Oral 'Vaccine' Era for HIV Dawns: Merck Launches Phase III Trial of Once-Monthly Oral PrEP Candidate Islatravir
Nov 26, 2020 11:23
CST Updated
11:23
MSD
Pharmaceutical R&D and Manufacturer
Bill and Melinda Gates Foundation
Grant Foundation
MSD Announces Collaboration with the Bill & Melinda Gates FoundationMSD recently announced a collaboration with the Bill & Melinda Gates Foundation. This partnership will conduct IMPOWER 22, a Phase III pivotal, randomized, multicenter, double-blind, active-controlled clinical study, among women and adolescent girls at high risk of HIV-1 infection in sub-Saharan Africa. The study aims to evaluate the efficacy and safety of MSD’s novel oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), islatravir (formerly known as MK-8591), as a once-monthly oral pre-exposure prophylaxis (PrEP) regimen. The study is scheduled to commence in early 2021.
In the IMPOWER 22 study, the active comparator is emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), administered orally once daily. During the study, approximately 4,500 cisgender women and adolescent girls aged 16 to 45 years will be randomly assigned (stratified by site and age) to receive either islatravir or FTC/TDF.
Dr. Roy D. Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at MSD Research Laboratories, stated: “Our collaboration with the Bill & Melinda Gates Foundation reflects our shared mission to end the global HIV epidemic through meaningful innovation in HIV prevention. Multiple clinical studies have confirmed the promising potential of islatravir as a once-monthly oral PrEP candidate. Through this partnership, we can further explore the potential of islatravir to help achieve one of the common goals of global public health: reducing the number of new HIV infections.”
Dr. Emilio Emini, Director of the Tuberculosis and HIV/AIDS Program at the Bill & Melinda Gates Foundation, stated, “Unless we can effectively prevent HIV infection among high-risk populations, the HIV epidemic will not be ended globally. This collaboration will help advance HIV science and may provide new options for preventing HIV infection among high-risk women in sub-Saharan Africa and around the world.”
In addition to IMPOWER 22, MSD plans to conduct further research in HIV prevention. These studies will include IMPOWER 24, a global Phase III clinical trial evaluating the efficacy and safety of islatravir as a once-monthly pre-exposure prophylaxis (PrEP) regimen in other key populations affected by the HIV epidemic, including men who have sex with men and transgender women.
In the realm of HIV treatment, islatravir is also poised to play a more significant role. At the 2020 International AIDS Conference, studies revealed that islatravir demonstrates efficacy far superior to other approved antiretroviral drugs, exhibits activity against HIV strains with resistance-associated mutations, and possesses a prolonged half-life in vivo. Meanwhile, researchers have evaluated the safety and efficacy of the combination of islatravir and doravirine, which has shown good tolerability across various dosages in current clinical trials.
Islatravir may be available in different formulations in the future, and further studies on PrEP and HIV treatment are ongoing.
In the IMPOWER 22 study, the active comparator is emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), administered orally once daily. During the study, approximately 4,500 cisgender women and adolescent girls aged 16 to 45 years will be randomly assigned (stratified by site and age) to receive either islatravir or FTC/TDF.
Dr. Roy D. Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at MSD Research Laboratories, stated: “Our collaboration with the Bill & Melinda Gates Foundation reflects our shared mission to end the global HIV epidemic through meaningful innovation in HIV prevention. Multiple clinical studies have confirmed the promising potential of islatravir as a once-monthly oral PrEP candidate. Through this partnership, we can further explore the potential of islatravir to help achieve one of the common goals of global public health: reducing the number of new HIV infections.”
Dr. Emilio Emini, Director of the Tuberculosis and HIV/AIDS Program at the Bill & Melinda Gates Foundation, stated, “Unless we can effectively prevent HIV infection among high-risk populations, the HIV epidemic will not be ended globally. This collaboration will help advance HIV science and may provide new options for preventing HIV infection among high-risk women in sub-Saharan Africa and around the world.”
In addition to IMPOWER 22, MSD plans to conduct further research in HIV prevention. These studies will include IMPOWER 24, a global Phase III clinical trial evaluating the efficacy and safety of islatravir as a once-monthly pre-exposure prophylaxis (PrEP) regimen in other key populations affected by the HIV epidemic, including men who have sex with men and transgender women.
In the realm of HIV treatment, islatravir is also poised to play a more significant role. At the 2020 International AIDS Conference, studies revealed that islatravir demonstrates efficacy far superior to other approved antiretroviral drugs, exhibits activity against HIV strains with resistance-associated mutations, and possesses a prolonged half-life in vivo. Meanwhile, researchers have evaluated the safety and efficacy of the combination of islatravir and doravirine, which has shown good tolerability across various dosages in current clinical trials.
Islatravir may be available in different formulations in the future, and further studies on PrEP and HIV treatment are ongoing.