Lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) - (PURPOSE-5)

November 6, 2026: Gilead Sciences (NASDAQ: GILD) reported Phase 2 PURPOSE 5 results for twice-yearly injectable lenacapavir as HIV PrEP in people in the UK and France not taking PrEP at enrollment; the data will be presented at HIV Glasgow 2026. At Week 52, PrEP persistence was significantly higher with lenacapavir versus daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF): 85.6% (154/180) vs 46.3% (37/80), a 39.3-point difference (95% CI 26.66%-51.41%; p<0.0001).

The ongoing open-label randomized study enrolled 267 participants and was designed to compare persistence between long-acting injectable PrEP and daily oral PrEP. Zero HIV acquisitions occurred in the lenacapavir arm during the 52-week study period; one HIV acquisition occurred in the F/TDF arm, with drug-level analysis consistent with fewer than two doses per week. Retention at Week 52 was 89.4% for lenacapavir and 83.9% for F/TDF.

Safety was generally consistent with prior studies. Serious adverse events were uncommon (3.9% lenacapavir; 3.4% F/TDF), none were considered treatment-related, and no participants discontinued lenacapavir بسبب adverse events. Common treatment-related events with lenacapavir were mild/moderate injection-site reactions, including nodules (67.8%), pain (60.0%), induration (20.6%), and erythema (17.8%).