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NewsThe FDA has approved pritelivir (Hovilpri) to treat mucocutaneous herpes simplex virus (HSV) lesions in immunocompromised adults who haven't responded to prior therapies — marking the first new HSV treatment in more than two decades. In a phase 3 trial, 62.7% of pritelivir patients saw lesion healing compared to just 34% in the control group. Headache was the most commonly reported side effect.
The FDA has approved pritelivir (Hovilpri, Asahi Kasei) to treat mucocutaneous lesions caused by herpes simplex virus (HSV) in immunocompromised adults who have failed previous therapies. This marks the first new HSV treatment approved in over 20 years — a significant milestone for patients with refractory or resistant disease who have had limited options.
The approval was backed by data from the phase 3 PRIOH-1 trial, a randomized, controlled, open-label study involving 101 immunocompromised patients with refractory or resistant HSV. Pritelivir demonstrated superior efficacy over the control group, with headache being the most commonly reported adverse event.
By the Numbers:
Why it matters: For immunocompromised patients — such as those living with HIV or undergoing transplants — drug-resistant HSV can be a serious, hard-to-treat complication. Pritelivir's approval fills a critical gap, offering a new mechanism of action after decades without a novel HSV therapy.
