Safety Information
Safety and tolerability profile
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
Safety and tolerability of ZEPATIER® (elbasvir and grazoprevir) in patients with chronic hepatitis C treated with ZEPATIER for 12 weeks, from an integrated analysis of Phase 2 and Phase 3 clinical trials1
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg.
Please consult the ZEPATIER SmPC before prescribing.
| Adverse events (≥5%) | ZEPATIER n=1,033, % (n) | ZEPATIER + RBV n=657, % (n) | Placebo n=105, % (n) |
|---|---|---|---|
| ≥1 AE | 71% (738) | 84% (549) | 69% (72) |
| Fatigue | 16% (167) | 29% (187) | 17% (18) |
| Headache | 18% (186) | 21% (137) | 18% (19) |
| Nausea | 8% (82) | 15% (100) | 8% (8) |
| Insomnia | 4% (42) | 11% (71) | 6% (6) |
| Drug-related AE* | 40% (414) | 68% (44) | 39% (41) |
| Serious AE | 2% (25) | 3% (17) | 3% (3) |
| Serious drug-related AE | <1% (1) | <1% (3) | 0 (0) |
| Death** | <1% (2) | <1% (1) | 0 (0) |
| Discontinued due to an AE† | <1% (5) | 2% (11) | 1% (1) |
| Discontinued due to a drug-related AE‡ | <1% (3) | <1% (5) | 1% (1) |
| Discontinued due to a serious AE | <1% (1) | <1% (2) | 0 (0) |
| Discontinued due to a serious drug-related AE | 0 (0) | 0 (0) | 0 (0) |
Adapted from Dusheiko et al, 20151
*Determined by the investigator.
**There were 3 deaths: ZEPATIER, post-appendectomy complication n=1, coronary artery disease n=1; ZEPATIER + RBV motor vehicle accident n=1.
†Study medication withdrawn.
‡Nine patients discontinued due to a drug-related AE: ZEPATIER, n=3 (ALT increase, n=2; anxiety, n=1); ZEPATIER + RBV, n=5 (asthenia, mood lability, palpitations, tachycardia, depression, n=1 each); placebo, n=1 (pruritus).
Every patient is counted a single time for each applicable row and column. A specific AE appears on this report only if its incidence in one or more columns meets the incidence criterion in the report title, after rounding.
AE=Adverse Event; RBV = Ribavirin.
Reference
- Duisheiko, GM et al. Safety and tolerability of elbsavir/grazoprevir in patients with chronic hepatitis C: an integrated analysis of Phase 2-3 trials. Presented at: American Association for the Study of Liver Diseases Meeting; November 13–17 2015; Boston, MA.
Supporting documentation
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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