Abstract

Background

We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis.

Methods

Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed.

Results

Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated.

Conclusions

Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.

Details

Title
Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
Author
Grebely, Jason 1 ; Puoti, Massimo 2 ; Wedemeyer, Heiner 3 ; Cooper, Curtis 4 ; Sulkowski, Mark S 5 ; Foster, Graham R 6 ; Berg, Thomas 7 ; Villa, Erica 8 ; Rodriguez-Perez, Federico 9 ; Wyles, David L 10 ; Schnell, Gretja 11 ; Alami, Negar N 11 ; Zhang, Zhenzhen 11 ; Dumas, Emily 11 ; Dore, Gregory J 1 

 The Kirby Institute, UNSW Sydney, Sydney, Australia 
 Azienda Ospedaliera Ospedale Niguarda Ca’ Granda, Milan, Italy 
 Medizinische Hochschule Hannover, Hannover, Germany 
 Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada 
 Viral Hepatitis Center, Johns Hopkins University, Baltimore, Maryland 
 Queen Mary University of London and Barts Health NHS Trust, London, United Kingdom 
 Universitätsklinikum Leipzig, Leipzig, Germany 
 University of Modena and Reggio Emilia, Modena, Italy 
 Gastroenterology Department, VA Caribbean Healthcare System, San Juan, Puerto Rico 
10  Infectious Diseases Division, Department of Medicine at Denver Health, Denver, Colorado 
11  AbbVie Inc., North Chicago, Illinois 
Publication year
2018
Publication date
Nov 2018
Publisher
Oxford University Press
e-ISSN
23288957
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3170976315
Copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.