This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.
This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

Safety and Tolerability profile

Safety and tolerability of ZEPATIER® in patients with chronic hepatitis C treated with ZEPATIER for 12 weeks, from an integrated analysis of phase 2 and phase 3 clinical trials1

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

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.

*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Study medication withdrawn.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).

RBV=ribavirin; AE=Adverse event

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)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-ZEP-00148 | Date of Preparation: November 2021