The Phase II trial for a weekly regimen has potential to address stigma and privacy issues.
Last week, leading pharma giants Gilead Sciences and Merck, known as MSD outside the U.S. and Canada, have announced they would be launching a Phase II clinical trial looking to evaluate an investigational, weekly oral combination ‘treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy’. “Partnerships and collaborations are critical to continuing the tremendous progress that has been made toward ending the HIV epidemic,” said Jared Baeten, Vice President, HIV Clinical Development, Gilead. The two announced their partnership back in March this year, with which they are looking to build onto their respective legacies ‘transforming HIV care by focusing on long-acting therapies, which may represent a meaningful innovation in HIV drug development.’
“The initiation of this study is key to further understanding the potential of islatravir and lenacapavir in combination for the treatment of HIV-1, and demonstrates Merck and Gilead’s shared commitment to address the unmet needs of people living with HIV and to contribute to global efforts to end the pandemic,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. Both drugs have long half-lives and had previously demonstrated activity at low dosages in separate trials. This is believed to support the development of the duo as a combination therapy. Though there are daily, single tablet oral regimens available on the market for people living with the virus, a less frequent oral or injectable regimen option could help address issues related to stigma, adherence, and privacy.