The US Food and Drug Administration (FDA) has approved Hovilpri (pritelivir) tablets for immunocompromised adults battling herpes simplex virus (HSV) infections that have failed to respond to standard antiviral treatments.
The approval offers a new treatment option for patients with weakened immune systems who develop persistent skin and mucosal lesions caused by HSV and do not respond to acyclovir, valacyclovir or famciclovir.
Hovilpri is approved for adults with mucocutaneous lesions—painful sores affecting the skin or mucosal surfaces, including the lips, nostrils, eyes and genitals.
The FDA approval is backed by results from the Phase 3 PRIOH-1 trial, which evaluated Hovilpri in immunocompromised patients whose HSV infections had not responded to existing antiviral therapies.
In the trial, 101 adults were randomly assigned to receive either Hovilpri or treatments selected by the investigators. Treatment continued for up to 28 days, with an extension to 42 days permitted for patients whose lesions were improving but had not completely healed.
The results showed that 63% of patients receiving Hovilpri achieved complete healing of all lesions within 28 days, compared with 34% of those receiving other available treatments.
The findings point to a potential treatment advance for patients facing persistent HSV infections, particularly those whose weakened immune systems make outbreaks harder to control.
HSV-1 and HSV-2 are common viral infections that can cause painful, fluid-filled blisters. The lesions may break open and form crusts as they heal. Once acquired, the infection remains in the body and cannot be cured. The virus can remain dormant before reactivating, causing recurrent outbreaks or the release of infectious viral particles even when symptoms are absent.
Although several antiviral drugs are available to manage HSV outbreaks, treatment can be especially challenging for immunocompromised patients. These individuals may experience more frequent or severe outbreaks, and their infections may persist when the virus develops resistance to medication or patients cannot tolerate treatment-related side effects.
Hovilpri's approval addresses this difficult-to-treat patient population, providing another option when established therapies fail.
Participants in the Phase 3 trial had a range of conditions associated with weakened immune systems, including blood cancers and other hematologic disorders, hematopoietic stem-cell transplantation, HIV infection, autoimmune and inflammatory diseases, non-hematologic malignancies and solid-organ transplantation.
For these patients, persistent HSV lesions can pose a significant treatment challenge, particularly when standard antiviral drugs are ineffective.
The FDA's approval of Hovilpri marks a new option for immunocompromised adults with mucocutaneous HSV infections that have not responded to the three established antiviral treatments evaluated in the approval indication.
