12 weeks ombitasvir/paritaprevir-ritonavir + ribavirin achieve high SVR rates in HCV-4 patients with advanced fibrosis

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Abstract

Background: Ombitasvir/paritaprevir-ritonavir (OBT/PTV-r) plus ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype 4 patients with advanced fibrosis has been only investigated in clinical trials. Aims: To assess safety and efficacy of OBT/PTV-r + RBV for 12 weeks in real-life HCV-4 patients with advanced fibrosis. Methods: HCV-4 patients with advanced fibrosis consecutively receiving OBT/PTV-r + RBV for 12 weeks in a single center were enrolled. Fibrosis was staged by transient elastography (TE) (F3: ≥10 kPa; F4 ≥11.9 kPa) or histologically. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks post-treatment. Results: Between January 2016 and February 2017, 49 HCV-4 patients were included: median age 54 (39-72) years, 84% males, 59% Egyptians, 35% fibrosis F3 and 65% F4, all Child Pugh class A. Median RBV dose was 1200 (200-1200) mg/day. At ITT analysis, 47 (96%) patients achieved an SVR (100% at PP analysis). SVR was not affected by ancestry (Egyptian vs. Italian 97% vs. 95%, p = 1.0), fibrosis stage (F3 vs. F4 100% vs. 94%, p = .53), presence of baseline resistance associated substitutions (RASs) or RBV reduction. Conclusions: We report 100% SVR with 12-weeks of OBT/PTV-r + RBV in HCV-4 patients with advanced liver disease, including compensated cirrhotics.

LanguageEnglish
Pages703-706
JournalDigestive and Liver Disease
Volume50
Issue number7
DOIs
Publication statusPublished - 2018

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Ritonavir
Ribavirin
Hepacivirus
Fibrosis
Elasticity Imaging Techniques
ABT-450
ABT-267
Liver Diseases
Genotype
Clinical Trials
RNA
Safety

Keywords

  • DAA
  • Genotype 4
  • Paritaprevir
  • RAS

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

@article{3401c705c5d746a39d2bb41d65c9afd1,
title = "12 weeks ombitasvir/paritaprevir-ritonavir + ribavirin achieve high SVR rates in HCV-4 patients with advanced fibrosis",
abstract = "Background: Ombitasvir/paritaprevir-ritonavir (OBT/PTV-r) plus ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype 4 patients with advanced fibrosis has been only investigated in clinical trials. Aims: To assess safety and efficacy of OBT/PTV-r + RBV for 12 weeks in real-life HCV-4 patients with advanced fibrosis. Methods: HCV-4 patients with advanced fibrosis consecutively receiving OBT/PTV-r + RBV for 12 weeks in a single center were enrolled. Fibrosis was staged by transient elastography (TE) (F3: ≥10 kPa; F4 ≥11.9 kPa) or histologically. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks post-treatment. Results: Between January 2016 and February 2017, 49 HCV-4 patients were included: median age 54 (39-72) years, 84{\%} males, 59{\%} Egyptians, 35{\%} fibrosis F3 and 65{\%} F4, all Child Pugh class A. Median RBV dose was 1200 (200-1200) mg/day. At ITT analysis, 47 (96{\%}) patients achieved an SVR (100{\%} at PP analysis). SVR was not affected by ancestry (Egyptian vs. Italian 97{\%} vs. 95{\%}, p = 1.0), fibrosis stage (F3 vs. F4 100{\%} vs. 94{\%}, p = .53), presence of baseline resistance associated substitutions (RASs) or RBV reduction. Conclusions: We report 100{\%} SVR with 12-weeks of OBT/PTV-r + RBV in HCV-4 patients with advanced liver disease, including compensated cirrhotics.",
keywords = "DAA, Genotype 4, Paritaprevir, RAS",
author = "Elisabetta Degasperi and Alessio Aghemo and Stefania Paolucci and Roberta D'Ambrosio and Marta Borghi and Riccardo Perbellini and Federica Novazzi and {De Nicola}, Stella and Giovanna Lunghi and Fausto Baldanti and Pietro Lampertico",
year = "2018",
doi = "10.1016/j.dld.2018.02.003",
language = "English",
volume = "50",
pages = "703--706",
journal = "Digestive and Liver Disease",
issn = "1590-8658",
publisher = "Elsevier B.V.",
number = "7",

