February 17, 2026 — Leads & Copy —Gilead Sciences, Inc. (Nasdaq: GILD) has announced new clinical and real-world data from its HIV treatment and prevention portfolio and research pipeline.
The data will be presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026), held February 22-25 in Denver, Colorado. The presentations will focus on expanding therapeutic options for communities affected by HIV. Notable abstracts include Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, which examined the efficacy and safety of a single-tablet combination regimen of bictegravir and lenacapavir for HIV treatment.
According to Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences, the company is committed to ending the HIV epidemic globally through scientific innovation and the development of novel options responsive to the needs of people with HIV.
Gilead will present data at CROI 2026 demonstrating how new regimens can potentially expand options and optimize HIV treatment. The Phase 3 ARTISTRY-1 and ARTISTRY-2 trials will highlight the efficacy and safety of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in people living with HIV who are virologically suppressed and switched from their prior antiretroviral therapy to the combination. Both studies were selected for the late-breaking abstract program. These findings provide further detail on the positive topline results from ARTISTRY-1 and ARTISTRY-2, announced in November and December 2025.
Additional research will expand scientific understanding of Gilead’s exploratory HIV treatment combinations, including:
96-week viral suppression results from a Phase 2 study evaluating islatravir plus lenacapavir, which has the potential to be the first weekly oral HIV treatment regimen.
Patient-reported outcomes from lenacapavir in combination with the broadly neutralizing antibodies (bNAbs) teropavimab (GS-5423, TAB) and zinlirvimab (GS-2872, ZAB), which has the potential to be the first twice-yearly HIV treatment regimen.
Results on the safety, pharmacokinetics, and antiviral activity of GS-3242, an investigational long-acting integrase inhibitor being evaluated for potential twice-yearly dosing for HIV treatment, in a combination regimen that would include lenacapavir.
Gilead will also present new research focused on broadening HIV prevention options to help meet the needs of diverse populations who need or want pre-exposure prophylaxis (PrEP) and expanding understanding of how less frequent dosing strategies could help to support uptake and persistence. This includes further data from the PURPOSE program spotlighting the efficacy and safety profile of twice-yearly subcutaneous lenacapavir for PrEP among broad and geographically diverse populations, including cisgender men and women, and gender-diverse individuals, plus updates on the resistance profile of lenacapavir as a long‑acting PrEP option.
Real-world data on concomitant medication use in people taking PrEP in the United States will be presented, including insights into coadministration with lenacapavir, along with the design of the Phase 3 trial for investigational once-yearly intramuscular lenacapavir for PrEP and a model-informed drug development approach to support dose selection.
Gilead continues to advance efforts to identify an efficacious, scalable cure for HIV. At CROI 2026, Gilead will present new data from the first HIV cure clinical program conducted in South Africa, including genetic characterization and viral control data from cisgender women participating in the FRESH (Females Rising through Education, Support, and Health) cohort.
Bictegravir and lenacapavir, islatravir and lenacapavir, teropavimab and zinlirvimab, and GS-3242 are investigational and not approved anywhere globally. Their safety and efficacy have not been established by the U.S. FDA.
Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
There is currently no cure for HIV or AIDS.
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Source: Gilead Sciences, Inc.
