Safety profile of HOVILPRI® (pritelivir) tablets was demonstrated in the clinical trial1,2
The adverse reaction (all grades) occurring in more than 5% of participants was headache, which occurred in 6% and 4% of patients who received HOVILPRI and investigator’s choice, respectively.1
A lower rate of drug-related treatment-emergent adverse events (TEAEs) was reported in participants who were treated with HOVILPRI (22%) compared with participants who were treated with investigator's choice (54%). Discontinuations due to drug-related TEAEs occurred in 2% and 20% of participants, respectively.1
| Safety population2,* | HOVILPRI (n=51) |
Investigator’s choice (n=50) |
|---|---|---|
| Participants with any TEAEs, n (%) | 40 (78.4%) | 44 (88.0%) |
| Exposure-adjusted event rate per patient year | 42.8 | 102.0 |
| Drug-related TEAEs, n (%) | 11 (22.0%) | 27 (54.0%) |
| Treatment-emergent serious adverse events (AEs), n (%) | 10 (19.6%) | 15 (30.0%) |
| Treatment discontinuation due to any TEAE | 2 (3.9%) | 11 (22.0%) |
| Treatment discontinuation due to drug-related TEAEs, n (%) | 1 (2.0%) | 10 (20.0%) |
| Participants with any TEAEs of special interest, n (%) | 13 (25.5%) | 27 (54.0%) |
| Skin disorders | 5 (9.8%) | 8 (16.0%) |
| Hematologic AE | 5 (9.8%) | 14 (28.0%) |
| Renal/Urinary disorders | 3 (5.9%) | 13 (26.0%) |
| Electrolyte abnormalities | 1 (2.0%) | 8 (16.0%) |
Scroll to view
Adverse reaction and drug-related events
Fewer renal/urinary disorders, electrolyte abnormalities, and hematologic AEs observed vs investigator's choice.2
*Safety population was defined as all patients who received at least 1 dose of the trial medication.2
See the dosing
AE, adverse event; MOA, mechanism of action; TEAE, treatment-emergent adverse event.
References: 1. HOVILPRI. Prescribing information. Asahi Kasei Therapeutics. 2. Data on file. Asahi Kasei Therapeutics.