Gilead Reports Positive Results in Oral HIV Treatment Study
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Gilead Reports Positive Results in Oral HIV Treatment Study
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Gilead Reports Positive Results in Oral HIV Treatment Study
Gilead Sciences has announced promising outcomes from its research on an oral treatment for HIV.
The study focuses on the combination of two drugs—islatravir and lenacapavir—with the goal of evaluating their safety and antiviral efficacy when administered weekly.
This Phase 2 clinical trial involves adults with HIV-1 who have achieved viral suppression through antiretroviral therapy (ART).
The primary endpoint is the proportion of participants with an HIV-1 RNA viral load of ≥50 copies/mL at Week 24.
This study marks the first collaborative effort between Gilead and Merck & Co. to develop a potential long-acting HIV treatment. Building on their partnership, established in March 2021, the companies aim to introduce innovative solutions in HIV care by focusing on long-acting therapies. Both companies believe that such approaches could represent a significant breakthrough in HIV treatment.
Drug Profiles: Islatravir and Lenacapavir
- Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) developed by Merck. It is designed for use in combination with other antiretroviral drugs to treat HIV-1.
- Lenacapavir is a long-acting capsid inhibitor developed by Gilead. It is currently under review in the U.S. and the European Union for use alongside other antiretrovirals to treat multi-drug-resistant HIV-1.
Both islatravir and lenacapavir exhibit long half-lives, and clinical studies have demonstrated their effectiveness at low doses, supporting the possibility of developing them into long-acting oral and injectable formulations. While many HIV patients already benefit from single-tablet daily regimens, longer-acting options—whether oral or injectable—could address concerns related to treatment preferences, stigma, adherence, and privacy.
Expert Perspectives
Dr. Jared Baeten, Vice President of HIV Clinical Development at Gilead, emphasized the importance of collaboration in making progress toward ending the HIV epidemic:
“Partnerships and cooperation are essential to advancing our efforts in HIV treatment. This innovative study builds on the strengths of both companies, contributing to ongoing scientific progress that brings us closer to our goal of ending the HIV epidemic. The launch of this trial is an important step toward offering long-acting options that meet the diverse needs and preferences of people living with HIV.”
Similarly, Dr. Joan Butterton, Vice President of Global Clinical Development for Infectious Diseases at Merck Research Laboratories, noted:
“This study is crucial in exploring the potential of islatravir and lenacapavir as a combination therapy for HIV-1. It reflects our shared commitment to addressing unmet needs in HIV treatment and making meaningful contributions to global efforts aimed at ending this epidemic.”
This collaborative research has the potential to deliver transformative, long-acting treatments, offering new hope for people living with HIV worldwide.
Gilead Reports Positive Results in Oral HIV Treatment Study
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