Gilead Sciences presented findings from over 40 HIV studies at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024), showcasing advancements in treatment and prevention strategies. The data include results from the PURPOSE 2 trial, evaluating lenacapavir for HIV prevention, and long-term outcomes from the BICSTaR study on Biktarvy. These findings emphasize Gilead's commitment to addressing unmet needs and ending the HIV epidemic.
Lenacapavir for HIV Prevention: The PURPOSE 2 Trial
The PURPOSE 2 trial (NCT04925752) is a pivotal Phase 3 study assessing twice-yearly injectable lenacapavir for HIV prevention among cisgender men and gender-diverse individuals. Lenacapavir, a capsid inhibitor, could become the first twice-yearly HIV prevention option if approved. Full results were presented at HIV Glasgow, expanding on data previously shared at the HIV Research for Prevention Conference in Lima, Peru.
Biktarvy's Long-Term Efficacy: The BICSTaR Study
Four-year outcomes from the BICSTaR study (NCT03580668), a global, observational, real-world study, demonstrate the effectiveness, safety, and tolerability of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) in treatment-naïve and treatment-experienced individuals with HIV and comorbidities. As the HIV-positive population ages, managing comorbidities becomes crucial, and BICSTaR provides insights into coordinated, person-centered HIV care.
Investigational Once-Weekly Oral Regimen: Lenacapavir and Islatravir
Late-breaking data from a Phase 2 study (NCT05052996) evaluating a once-weekly oral combination regimen of lenacapavir and islatravir were presented. This investigational treatment could offer a more convenient dosing schedule for people with HIV. Additional research includes evaluating lenacapavir with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment with twice-yearly dosing.
Further Research and Pipeline Updates
Gilead also presented data on GS-1720, a selective integrase strand transfer inhibitor (INSTI) being evaluated in a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182. This aims to provide new long-acting treatment options. Additional late-breaker presentations covered treatment-emergent resistance associated mutations (TE-RAMs) and clinical features during second-generation INSTI failure from the ROSETTA-registry.
Gilead's Commitment
"We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery," said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. "Our contributions to HIV Glasgow 2024 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovations in HIV research."
