title: Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life.
abstract: Chronic hepatitis C virus (HCV) infection is a major cause of chronic liver disease and liver-related death. Recently, multiple regimens of different direct-acting antiviral agents (DAAs) have been registered. Although treatment with sofosbuvir (SOF) and simeprevir (SMV) is registered for the treatment of genotype 4 patients in some countries, data on efficacy of this combination are lacking. We aimed to assess the efficacy of SOF and SMV with or without RBV during 12 weeks in a real-life cohort of genotype 4 HCV patients. A retrospective multicentre observational study was conducted in 4 hospitals in Amsterdam, the Netherlands, including patients with advanced liver fibrosis or liver cirrhosis treated with SOF plus SMV with or without RBV during 12 weeks for a genotype 4 chronic HCV infection from 1 January 2015 to 1 August 2015. Sustained viral response (SVR) was established at week 12 after end of treatment. A total of 53 patients with genotype 4 HCV infection, treatment naïve and experienced, were included. SVR was achieved in 49 of 53 patients (92%). The four failures all had a virological relapse and did not receive ribavirin. Three were nonresponder to earlier interferon-based treatment, and one was treatment naive. In this real-life cohort of patients with HCV genotype 4 infection and advanced liver fibrosis/cirrhosis, we show that treatment with SOF and SMV is effective. The addition of RBV could be considered in treatment-experienced patients as recommended in guidelines.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: S B
authors.initials: SB
authors.lastname: Willemse
authors.affiliation: Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis locatie Oost, Amsterdam, the Netherlands.
authors.forename: L C
authors.initials: LC
authors.lastname: Baak
authors.affiliation: Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis locatie West, Amsterdam, the Netherlands.
authors.forename: S D
authors.initials: SD
authors.lastname: Kuiken
authors.affiliation: Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis locatie Oost, Amsterdam, the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: van der Sluys Veer
authors.affiliation: Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis locatie West, Amsterdam, the Netherlands.
authors.forename: K D
authors.initials: KD
authors.lastname: Lettinga
authors.affiliation: Department of Infectious Diseases, CINIMA, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: J T M
authors.initials: JT
authors.lastname: van der Meer
authors.affiliation: Department of Gastroenterology and Hepatology, Slotervaart Ziekenhuis, Amsterdam, the Netherlands.
authors.forename: A C T M
authors.initials: AC
authors.lastname: Depla
authors.affiliation: Department of Gastroenterology and Hepatology, Slotervaart Ziekenhuis, Amsterdam, the Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Tuynman
authors.affiliation: Department of Gastroenterology and Hepatology, VU Medical Center, Amsterdam, the Netherlands.
authors.forename: C M J
authors.initials: CM
authors.lastname: van Nieuwkerk
authors.affiliation: Department of Medical Microbiology, Section of Clinical Virology, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: C J
authors.initials: CJ
authors.lastname: Schinkel
authors.affiliation: Department of Medical Microbiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Kwa
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, the Netherlands.|Department of Infectious Diseases, CINIMA, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: van der Valk
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000473:pathology* / Q000821:virology; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011480:Protease Inhibitors; D012008:Recurrence; D012189:Retrospective Studies; D000069616:Simeprevir / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D011480:Protease Inhibitors; D000069616:Simeprevir; D000069474:Sofosbuvir
keywords: HCV genotype 4; direct-acting antivirals (DAAs); simeprevir; sofosbuvir