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

Research output: Contribution to journalArticle

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 (US)
JournalLiver International
DOIs
StateAccepted/In press - 2017

Fingerprint

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

Keywords

  • Antiviral agents
  • Direct-acting antivirals
  • NS5A inhibitor
  • Polymerase inhibitor

ASJC Scopus subject areas

  • Hepatology

Cite this

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, 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.",
keywords = "Antiviral agents, Direct-acting antivirals, NS5A inhibitor, Polymerase inhibitor",
author = "Tarik Asselah and Stefan Bourgeois and Stephen Pianko and Stefan Zeuzem and Mark Sulkowski and Foster, {Graham R.} and Lingling Han and John Mcnally and Anu Osinusi and Brainard, {Diana M.} and Subramanian, {G. Mani} and Gane, {Edward J.} and Feld, {Jordan J.} and Alessandra Mangia",
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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

PY - 2017

Y1 - 2017

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 - Antiviral agents

KW - Direct-acting antivirals

KW - NS5A inhibitor

KW - Polymerase inhibitor

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