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

doi:10.1111/liv.13534

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

Liver Int. 2018 Mar;38(3):443-450. doi: 10.1111/liv.13534. Epub 2017 Oct 22.

Authors

Affiliations

¹ Department of Hepatology, Hôpital Beaujon, APHP, INSERM CRI, UMR1149, University Paris-Diderot, Clichy, France.
² Campus Stuivenberg, Antwerp, Belgium.
³ Monash Health and Monash University, Clayton, Vic., Australia.
⁴ Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany.
⁵ Johns Hopkins University, Baltimore, MD, USA.
⁶ Queen Mary University London, London, UK.
⁷ Gilead Sciences Inc., Foster City, CA, USA.
⁸ Auckland Clinical Studies Ltd, Auckland, New Zealand.
⁹ Toronto Centre for Liver Disease, Toronto, ON, Canada.
¹⁰ Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.

PMID: 28756625
DOI: 10.1111/liv.13534

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.

Keywords: NS5A inhibitor; antiviral agents; direct-acting antivirals; polymerase inhibitor.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Antiviral Agents / therapeutic use*
Carbamates / therapeutic use*
Drug Administration Schedule
Drug Therapy, Combination
Female
Hepacivirus / genetics
Hepatitis C, Chronic / complications
Hepatitis C, Chronic / drug therapy*
Heterocyclic Compounds, 4 or More Rings / therapeutic use*
Humans
Liver Cirrhosis / drug therapy*
Liver Cirrhosis / virology
Male
Middle Aged
Retrospective Studies
Severity of Illness Index
Sofosbuvir / therapeutic use*
Sustained Virologic Response

Substances

Antiviral Agents
Carbamates
Heterocyclic Compounds, 4 or More Rings
velpatasvir
Sofosbuvir