The U.S. Food and Drug Administration (FDA) approved Hovilpri (pritelivir) on October 9, 2026, a tablet medication for treating lesions caused by the herpes simplex virus in immunocompromised adults who have not responded to treatments with acyclovir, valacyclovir, or famciclovir.
The authorization provides a new alternative for patients with weakened immune systems, who may experience more frequent and severe outbreaks. However, this is not a cure for herpes: the treatment is aimed at the lesions, not at permanently eliminating the virus from the body.
According to the official announcement by the FDA, the medication is indicated for mucocutaneous lesions, that is, those that affect the skin or mucous membranes, including areas such as the lips, nostrils, eyes, and genitals.
63% of the patients achieved complete healing within 28 days
The approval was based on the results from Part C of the phase 3 clinical trial PRIOH-1, which involved 101 immunocompromised adults with lesions caused by the herpes simplex virus who had not responded to the mentioned antivirals.
Participants were randomly assigned to receive Hovilpri or one of the available treatments chosen by the investigator. It was an open-label study, meaning that both the participants and the medical team were aware of which treatment was being administered.
The main efficacy indicator was the proportion of patients whose lesions had completely healed within the first 28 days of treatment. 63% of those who received Hovilpri achieved this result, compared to 34% of those treated with the alternatives selected by the researchers, according to the FDA.
The treatment could be extended up to 42 days when the lesions showed improvement by day 28, but had not yet fully healed. The data specifically pertains to the studied population and should not be interpreted as demonstrated efficacy for all individuals with herpes.
Among the participants were individuals with different conditions that affect the immune system, including HIV infections, oncological diseases, autoimmune disorders, and a history of transplants.
What does approval mean and what are the precautions?
Simple herpes, caused by the HSV-1 and HSV-2 viruses, can lead to painful blisters or ulcers. After infection, the virus can remain dormant and reactivate, even with periods of viral shedding without symptoms. Therefore, the healing of lesions does not equate to the disappearance of the infection.
The FDA granted Hovilpri a priority review for this indication. The decision is limited to immunocompromised adults with lesions that do not respond to the specified antivirals and does not constitute a general authorization to treat any episode of herpes.
Regarding safety, the FDA noted that headache was the most common adverse reaction and warned of potential interactions with other medications. Therefore, it referred healthcare professionals to the official prescribing information before using Hovilpri.
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