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Gilead to Present New HIV Treatment and Prevention Data at CROI 2026, With a Focus on Expanding Options
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- Pivotal Phase 3 Findings Support the Potential of a Novel Single-Tablet Combination of Bictegravir and Lenacapavir for HIV Treatment -
- Latest Data from the PURPOSE Program Further Demonstrates the Safety and Efficacy Profile of Twice-Yearly Lenacapavir for HIV Prevention -
February 17, 2026
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced details of new clinical and real-world data from its innovative HIV treatment and prevention portfolio and research pipeline that will be presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) being held from February 22-25 in Denver, Colorado. Focusing on expanding therapeutic options to meet the diverse needs of communities affected by HIV, notable late-breaking abstracts include Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials that explored the efficacy and safety of an investigational, single-tablet combination regimen of bictegravir and lenacapavir for HIV treatment.
"Striving for continuous progress in HIV means delivering transformative therapies that support people across their entire treatment journey, aiming for sustained long-term health," said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. "Our commitment to ending the HIV epidemic globally fuels our scientific innovation and our goal to develop novel options that are responsive to the needs and preferences of people with HIV."
HIV Treatment Research
At CROI 2026, Gilead will present data showing how new regimens can potentially expand options and optimize HIV treatment.
Results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials will highlight the efficacy and safety of an investigational, single-tablet combination regimen 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 novel combination. Both studies were selected to be in the late-breaking abstract program. The 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.
HIV Prevention Research
Gilead will present new research focused on broadening HIV prevention options to help meet the needs of diverse populations worldwide who need or want pre-exposure prophylaxis (PrEP), expanding understanding of how less frequent dosing strategies could help to support uptake and persistence:
• 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.
• 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, including insights into coadministration with lenacapavir.
• The design of the Phase 3 trial for investigational once-yearly intramuscular lenacapavir for PrEP, plus a model-informed drug development approach to support dose selection.
HIV Cure Research
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.
For more information about the research Gilead will present at CROI 2026, including abstracts and their corresponding oral and poster sessions, please visit: https://www.croiconference.org.
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. The safety and efficacy of this combination use has not been established by the U.S. FDA.
The combination of islatravir and lenacapavir is investigational. The safety and efficacy of this combination use has not been established by the U.S. FDA.
Teropavimab and zinlirvimab are investigational compounds. The use of these compounds alone or in combination with lenacapavir are investigational, are not approved by any regulatory authority, and their safety and efficacy has not been established.
Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment that could uniquely fit into the lives of people with HIV.
GS-3242 is an investigational compound, and alone or in combination with lenacapavir, is not approved by any regulatory authority. Its safety and efficacy are unknown.
There is currently no cure for HIV or AIDS.
Link to full press release
https://www.gilead.com/news/news-details/2026/gilead-to-present-new-hiv-treatment-and-prevention-data-at-croi-2026-with-a-focus-on-expanding-options
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