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.
dc.contributor.author | Grebely, J | |
dc.contributor.author | Puoti, M | |
dc.contributor.author | Wedemeyer, H | |
dc.contributor.author | Cooper, C | |
dc.contributor.author | Sulkowski, MS | |
dc.contributor.author | Foster, GR | |
dc.contributor.author | Berg, T | |
dc.contributor.author | Villa, E | |
dc.contributor.author | Rodriguez-Perez, F | |
dc.contributor.author | Wyles, DL | |
dc.contributor.author | Schnell, G | |
dc.contributor.author | Alami, NN | |
dc.contributor.author | Zhang, Z | |
dc.contributor.author | Dumas, E | |
dc.contributor.author | Dore, GJ | |
dc.date.accessioned | 2019-03-11T15:27:31Z | |
dc.date.available | 2018-09-25 | |
dc.date.available | 2019-03-11T15:27:31Z | |
dc.date.issued | 2018-09-27 | |
dc.date.submitted | 2018-12-06T12:36:55.623Z | |
dc.identifier.issn | 2328-8957 | |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/56047 | |
dc.description.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. | en_US |
dc.format.extent | ofy248 | |
dc.language | eng | |
dc.language.iso | en | en_US |
dc.publisher | Oxford University Press | en_US |
dc.relation.ispartof | Open Forum Infect Dis | |
dc.rights | This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. | |
dc.rights | Attribution 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/us/ | * |
dc.subject | PWID | en_US |
dc.subject | drug use | en_US |
dc.subject | hepatitis C virus | en_US |
dc.subject | opioid substitution therapy | en_US |
dc.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. | en_US |
dc.type | Article | en_US |
dc.rights.holder | © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. | |
dc.identifier.doi | 10.1093/ofid/ofy248 | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/30430131 | en_US |
pubs.issue | 11 | en_US |
pubs.notes | No embargo | en_US |
pubs.publication-status | Published online | en_US |
pubs.publisher-url | https://doi.org/10.1093/ofid/ofy248 | |
pubs.volume | 5 | en_US |
dcterms.dateAccepted | 2018-09-25 | |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |
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Except where otherwise noted, this item's license is described as This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.