FDA approves once-daily Idvynso tablet for treating HIV

The U.S. Food and Drug Administration has approved Merck’s Idvynso (doravirine/islatravir), a new, once-daily, two-drug single tablet for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL).

The single tablet, containing 100 mg doravirine and 0.25 mg islatravir, is for adults on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

Idvynso is contraindicated for use with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers and lamivudine or emtricitabine.

The approval is based on data from two randomized, active-controlled, noninferiority trials. In the double-blind Trial 052, participants were randomly assigned to stay on Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; 171 individuals) or switch to Idvynso (342 individuals). Results showed that 1% of participants in both groups had a viral load of ≥50 copies/mL at 48 weeks.

In the open-label Trial 051, participants were randomly assigned to stay on their oral antiretroviral therapy (ART) regimen (185 individuals) or switch to Idvynso (366 individuals). Results showed that 1% of participants who were switched to Idvynso had a viral load of ≥50 copies/mL at week 48 versus 5% who continued on ART.

“As the only two-drug, non-integrase strand transfer inhibitor, tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options,” Eliav Barr, senior vice president and chief medical officer at Merck Research Laboratories, said in a statement. “As the health needs of adults living with HIV change over time, Idvynso gives clinicians a new choice for HIV treatment.”

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