Merck’s Doravirine and Islatravir Met Primary Endpoints for Treatment of HIV-1

Phase 3 ILLUMINATE showed the percentage of individuals with HIV-1 RNA levels ≥50 copies/mL for the once-a-day combination pill of doravirine/islatravir.

Merck announced positive top-line results from two pivotal phase 3 trials of the once-a-day combination pill of doravirine/islatravir (DOR/ISL) for individuals with HIV-1 who are virologically suppressed on different antiretroviral therapy regimens (ART), the company said in a statement.

“We are encouraged by the results from the Phase 3 ILLUMINATE SWITCH A and B trials, in which the DOR/ISL dual regimen efficacy was comparable to certain commonly used 3-drug regimens,” Joan Butterton, MD, vice president of global clinical development and infectious diseases at Merck Research Laboratories, said in the statement. “We will continue to study doravirine/islatravir in diverse populations of people living with HIV and look forward to sharing data from these trials.”

Both trials met the primary efficacy endpoint of percentage of individuals with HIV-1 RNA levels ≥50 copies/mL. The safety and tolerability profile of DOR/ISL during the trials are consistent with previously reported phase 2 studies.

The ILLUMINATE clinical trials included individuals with HIV-1 who are virologically suppressed on ART, those who are heavily treatment experienced, and those who are new to HIV treatment. The program also included pediatric individuals with HIV-1 weighing at least 77.1 pounds who are virologically suppressed and have been treated.

Doravirine is approved for the treatment of individuals with HIV-1 in combination with other antiretrovirals as a single agent and a component of a single-tablet regimen. Islatravir, created by Merck, is an investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of individuals living with HIV-2 infection in combination with other antiretrovirals.

Reference

Merck announces positive top-line results from pivotal phase 3 trials evaluating investigational, once-daily oral fixed dose combination of Doravirine/Islatravir for the treatment of people with HIV-1 infection. Merck. News release. October 25, 2021. Accessed October 25, 2021. https://www.merck.com/news/merck-announces-positive-top-line-results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-fixed-dose-combination-of-doravirine-islatravir-for-the-treatment-of-people-with-hiv-1/