Merck’s IDVYNSO earns FDA nod as a once-daily, two-drug HIV regimen

FDA approved IDVYNSO, a once-daily two-drug regimen (doravirine/islatravir) for adults with virologically suppressed HIV-1, intended to replace their current antiretroviral therapy. It is the first non-INSTI, tenofovir-free two-drug therapy to demonstrate non-inferiority to a three-drug regimen in two Phase 3 trials (052 vs BIKTARVY and 051 vs baseline ART). The product will be available in pharmacies after May 11 and carries contraindications with strong CYP3A inducers and with lamivudine or emtricitabine, plus safety considerations including potential severe skin reactions and drug interactions. Trials enrolled 708 participants with diverse demographics, supporting another option in HIV treatment.