HOVILPRI® (pritelivir) demonstrated superior lesion healing rates* vs investigator's choice in a clinical trial in immunocompromised adults with refractory (with or without documented resistance) herpes simplex virus (HSV) infections
Primary end point
Response rate: Proportion of participants with lesions healed up to Day 28* (PRIOH-1 Phase 3 trial Part C)1
More patients taking HOVILPRI reached complete lesion resolution at up to Day 281
Primary efficacy end point
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,†
†The confidence interval is based on the stratified Sato method, and the P value is from the stratified Cochran-Mantel-Haenszel (CMH) test.1
‡Values determined using the CMH test, which was used to compare treatment groups, adjusting for protocol versions that reflected change in the control arm design.1
Secondary end point
Complete lesion healing rate* (PRIOH-1 Phase 3 trial Part C)1,2
Lesion resolution observed up to Day 421
Key secondary efficacy end point
The observed response rate was 82% in patients who were treated with HOVILPRI vs 42% in patients who were treated with investigator's choice treatments, with an adjusted treatment difference of 40%‡ (95% CI: 22.7, 57.7).§ 33% of patients whose lesions were improving by Day 28 in the HOVILPRI arm extended treatment up to 42 days.1
Data are presented for descriptive purposes only. No clinical or statistical conclusions can be drawn from these findings.
‡Values determined using the 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.1
HSV detection rate vs investigator’s choice2
Mean individual HSV DNA detection rate in lesion swabs2,¶,#
Clinical shedding rates measured by HSV-positive swabs were evaluated in patients who were treated with HOVILPRI vs investigator’s choice treatments. Data are presented for descriptive purposes only. No clinical or statistical conclusions can be drawn from these findings.2
¶Clinical shedding rate (number of HSV-positive PCR swabs per patient relative to the total number of swabs collected per patient) from HSV PCR swabs taken from HSV lesion(s) until the posttreatment visit. Patients who had a positive HSV DNA PCR result at baseline and at least 1 postbaseline HSV DNA PCR result were included. If multiple swabs were taken and analyzed for a visit, only the swab with the highest amount of DNA was included.2
#HSV DNA limit of detection ≥150 copies/mL.2
Hospitalization rates2
Hospitalization rates were evaluated at US PRIOH-1 (Part C) study sites in patients receiving HOVILPRI vs investigator’s choice. No statistical testing was performed on these data. No clinical or statistical conclusions can be drawn from these findings.
Scroll to view
Explore the safety data
CMH, Cochran-Mantel-Haenszel; HSV, herpes simplex virus; MOA, mechanism of action; PCR, polymerase chain reaction.
References: 1. HOVILPRI. Prescribing information. Asahi Kasei Therapeutics. 2. Data on file. Asahi Kasei Therapeutics.