Gilead and Merck Launch Phase 2 Trial of Weekly Oral Two-Drug HIV Regimen: Lenacapavir + Islatravir

October 26, 2021 /BioonBIOON/ -- Gilead and Merck & Co. recently announced the initiation of a Phase 2 clinical study to evaluate, in HIV-1-infected adults who have achieved virologic suppression on antiretroviral therapy, the ... byOnce-weekly oral regimen of islatravir and lenacapavirsafety and antiviral efficacy. The primary endpoint was the proportion of patients with HIV-1 RNA viral load ≥50 copies/mL at Week 24 of treatment.

This clinical study is the first in a collaboration between MSD and Gilead Sciences to develop a potential long-acting HIV treatment regimen.. Through the collaboration announced by MSD and Gilead Sciences in March 2021, the two companies seek to build upon their legacy of transforming HIV care by focusing on long-acting therapies. Both parties believe that long-acting therapies may represent a meaningful innovation in HIV drug development.

Islatravir is a novel oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development by MSD., for use in combination with other antiretroviral agents for the treatment of HIV-1-infected patients.Lenacapavir is a long-acting HIV-1 capsid inhibitor developed by Gilead Sciences., currently under review in the United States and the European Union: in combination with other antiretroviral agents, for the treatment of patients with multidrug-resistant HIV-1 infection who have previously received multiple regimens.

Both islatravir and lenacapavir have long half-lives and have demonstrated activity at low doses in independent clinical studies, supporting their development as long-acting combination regimens, including oral and injectable formulations.。Although people living with HIV can take a once-daily single-tablet oral regimen, lower-dose oral or injectable regimens have the potential to address patient preferences, as well as issues related to stigma, adherence, and privacy.

Dr. Jared Baeten, Vice President of HIV Clinical Development at Gilead Sciences, stated: “Partnerships and collaborations are essential to continuing the significant progress toward ending the HIV epidemic. This innovative research collaboration builds on the efforts of both companies, leveraging continuous scientific advancements in HIV to help bring an end to the epidemic. Launching this trial marks an important step toward our goal of providing long-acting options that address the diverse needs and preferences of people living with HIV.”

Dr. Joan Butterton, Vice President, Global Clinical Development, Infectious Diseases, MSD Research Laboratories, stated: “The initiation of this study is key to further understanding the potential of the islatravir and lenacapavir combination for the treatment of HIV-1, and demonstrates the shared commitment of MSD and Gilead to addressing the unmet needs of people living with HIV, and contributing to global efforts to end this epidemic.” (Bioon.com)

Original Source:Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults