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 AE71% (738)84% (549)69% (72)
Fatigue16% (167)29% (187)17% (18)
Headache18% (186)21% (137)18% (19)
Nausea8% (82)15% (100)8% (8)
Insomnia4% (42)11% (71)6% (6)
Drug-related AE*40% (414)68% (44)39% (41)
Serious AE2% (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 AE0 (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Study medication withdrawn.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

  1. 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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