Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis

Tarik Asselah, Stefan Bourgeois, Stephen Pianko, Stefan Zeuzem, Mark Sulkowski, Graham R Foster, Lingling Han, John McNally, Anu Osinusi, Diana M Brainard, G Mani Subramanian, Edward J Gane, Jordan J Feld, Alessandra Mangia

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Abstract

BACKGROUND & AIMS: Patients with chronic hepatitis C virus infection and advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4) have been identified as a priority group for immediate treatment. We evaluated the safety and efficacy of sofosbuvir-velpatasvir in patients with hepatitis C virus genotype 1-6 infection and compensated cirrhosis or advanced fibrosis.

METHODS: This retrospective analysis included 501 patients with compensated cirrhosis or advanced fibrosis (F3/F4), as defined by >0.59 on Fibrotest, >9.5 kPa on Fibroscan, or F3/F4 (Metavir) or F4 (Ishak) on liver biopsy. Patients received sofosbuvir-velpatasvir for 12 weeks. Sustained virological response 12 weeks after treatment was determined.

RESULTS: Forty-four per cent of patients had cirrhosis. Sustained virological response 12 weeks after treatment was achieved by 98% of patients (490/501; 95% confidence interval, 96-99). Sustained virological response 12 weeks after treatment rates were 100% for hepatitis C virus genotypes 2 (85/85), 4 (60/60), 5 (13/13), and 6 (20/20). Sustained virological response 12 weeks after treatment rates were 98% (167/170) in hepatitis C virus genotype 1 patients and 95% (145/153) in hepatitis C virus genotype 3 patients. Among patients with cirrhosis 96% (212/220) achieved sustained virological response 12 weeks after treatment, vs 99% (278/281) for those with advanced fibrosis. Sustained virological response 12 weeks after treatment was 98% (306/311) for treatment-naïve patients and 97% (184/190) for treatment-experienced patients. No patients discontinued treatment due to adverse events. Eight patients reported nine serious adverse events; none was considered related to study procedures or drugs.

CONCLUSIONS: Sofosbuvir plus velpatasvir is highly effective and safe for treating patients with hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 and advanced fibrosis or compensated cirrhosis.

Original languageEnglish
JournalLiver International
DOIs
Publication statusE-pub ahead of print - Jul 30 2017

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Hepacivirus
Fibrosis
Genotype
Therapeutics
velpatasvir
Sofosbuvir
Chronic Hepatitis C
Virus Diseases
Confidence Intervals

Keywords

  • Journal Article

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Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis. / Asselah, Tarik; Bourgeois, Stefan; Pianko, Stephen; Zeuzem, Stefan; Sulkowski, Mark; Foster, Graham R; Han, Lingling; McNally, John; Osinusi, Anu; Brainard, Diana M; Subramanian, G Mani; Gane, Edward J; Feld, Jordan J; Mangia, Alessandra.

In: Liver International, 30.07.2017.

Research output: Contribution to journalArticle

Asselah, T, Bourgeois, S, Pianko, S, Zeuzem, S, Sulkowski, M, Foster, GR, Han, L, McNally, J, Osinusi, A, Brainard, DM, Subramanian, GM, Gane, EJ, Feld, JJ & Mangia, A 2017, 'Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis', Liver International. https://doi.org/10.1111/liv.13534
Asselah, Tarik ; Bourgeois, Stefan ; Pianko, Stephen ; Zeuzem, Stefan ; Sulkowski, Mark ; Foster, Graham R ; Han, Lingling ; McNally, John ; Osinusi, Anu ; Brainard, Diana M ; Subramanian, G Mani ; Gane, Edward J ; Feld, Jordan J ; Mangia, Alessandra. / Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis. In: Liver International. 2017.
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abstract = "BACKGROUND & AIMS: Patients with chronic hepatitis C virus infection and advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4) have been identified as a priority group for immediate treatment. We evaluated the safety and efficacy of sofosbuvir-velpatasvir in patients with hepatitis C virus genotype 1-6 infection and compensated cirrhosis or advanced fibrosis.METHODS: This retrospective analysis included 501 patients with compensated cirrhosis or advanced fibrosis (F3/F4), as defined by >0.59 on Fibrotest, >9.5 kPa on Fibroscan, or F3/F4 (Metavir) or F4 (Ishak) on liver biopsy. Patients received sofosbuvir-velpatasvir for 12 weeks. Sustained virological response 12 weeks after treatment was determined.RESULTS: Forty-four per cent of patients had cirrhosis. Sustained virological response 12 weeks after treatment was achieved by 98{\%} of patients (490/501; 95{\%} confidence interval, 96-99). Sustained virological response 12 weeks after treatment rates were 100{\%} for hepatitis C virus genotypes 2 (85/85), 4 (60/60), 5 (13/13), and 6 (20/20). Sustained virological response 12 weeks after treatment rates were 98{\%} (167/170) in hepatitis C virus genotype 1 patients and 95{\%} (145/153) in hepatitis C virus genotype 3 patients. Among patients with cirrhosis 96{\%} (212/220) achieved sustained virological response 12 weeks after treatment, vs 99{\%} (278/281) for those with advanced fibrosis. Sustained virological response 12 weeks after treatment was 98{\%} (306/311) for treatment-na{\"i}ve patients and 97{\%} (184/190) for treatment-experienced patients. No patients discontinued treatment due to adverse events. Eight patients reported nine serious adverse events; none was considered related to study procedures or drugs.CONCLUSIONS: Sofosbuvir plus velpatasvir is highly effective and safe for treating patients with hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 and advanced fibrosis or compensated cirrhosis.",
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T1 - Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis

