FDA Approves Pritelivir Tablets for Resistant Herpes Lesions
The FDA approved pritelivir (Hovilpri) tablets for mucocutaneous herpes simplex virus lesions in immunocompromised patients who have not responded to other therapies. Pritelivir is an oral helicase-primase inhibitor that targets HSV-1 and HSV-2 strains resistant to nucleoside analogue- and foscarnet-based treatments. In the phase III PRIOH-1 trial, 63% of patients taking 100 mg once daily had all lesions healed by day 28, compared with 34% of those given investigator-selected comparators, and headache was the most frequent adverse reaction.
Pritelivir is an oral helicase-primase inhibitor. It targets HSV-1 and HSV-2 strains resistant to nucleoside analogues and foscarnet. These infections can cause mucocutaneous lesions on the lips, nostrils, eyes, and genitals, especially in people with weakened immunity.
The approval was based on the open-label phase III PRIOH-1 trial. It enrolled 101 immunocompromised patients whose mucocutaneous HSV had not responded to acyclovir, valacyclovir, or famciclovir. Their conditions included blood cancers or disorders, stem-cell transplants, HIV, autoimmune or inflammatory diseases, other cancers, or organ transplants. By day 28, 63% taking 100 mg once daily had all lesions healed versus 34% on investigator-selected comparators; headache was the adverse reaction reported most often.
The approval may offer an option for immunocompromised people with HSV lesions that resist standard drugs, potentially reducing prolonged symptoms and treatment burden. It could also draw attention to antiviral resistance in patients with cancer, transplants, HIV, or autoimmune conditions. Access, cost, and monitoring may shape real-world reach. Clinicians may need to weigh benefits against adverse effects such as headache. More options could improve quality of life, though long-term outcomes and broader use remain uncertain.