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Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies
BACKGROUND: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and s...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808802/ https://www.ncbi.nlm.nih.gov/pubmed/29450210 http://dx.doi.org/10.1093/ofid/ofy001 |
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author | Grebely, Jason Feld, Jordan J Wyles, David Sulkowski, Mark Ni, Liyun Llewellyn, Joe Mir, Heshaam M Sajed, Nika Stamm, Luisa M Hyland, Robert H McNally, John Brainard, Diana M Jacobson, Ira Zeuzem, Stefan Bourlière, Marc Foster, Graham Afdhal, Nezam Dore, Gregory J |
author_facet | Grebely, Jason Feld, Jordan J Wyles, David Sulkowski, Mark Ni, Liyun Llewellyn, Joe Mir, Heshaam M Sajed, Nika Stamm, Luisa M Hyland, Robert H McNally, John Brainard, Diana M Jacobson, Ira Zeuzem, Stefan Bourlière, Marc Foster, Graham Afdhal, Nezam Dore, Gregory J |
author_sort | Grebely, Jason |
collection | PubMed |
description | BACKGROUND: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. METHODS: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible. RESULTS: Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%, P = .06), SVR12 (94% vs 97%, P = .06), relapse (0.5% vs 2.1%, P = .19), adverse events (78% vs 77%, P = .79), or serious adverse events (3.6% vs 2.4%, P = .24). There was no difference in SVR12 in patients with cirrhosis (99% vs 95%, P = .25) or those with G3 (95% vs 95%, P = .77) in those receiving OST. Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). CONCLUSION: Sofosbuvir-based therapies are effective and safe in patients receiving OST. |
format | Online Article Text |
id | pubmed-5808802 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-58088022018-02-15 Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies Grebely, Jason Feld, Jordan J Wyles, David Sulkowski, Mark Ni, Liyun Llewellyn, Joe Mir, Heshaam M Sajed, Nika Stamm, Luisa M Hyland, Robert H McNally, John Brainard, Diana M Jacobson, Ira Zeuzem, Stefan Bourlière, Marc Foster, Graham Afdhal, Nezam Dore, Gregory J Open Forum Infect Dis Major Article BACKGROUND: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. METHODS: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible. RESULTS: Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%, P = .06), SVR12 (94% vs 97%, P = .06), relapse (0.5% vs 2.1%, P = .19), adverse events (78% vs 77%, P = .79), or serious adverse events (3.6% vs 2.4%, P = .24). There was no difference in SVR12 in patients with cirrhosis (99% vs 95%, P = .25) or those with G3 (95% vs 95%, P = .77) in those receiving OST. Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). CONCLUSION: Sofosbuvir-based therapies are effective and safe in patients receiving OST. Oxford University Press 2018-02-09 /pmc/articles/PMC5808802/ /pubmed/29450210 http://dx.doi.org/10.1093/ofid/ofy001 Text en The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ 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. |
spellingShingle | Major Article Grebely, Jason Feld, Jordan J Wyles, David Sulkowski, Mark Ni, Liyun Llewellyn, Joe Mir, Heshaam M Sajed, Nika Stamm, Luisa M Hyland, Robert H McNally, John Brainard, Diana M Jacobson, Ira Zeuzem, Stefan Bourlière, Marc Foster, Graham Afdhal, Nezam Dore, Gregory J Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title | Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title_full | Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title_fullStr | Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title_full_unstemmed | Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title_short | Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies |
title_sort | sofosbuvir-based direct-acting antiviral therapies for hcv in people receiving opioid substitution therapy: an analysis of phase 3 studies |
topic | Major Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808802/ https://www.ncbi.nlm.nih.gov/pubmed/29450210 http://dx.doi.org/10.1093/ofid/ofy001 |
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