– 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 –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the 20th European AIDS Conference (EACS) to be held in Paris, France from October 15-18. As the leader in HIV innovation, Gilead will provide an update on its strategic initiatives, key collaborations, and share new scientific data from its HIV research and development programs. The research that will be presented at EACS 2025, along with the Gilead-led symposia and supported community forums, reflect the company’s person-centered approach to advancing scientific discovery and underscores its focus on community partnership to help end the HIV epidemic.
“It is fitting that thousands of scientists and community stakeholders will gather in Paris for EACS 2025,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “The first Declaration on Fast-Track Cities to end the HIV epidemic was signed in Paris on World AIDS Day in 2014. Fueled by Gilead’s longstanding commitment to develop and deliver HIV prevention and treatment options tailored to the individual’s needs, my colleagues and I continue to strive for a future without HIV, in Europe and around the world.”
Gilead’s EACS 2025 program highlights include:
HIV Prevention Research
Expanding reach to populations in Europe not currently using PrEP: Researchers will present the strategies that supported the recruitment of people in high-priority populations across France and the UK for the Phase 2 PURPOSE 5 trial (N06513CT312), which is evaluating the persistence of twice-yearly lenacapavir among people who need or want PrEP but who have not previously engaged with existing HIV prevention options. Through collaboration with community advisory groups, thoughtful site selection and targeted recruitment goals for understudied populations, the study team achieved its enrollment goals and established a model for future HIV prevention studies.
Safety data build understanding around concomitant use of lenacapavir: Further data from the PURPOSE 2 trial examined the concomitant use of lenacapavir by people also taking statins administered to lower cholesterol and PDE-5 inhibitors to treat erectile dysfunction. Lenacapavir is a moderate inhibitor of the enzyme CYP3A4 and could potentially increase levels of these classes of drugs. The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustment.
HIV Treatment Research
Five-year outcomes from the BICSTaR (NCT03580668) Study: Long-term, real-world data were analyzed from individuals with HIV who were enrolled in Canada, France and Germany. The five-year outcomes are consistent with the results observed from multiple Phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. The results underscore the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV. This could help inform treatment strategies for these groups.
Demographic profile of ARTISTRY-1 participants: Baseline characteristics from the Phase 3 portion of an ongoing study (NCT05502341) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily oral regimen of bictegravir and lenacapavir. The results contextualize the unmet need for people living with HIV on complex regimens who may benefit from a single-tablet regimen. In September, the last patient completed their Week 48 visit in the Phase 3 portion of ARTISTRY-1. A topline data readout for the primary endpoint is anticipated to be announced before the end of the year.
Late-breaking: Week 96 outcomes of an oral combination of Islatravir and Lenacapavir: Data from an ongoing, randomized, open-label Phase 2 study (NCT05052996) demonstrate that switching to an investigational once-weekly combination regimen of islatravir and lenacapavir enabled people living with HIV to maintain viral suppression to two years. At 96 weeks, based on the Missing = Failure and Missing = Excluded analyses, respectively, 88.5% (46/52) and 100% (n=46/46) of adults treated with the novel investigation combination maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) demonstrating the potential of the combination, which could become the first weekly oral HIV treatment option. Two Phase 3 studies – ISLEND-1 and ISLEND-2 are ongoing.
Week 52 results of twice-yearly regimen of Lenacapavir and broadly neutralizing antibodies (bNAbs): The Phase 2 (NCT05729568) open-label study from Gilead’s long-acting treatment pipeline demonstrated that twice-yearly lenacapavir in combination with bNAbs (teropavimab [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB]) maintained viral suppression in people with HIV with susceptible viruses out to 52 weeks and was generally well tolerated. The investigational combination has the potential to be the first twice-yearly complete regimen. The novel treatment combination is now progressing to Phase 3 clinical development.
Gilead’s symposia at EACS are focused on exploring the treatment needs of women with HIV throughout life, plus long-acting PrEP options and opportunities to address unmet HIV prevention needs:
- A long shot becomes reality: Be part of history (October 15, 1-2 p.m. CEST)
- Her life – A different journey to long-term success? (October 15, 3-4 p.m. CEST)
- What’s preventing us from HIV prevention? Leaving no person behind (October 17, 8-9 a.m. CEST)
Overview of Scientific Presentations
| HIV PREVENTION RESEARCH |
| Recruitment of Disproportionately Affected Populations in the PURPOSE 5 Study Evaluating Lenacapavir for PrEP in France and the UK |
| Analysis of Barriers to Testing for HIV Prevention and Linkage to Care Among Migrants in Europe |
| Commonly Prescribed Concomitant Medications and Clinical Safety Findings with Lenacapavir for PrEP in PURPOSE 2 |
| Annual Persistence to Twice-Yearly Lenacapavir vs Daily Oral F/TDF for PrEP in the PURPOSE 2 Trial |
| HIV TREATMENT RESEARCH |
| Efficacy and Safety of a Twice-Yearly Regimen of Lenacapavir, Teropavimab, and Zinlirvimab: Phase 2 Week 52 Results |
| Oral Weekly ISL/LEN in VS PWH: 96 Week Outcomes from a Phase 2 Study |
| Five-Year Extended Follow-Up of the Observational BICSTaR Cohort: Final Analysis in PWH Receiving B/F/TAF in Routine Clinical Practice |
| Demographics and Clinical Characteristics of Phase 3 Participants in ARTISTRY-1, An Open- Label Study Comparing a BIC/LEN STR With Complex ART Regimens |
For more information about Gilead at EACS 2025, including a complete list of abstracts and their corresponding oral and poster sessions, please visit: https://eacs-conference.com
Lenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU.
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination.
The combination of islatravir and lenacapavir is investigational. Use in combination for the treatment of HIV has not been approved by any regulatory authority.
Teropavimab and zinlirvimab are investigational compounds. The use of these compounds in combination with lenacapavir are investigational, are not approved by any regulatory authority, and their safety and efficacy has not been established. The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established.
There is currently no cure for HIV or AIDS.
Please see below for U.S. and E.U. Indications and Important Safety Information, including Boxed Warning, for Yeztugo and Yeytuo.
Please see below for U.S. Indications and Important Safety Information, including Boxed Warning, for Biktarvy.
