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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

Indication

8 evidence topics · 5 sources

U.S. indication: full prescribing information

“HOVILPRI is indicated in immunocompromised adults for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir [see Clinical Studies (14.1)].” (opens the prescribing information at this quote)

U.S. indication: Highlights of prescribing information

“HOVILPRI is a herpes simplex virus (HSV) helicase-primase inhibitor indicated in immunocompromised adults for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir.” (opens the prescribing information at this quote)

U.S. indication: FDA plain-language description

“FDA has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems (i.e., immunocompromised patients) who have mucocutaneous lesions caused by herpes simplex virus (HSV) infection and have not responded to other therapies (acyclovir, valacyclovir, or famciclovir).” (opens the source at this quote in a new tab)

“Mucocutaneous lesions occur on skin or mucosal surfaces, such as lips, nostrils, eyes and genitals.” (opens the source at this quote in a new tab)

FieldQuoted record
FDA-approved use on approval date“To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies”
U.S. indication: patient information wording

“HOVILPRI is a prescription medicine used in adults with weakened immune systems (immunocompromised) to treat lesions caused by herpes simplex virus (HSV) infection that have not improved with the medicines acyclovir, valacyclovir, or famciclovir.” (opens the prescribing information at this quote)

“HOVILPRI does not cure HSV infection.” (opens the prescribing information at this quote)

“It is not known if HOVILPRI is safe and effective in children less than 18 years of age.” (opens the prescribing information at this quote)

Definition of refractory infection in the trial supporting the indication

“Refractory HSV infection (clinical failure) was defined as no clinical improvement after at least 7 days of standard-of-care nucleoside analogue treatment [acyclovir (ACV), valacyclovir (VACV) or famciclovir (FCV)], with or without laboratory confirmed genotypic/phenotypic resistance for the current HSV outbreak.” (opens the prescribing information at this quote)

“At enrollment, the majority of participants, 71%, had refractory HSV infection and 29% had laboratory confirmed ACV resistance.” (opens the prescribing information at this quote)

Limits of the indication stated in the label

“Participants with ocular, CNS, or disseminated HSV disease were not enrolled.” (opens the prescribing information at this quote)

“Because HSV establishes lifelong latent infection, treatment is not curative.” (opens the prescribing information at this quote)

“Inform patients that HOVILPRI is indicated to heal lesions caused by HSV but is not a cure for HSV infection.” (opens the prescribing information at this quote)

“The safety and efficacy of HOVILPRI have not been established in pediatric patients 18 years of age and younger.” (opens the prescribing information at this quote)

Indication as stated on the manufacturer's healthcare professional website

“HOVILPRI® (pritelivir) tablets are a once-daily* oral therapy for immunocompromised adults for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir.” (opens the source at this quote in a new tab)

“HOVILPRI is a 100-mg tablet taken once daily following a 400-mg loading dose on Day 1.” (opens the source at this quote in a new tab)

“HOVILPRI is not a cure for HSV.” (opens the source at this quote in a new tab)

Indication targeted by the European Union paediatric investigation plan

“Treatment of acyclovir-resistant mucocutaneous herpes simplex infections in immunocompromised paediatric patients from 6 years to less than 18 years of age.” (opens the source at this quote in a new tab)