FDA approves pritelivir for refractory HSV lesions

In a phase 3 trial, complete lesion healing occurred in 63% of patients receiving pritelivir vs. 34% receiving comparator treatments.

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The FDA approved pritelivir tablets for immunocompromised adults with mucocutaneous HSV lesions unresponsive to acyclovir, valacyclovir, or famciclovir.
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Approval was supported by part C of the randomized, open-label, comparator-controlled phase 3 PRIOH-1 trial, which enrolled 101 participants.
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In PRIOH-1, complete lesion healing by day 28 occurred in 63% of pritelivir recipients and 34% of participants receiving comparator treatments.
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Treatment continued for up to 28 days, with extension to 42 days permitted for participants whose lesions were improving but not fully healed.
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Headache was the most commonly reported adverse reaction, and the FDA advised clinicians to consult prescribing information about certain drug interactions.

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