Merck Reports Positive Final Results from Phase 3 Trials of Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for HIV-1 Infection

Merck announced positive top-line results from two pivotal Phase 3 trials of a 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). Detailed findings from these studies will be presented at a future scientific congress and will form the basis of global regulatory applications.

The ILLUMINATE SWITCH A (MK-8591A-017) Study is a randomized, active-controlled, open-label clinical trial to evaluate a switch from ART to investigational, oral, once-daily DOR/ISL (100 mg/0.75 mg) (MK-8591A), in adults with HIV-1 who are virologically suppressed. This trial randomized 672 patients 1:1 to either switch to DOR/ISL or continue with their current baseline ART regimen through W...

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