Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study

Christina Sølund, Ellen Sloth Andersen, Belinda Mössner, Alex Lund Laursen, Birgit Røge, Mette Kjær, Jan Gerstoft, Peer Brehm Christensen, Martin Schou Pedersen, Kristian Schønning, Ulrik Fahnøe, Jens Bukh, Nina Weis

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

ObjectiveNew 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 methodsWe 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.ResultsA 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.ConclusionsWe 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.
OriginalsprogEngelsk
TidsskriftEuropean Journal of Gastroenterology and Hepatology
Vol/bind30
Udgave nummer10
Sider (fra-til)1177-1186
ISSN0954-691X
DOI
StatusUdgivet - 2018

Citer dette

Sølund, Christina ; Andersen, Ellen Sloth ; Mössner, Belinda ; Laursen, Alex Lund ; Røge, Birgit ; Kjær, Mette ; Gerstoft, Jan ; Christensen, Peer Brehm ; Pedersen, Martin Schou ; Schønning, Kristian ; Fahnøe, Ulrik ; Bukh, Jens ; Weis, Nina. / Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals : a clinical randomized study. I: European Journal of Gastroenterology and Hepatology. 2018 ; Bind 30, Nr. 10. s. 1177-1186.
@article{b17d8e7db3bb4b968af11e12cc9138c6,
title = "Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study",
abstract = "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.",
author = "Christina S{\o}lund and Andersen, {Ellen Sloth} and Belinda M{\"o}ssner and Laursen, {Alex Lund} and Birgit R{\o}ge and Mette Kj{\ae}r and Jan Gerstoft and Christensen, {Peer Brehm} and Pedersen, {Martin Schou} and Kristian Sch{\o}nning and Ulrik Fahn{\o}e and Jens Bukh and Nina Weis",
year = "2018",
doi = "10.1097/MEG.0000000000001192",
language = "English",
volume = "30",
pages = "1177--1186",
journal = "European Journal of Gastroenterology and Hepatology",
issn = "0954-691X",
publisher = "Lippincott Williams & Wilkins, Ltd.",
number = "10",

}

Sølund, C, Andersen, ES, Mössner, B, Laursen, AL, Røge, B, Kjær, M, Gerstoft, J, Christensen, PB, Pedersen, MS, Schønning, K, Fahnøe, U, Bukh, J & Weis, N 2018, 'Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study' European Journal of Gastroenterology and Hepatology, bind 30, nr. 10, s. 1177-1186. https://doi.org/10.1097/MEG.0000000000001192

Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals : a clinical randomized study. / Sølund, Christina; Andersen, Ellen Sloth; Mössner, Belinda; Laursen, Alex Lund; Røge, Birgit; Kjær, Mette; Gerstoft, Jan; Christensen, Peer Brehm; Pedersen, Martin Schou; Schønning, Kristian; Fahnøe, Ulrik; Bukh, Jens; Weis, Nina.

I: European Journal of Gastroenterology and Hepatology, Bind 30, Nr. 10, 2018, s. 1177-1186.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals

T2 - a clinical randomized study

AU - Sølund, Christina

AU - Andersen, Ellen Sloth

AU - Mössner, Belinda

AU - Laursen, Alex Lund

AU - Røge, Birgit

AU - Kjær, Mette

AU - Gerstoft, Jan

AU - Christensen, Peer Brehm

AU - Pedersen, Martin Schou

AU - Schønning, Kristian

AU - Fahnøe, Ulrik

AU - Bukh, Jens

AU - Weis, Nina

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

U2 - 10.1097/MEG.0000000000001192

DO - 10.1097/MEG.0000000000001192

M3 - Journal article

VL - 30

SP - 1177

EP - 1186

JO - European Journal of Gastroenterology and Hepatology

JF - European Journal of Gastroenterology and Hepatology

SN - 0954-691X

IS - 10

ER -