The article examines the objective, findings, and clinical context described in FDA approves pritelivir for refractory HSV lesions.
Approach:
Evidence: Approval was supported by part C of the randomized, open-label, comparator-controlled phase 3 PRIOH-1 trial (NCT03073967).
Participants and treatment: The trial randomly assigned 101 immunocompromised adults to pritelivir or investigator-selected available treatment. Treatment lasted up to 28 days, with extension to 42 days permitted for participants whose lesions were improving but not fully healed.
Primary endpoint: The primary endpoint was complete healing of all lesions during treatment through day 28.
Key Findings:
By day 28, all lesions had healed in 63% of pritelivir recipients and 34% of comparator-treatment recipients.
Headache was the most commonly reported adverse reaction with pritelivir.
The FDA advised clinicians to consult prescribing information for certain drug interactions.
Interpretation:
The FDA approved pritelivir (Hovilpri) tablets for immunocompromised adults with mucocutaneous HSV lesions that do not respond to acyclovir, valacyclovir, or famciclovir. The FDA granted the indication priority review.
Limitations:
The provided context does not report additional trial outcomes, detailed safety rates, or confidence intervals.