AU - Asselah, Tarik

AU - Bourgeois, Stefan

AU - Pianko, Stephen

AU - Zeuzem, Stefan

AU - Sulkowski, Mark

AU - Foster, Graham R

AU - Han, Lingling

AU - McNally, John

AU - Osinusi, Anu

AU - Brainard, Diana M

AU - Subramanian, G Mani

AU - Gane, Edward J

AU - Feld, Jordan J

AU - Mangia, Alessandra

N1 - © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2017/7/30

Y1 - 2017/7/30

N2 - BACKGROUND & AIMS: Patients with chronic hepatitis C virus infection and advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4) have been identified as a priority group for immediate treatment. We evaluated the safety and efficacy of sofosbuvir-velpatasvir in patients with hepatitis C virus genotype 1-6 infection and compensated cirrhosis or advanced fibrosis.METHODS: This retrospective analysis included 501 patients with compensated cirrhosis or advanced fibrosis (F3/F4), as defined by >0.59 on Fibrotest, >9.5 kPa on Fibroscan, or F3/F4 (Metavir) or F4 (Ishak) on liver biopsy. Patients received sofosbuvir-velpatasvir for 12 weeks. Sustained virological response 12 weeks after treatment was determined.RESULTS: Forty-four per cent of patients had cirrhosis. Sustained virological response 12 weeks after treatment was achieved by 98% of patients (490/501; 95% confidence interval, 96-99). Sustained virological response 12 weeks after treatment rates were 100% for hepatitis C virus genotypes 2 (85/85), 4 (60/60), 5 (13/13), and 6 (20/20). Sustained virological response 12 weeks after treatment rates were 98% (167/170) in hepatitis C virus genotype 1 patients and 95% (145/153) in hepatitis C virus genotype 3 patients. Among patients with cirrhosis 96% (212/220) achieved sustained virological response 12 weeks after treatment, vs 99% (278/281) for those with advanced fibrosis. Sustained virological response 12 weeks after treatment was 98% (306/311) for treatment-naïve patients and 97% (184/190) for treatment-experienced patients. No patients discontinued treatment due to adverse events. Eight patients reported nine serious adverse events; none was considered related to study procedures or drugs.CONCLUSIONS: Sofosbuvir plus velpatasvir is highly effective and safe for treating patients with hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 and advanced fibrosis or compensated cirrhosis.

AB - BACKGROUND & AIMS: Patients with chronic hepatitis C virus infection and advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4) have been identified as a priority group for immediate treatment. We evaluated the safety and efficacy of sofosbuvir-velpatasvir in patients with hepatitis C virus genotype 1-6 infection and compensated cirrhosis or advanced fibrosis.METHODS: This retrospective analysis included 501 patients with compensated cirrhosis or advanced fibrosis (F3/F4), as defined by >0.59 on Fibrotest, >9.5 kPa on Fibroscan, or F3/F4 (Metavir) or F4 (Ishak) on liver biopsy. Patients received sofosbuvir-velpatasvir for 12 weeks. Sustained virological response 12 weeks after treatment was determined.RESULTS: Forty-four per cent of patients had cirrhosis. Sustained virological response 12 weeks after treatment was achieved by 98% of patients (490/501; 95% confidence interval, 96-99). Sustained virological response 12 weeks after treatment rates were 100% for hepatitis C virus genotypes 2 (85/85), 4 (60/60), 5 (13/13), and 6 (20/20). Sustained virological response 12 weeks after treatment rates were 98% (167/170) in hepatitis C virus genotype 1 patients and 95% (145/153) in hepatitis C virus genotype 3 patients. Among patients with cirrhosis 96% (212/220) achieved sustained virological response 12 weeks after treatment, vs 99% (278/281) for those with advanced fibrosis. Sustained virological response 12 weeks after treatment was 98% (306/311) for treatment-naïve patients and 97% (184/190) for treatment-experienced patients. No patients discontinued treatment due to adverse events. Eight patients reported nine serious adverse events; none was considered related to study procedures or drugs.CONCLUSIONS: Sofosbuvir plus velpatasvir is highly effective and safe for treating patients with hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 and advanced fibrosis or compensated cirrhosis.

KW - Journal Article

U2 - 10.1111/liv.13534

DO - 10.1111/liv.13534

M3 - Article

JO - Liver International

JF - Liver International

SN - 1478-3223

ER -