FDA approves Merck's once-daily IDVYNSO (doravirine/islatravir) HIV-1 treatment

The FDA approved IDVYNSO, a once-daily single tablet combining 100 mg of doravirine and 0.25 mg of islatravir, for adults with HIV-1 who are virologically suppressed. Merck says it is the first non-INSTI, tenofovir-free, once-daily complete two-drug regimen to show non-inferior efficacy against three-drug BIKTARVY in a head-to-head Phase 3 trial. The approval adds a new oral option to Merck's HIV franchise.

• Once-daily tablet: doravirine 100 mg and islatravir 0.25 mg
• Indication: adults with HIV-1 who are virologically suppressed
• Head-to-head non-inferiority against BIKTARVY in Phase 3
• Contraindicated with strong CYP3A inducers and with lamivudine or emtricitabine