Merck Receives FDA Approval for Monthly Oral Islatravir for HIV Prevention

Merck today announced that the FDA has approved monthly oral islatravir for HIV pre-exposure prophylaxis (PrEP) in adults at risk of HIV-1 infection. In the Phase 3 IMPOWER-010 trial, monthly oral islatravir demonstrated non-inferiority to daily oral emtricitabine/tenofovir disoproxil fumarate for HIV prevention. Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a long intracellular half-life enabling monthly dosing. This approval provides individuals at risk of HIV a more convenient monthly oral PrEP option compared to daily regimens.