Gilead Reveals New Data From PURPOSE 2 Trial at HIV Prevention Conference

Gilead Sciences, Inc. has unveiled additional findings from its critical Phase 3 PURPOSE 2 trial, which evaluates the efficacy and safety of the HIV-1 capsid inhibitor lenacapavir, administered biannually for HIV prevention among cisgender men and gender-diverse individuals. The new data, presented at the 5th HIV Research for Prevention Conference (HIVR4P) in Lima, Peru, demonstrated a 96% reduction in HIV infections with lenacapavir compared to background HIV incidence.

Lenacapavir showed significant efficacy, with only two incident cases of HIV among the 2,179 participants receiving the biannual injections, resulting in a 99.9% prevention rate. This outcome was markedly better than the background HIV incidence (bHIV) rate of 2.37/100 person-years and also surpassed the performance of once-daily Truvada, which had nine incident cases among 1,086 individuals.

The PURPOSE 2 trial is a double-blind, multicenter study that enrolled 3,273 participants from 88 sites across Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. Participants, including cisgender gay and bisexual men, transgender women, transgender men, and non-binary individuals aged 16 years and older, were randomized in a 2:1 ratio to receive either lenacapavir or Truvada. The trial design reflects the diverse demographics most affected by HIV, emphasizing gender, racial, ethnic, and geographic diversity.

Safety data from the trial indicated that lenacapavir was generally well-tolerated, with no new or significant safety concerns. The most common adverse events (AEs) included injection site reactions (ISRs), rectal chlamydia, and oropharyngeal and rectal gonococcal infections. Serious AEs were slightly less frequent in the lenacapavir group compared to the Truvada group, and few participants discontinued the trial due to ISRs. The incidence of ISRs decreased with subsequent injections.

The study's participant diversity was noteworthy, with 67% of participants being non-White, including 38% Black and 63% Hispanic/Latine individuals. Over 20% of the participants were gender-diverse, including 15% transgender women, 1% transgender men, and 6% non-binary individuals. The trial also included a significant proportion of younger participants, with about one-third being 25 years old or younger.

More comprehensive data from PURPOSE 2 will be disseminated in future publications and conference presentations. Gilead is preparing to initiate regulatory filings for lenacapavir for PrEP by the end of 2024. The company has also announced voluntary licensing agreements with six pharmaceutical companies to produce and distribute cost-effective versions of lenacapavir in 120 low- and lower-middle-income countries, enhancing access to this potential treatment in high-incidence regions.

Gilead's ongoing commitment to HIV research is demonstrated through the PURPOSE program, which includes five global trials focused on innovative science, trial design, community engagement, and health equity. The program aims to evaluate the safety and efficacy of lenacapavir as a twice-yearly injectable to reduce the risk of HIV.

Lenacapavir, along with other investigational and approved HIV treatments, is part of Gilead's broader strategy to provide long-acting, effective HIV prevention options. The company's dedication to combating HIV spans over three decades, marked by significant advancements in treatment, prevention, and research aimed at transforming HIV into a manageable chronic condition.

The company is actively pursuing additional methodologies to support access in various regions, particularly in upper-middle and high-income countries, ensuring efficient regulatory processes and manufacturing plans. This includes offering open-label lenacapavir to participants in the trial countries until it becomes widely available.

Gilead's approach combines rigorous scientific research with strategic partnerships, aiming to deliver transformative impacts on global HIV prevention efforts. The company's holistic strategy underscores its commitment to ending the HIV epidemic worldwide through innovation, accessibility, and community collaboration.