Gilead's lenacapavir posts one infection in 5,295 person-years at AIDS 2026
Long-term follow-up from PURPOSE 2 extends the twice-yearly PrEP shot's efficacy signal past its approval, as Gilead pushes access deals across Latin America.
Executive Summary
- Gilead is presenting extended open-label follow-up from a completed Phase 3 PrEP trial, adding a second year of real-world data to a result that already supported approval.
- New infections stayed close to zero over an extended, unblinded stretch of dosing, and adherence to the twice-yearly injection held near the level seen in the blinded phase.
- The drug already carries the field's own recent precedent for capsid inhibition in PrEP, and Gilead's other lenacapavir studies chart the mechanism's spread into once-yearly dosing and treatment settings.
- Beyond the science, the presentation is paired with an access push into Latin America and expanded supply commitments, which extends the drug's reach rather than its data package.
The presentation
Gilead Sciences, Inc. said it will present new long-term follow-up data from the open-label extension phase of PURPOSE 2 (NCT04925752) at the International AIDS Conference in Rio de Janeiro, July 26-31, 2026. The trial tested twice-yearly subcutaneous lenacapavir against daily oral Truvada for HIV pre-exposure prophylaxis in cisgender women across the United States, Brazil, South Africa, and five other countries, enrolling 3,292 participants. "Progress against the HIV epidemic requires both scientific innovation and enduring partnerships with communities around the world," said Jared Baeten, Gilead's senior vice president of clinical development and virology therapeutic area head. Gilead+1Gilead to Present New HIV Research at AIDS 2026 Across Prevention, Treatment and CureJul 21, 2026Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV InfectionNCT04925752
The result
The open-label extension logged more than 5,295 person-years of follow-up, with one HIV infection among participants who continued lenacapavir and zero infections among those who switched to lenacapavir from daily oral Truvada. Adherence, defined as receiving injections on the twice-yearly schedule, held at 92% through 52 weeks, and the safety profile was consistent with the randomized blinded phase, with no new signals identified. That extension follows a blinded-phase interim analysis in which lenacapavir cut HIV incidence by 96% versus the background rate and beat daily Truvada with a p-value of 0.00245, results that led Gilead's data monitoring committee to stop the blinded phase early and move everyone to open-label lenacapavir. GileadGilead to Present New HIV Research at AIDS 2026 Across Prevention, Treatment and CureJul 21, 2026
Where the drug stands
Lenacapavir already carries FDA approval for PrEP under the brand Yeztugo, cleared in June 2025 on the strength of the PURPOSE 1 and PURPOSE 2 data, after the FDA granted it Breakthrough Therapy Designation in October 2024. The drug is also approved as Sunlenca for HIV treatment in a separate indication. Because the approval already stands, the open-label extension's job is to confirm the result holds as more participants accumulate time on the drug, not to establish it for the first time.
Competitive position
Within the same target-indication pairing, HIV-1 capsid inhibition for PrEP, the field holds one other Phase 3 program, Gilead's own once-yearly lenacapavir formulation under study in NCT07047716. The nearest mechanism-distinct comparator in PrEP is ViiV Healthcare's long-acting cabotegravir, an integrase inhibitor already in Phase 4 follow-up. Gilead is also advancing lenacapavir in HIV treatment combinations, including with bictegravir, extending the same capsid-inhibitor mechanism from prevention into therapy. NCT04925752Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV InfectionNCT04925752
Access and regulatory reach
The presentation arrives alongside Gilead's disclosure that it is engaging with the Pan American Health Organization to expand access to lenacapavir across Latin America and advancing regulatory filings in the region, while preparing for generic availability and expanded no-profit supply commitments tied to PEPFAR and the Global Fund. Those access mechanics run alongside the clinical data rather than being tested by them. GileadGilead to Present New HIV Research at AIDS 2026 Across Prevention, Treatment and CureJul 21, 2026
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