Monthly Oral PrEP Found Effective for HIV-1 Prevention
New Jersey-based Merck announced results from a Phase 2a clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of six monthly oral doses, over 24 weeks, of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of HIV-1 infection in adults at low risk of contracting HIV-1.
After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.
Most adverse events (AEs) were mild, and there were no serious drug-related AEs in people who received islatravir.
The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose.
“The 24-week analysis of investigational, once-monthly oral islatravir not only builds upon the PK data we have already seen but also provides encouraging support for the safety and tolerability profile of this HIV-1 PrEP regimen,” said Dr. Joan Butterton, VP, global clinical development, infectious diseases, Merck Research Laboratories, in a press release.
“As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”
Islatravir is currently being evaluated across various dosing regimens for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. An overview of the islatravir treatment and prevention development program is available at this Merck weblink.
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