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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)703-706
Number of pages4
JournalDigestive and Liver Disease
Volume50
Issue number7
DOIs
Publication statusPublished - Jul 2018

Fingerprint

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

Keywords

  • Adult
  • Aged
  • Anilides/therapeutic use
  • Antiviral Agents/therapeutic use
  • Carbamates/therapeutic use
  • Drug Therapy, Combination
  • Female
  • Hepacivirus/classification
  • Hepatitis C, Chronic/complications
  • Humans
  • Italy
  • Liver/pathology
  • Liver Cirrhosis/drug therapy
  • Macrocyclic Compounds/therapeutic use
  • Male
  • Middle Aged
  • Ribavirin/administration & dosage
  • Ritonavir/therapeutic use
  • Sustained Virologic Response

Cite this

@article{af69b23b2076444d86c3be904961ba32,
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 = "Adult, Aged, Anilides/therapeutic use, Antiviral Agents/therapeutic use, Carbamates/therapeutic use, Drug Therapy, Combination, Female, Hepacivirus/classification, Hepatitis C, Chronic/complications, Humans, Italy, Liver/pathology, Liver Cirrhosis/drug therapy, Macrocyclic Compounds/therapeutic use, Male, Middle Aged, Ribavirin/administration & dosage, Ritonavir/therapeutic use, Sustained Virologic Response",
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",
note = "Copyright {\circledC} 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.",
year = "2018",
month = "7",
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

N1 - Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

PY - 2018/7

Y1 - 2018/7

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 - Adult

KW - Aged

KW - Anilides/therapeutic use

KW - Antiviral Agents/therapeutic use

KW - Carbamates/therapeutic use

KW - Drug Therapy, Combination

KW - Female

KW - Hepacivirus/classification

KW - Hepatitis C, Chronic/complications

KW - Humans

KW - Italy

KW - Liver/pathology

KW - Liver Cirrhosis/drug therapy

KW - Macrocyclic Compounds/therapeutic use

KW - Male

KW - Middle Aged

KW - Ribavirin/administration & dosage

KW - Ritonavir/therapeutic use

KW - Sustained Virologic Response

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

JF - Digestive and Liver Disease

SN - 1590-8658

IS - 7

ER -