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Sofosbuvir/Velpatasvir in Patients With Hepatitis C Virus Genotypes 1-6 and Compensated Cirrhosis or Advanced Fibrosis.
Asselah T1,
Bourgeois S2,
Pianko S3,
Zeuzem S4,
Sulkowski M5,
Foster GR6,
Han L7,
McNally J7,
Osinusi A7,
Brainard DM7,
Subramanian GM7,
Gane EJ8,
Feld JJ9,
Mangia A10.
Abstract
BACKGROUND & AIMS:
Patients with chronic hepatitis C virus (HCV) 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 HCV 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 (SVR12) was determined.
RESULTS:
Forty-four percent of patients had cirrhosis. SVR12 was achieved by 98% of patients (490/501; 95% CI, 96%-99%). SVR12 rates were 100% for HCV genotypes 2 (85/85), 4 (60/60), 5 (13/13), and 6 (20/20). SVR12 rates were 98% (167/170) in HCV genotype 1 patients and 95% (145/153) in HCV genotype 3 patients. Among patients with cirrhosis 96% (212/220) achieved SVR12, versus 99% (278/281) for those with advanced fibrosis. SVR12 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 HCV genotypes 1, 2, 3, 4, 5, or 6 and advanced fibrosis or compensated cirrhosis. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
KEYWORDS:
NS5A inhibitor; antiviral agents; direct-acting antivirals; polymerase inhibitor
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