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Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals

a clinical randomized study

Sølund, Christinaa,c,f; Andersen, Ellen S.d; Mössner, Belindah; Laursen, Alex L.j; Røge, Birgit T.l; Kjær, Mette S.e,g; Gerstoft, Jand,g; Christensen, Peer B.h,i; Pedersen, Martin S.c,f,b,k; Schønning, Kristiang,b; Fahnøe, Ulrikc,f; Bukh, Jensa,c,f; Weis, Ninaa,g

European Journal of Gastroenterology & Hepatology: October 2018 - Volume 30 - Issue 10 - p 1177–1186
doi: 10.1097/MEG.0000000000001192
Original Articles: Hepatology

Objective New potent direct-acting antiviral (DAA) regimens against hepatitis C virus have been approved in recent years. However, information about the rate of adverse events (AEs) across different DAA regimens is limited. We aimed to evaluate differences in AEs and treatment efficacy in patients with chronic hepatitis C (CHC), genotype (GT) 1 or 3, randomized to two different treatment arms, correspondingly.

Patients and methods We randomly assigned 96 patients in a 1 : 1 ratio, to treatment for 12 weeks with either paritaprevir/ombitasvir/ritonavir/dasabuvir/ribavirin (RBV) or ledipasvir/sofosbuvir (SOF)/RBV if infected with GT1 (72 patients) or to daclatasvir/SOF/RBV for 12 weeks or SOF/RBV for 24 weeks, if infected with GT3 (24 patients). Data on AEs were collected throughout the entire study period.

Results A total of 70 (97%) patients with CHC with GT1 and 20 (83%) patients with GT3 achieved cure. The GT3 treatment arm was prematurely terminated, owing to change in national treatment guidelines. Thus, only AEs for GT1 patients are described. AEs occurred in 70 (97%) GT1 patients, and most common AEs were anemia (n=56/78%), fatigue (n=53/74%), and headache (n=33/46%). No difference was observed in relation to treatment group (P=1.0), anemia (P=1.0), or liver cirrhosis (P=0.53). In seven (11%) patients, AEs assessed by the investigator to be possibly related to the DAA regimen were still present 12 weeks after treatment.

Conclusions We found no difference in AEs possibly related to the DAA regimen in patients with CHC, but surprisingly, AEs possibly related to the DAA regimen persisted in a significant number of patients after treatment. This finding can be of importance for clinicians in relation to patient information concerning AEs possibly related to DAA treatment.

Departments of aInfectious Diseases

bClinical Microbiology

cCopenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases and Clinical Research Centre, Copenhagen University Hospital, Hvidovre

Departments of dInfectious Diseases

eHepatology, Copenhagen University Hospital, Rigshospitalet

Departments of fImmunology and Microbiology

gClinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen

hDepartment of Infectious Diseases, Odense University Hospital

iDepartment of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense

jDepartment of Infectious Diseases, Aarhus University Hospital, Skejby

kDepartment of Science and Environment, Roskilde University, Roskilde

lDepartment of Medicine, Lillebaelt Hospital, Kolding, Denmark

Correspondence to Nina Weis, PhD, MD, Department of Infectious Diseases, Copenhagen University Hospital, Kettegaard Alle 30, DK 2650 Hvidovre, Denmark Tel: +45 386 23514; fax: +45 386 23504; e-mail:

Received March 12, 2018

Accepted April 19, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.