Lenacapavir, the twice-yearly injectable HIV prevention drug approved by the FDA in June 2025, continues to post strong real-world results as new long-term follow-up data was presented at the AIDS 2026 conference this summer. The drug, developed by Gilead Sciences, is administered by injection once every six months and was approved for pre-exposure prophylaxis (PrEP) after two landmark Phase 3 trials — PURPOSE 1, involving cisgender women in Africa, and PURPOSE 2, involving gay and bisexual men and gender-diverse people across seven countries including the United States.

In the newly reported open-label extension data, more than 95% of eligible participants across both trials chose to continue on lenacapavir or switch to it from daily oral PrEP. Adherence remained high, with 96% of PURPOSE 1 participants and 92% of PURPOSE 2 participants receiving their injections on schedule through 52 weeks. In the PURPOSE 2 extension phase specifically, researchers reported just one HIV infection among participants who stayed on lenacapavir, and no infections among those who switched to it from daily pills. No new safety concerns were identified.

The rollout is also expanding globally: the U.S. State Department announced that the President’s Emergency Plan for AIDS Relief (PEPFAR) will distribute lenacapavir in 8 to 12 high-burden countries during 2026, with a particular focus on reducing new infections among pregnant and breastfeeding people. Separately, researchers are already testing a once-yearly version of the drug — early Phase 1 data presented at the Conference on Retroviruses and Opportunistic Infections showed the formulation maintained effective drug concentrations for at least 56 weeks, suggesting an annual injection option could be feasible in future years.