Gilead and Merck just announced the start of their Phase II clinical trial for a combination treatment to support people living with HIV who are virologically suppressed on antiretroviral therapy.
The study is part of a recent movement towards long-acting care for people living with HIV, and involves a once-weekly oral regimen made up of islatravir and lenacapavir. These kinds of care options seek to fulfill the variety of needs and preferences present within the community of people living with HIV.
Both drugs have long half-lives and have previously demonstrated activity and low dosages. While there are currently daily oral or injectable treatment options for people with HIV-1, there are not many options that allow for less frequent dosing. These options may be more accessible, more cost-effective, and help to give more people access to treatment by appealing to broader preferences as well as reducing issues related to stigma and privacy of treatment.
This phase of the study focuses on safety and the evaluation of the drugs’ antiviral effect, with the primary endpoint of an RNA viral load greater than or equal to 50c/ml at 24 weeks.
This clinical research study is open-label, active-controlled, and takes place across multiple centers. The participants will be randomly assigned in a 2:1 ratio to receive various doses of the combination therapy. The medications will be administered for 48 weeks in total.
Vice President of HIV clinical development at Gilead, Jared Baeten, described the collaboration in an interview with BusinessWire:
“Partnerships and collaborations are critical to continuing the tremendous progress that has been made toward ending the HIV epidemic...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.”
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