Pritelivir Gains FDA Approval for Tough-to-Treat HSV in Immunocompromised Adults
The FDA has approved pritelivir (Hovilpri) for mucocutaneous herpes simplex virus lesions that have not responded to standard antivirals in adults with weakened immune systems. The drug is a helicase-primase inhibitor and does not need activation by viral thymidine kinase. In the phase 3 PRIOH-1 trial, all lesions healed by day 28 in 63% of pritelivir recipients versus 34% of those receiving investigator-selected therapy.
Pritelivir, sold as Hovilpri, is approved for adults with weakened immune systems who have herpes simplex lesions on skin or mucous membranes that have not responded to usual antivirals. The label covers cases whether or not resistance is present. Unlike nucleoside analogues, this drug blocks the viral helicase-primase enzyme and does not require activation by viral thymidine kinase.
In the phase 3 PRIOH-1 trial, 63% of pritelivir recipients had every lesion heal by day 28, compared with 34% of those who received therapy chosen by investigators. The adjusted difference was 28.4 percentage points, and the result had a P value of .0047.
For immunocompromised adults whose HSV lesions resist standard antivirals, this approval may offer another treatment route when existing options fail. It could reduce prolonged symptom burden and may lessen some need for repeated or alternative therapies, though access, cost, and real-world performance remain uncertain. Clinicians and patients may see it as a targeted option for a difficult-to-treat infection, but its broader public-health effect is likely limited to this specific population.