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New Data Show Twice-Yearly Lenacapavir Achieved Nearly Twice the One-Year Persistence of Daily Oral F/TDF in HIV Prevention
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November 6, 2026
PURPOSE 5 is the first randomized study designed specifically to compare persistence between a long-acting injectable HIV prevention option and daily oral PrEP among individuals who would benefit from PrEP and were not currently taking oral PrEP. The Phase 2 study conducted in the United Kingdom and France evaluates whether twice-yearly lenacapavir can improve persistence compared with daily oral F/TDF over 52 weeks.
- Zero HIV Acquisitions Occurred Among Participants Receiving Twice-Yearly Lenacapavir During the 52-Week Study Period -
- PURPOSE 5 Study Findings Highlight the Potential of Long-Acting HIV Prevention Option to Address Persistence Challenges with Up to a Full Year of Protection After Second Dose -
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from the PURPOSE 5 trial showing significantly higher persistence-defined as consistent and continuous on-time use-among people starting twice-yearly injectable lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP), compared with those starting daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF). The trial included people in the United Kingdom (UK) and France who would benefit from PrEP. These data will be presented at HIV Glasgow 2026.
Key Highlights:
Twice-yearly lenacapavir achieved significantly higher one-year PrEP persistence than daily oral F/TDF, with 85.6% of participants receiving twice-yearly lenacapavir remaining persistent through Week 52 compared with 46.3% for participants taking once-daily F/TDF (p<0.0001).
PURPOSE 5 is the first randomized study specifically designed to compare persistence between a long-acting HIV prevention option and daily oral PrEP among individuals not currently taking PrEP.
Zero HIV acquisitions occurred among participants receiving twice-yearly lenacapavir during the 52-week study period.
Results highlight the potential of twice-yearly lenacapavir to address persistence challenges that can limit the effectiveness of HIV prevention efforts.
"In PURPOSE 5, people in France and the United Kingdom receiving twice-yearly lenacapavir injections were much more likely to keep taking PrEP effectively compared with those receiving daily PrEP tablets. These findings suggest long-acting injections for PrEP may help address a very important barrier to sustained HIV prevention for people who need it. It is notable that the study was able to reach a high proportion of new PrEP users."
"This study was designed specifically to evaluate one of the most important challenges in HIV prevention today: helping people remain on PrEP for as long as they need protection," said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. "These results demonstrate that twice-yearly lenacapavir has the potential to help close the gap between starting PrEP and staying on PrEP which can have an important impact on our efforts to end the HIV epidemic in Europe and around the world."
PURPOSE 5 Results
PURPOSE 5 is an ongoing Phase 2, randomized, open-label study evaluating PrEP persistence among individuals with HIV prevention needs in the United Kingdom and France who were not taking PrEP at the time of enrollment. Participants were randomized 2:1 to receive either twice-yearly lenacapavir or daily oral F/TDF and were followed for 52 weeks.
A total of 267 participants enrolled in the study, including cisgender men (72.3%), cisgender women (7.1%) and gender-diverse individuals (20.6%). 37.8% were PrEP-naïve at baseline.
At Week 52:
85.6% (154/180) of participants receiving twice-yearly lenacapavir remained persistent on PrEP
46.3% (37/80) of participants receiving daily oral F/TDF remained persistent on PrEP
The difference of 39.3 (95% CI: 26.66% - 51.41%) was statistically significant ( p<0.0001)
Zero HIV acquisitions occurred among participants receiving lenacapavir. One HIV acquisition was reported in the F/TDF group; drug-level analysis at the time of diagnosis was consistent with fewer than two doses of F/TDF per week. Participant retention across both groups remained high throughout the study, with 89.4% of participants in the lenacapavir group and 83.9% of participants in the F/TDF group attending the Week 52 study visit.
For the purpose of this study Gilead used strict protocol definitions of persistence. For lenacapavir persistence was defined as receipt of on-time LEN injection at Day 1/baseline and week 26 (+/- 2 weeks) and on-time follow-up visit at week 52. For F/TDF persistence was defined as dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations consistent with ≥ 4 doses/week (≥ 700 fmol/punch) at Weeks 13, 26, 39, and 52.
link to full press release
https://www.gilead.com/news/news-details/2026/new-data-show-twice-yearly-lenacapavir-achieved-nearly-twice-the-one-year-persistence-of-daily-oral-ftdf-in-hiv-prevention
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