Gilead will present long-term Phase 3 PURPOSE trial data showing sustained efficacy of twice-yearly lenacapavir for HIV PrEP, full ISLEND once-weekly HIV treatment results, and pipeline updates at AIDS 2026.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Gilead Sciences will present new long-term clinical data across its HIV prevention, treatment, and cure programs at the 26th International AIDS Conference (AIDS 2026), taking place from July 26 to 31 in Rio de Janeiro, Brazil. The presentations include 52-week open-label extension results from the Phase 3 PURPOSE trials evaluating twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP), full Phase 3 ISLEND data on an investigational once-weekly oral HIV treatment, and updates from its long-acting treatment pipeline.
Long-Term PURPOSE Data Reinforce Twice-Yearly Lenacapavir for HIV Prevention
The conference will feature new 52-week open-label extension (OLE) data from the Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) studies, which evaluated twice-yearly lenacapavir as PrEP in diverse populations at risk of HIV acquisition.
Following completion of the randomized blinded phases, more than 95% of eligible participants across both studies chose to continue or switch to lenacapavir from daily oral PrEP regimens, including Truvada® and Descovy®.
The long-term follow-up included more than 7,178 person-years in PURPOSE 1 and 5,295 person-years in PURPOSE 2. No new HIV infections occurred during the OLE phase in PURPOSE 1, including among participants who switched from daily oral PrEP. PURPOSE 2 reported one HIV infection among participants who remained on lenacapavir and no infections among those who switched from oral PrEP.
Adherence remained high, with 96% of participants in PURPOSE 1 and 92% in PURPOSE 2 receiving scheduled twice-yearly injections through 52 weeks.
The safety profile remained consistent with earlier findings, with no new safety signals and comparable safety among participants who continued lenacapavir and those who switched from oral PrEP.
Additional prevention research will examine reasons participants selected lenacapavir during the extension phase, evaluate alternative injection sites, and present survey findings on PrEP awareness across multiple countries.
Once-Weekly Oral HIV Treatment to Report Full Phase 3 Results
Gilead and Merck will present full results from the Phase 3 ISLEND trials evaluating an investigational once-weekly oral single-tablet regimen combining lenacapavir with islatravir. The late-breaking presentation follows positive topline results announced in June and represents one of the most advanced long-acting oral treatment approaches under clinical development.
Islatravir is a next-generation nucleoside analogue, while lenacapavir is the first approved HIV capsid inhibitor. Together, the combination could provide a once-weekly alternative to daily antiretroviral therapy if approved.
Long-Acting HIV Pipeline Continues to Expand
Additional treatment data include five-year pediatric outcomes for Biktarvy® from study NCT02881320 and two-year real-world findings from the BICSTaR study (NCT03580668), evaluating treatment effectiveness after switching to once-daily Biktarvy in people living with HIV.
Gilead will also report Week 104 results from a Phase 2 study (NCT05729568) evaluating lenacapavir combined with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872). This investigational regimen is currently advancing into the Phase 3 Daybreak 1 (NCT07682961) and Daybreak 2 (NCT07683000) trials as a potential complete twice-yearly HIV treatment.
Further pipeline presentations will characterize the resistance profile of investigational integrase inhibitor GS-3242, which is being studied with lenacapavir in the Phase 2 Pulsar 1 (NCT07645287) and Pulsar 2 (NCT07708727) studies as another potential twice-yearly injectable regimen.
The company will also provide updates from its HIV cure research program during the conference.
Global Access Strategy Expands Following Yeztugo Approval
Gilead recently expanded its global access partnership with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, increasing the planned reach of its no-profit supply program for twice-yearly lenacapavir from 2 million to up to 3 million people through 2028. Lenacapavir is now available in 10 priority countries across sub-Saharan Africa, while generic manufacturing partners continue preparations for broader access following regulatory approvals.
The company is also working with the Pan American Health Organization (PAHO) to expand access across Latin America while advancing regional regulatory submissions.
Commenting on the upcoming presentations, Jared Baeten, MD, PhD, Senior Vice President of Clinical Development and Head of Gilead’s Virology Therapeutic Area, said the data reflect the company’s continued focus on expanding prevention, treatment, and cure options while working with communities worldwide to address the evolving needs of people affected by HIV.
The AIDS 2026 presentations further strengthen the growing clinical evidence supporting long-acting HIV therapies, with twice-yearly lenacapavir and investigational once-weekly oral treatment strategies representing important developments that could broaden therapeutic options and improve adherence for people at risk of or living with HIV.
Reference
Gilead to Present New HIV Research at AIDS 2026 Across Prevention, Treatment and Cure