Statistically Superior Lesion Healing Rates Achieved Up to Day 28 vs investigator's choice1
Up to Day 28, HOVILPRI achieved a significantly higher rate‡ of complete lesion healing vs investigator’s choice (63% vs 34%, respectively; adjusted treatment difference 28.4%§; P=0.0047 [95% CI: 9.6, 47.3]).1,¶
Safety Profile Demonstrated In The Clinical Trial1,2
A Phase 3 clinical trial evaluated safety in 101 adult immunocompromised patients with refractory HSV.1
Convenient Once-Daily Oral Dosing1
Recommended dosage: Initiate treatment with a loading dose of 400 mg (four 100-mg tablets) on Day 1, followed by a maintenance dose of 100 mg (1 tablet) daily by mouth, with or without food, until HSV lesions have healed.
PRIOH-1 (Part C): HOVILPRI was studied vs investigator’s choice of treatment in a randomized, open-label, comparator-controlled, superiority trial (Part C) in immunocompromised adults with refractory ± resistant (R±R) mucocutaneous herpes simplex virus (HSV) infections.1
Primary end point: Response rate up to Day 28, as assessed by the investigator as complete healing (complete epithelialization) of all lesions.1
Investigator’s choice arm: Intravenous (IV) foscarnet, IV or topical cidofovir, or topical imiquimod.1
‡Response rate was defined as all mucocutaneous HSV lesions healed by complete epithelialization within the treatment period and no appearance of new lesions post end of treatment, as assessed by the investigator.1
§Values were determined using the stratified Cochran-Mantel-Haenszel (CMH) test, which was used to compare treatment groups, adjusting for protocol versions that reflected change in the control arm design.1
¶The confidence interval is based on the stratified Sato method, and the P value is from the stratified CMH test.1
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HSV, herpes simplex virus; IV, intravenous; MOA, mechanism of action; R±R, refractory with or without resistance.
References: 1. HOVILPRI. Prescribing information. Asahi Kasei Therapeutics. 2. Data on file. Asahi Kasei Therapeutics.