for HIV-1 infection in virologically suppressed adults (maintenance regimen)
FDA approved Idvynso (doravirine/islatravir) on April 20, 2026 — ahead of the May 10 2026 PDUFA target. Once-daily oral two-drug single-tablet regimen for adults with virologically-suppressed HIV-1. First NRTTI-containing complete regimen; positioned as a maintenance alternative to integrase-inhibitor backbones (Biktarvy, Dovato).
HIV-1 is a chronic viral infection that attacks the immune system, leaving the body vulnerable to life-threatening infections and cancers if untreated. Idvynso combines doravirine, which blocks a key viral enzyme, with islatravir, a new type of drug that disrupts HIV's ability to copy its genetic material. Together, they may offer a simpler maintenance option for controlled HIV with fewer drugs than standard three-medication regimens.
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Source: ClinicalTrials.gov