The FDA has approved Merck’s once-daily, two-drug regimen for adults with virologically suppressed HIV-1.
The treatment combines 100 mg doravirine and 0.25 mg islatravir and is indicated for patients with no history of virologic treatment failure and no known resistance to doravirine, according to an April 21 news release from the company.
The regimen is the first non-INSTI, tenofovir-free, once-daily, complete two-drug option shown to have noninferior efficacy compared to a three-drug regimen in phase 3 trials.
Approval was supported by data from two phase 3 trials involving 708 participants. At 48 weeks, viral suppression rates were comparable to standard regimens, with 92% to 96% of patients maintaining HIV-1 RNA less than 50 copies per milliliter, the release said.
The drug will be available in pharmacies after May 11.
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