HOVILPRI (Pritelivir)

HOVILPRI (pritelivir) is an oral antiviral approved by the US FDA on 9 October 2026 for immunocompromised adults whose herpes simplex virus (HSV) skin or mucous-membrane lesions have not responded to acyclovir, valacyclovir or famciclovir. It can be used whether or not resistance has been shown in a laboratory test.

Pritelivir works differently from the usual herpes medicines. It blocks the HSV helicase-primase complex, an enzyme the virus needs to copy its DNA, and acts against both HSV-1 and HSV-2. Because this target is not the one acyclovir-type drugs act on, it remains active when those drugs have failed. The developer describes it as the first FDA-approved HSV treatment with a new mechanism of action in nearly 30 years.

Until now, refractory lesions in these patients have usually been treated with intravenous foscarnet or cidofovir. In the PRIOH-1 trial, 63% of patients on HOVILPRI had all lesions healed by day 28, compared with 34% on the investigator’s choice of treatment (mostly IV foscarnet); by day 42 the figures were 82% and 42%.

HOVILPRI treats the lesions; it does not cure HSV infection. Patients on transplant antiviral prophylaxis may also be using medicines such as Prevymis (letermovir) or Livtencity (maribavir) for CMV, which are different viruses and treatments.

• Acid-reducing medicines can make it less effective. Avoid esomeprazole and rabeprazole, omeprazole or lansoprazole above 20 mg a day, and pantoprazole above 40 mg a day. Take HOVILPRI at least 2 hours before or 12 hours after an H2-blocker such as famotidine, and 2 hours apart from antacids. Low pritelivir levels can lead to treatment failure and resistance.
• Pritelivir blocks the BCRP transporter and can raise the levels of medicines that depend on it (in a study, rosuvastatin levels rose by about 1.4–1.7 times); the treating doctor should review all current medicines.
• In the trial, liver enzyme rises (ALT at least 2.5 times the upper limit) were seen in 8% of patients on HOVILPRI compared with 2% on other treatment, and one patient stopped HOVILPRI because of raised liver enzymes.
• The most common side effect was headache (6%). Overall, fewer patients had side effects on HOVILPRI (22%) than on the comparison treatments (54%).
• There are no human data in pregnancy or breastfeeding. It is not approved for children; a study in ages 6 to 17 is still required by the FDA.
• It has not been studied in severe liver impairment (Child-Pugh C) or in patients on dialysis. Patients with HSV of the eye, brain or widespread (disseminated) infection were not included in the trial.

Who usually needs HOVILPRI?

Transplant recipients, people having cancer treatment, people living with HIV and others with weak immunity, whose herpes lesions keep growing or do not heal despite acyclovir, valacyclovir or famciclovir. The decision to use it is made by the treating infectious-disease specialist, transplant physician or oncologist.

What documents are needed to import it?

• Prescription from the treating specialist, with dose and expected duration
• Clinical notes showing that standard HSV antivirals were tried and failed (and the resistance test report, if done)
• Patient’s government photo ID (or the hospital’s details for a hospital order)

We confirm an order only after the prescription has been checked.

How many tablets will a course need?

The label dose is four 100 mg tablets on day 1, then one tablet a day until the lesions heal. In the trial, treatment ran up to 28 days and was extended to 42 days if lesions were still improving. A 32-tablet carton covers day 1 plus 28 further days; your doctor decides how many cartons are needed.

How is it stored?

At normal room temperature, 20–25 °C (short periods between 15 and 30 °C are allowed). The FDA approval letter gives a shelf life of 48 months from manufacture, so it does not need cold-chain shipping.

Is HOVILPRI available in India?

Not as a registered medicine. As of October 2026 it is approved only in the USA, and its US launch is expected by the end of 2026. Once the maker begins supply, it can be imported for a named patient on a doctor’s prescription.

HOVILPRI is very new, so the first supply will depend on the US commercial launch and on export permission from the maker’s distributor. We tell every enquirer the realistic timeline before taking an order, and we import only from authorised channels, in the patient’s name.

For HOVILPRI price in India and expected availability: Call +91 96548 60915, WhatsApp +91 93100 90915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA approval on 9 October 2026 (NDA 221154; new molecular entity, priority review, Fast Track and Breakthrough Therapy designations).
• European Union and Japan: No approval found as of October 2026.
• India: Not approved by CDSCO.

Sources:

• HOVILPRI US Prescribing Information (FDA, October 2026)
• FDA approval letter, NDA 221154
• Asahi Kasei press release on the FDA approval (13 October 2026)

Information last checked: October 2026.

What is HOVILPRI used for?

To treat herpes simplex skin and mucous-membrane lesions in immunocompromised adults when acyclovir, valacyclovir or famciclovir have not worked.

Is HOVILPRI a tablet or an injection?

A tablet. This matters because the older options for refractory HSV, foscarnet and cidofovir, are mainly given by intravenous drip.

How is pritelivir different from acyclovir?

Acyclovir-type drugs act on the viral DNA polymerase. Pritelivir blocks a different enzyme, the helicase-primase complex, so it can work on strains that no longer respond to acyclovir.

Can I take HOVILPRI with an antacid or omeprazole?

Only with care. Some acid reducers lower pritelivir levels. Space antacids 2 hours apart, avoid esomeprazole and rabeprazole, and keep omeprazole to 20 mg or less a day. Check every acid medicine with your doctor.

Who makes HOVILPRI?

It was developed by AiCuris Anti-infective Cures AG, now part of Asahi Kasei Therapeutics, which distributes it in the USA.

Is HOVILPRI FDA approved?

Yes. The FDA approved it on 9 October 2026 after priority review.