Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection

Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection

David Bernstein,1 Rakesh Tripathi,2 Daniel E Cohen2 1Zucker School of Medicine, Hofstra University, Hempstead, New York, NY, USA; 2AbbVie Inc., North Chicago, IL, USA Background: This international, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT01609933) was conducted to...

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Autores principales: Bernstein D, Tripathi R, Cohen DE
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2019
Materias:
direct-acting antiviral
retreatment
virologic failure
Diseases of the digestive system. Gastroenterology
RC799-869
Acceso en línea:https://doaj.org/article/c3bb15136c2543d7be125f6855018503
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spelling oai:doaj.org-article:c3bb15136c2543d7be125f68550185032021-12-02T04:13:03ZOmbitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection1179-1535https://doaj.org/article/c3bb15136c2543d7be125f68550185032019-02-01T00:00:00Zhttps://www.dovepress.com/ombitasvir-paritaprevir-and-ritonavir-with-peginterferon-alpha2a-plus--peer-reviewed-article-HMERhttps://doaj.org/toc/1179-1535David Bernstein,1 Rakesh Tripathi,2 Daniel E Cohen2 1Zucker School of Medicine, Hofstra University, Hempstead, New York, NY, USA; 2AbbVie Inc., North Chicago, IL, USA Background: This international, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT01609933) was conducted to evaluate the safety and efficacy of an enhanced regimen consisting of the direct-acting antivirals (DAAs) ombitasvir, paritaprevir, and ritonavir administered for 24 weeks, combined with pegylated interferon-α2a plus ribavirin (pegIFN-α2a/RBV) for 48 weeks, in patients with chronic hepatitis C virus (HCV) genotype 1 infection who had experienced virologic failure with a prior DAA regimen. This study was undertaken at a time when options were limited for the retreatment of patients who had failed prior DAA therapy. Methods and results: Thirty-two patients were enrolled; the majority were male (78%) and White (94%), and the median age was 54.5 years. Twelve weeks after the last dose of study drug, sustained virologic response was achieved in 81.3% of patients. Five patients prematurely discontinued the study drugs and one patient relapsed. Safety and tolerability were similar to prior studies of pegIFN-α2a/RBV alone.Conclusion: Given the availability of highly efficacious DAA regimens that are both IFN- and RBV-free, this regimen is no longer relevant in today’s HCV treatment landscape. Keywords: direct-acting antiviral, retreatment, virologic failureBernstein DTripathi RCohen DEDove Medical Pressarticledirect-acting antiviralretreatmentvirologic failureDiseases of the digestive system. GastroenterologyRC799-869ENHepatic Medicine: Evidence and Research, Vol Volume 11, Pp 35-40 (2019)
institution DOAJ
collection DOAJ
language EN
topic direct-acting antiviral
retreatment
virologic failure
Diseases of the digestive system. Gastroenterology
RC799-869
spellingShingle direct-acting antiviral
retreatment
virologic failure
Diseases of the digestive system. Gastroenterology
RC799-869
Bernstein D
Tripathi R
Cohen DE
Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
description David Bernstein,1 Rakesh Tripathi,2 Daniel E Cohen2 1Zucker School of Medicine, Hofstra University, Hempstead, New York, NY, USA; 2AbbVie Inc., North Chicago, IL, USA Background: This international, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT01609933) was conducted to evaluate the safety and efficacy of an enhanced regimen consisting of the direct-acting antivirals (DAAs) ombitasvir, paritaprevir, and ritonavir administered for 24 weeks, combined with pegylated interferon-α2a plus ribavirin (pegIFN-α2a/RBV) for 48 weeks, in patients with chronic hepatitis C virus (HCV) genotype 1 infection who had experienced virologic failure with a prior DAA regimen. This study was undertaken at a time when options were limited for the retreatment of patients who had failed prior DAA therapy. Methods and results: Thirty-two patients were enrolled; the majority were male (78%) and White (94%), and the median age was 54.5 years. Twelve weeks after the last dose of study drug, sustained virologic response was achieved in 81.3% of patients. Five patients prematurely discontinued the study drugs and one patient relapsed. Safety and tolerability were similar to prior studies of pegIFN-α2a/RBV alone.Conclusion: Given the availability of highly efficacious DAA regimens that are both IFN- and RBV-free, this regimen is no longer relevant in today’s HCV treatment landscape. Keywords: direct-acting antiviral, retreatment, virologic failure
format article
author Bernstein D
Tripathi R
Cohen DE
author_facet Bernstein D
Tripathi R
Cohen DE
author_sort Bernstein D
title Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
title_short Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
title_full Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
title_fullStr Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
title_full_unstemmed Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
title_sort ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis c virus genotype 1 infection
publisher Dove Medical Press
publishDate 2019
url https://doaj.org/article/c3bb15136c2543d7be125f6855018503
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