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The U.S. Food and Drug Administration has approved Merck's Idvynso (doravirine/islatravir) The approval is based on data from two randomized, active-controlled, noninferiority trials.
The FDA has approved Merck's Idvynso, a once-daily two-drug HIV-1 treatment tablet.
重點
- Idvynso showed noninferior efficacy to current regimens in phase 3 trials, with 1% viral rebound at 48 weeks.
- Idvynso cannot be used with strong CYP3A enzyme inducers, lamivudine, or emtricitabine.
- Idvynso is the first approved two-drug, non-integrase inhibitor, tenofovir-free regimen for HIV-1 in adults.
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