisition across cisgender women, men who have sex with men, transgender women, transgender men, and gender-nonbinary participants, according to Yale School of Medicine's review of the trial data.

The drug's long dosing interval is intended to address a persistent challenge in HIV prevention: adherence to daily oral PrEP pills, which many users find difficult to sustain due to pill fatigue and stigma concerns.

Not every result has been perfect. At the 2026 Conference on Retroviruses and Opportunistic Infections (CROI), researchers reported that four individuals across the two major lenacapavir trials acquired HIV despite receiving on-time injections, prompting ongoing discussion among clinicians about why a small number of "breakthrough" infections occurred even with proper dosing, according to a report from the San Francisco AIDS Foundation.

Gilead Sciences has also granted voluntary licenses to generic manufacturers to help expand affordable global supply, according to Unitaid.

Sources: The Global Fund, San Francisco AIDS Foundation / CROI 2026.