}

TY - JOUR

T1 - 12 weeks ombitasvir/paritaprevir-ritonavir + ribavirin achieve high SVR rates in HCV-4 patients with advanced fibrosis

AU - Degasperi, Elisabetta

AU - Aghemo, Alessio

AU - Paolucci, Stefania

AU - D'Ambrosio, Roberta

AU - Borghi, Marta

AU - Perbellini, Riccardo

AU - Novazzi, Federica

AU - De Nicola, Stella

AU - Lunghi, Giovanna

AU - Baldanti, Fausto

AU - Lampertico, Pietro

PY - 2018

Y1 - 2018

N2 - Background: Ombitasvir/paritaprevir-ritonavir (OBT/PTV-r) plus ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype 4 patients with advanced fibrosis has been only investigated in clinical trials. Aims: To assess safety and efficacy of OBT/PTV-r + RBV for 12 weeks in real-life HCV-4 patients with advanced fibrosis. Methods: HCV-4 patients with advanced fibrosis consecutively receiving OBT/PTV-r + RBV for 12 weeks in a single center were enrolled. Fibrosis was staged by transient elastography (TE) (F3: ≥10 kPa; F4 ≥11.9 kPa) or histologically. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks post-treatment. Results: Between January 2016 and February 2017, 49 HCV-4 patients were included: median age 54 (39-72) years, 84% males, 59% Egyptians, 35% fibrosis F3 and 65% F4, all Child Pugh class A. Median RBV dose was 1200 (200-1200) mg/day. At ITT analysis, 47 (96%) patients achieved an SVR (100% at PP analysis). SVR was not affected by ancestry (Egyptian vs. Italian 97% vs. 95%, p = 1.0), fibrosis stage (F3 vs. F4 100% vs. 94%, p = .53), presence of baseline resistance associated substitutions (RASs) or RBV reduction. Conclusions: We report 100% SVR with 12-weeks of OBT/PTV-r + RBV in HCV-4 patients with advanced liver disease, including compensated cirrhotics.

AB - Background: Ombitasvir/paritaprevir-ritonavir (OBT/PTV-r) plus ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype 4 patients with advanced fibrosis has been only investigated in clinical trials. Aims: To assess safety and efficacy of OBT/PTV-r + RBV for 12 weeks in real-life HCV-4 patients with advanced fibrosis. Methods: HCV-4 patients with advanced fibrosis consecutively receiving OBT/PTV-r + RBV for 12 weeks in a single center were enrolled. Fibrosis was staged by transient elastography (TE) (F3: ≥10 kPa; F4 ≥11.9 kPa) or histologically. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks post-treatment. Results: Between January 2016 and February 2017, 49 HCV-4 patients were included: median age 54 (39-72) years, 84% males, 59% Egyptians, 35% fibrosis F3 and 65% F4, all Child Pugh class A. Median RBV dose was 1200 (200-1200) mg/day. At ITT analysis, 47 (96%) patients achieved an SVR (100% at PP analysis). SVR was not affected by ancestry (Egyptian vs. Italian 97% vs. 95%, p = 1.0), fibrosis stage (F3 vs. F4 100% vs. 94%, p = .53), presence of baseline resistance associated substitutions (RASs) or RBV reduction. Conclusions: We report 100% SVR with 12-weeks of OBT/PTV-r + RBV in HCV-4 patients with advanced liver disease, including compensated cirrhotics.

KW - DAA

KW - Genotype 4

KW - Paritaprevir

KW - RAS

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U2 - 10.1016/j.dld.2018.02.003

DO - 10.1016/j.dld.2018.02.003

M3 - Article

VL - 50

SP - 703

EP - 706

JO - Digestive and Liver Disease

T2 - Digestive and Liver Disease

JF - Digestive and Liver Disease

SN - 1590-8658

IS - 7

ER -