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Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1‐6 and compensated cirrhosis or advanced fibrosis
Author(s) -
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
Publication year - 2018
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13534
Subject(s) - medicine , cirrhosis , gastroenterology , sofosbuvir , hepatitis c virus , adverse effect , fibrosis , hepatitis c , liver biopsy , virus , biopsy , ribavirin , immunology
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.