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

Christina Sølund; Ellen S. Andersen; Belinda Mössner; Alex L. Laursen; Birgit T. Røge; Mette S. Kjær; Jan Gerstoft; Peer B. Christensen; Martin S. Pedersen; Kristian Schønning; Ulrik Fahnøe; Jens Bukh; Nina Weis

doi:10.1097/MEG.0000000000001192

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

Christina Sølund, Ellen S. Andersen, Belinda Mössner, Alex L. Laursen, Birgit T. Røge, Mette S. Kjær, Jan Gerstoft, Peer B. Christensen, Martin S. Pedersen, Kristian Schønning, Ulrik Fahnøe, Jens Bukh, Nina Weis^*

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

5 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	European Journal of Gastroenterology and Hepatology
Vol/bind	30
Udgave nummer	10
Sider (fra-til)	1177-1186
Antal sider	10
ISSN	0954-691X
DOI	https://doi.org/10.1097/MEG.0000000000001192
Status	Udgivet - 2018

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10.1097/MEG.0000000000001192

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Sølund, C., Andersen, E. S., Mössner, B., Laursen, A. L., Røge, B. T., Kjær, M. S., Gerstoft, J., Christensen, P. B., Pedersen, M. S., 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, 30(10), 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 S.; Mössner, Belinda et al.
I: European Journal of Gastroenterology and Hepatology, Bind 30, Nr. 10, 2018, s. 1177-1186.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Sølund, C, Andersen, ES, Mössner, B, Laursen, AL, Røge, BT, Kjær, MS, 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

@article{b5912259f4894addaae0ec95b64185d2,

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.",

keywords = "adverse events, direct-acting antivirals, genotype 1, hepatitis C virus, ledipasvir and sofosbuvir, ombitasvir and dasabuvir, paritaprevir, randomized, ribavirin",

author = "Christina S{\o}lund and Andersen, {Ellen S.} and Belinda M{\"o}ssner and Laursen, {Alex L.} and R{\o}ge, {Birgit T.} and Kj{\ae}r, {Mette S.} and Jan Gerstoft and Christensen, {Peer B.} and Pedersen, {Martin S.} 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",

}

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 S.

AU - Mössner, Belinda

AU - Laursen, Alex L.

AU - Røge, Birgit T.

AU - Kjær, Mette S.

AU - Gerstoft, Jan

AU - Christensen, Peer B.

AU - Pedersen, Martin S.

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.

KW - adverse events

KW - direct-acting antivirals

KW - genotype 1

KW - hepatitis C virus

KW - ledipasvir and sofosbuvir

KW - ombitasvir and dasabuvir

KW - paritaprevir

KW - randomized

KW - ribavirin

U2 - 10.1097/MEG.0000000000001192

DO - 10.1097/MEG.0000000000001192

M3 - Journal article

C2 - 29994874

AN - SCOPUS:85053903677

SN - 0954-691X

VL - 30

SP - 1177

EP - 1186

JO - European Journal of Gastroenterology and Hepatology

JF - European Journal of Gastroenterology and Hepatology

IS - 10

ER -

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

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