Gilead Showcases HIV Research Advances at EACS 2025

10/15/2025 – 03:30 AM

– New Data Showcase Safety Profile of Twice-Yearly Lenacapavir for Pre-Exposure Prophylaxis (PrEP) with Other Medications and Recruitment Strategies for PURPOSE 5 –

– Five-Year BICSTaR Results Offer Insights into Long-Term Treatment with Biktarvy®, Helping Inform the Future of Coordinated, Person-Centered HIV Care –

– Latest Results on Novel Long-Acting Combination Regimens, Including Once-Weekly and Twice-Yearly Treatment Options –

FOSTER CITY, Calif. – Gilead Sciences, Inc. (Nasdaq: GILD) is set to present a comprehensive update on its HIV research and development programs at the 20th European AIDS Conference (EACS) in Paris, France, from October 15-18. The company’s presentations will encompass strategic initiatives, key collaborations, and new scientific data, reinforcing Gilead’s commitment to a person-centered approach aimed at eradicating the HIV epidemic.

“The EACS 2025 gathering in Paris is particularly significant,” stated Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “It echoes the spirit of the first Declaration on Fast-Track Cities to end the HIV epidemic, signed here in 2014. Our work is driven by a dedication to create prevention and treatment options tailored to individual needs, furthering our ambition for a future without HIV across Europe and the globe.”

Gilead’s EACS 2025 program key highlights:

HIV Prevention Research

Expanding PrEP Access in Europe: A key focus will be the presentation of recruitment strategies used in the Phase 2 PURPOSE 5 trial (N06513CT312), which is evaluating the long-term efficacy and safety of twice-yearly lenacapavir as PrEP in populations across France and the UK who are not currently engaged with existing HIV prevention methods. The study’s team collaborated with community advisory groups and employed strategic site selection and recruitment protocols to achieve enrollment goals and establish a blueprint for future HIV prevention studies. Industry analysts note that such targeted recruitment strategies are crucial in reaching underserved populations and tailoring HIV prevention efforts to specific community needs.

Lenacapavir Safety Profile: Additional data from the PURPOSE 2 trial will shed light on the concurrent use of lenacapavir with statins and PDE-5 inhibitors. Gilead’s data suggests that lenacapavir, a moderate CYP3A4 inhibitor, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustments. This is significant because it broadens the potential patient pool for lenacapavir by clarifying the interaction profile with commonly used medications.

HIV Treatment Research

BICSTaR Study – 5-Year Outcomes: Long-term, real-world data analysis from individuals with HIV in Canada, France, and Germany, enrolled in the BICSTaR study (NCT03580668), showcase the sustained efficacy and safety profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, B/F/TAF). The study’s five-year outcomes align with Phase 3 clinical trials, demonstrating sustained viral suppression, favorable safety and tolerability, and a high barrier to resistance. These findings, observed in both treatment-naïve and treatment-experienced individuals with a high incidence of co-morbidities, underscore the importance of patient-reported outcomes and person-centered approaches in HIV research and treatment strategies, particularly in addressing mental health.

ARTISTRY-1 Participant Demographics: A demographic overview of participants in the Phase 3 ARTISTRY-1 study (NCT05502341) will be presented, emphasizing the unmet need among individuals living with HIV who are on complex treatment regimens. The study is evaluating the effectiveness and usability of switching to a once-daily oral regimen of bictegravir and lenacapavir. Topline data from the primary endpoint is expected to be announced later this year. This trial is closely watched by investors, as a successful outcome could pave the way for a streamlined treatment option, potentially expanding Gilead’s market share in the HIV treatment sector.

Islatravir and Lenacapavir Combination – Week 96 Outcomes: Late-breaking data from an ongoing Phase 2 study (NCT05052996) will highlight the efficacy of switching to a once-weekly combination regimen of islatravir and lenacapavir. At 96 weeks, 88.5% and 100% of participants maintained an undetectable viral load, respectively, based on different analysis methodologies. These results signal the potential for less frequent dosing options, which could dramatically improve patient adherence and quality of life, though further trials are needed before regulatory submission.

Lenacapavir and bNAbs – Twice-Yearly Regimen Week 52 Results: Phase 2 data (NCT05729568) regarding Gilead’s long-acting treatment pipeline, demonstrating that a twice-yearly regimen of lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab (GS-5423, TAB) and zinlirvimab (GS-2872, ZAB), effectively maintained viral suppression over 52 weeks. Data suggest the investigational combination could potentially evolve into the first twice-yearly complete treatment. With the novel treatment combination progressing forward to Phase 3 of clinical development, Gilead’s long-acting injectable portfolio could transform HIV therapy.

Gilead’s symposia at EACS:

1. A long shot becomes reality: Be part of history (October 15, 1-2 p.m. CEST)
2. Her life – A different journey to long-term success? (October 15, 3-4 p.m. CEST)
3. What’s preventing us from HIV prevention? Leaving no person behind​ (October 17, 8-9 a.m. CEST)

Overview of Scientific Presentations

These studies offer crucial insights into long-acting treatment and prevention options, with implications for patient compliance, quality of life and overall public health strategies. Further evaluation of clinical data, cost-effectiveness analyses, and real-world impact will be crucial in understanding the full potential of these approaches in the global fight against HIV.

Disclaimer: Lenacapavir for PrEP is still investigational outside of the U.S. and EU and has not yet been approved. Bictegravir and lenacapavir combination, islatravir and lenacapavir combination, teropavimab, and zinlirvimab are all investigational compounds and their use has not been approved by any regulatory authority. There is currently no cure for HIV or AIDS. Treatment can only provide suppression of the virus. Please consult full prescribing information for approved medications, including boxed warnings.

Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.

About Gilead Sciences

Gilead Sciences, Inc. is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Full Prescribing Information for Truvada, Yeztugo, and Biktarvy including Boxed Warning, are available at www.gilead.com.

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