Cargando…
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
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 infecte...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6222025/ https://www.ncbi.nlm.nih.gov/pubmed/30430131 http://dx.doi.org/10.1093/ofid/ofy248 |
_version_ | 1783369120093306880 |
---|---|
author | Grebely, Jason Puoti, Massimo Wedemeyer, Heiner Cooper, Curtis Sulkowski, Mark S Foster, Graham R Berg, Thomas Villa, Erica Rodriguez-Perez, Federico Wyles, David L Schnell, Gretja Alami, Negar N Zhang, Zhenzhen Dumas, Emily Dore, Gregory J |
author_facet | Grebely, Jason Puoti, Massimo Wedemeyer, Heiner Cooper, Curtis Sulkowski, Mark S Foster, Graham R Berg, Thomas Villa, Erica Rodriguez-Perez, Federico Wyles, David L Schnell, Gretja Alami, Negar N Zhang, Zhenzhen Dumas, Emily Dore, Gregory J |
author_sort | Grebely, Jason |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6222025 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-62220252018-11-14 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 Grebely, Jason Puoti, Massimo Wedemeyer, Heiner Cooper, Curtis Sulkowski, Mark S Foster, Graham R Berg, Thomas Villa, Erica Rodriguez-Perez, Federico Wyles, David L Schnell, Gretja Alami, Negar N Zhang, Zhenzhen Dumas, Emily Dore, Gregory J Open Forum Infect Dis Major Articles 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. Oxford University Press 2018-09-27 /pmc/articles/PMC6222025/ /pubmed/30430131 http://dx.doi.org/10.1093/ofid/ofy248 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 Articles Grebely, Jason Puoti, Massimo Wedemeyer, Heiner Cooper, Curtis Sulkowski, Mark S Foster, Graham R Berg, Thomas Villa, Erica Rodriguez-Perez, Federico Wyles, David L Schnell, Gretja Alami, Negar N Zhang, Zhenzhen Dumas, Emily Dore, Gregory J 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Major Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6222025/ https://www.ncbi.nlm.nih.gov/pubmed/30430131 http://dx.doi.org/10.1093/ofid/ofy248 |
work_keys_str_mv | AT grebelyjason efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT puotimassimo efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT wedemeyerheiner efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT coopercurtis efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT sulkowskimarks efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT fostergrahamr efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT bergthomas efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT villaerica efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT rodriguezperezfederico efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT wylesdavidl efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT schnellgretja efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT alaminegarn efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT zhangzhenzhen efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT dumasemily efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials AT doregregoryj efficacyandsafetyofombitasvirparitaprevirritonaviranddasabuvirwithorwithoutribavirininpatientswithchronichepatitiscvirusgenotype1infectionreceivingopioidsubstitutiontherapyaposthocanalysisof12clinicaltrials |