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 language | English |
|---|---|
| Pages (from-to) | 703-706 |
| Number of pages | 4 |
| Journal | Digestive and Liver Disease |
| Volume | 50 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Jul 2018 |
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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
12 weeks ombitasvir/paritaprevir-ritonavir + ribavirin achieve high SVR rates in HCV-4 patients with advanced fibrosis. / Degasperi, Elisabetta; Aghemo, Alessio; Paolucci, Stefania; D'Ambrosio, Roberta; Borghi, Marta; Perbellini, Riccardo; Novazzi, Federica; De Nicola, Stella; Lunghi, Giovanna; Baldanti, Fausto; Lampertico, Pietro.
In: Digestive and Liver Disease, Vol. 50, No. 7, 07.2018, p. 703-706.Research output: Contribution to journal › Article
}
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 -