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Late-Breaking Clinical Data and Real-World Evidence Presented at HIV Glasgow as Gilead Extends Leadership Efforts Toward Ending the Epidemic
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November 7, 2024
- Full Results From PURPOSE 2 Study Exploring Lenacapavir as a Potential Twice-Yearly HIV Prevention Option Among a Broad and Geographically Diverse Range of Cisgender Men and Gender-Diverse People -
- Four-Year Outcomes From Real-World BICSTaR Study Further Demonstrate the Consistent Efficacy and Safety Profile of Biktarvy, Providing Insights for HIV Clinical Care -
- Late-Breaking Oral Presentation From Phase 2 Study Evaluating an Investigational Once-Weekly Oral Combination Treatment Regimen of Islatravir/Lenacapavir -
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic.
"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."
HIV Prevention Research
A late-breaking oral presentation at HIV Glasgow will be the first in-depth look at the full results from the PURPOSE 2 trial (NCT04925752), including data not presented last month at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 2 is a pivotal Phase 3 trial evaluating twice-yearly lenacapavir, Gilead's injectable HIV-1 capsid inhibitor for the investigational use of HIV prevention, among a broad and geographically diverse range of cisgender men and gender-diverse people. The trial is part of a comprehensive program assessing lenacapavir in a variety of populations who need or want pre-exposure prophylaxis (PrEP) and, if approved, would be the first and only twice-yearly HIV prevention choice.
Prevention research presented at HIV Glasgow will also include a systematic review and meta-analysis of real-world data mapping HIV prevalence against PrEP uptake, health economic data on the impact of PrEP in France and the return on investment that HIV prevention has yielded for the French healthcare system. Data will also be presented from a study examining same-day PrEP initiation and its effect on PrEP uptake at a Canadian clinic.
HIV Treatment Research
Continuous scientific discovery in HIV treatment is a pillar of Gilead's commitment to help end the epidemic. At HIV Glasgow, presented study results and analyses will include further evaluation of Biktarvy • (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, late-breaking data from the Phase 2 study (NCT05052996) evaluating an investigational once-weekly oral combination regimen of lenacapavir and islatravir will be presented during an oral session.
Specifically, Biktarvy presentations will include four-year outcomes from BICSTaR, (NCT03580668) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like.
Additional research studies evaluating Biktarvy include three-year outcomes from ALLIANCE, an ongoing Phase III study (NCT03547908) evaluating the efficacy and safety of the single-tablet regimen versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy.
Gilead will also present outcomes from the Phase 2 portion of the ARTISTRY-1 study (NCT05502341) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily regimen of lenacapavir and bictegravir.
Additional lenacapavir data to be presented at HIV Glasgow will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing.
HIV treatment research pipeline findings also include a presentation of new pharmacokinetic and resistance data on GS-1720, a selective integrase strand transfer inhibitor (INSTI). The agent is being evaluated as a component of a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182 aimed at providing new long-acting treatment options for people with HIV.
A late-breaker presentation will compare the rate of treatment emergent resistance associate mutations (TE-RAMs) in people with HIV taking three-drug single tablet regimens and cabotegravir+rilpivirine. A separate late-breaker oral presentation will explore clinical features and resistance patterns during second-generation INSTI failure from the ROSETTA-registry.
Full press release link:
https://investors.gilead.com/news/news-details/2024/Late-Breaking-Clinical-Data-and-Real-World-Evidence-Presented-at-HIV-Glasgow-as-Gilead-Extends-Leadership-Efforts-Toward-Ending-the-Epidemic/default.aspx
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