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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

Co-prescribed/Concomitant therapies

13 evidence topics · 5 sources

Acid-reducing agents named in the patient information

“Especially tell your healthcare provider if you take medicines used to lower stomach acid, including:” (opens the prescribing information at this quote)

“proton pump inhibitors (PPIs) (such as esomeprazole, rabeprazole, omeprazole, lansoprazole, or pantoprazole).” (opens the prescribing information at this quote)

“H2-receptor blockers (such as famotidine, ranitidine).” (opens the prescribing information at this quote)

“antacids (medicines such as Tums, Mylanta, Maalox).” (opens the prescribing information at this quote)

Proton pump inhibitors to avoid during treatment

“Avoid taking the following proton pump inhibitor medicines during treatment with HOVILPRI:” (opens the prescribing information at this quote)

“esomeprazole or rabeprazole” (opens the prescribing information at this quote)

“omeprazole or lansoprazole (daily dose above 20 mg)” (opens the prescribing information at this quote)

“pantoprazole (daily dose above 40 mg)” (opens the prescribing information at this quote)

“Talk to your healthcare provider before taking any of these medicines.” (opens the prescribing information at this quote)

Proton pump inhibitor doses that may be continued, and timing of H2-receptor antagonists and antacids

“Concomitant use of omeprazole, lansoprazole, or pantoprazole below the doses listed above is acceptable, as these lower doses do not reduce pritelivir exposure to a clinically relevant extent.” (opens the prescribing information at this quote)

“Take HOVILPRI 2 hours before or 12 hours after taking a H2-receptor antagonist” (opens the prescribing information at this quote)

“Separate any dosing of antacids from HOVILPRI dosing by 2 hours” (opens the prescribing information at this quote)

Acid-reducing agents taken with pritelivir in PRIOH-1 Parts C to F

“In the Phase 3 trial (PRIOH-1, Parts C-F), pritelivir exposures were evaluated for participants who received concomitant omeprazole or lansoprazole (≤20 mg daily), pantoprazole (≤40 mg daily), or an H2-receptor antagonist (with pritelivir administered at least 2 hours before or 12 hours after the H2-receptor antagonist).” (opens the prescribing information at this quote)

“Pritelivir exposures in participants receiving these acid-reducing agents were not clinically meaningfully different from those in participants who did not receive any acid-reducing agents” (opens the prescribing information at this quote)

Proton pump inhibitors interrupted in the renal and hepatic impairment trials

“As per protocol, for the subjects in the renal impairment groups taking proton pump inhibitors (PPIs; 29.2%), PPI dosing was interrupted from 3 days prior to 24 hours after administration of pritelivir.” (opens the source at this quote in a new tab)

“As per protocol, for the subjects in the hepatic impairment group taking PPIs (25%), PPI dosing was interrupted from 3 days prior to 24 hours after administration of pritelivir.” (opens the source at this quote in a new tab)

Substrates of the breast cancer resistance protein

“Co-administration of HOVILPRI with a BCRP substrate may increase the plasma concentrations of the BCRP substrate” (opens the prescribing information at this quote)

“Refer to the prescribing information for co-administered drugs for additional information.” (opens the prescribing information at this quote)

Disclosure of all other medicines

“Inform patients that HOVILPRI may interact with some drugs; therefore, advise patients to report the use of any other medications to their healthcare provider” (opens the prescribing information at this quote)

“Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.” (opens the prescribing information at this quote)

“HOVILPRI may affect the way other medicines work, and other medicines may affect the way HOVILPRI works.” (opens the prescribing information at this quote)

Underlying conditions of participants treated in PRIOH-1 Part C

“Participants represented a wide range of immunosuppressive clinical conditions, including one or more of the following underlying conditions: hematologic malignancy/disorder (47%), hematopoietic stem-cell transplantation (40%), HIV infection (38%), autoimmune/inflammatory diseases (29%), non-hematologic malignancies (26%) or solid-organ transplantation (4%).” (opens the prescribing information at this quote)

“There were no clinically significant differences in the pharmacokinetics of pritelivir based on age (19 to 84 years), gender, race (including American Indian/Alaska Native, Asian, Black/African American, White, or other), body weight (48 to 176 kg), or underlying immunocompromised condition (including HIV/AIDS, oncology, transplant, or autoimmune/inflammatory disorder).” (opens the prescribing information at this quote)

Antiretroviral therapy in PRIOH-1 Part A

“In the pritelivir arm, approximately half of the patients had HIV infection (53.3%), with another third having undergone HCT (33.3%).” (opens the source at this quote in a new tab)

“All but 1 participant with HIV were confirmed to be receiving antiretroviral therapy” (opens the source at this quote in a new tab)

Other antivirals active against herpes simplex virus during PRIOH-1

“One reported TEAE of cytomegalovirus reactivation resulted in treatment discontinuation not attributed to the trial medication, which required administration of foscarnet, a prohibited concomitant medication.” (opens the source at this quote in a new tab)

“A 3-day washout period was mandated for participants treated with foscarnet in Part A switching to Part B.” (opens the source at this quote in a new tab)

“Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.” (opens the source at this quote in a new tab)

Therapy after lesion healing: prescribing information

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

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

“until HSV lesions have healed” (opens the prescribing information at this quote)

Recurrence after the end of treatment in PRIOH-1 Part A

“Within the 4-week follow-up period, lesion recurrence was observed in 3 of 14 pritelivir-treated participants and in none of the 4 participants who achieved lesion healing in the foscarnet arm” (opens the source at this quote in a new tab)

Secondary prophylaxis after healing in a published case

“The patient started secondary prophylaxis with pritelivir (100 mg/d following loading dose of 400 mg) for 3 months through expanded access approval, and no recurrences were reported.” (opens the source at this quote in a new tab)

“As the test indicated a lack of HSV-specific T-cell response and the patient experienced recurrent mouth ulcerations after stopping prophylaxis, pritelivir was reintroduced, leading to sustained clinical response.” (opens the source at this quote in a new tab)