Advertisment
Gilead Sciences Unveils Groundbreaking HIV Research at 25th International AIDS Conference
Gilead Sciences, Inc announced its program for the upcoming 25th International AIDS Conference (AIDS 2024), taking place in Munich, Germany, and virtually, from July 22-26. As the leading innovator in HIV, Gilead will share new data from its research and development programs and Gilead-supported collaborations that unite leading scientific innovation and partnership aimed at ending the HIV epidemic. “The AIDS 2024 conference convenes the global HIV community – scientists, advocates, and partners from the public and private sectors,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Clinical Development, Gilead Sciences. “Our contributions to this year’s meeting demonstrate Gilead’s leadership in person-centered innovations across HIV prevention, treatment, and cure. Our scientific advancements are grounded in collaboration with community and research partners around the world. I look to a future where every person has options to help obtain their own HIV prevention or treatment success and where we’ve come together to end the HIV epidemic.”
Gilead’s AIDS 2024 program highlights include:
Late-breaking: Full data from pivotal PURPOSE 1 trial: Data evaluating lenacapavir, an investigational, twice-yearly medicine for HIV prevention, will be presented at the Co-Chairs’ Choice session on July 24, 10:30 a.m.-noon, CEST. Developed in partnership with communities affected by HIV around the world, the PURPOSE clinical trials comprise the most comprehensive and diverse HIV prevention trial program ever conducted. PURPOSE 1 is the first HIV prevention trial to intentionally include pregnant and lactating women. In June, the topline results from an interim analysis of the Phase 3 trial were announced, demonstrating 100% efficacy for the investigational use of HIV prevention in cisgender women.
Oral presentation: Week 48 outcomes from ARTISTRY-1: The latest data from an ongoing Phase 2/3 study (NCT05502341) designed to evaluate an investigational once-daily single-tablet regimen of bictegravir and lenacapavir in virologically suppressed people with HIV who are on a complex regimen.
Two-year outcomes from BICSTaR: The latest findings from an ongoing global, observational study evaluating the effectiveness, safety and tolerability of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities.Additional research studies evaluating Biktarvy include five-year outcomes from the pivotal trials evaluating Biktarvy as a long-term treatment option in older adults with a high burden of comorbidities and the Hispanic/Latine community, respectively.
HIV treatment research pipeline findings will also include new data on GS-1720 and GS-4182. Both investigational agents are being clinically evaluated as part of potential future once-weekly oral HIV treatment options. Additionally, resistance analyses from a study evaluating the investigational combination of lenacapavir + teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB) will be presented to support previously presented data demonstrating the potential of this combination as a novel, long-acting, twice-yearly treatment option.
Symposia focused on addressing barriers to HIV care and prevention: Two symposia to discuss the latest progress in policies and practical solutions from around the world to help achieve more equitable access to HIV care and services.
- What’s Preventing Us From Preventing? Pushing Together Towards the UNAIDS 2030 HIV Prevention Goals (July 24, 7-8 a.m., CEST) will convene experts and community members to strategize about working to achieve UNAIDS 2030 goals. Topics include forward-thinking policies, person-centered care and innovative solutions for health equity.
- How Treatment Selection Can Support Long-Term Success (July 25, 12-1 p.m., CEST) will bring together providers and the HIV community to explore ways to help achieve long-term success in HIV management. Discussions will focus on the importance of treatment selection from the outset, aiming for long-term, durable viral suppression.
Gilead-supported initiatives highlighting collaboration to advance health equity: To help end the HIV epidemic, it is essential to extend beyond science. Gilead will highlight two initiatives that aim to bridge gaps in HIV awareness and improve linkage to and retention in care:
- The Person-Centered Care (PCC) Program with the International AIDS Society (IAS) is a multidisciplinary, integrated and long-term, focused approach to care for people with and affected by HIV that is responsive to their evolving needs, priorities and preferences.
- RADIAN ® – a groundbreaking partnership between Gilead and the Elton John AIDS Foundation (EJAF) – will host a community exchange event, led by community leaders from Eastern Europe and Central Asia (EECA), to discuss how RADIAN-supported innovation and services are elevating efforts to end the HIV crisis in EECA.
Overview of Scientific Presentations
| HIV TREATMENT RESEARCH (B/F/TAF) |
| Efficacy and Safety of B/F/TAF in Hispanic/Latine Adults With HIV-1 Initiating First-Line Therapy: 5-Year Follow-Up From Two Phase 3 Studies |
| Switching To B/F/TAF in A Real-World Cohort of Older People With HIV And High Burden of Non AIDS-Related Comorbidities (BICSTaR) |
| LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) |
| Centring Community Leadership With Purpose: Inclusion Of Adolescents, Ciswomen, and Pregnant And Lactating Individuals in a Phase 3 Clinical Trial Evaluating Lenacapavir and F/TAF For PrEP |
| Twice-Yearly Lenacapavir or Daily Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Cisgender Women: Interim Analysis Results from the PURPOSE 1 Study |
| Experiences and Quality of Life with Long-Acting Lenacapavir from People With Multidrug-Resistant HIV-1 Enrolled in the Phase 2/3 CAPELLA Study |
| Injection Site Reactions with Subcutaneous Lenacapavir Administration at Alternate Injection Sites |
| Resistance Analyses During Treatment of Lenacapavir With Broadly Neutralizing Antibodies in PWH |
| HIV PIPELINE RESEARCH |
| Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in Virologically Suppressed People With HIV-1 on Complex ART Regimens at Baseline (Artistry-1) |
| Phase 1a PK and Safety of Single Ascending Doses of GS-1720 in Healthy Participants Supports Oral Weekly Administration and Phase 1b Dose Selection |
| Nonclinical Pharmacology Profile of GS-1720, a Novel, Highly Potent Once-Weekly Oral HIV-1 INSTI Inhibitor in Clinical Development |
| Safety and PK Profile of Single and Multiple Ascending Doses of GS-4182, an Oral Prodrug of Lenacapavir, in Participants Without HIV-1 |
| Nonclinical Profile of GS-4182, a Once-Weekly Oral Prodrug of the HIV-1 Capsid Inhibitor Lenacapavir in Clinical Development |
| ADDITIONAL HIV PREVENTION RESEARCH |
| Real-World Adherence of HIV-1 Oral PrEP Regimens in the United States: A Group-Based Trajectory Modeling Approach |
| HIV CURE RESEARCH |
| GS-8588, a Novel Envelope-Targeting Bispecific T-Cell Engager for HIV Cure |
For more information, including a complete list of abstracts and their corresponding oral and poster session titles, please visit: https://programme.aids2024.org/
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established.
GS-5423, GS-2872, GS-1720, GS-4182 and GS-8588 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown.
Lenacapavir, marketed as Sunlenca, 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 and prevention that could uniquely fit into the lives of people with HIV and individuals who need or want pre-exposure prophylaxis (PrEP).
The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program.
Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. Please also see below for the U.S. Indication and Important Safety Information for Sunlenca.
There is currently no cure for HIV or AIDS.
