FDA Approves Hovilpri for Hard-to-Treat Herpes Lesions in People With Weak Immune Systems

Published on October 13, 2026

The FDA has approved Hovilpri (pritelivir) to treat skin and mucosal lesions caused by the herpes simplex virus (HSV). These lesions are painful sores or blisters that can appear on the lips, mouth, eyes, or genital area. Hovilpri is for adults with weakened immune systems whose herpes infections have not improved after taking standard antiviral medicines such as acyclovir, famciclovir, or valacyclovir.

HSV stays in the body for life and can reactivate to cause painful outbreaks. People with weakened immune systems are more likely to experience severe or frequent outbreaks. Over time, their herpes infection may stop responding to usual treatments, making the sores hard to heal.

Hovilpri is a new type of antiviral medicine called a helicase-primase inhibitor. It works differently than older herpes drugs. Hovilpri works by blocking a key protein enzyme that the virus needs to copy its DNA. This helps stop the virus from multiplying and allows sores to heal.

The approval of Hovilpri was based on a clinical study of 101 adults with weakened immune systems whose herpes sores did not get better on standard antiviral treatments. Patients in the study had various underlying health conditions, including blood cancers, organ or stem cell transplants, HIV, or autoimmune diseases. Half of the patients took Hovilpri, while the other half received the study doctor’s choice of other available treatments.

Researchers checked how many patients had all of their sores completely healed after 28 days of treatment. In the study, 63% of people who took Hovilpri had complete healing of their sores by day 28, compared to only 34% of people who received other treatments. When treatment was extended to 42 days for improving sores, 82% of people in the Hovilpri group achieved complete healing compared to 42% in the comparison group.

Hovilpri was also better tolerated than the alternative treatments. Fewer patients stopped taking Hovilpri due to side effects compared to those receiving the other study treatments.

Hovilpri comes as a tablet that you take by mouth once a day, with or without food. You start with a higher starting dose on the first day, followed by daily doses until your sores heal completely. Hovilpri helps heal active sores, but it is not a cure for herpes infection.

The most common side effect reported with Hovilpri is headache. Some patients in clinical trials also experienced changes in liver function blood tests, so your healthcare provider may check your blood regularly.

Tell your healthcare provider about all the medicines you take, especially drugs used to lower stomach acid. Proton pump inhibitors, such as esomeprazole, omeprazole, or pantoprazole, can lower the amount of Hovilpri in your body and make it less effective. Other acid reducers, such as antacids or H2 blockers, must be taken at different times of the day than Hovilpri. 

If you are pregnant, planning to become pregnant, or breastfeeding, discuss your options with your healthcare provider before taking Hovilpri.

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