Merck has received FDA approval for Idynso, its two-drug regimen administered in a once-daily pill to treat HIV-1 infection in adults.
Idynso is a non-INSTI, tenofovir-free complete regimen consisting of 100 mg of doravirine and 0.25 mg of islatravir. The drug is for adults with virologically-suppressed HIV-1 with no history of virologic treatment failure. Patients must be on a stable antiretroviral regimen with no known substitutions associated with doravirine resistance.
The drug received approval due to demonstrating non-inferior efficacy compared to the three-drug regimen Biktarvy (BIC/FTC/TAF) in a double-blind phase 3 trial. At week 48, 1% of participants had a viral load of HIV-1 RNA 50 or more copies per mL, which was the same as those who continued treatment with BIC/FTC/TAF. In addition, IDYNSO was shown to be non-inferior to bART in an open-label trail. Again, 1% of participants reached a viral load of HIV-1 RNA 50 or more copies per mL compared to 5% of participants who continued with bART.