Merck’s doravirine/islatravir combination meets efficacy endpoint in HIV-1

Merck (MRK) announced topline results from two pivotal Phase 3 trials of the investigational, oral, two-drug, single-tablet regimen of doravirine/islatravir in adults with HIV-1 infection that is virologically suppressed on different antiretroviral therapy regimens. The success criterion for the primary efficacy hypothesis was met in both trials. DOR/ISL was demonstrated to be non-inferior to bART and non-inferior to BIC/FTC/TAF. The superiority criteria were not met in a third trial. Primary safety objectives of both trials were also met. The company is planning to present findings at a future scientific congress and will also plan to file these data with regulatory authorities. In the U.S., doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals, as a single agent and a component of a single-tablet regimen. Islatravir is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for the treatment of HIV-1.