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FDA Approves Merck’s Idvynso as New HIV-1 Treatment

4/22/2026

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Story summary
  • The U.S. Food and Drug Administration approved Merck's regimen Idvynso, combining doravirine and islatravir, for certain adults.
  • The approval could replace some antiretroviral therapies for HIV-1 in adults.
  • In late-stage studies, Merck's regimen matched Gilead's Biktarvy in effectiveness.
  • RBC Capital Markets analyst Trung Huynh cautions that initial commercial impact may be limited, with growth dependent on approvals for untreated patients.
  • Globally, about 40.8 million people live with HIV.