Merck & Co., Inc. announced positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B). At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels =50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). The safety and tolerability profile of DOR/ISL during the trials to date are consistent with the previously reported Phase 2 studies. Doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals, as a single agent (PIFELTRO) and a component of a single-tablet regimen (DELSTRIGO; DOR/3TC/TDF). Islatravir is Merck?s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of people living with HIV-1 infection in combination with other antiretrovirals. Detailed findings from these studies will be presented at a future scientific congress and will form the basis of global regulatory applications. The ILLUMINATE clinical trial program is evaluating DOR/ISL in a broad patient population, which includes people with HIV-1 who are virologically suppressed on ART, those who are heavily treatment experienced and those who are new to HIV treatment. The clinical trial program also includes pediatric participants with HIV-1 weighing at least 35 kg who are virologically suppressed and have not previously been treated. Merck is committed to enrolling diverse people in HIV-1 clinical trials, especially among communities who may be disproportionately impacted by HIV, such as women and those within the Black and Latinx communities.