USA – Gilead Sciences, and Merck have announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in HIV patients who are virologically suppressed on antiretroviral therapy.
Participants enrolled in the study are 18 years old and above. The study, which will take place at 25 locations across the United States.
The Phase 2 study will assess the safety and antiviral efficacy of an oral weekly regimen of Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, combined with Gilead’s investigational capsid inhibitor, lenacapavir.
The proportion of study participants with an HIV-1 RNA viral load of 50 c/mL at Week 24 is the primary endpoint.
According to the companies, both islatravir and lenacapavir have long half-lives and have shown activity at low doses in independent clinical studies.
“Partnerships and collaborations are critical to continuing the tremendous progress that has been made toward ending the HIV epidemic,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
“This innovative research collaboration builds on the efforts of both companies to help make the end of the epidemic a reality through continued scientific advances in HIV. Initiating the trial represents an important step forward toward our goal of offering long-acting options that can help address the differentiated needs and preferences of the diverse range of people living with HIV.”
Merck and Gilead announced a collaboration in March 2021 to build on their legacies of transforming HIV care by focusing on long-acting therapies, which could represent a significant innovation in HIV drug development.
Both islatravir and lenacapavir have long half-lives and have shown activity at low doses in independent clinical studies, supporting their development as an investigational combination regimen with long-acting oral and injectable formulations.
While daily, single tablet oral regimens are available for people living with HIV, oral or injectable regimen options that allow for less frequent dosing have the potential to address preference concerns as well as stigma, adherence, and privacy issues.
Lenacapavir and islatravir, both alone and in combination, are investigational and have not been approved anywhere in the world. Their safety and efficacy have yet to be proven. Currently, there is no cure for HIV or AIDS.