US FDA Approves Pritelivir (Hovilpri) for Refractory HSV Infection

The US FDA has approved pritelivir (Hovilpri) for treating mucocutaneous lesions caused by herpes simplex virus (HSV) infection in immunocompromised adults whose infection is refractory, with or without documented resistance, to acyclovir, valacyclovir, or famciclovir. Mechanism of action  Pritelivir inhibits the HSV helicase-primase complex, preventing viral DNA synthesis. It is active against HSV-1 and HSV-2.

Clinical evidence  In the Phase 3 PRIOH-1 trial involving 101 immunocompromised adults, lesions healed by Day 28 in 63% of participants receiving pritelivir versus 34% receiving investigator’s choice treatment. By Day 42, response rates were 82% and 42%, respectively. Dosage and administration  Available as 100 mg film-coated tablets  Day 1: 400 mg orally as a loading dose  Thereafter: 100 mg orally once daily, with or without food, until lesions heal  If a dose is missed,…