The FDA approved pritelivir (Hovilpri) tablets to treat mucocutaneous lesions caused by herpes simplex virus (HSV) infections in immunocompromised patients who haven’t responded to other treatments.
Pritelivir, an oral helicase-primase inhibitor, works against HSV-1 and HSV-2 strains resistant to nucleoside analogue- and foscarnet-based treatments. HSV infections are incurable and commonly cause mucocutaneous lesions, including on the lips, nostrils, eyes, and genitals, particularly in patients with compromised immune systems.
For these patients with treatment-refractory HSV infections, “achieving rapid lesion healing while maintaining tolerability is essential,” said Cynthia Wat, MD, chief medical officer for drugmaker Aicuris, in a previous statement announcing that pritelivir had been granted priority review.
The approval was based on results from the open-label, phase III PRIOH-1 trial, which compared once-daily pritelivir versus investigators’ choice of foscarnet, cidofovir, or imiquimod in 101 immunocompromised patients with mucocutaneous HSV infection who didn’t respond to acyclovir, valacyclovir, or famciclovir.
The trial’s participants had a wide range of immunosuppressive clinical conditions, including hematologic malignancy or disorder, hematopoietic stem-cell transplantation, HIV infection, autoimmune or inflammatory diseases, nonhematologic malignancies, or solid-organ transplantation.
By 28 days, 63% of patients treated with 100-mg pritelivir once daily achieved the study’s primary efficacy endpoint of all lesions healed compared with 34% of patients who received one of the investigators’ choice drugs.
The most common adverse reaction among patients who received pritelivir was headache.
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