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Hovilpri (pritelivir)

Refractory mucocutaneous herpes simplex virus infection in immunocompromised adults

Also known as AIC316
Last updated
239 sources

Product information and disease descriptionProduct descriptionProduct information

Access and distribution

16 evidence topics · 14 sources

U.S. commercial availability

“HOVILPRI is expected to be available in the United States before the end of 2026.” (opens the source at this quote in a new tab)

“U.S. Healthcare providers can learn more about HOVILPRI at www.hovilprihcp.com.” (opens the source at this quote in a new tab)

“Commercial availability is coming soon!” (opens the source at this quote in a new tab)

Distributor named on the label and company contact

“Distributed by: Asahi Kasei Therapeutics, Inc. Cary, North Carolina 27518” (opens the prescribing information at this quote)

“For more information, go to www.HOVILPRI.com or call 1-844-835-6947” (opens the prescribing information at this quote)

Specialty pharmacy or distribution network named after approval

No evidence found.

Packaging and storage
PackageNDCContents
Carton of 32 tablets“NDC 68992-100-32”“Each carton contains two blister wallets. Each blister wallet contains 16 film-coated tablets, for a total of 32 film-coated tablets per carton.”
Carton of 16 tablets“NDC 68992-100-16”“Each carton contains one blister wallet containing 16 film-coated tablets.”

“Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].” (opens the prescribing information at this quote)

Commercial infrastructure for the U.S. launch: Asahi Kasei statements, February 2026

“Veloxis Pharmaceuticals, Inc. has an established sales network targeting transplant physicians at transplant centers, cultivated through Envarsus XR.” (opens the source at this quote in a new tab)

“Compared to Aicuris building a sales organization from scratch, this enables a faster and more efficient product launch.” (opens the source at this quote in a new tab)

“Coverage of ≈50% of pritelivir target facilities enabled by Veloxis’s commercial infrastructure with transplant physicians based on Envarsus XR, supporting a rapid launch post-approval” (opens the source at this quote in a new tab)

“These patients are commonly seen in transplant centers and specialized hospital settings where Asahi Kasei maintains established commercial relationships and infrastructure.” (opens the source at this quote in a new tab)

Pre-approval commercial plan: AiCuris corporate presentation, August 2025

“Availability for retail patients is ensured via our specialty pharmacy network.” (opens the source at this quote in a new tab)

“NTAP, HECON model and a BIM at launch for Hospital scripts, ensure we are working with all third-party payers” (opens the source at this quote in a new tab)

“Our team consists of 6 MSLs overlapping with 30 Sales Representatives at launch.” (opens the source at this quote in a new tab)

“Prelaunch, Medical Affairs targets KOLs at the top 250 Transplant Centers (HSCT & SOT), which are also large teaching hospitals that treat other immunocompromised patients.” (opens the source at this quote in a new tab)

Information requests on the healthcare professional website

“Sign up to learn more about HOVILPRI” (opens the source at this quote in a new tab)

“Fill out the form below to receive more information or connect with a regional contact.” (opens the source at this quote in a new tab)

“Support and access services” (opens the source at this quote in a new tab)

“I understand these communications may include information about patient support programs, health-related topics, or market research.” (opens the source at this quote in a new tab)

Patient support or copay assistance program named by the manufacturer

No evidence found.

Expanded access protocol in the United States: purpose and population

“The purpose of the expanded access program (EAP) is to provide pritelivir to immunocompromised subjects with treatment resistant HSV type 1 or 2 who cannot participate in a clinical trial and for whom no approved treatment option is available.” (opens the source at this quote in a new tab)

“In view of the available pre-clinical and clinical data for pritelivir in immunocompromised subjects with treatment resistant HSV, the lack of treatment options, and the demand for compassionate use of pritelivir, AiCuris aims to provide access to pritelivir via this expanded access program (intermediate size treatment protocol) in the USA.” (opens the source at this quote in a new tab)

“The patient population is focused on those immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition.” (opens the source at this quote in a new tab)

“The program will continue until pritelivir becomes available through other mechanisms, or until Sponsor chooses to discontinue the program.” (opens the source at this quote in a new tab)

Expanded access protocol in the United States: main inclusion criteria

“Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic-cell or solid organ transplantation, and chronic use of immunosupressive treatment) men and women of any ethnic group aged ≥16 years.” (opens the source at this quote in a new tab)

“ACV-resistant and foscarnet-resistant/intolerant mucocutaneous HSV infection based on clinical failure (no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high doses of valacyclovir or famciclovir and/or foscarnet iv therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic/phenotypic testing or ACV-resistant and previously treated in PRIOH-1 Part C.” (opens the source at this quote in a new tab)

Expanded access protocol in the United States: registry record fields
FieldQuoted record
Official title“Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects with Treatment Resistant Herpes Simplex Virus Type 1 or 2”
Sponsor“AiCuris Anti-infective Cures AG”
Other study ID numbers“AIC316-03-E-01”
Expanded access type“Treatment IND/Protocol”
Last update posted“2025-02-10”
Expanded access status“Available”
Early access program with myTomorrows: establishment in 2020

“AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases and myTomorrows, a Netherlands-based HealthTech company facilitating access to medicines in development and real-world data collection, today announced a collaboration to develop an Early Access Program (EAP) for pritelivir, currently undergoing Phase II testing for treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.” (opens the source at this quote in a new tab)

“An Early Access Program (EAP), also known as Expanded Access Program or Managed Access Program, supports in a compliant and controlled way the treatment with a medicine currently not licensed in a patient's country of residence.” (opens the source at this quote in a new tab)

“Such treatment can be an option for patients who have high unmet medical need, have exhausted all registered treatment options and cannot participate in a clinical trial.” (opens the source at this quote in a new tab)

Early access program with myTomorrows: company description

“Aicuris supports expanded access requests for the treatment of eligible patients outside of the Phase 3 clinical trial and collaborates with myTomorrows to facilitate early access to pritelivir for acyclovir-refractory mucocutaneous HSV infections in immunocompromised patients.” (opens the source at this quote in a new tab)

“Eligible patients for an EAP are in high medical need, cannot participate in a clinical trial, and have exhausted all registered treatment options.” (opens the source at this quote in a new tab)

“If the physician agrees to a treatment with pritelivir oral tablets and to oversee the patient’s treatment, the physician needs to contact the myTomorrows medical team for more information on the EAP.” (opens the source at this quote in a new tab)

Early access program with myTomorrows: request process

“In collaboration with myTomorrows, AiCuris provides a potential pathway to access Pritelivir oral tablets for the treatment of active Herpes Simplex Virus (HSV) mucocutaneous infections that are refractory, with or without resistance, to both acyclovir and foscarnet, in immunocompromised patients.” (opens the source at this quote in a new tab)

“Each request is reviewed individually, based on the patient’s clinical situation and the program’s eligibility criteria. A detailed medical rationale may be required to assess eligibility.” (opens the source at this quote in a new tab)

“Your request will be reviewed by our team within 1 business day.” (opens the source at this quote in a new tab)

Compassionate use in Germany

“In December 2020, the "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" acknowledged to initiate a Compassionate Use Program for pritelivir in Germany.” (opens the source at this quote in a new tab)

Compassionate use programme in Belgium: indication, eligibility, and supply

“In this Compassionate Use Program (CUP) Pritelivir is indicated for the treatment of acyclovir-resistant and/or foscarnet-resistant/intolerant mucocutaneous HSV (Herpes Simplex Virus) infections in immunocompromised patients” (opens the source at this quote in a new tab)

“Considering the fact that foscarnet is not reimbursed for treating ACV-R mucocutaneous HSV infection in Belgium, resistance or intolerance to foscarnet treatment cannot be considered a mandatory inclusion criterion for the participation in the CUP.” (opens the source at this quote in a new tab)

“The patient cannot be satisfactorily treated with the approved and reimbursed alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues.” (opens the source at this quote in a new tab)

“Pritelivir will be provided free of charge by AiCuris / myTomorrows on an individual patient basis following the criteria stated in this program and from the approval of the Compassionate Use Program by FAMHP until:” (opens the source at this quote in a new tab)

“Inclusion in this program will end when drug reimbursement is obtained or when AiCuris/ myTomorrows decides to discontinue this program in case of reimbursement refusal after MA for this indication or in the light of newly emerged scientific data.” (opens the source at this quote in a new tab)

Compassionate use programme in Belgium: request, delivery, and treatment duration

“Pritelivir should be requested by the treating physician.” (opens the source at this quote in a new tab)

“Pritelivir will be delivered to the entity licensed to dispense medicinal products (e.g. pharmacy, hospital, private medical practice) associated with the requesting physician and the patient.” (opens the source at this quote in a new tab)

“Total duration between fully justified unsolicited request and delivery of the medication will be approximately 10 working days.” (opens the source at this quote in a new tab)

“If the lesion(s) has/have not healed completely within the timeframe of 28 days but are improving, it will be possible to prolong the treatment for an additional 14 days. The maximum total treatment duration is 42 days (6 weeks).” (opens the source at this quote in a new tab)

Compassionate access authorisation in France
FieldQuoted record (French)
Product“Pritelivir 100 mg, comprimé”
Access framework and status“Autorisation d'accès compassionnel (AAC) – En cours”
Granting criteria“Infection à HSV en situation d’échec, de résistance, d’intolérance ou de contre-indication au (val)aciclovir et foscarnet chez des patients adultes immunodéprimés”
Dosage“Posologie : 400 mg à J1 puis 100 mg/jour”
Treatment duration“la durée initiale de traitement est de 28 jours maximum, pouvant être prolongée de 14 jours maximum en cas d’amélioration incomplète de la maladie à HSV.”