Merck (MRK, Financial) announced that its two pivotal Phase 3 trials, MK-8591A-051 and MK-8591A-052, have met their primary endpoints. The trials evaluated a once-daily, two-drug single-tablet regimen of doravirine/islatravir (DOR/ISL) and demonstrated non-inferiority compared to standard antiretroviral therapy (ART) in adults with HIV-1 who have achieved virologic suppression.
Merck plans to present detailed results from these trials at upcoming scientific conferences and will submit the data to regulatory authorities. Doravirine, developed by Merck, is an innovative, once-daily oral non-nucleoside reverse transcriptase inhibitor. It works by binding to the HIV-1 virus's reverse transcriptase, preventing the conversion of RNA into DNA, thus blocking the replication of the HIV-1 virus. Doravirine is already approved in the U.S. for treating adults with HIV-1 who have not previously received antiretroviral therapy.
