FDA Approves Hovilpri for Resistant Herpes Lesions

The FDA has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous herpes simplex virus lesions that failed to respond to standard antivirals like acyclovir, valacyclovir, or famciclovir, according to the FDA's announcement.

HSV 1 and 2 cause painful, fluid filled blisters on skin and mucosal surfaces such as lips, genitals, and eyes. The infection cannot be cured once acquired, and people with compromised immune systems, including those with cancers, HIV, or organ transplants, often face more frequent and severe outbreaks that resist conventional treatment.

This approval rests on a Phase 3 trial, PRIOH 1 Part C, that randomized 101 immunocompromised adults whose HSV had not responded to existing therapies. Participants received either Hovilpri or an investigator selected alternative treatment for up to 28 days, extended to 42 if lesions were healing but incomplete. By day 28, all lesions had healed in 63 percent of the Hovilpri group compared with 34 percent of those on other available medications. Headache was the most common side effect reported.

Hovilpri received priority review for this indication. It represents a new option for a specific, hard to treat patient population rather than a general replacement for existing HSV antivirals.

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