Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life

S B Willemse, L C Baak, S D Kuiken, A van der Sluys Veer, K D Lettinga, J T M van der Meer, A C T M Depla, H Tuynman, C M J van Nieuwkerk, C J Schinkel, D Kwa, H W Reesink, M van der Valk

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)950-954
Number of pages5
JournalJournal of Viral Hepatology
Volume23
Issue number12
DOIs
Publication statusPublished - Dec 2016

Cite this

Willemse, S. B., Baak, L. C., Kuiken, S. D., van der Sluys Veer, A., Lettinga, K. D., van der Meer, J. T. M., ... van der Valk, M. (2016). Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life. Journal of Viral Hepatology, 23(12), 950-954. https://doi.org/10.1111/jvh.12567
Willemse, S B ; Baak, L C ; Kuiken, S D ; van der Sluys Veer, A ; Lettinga, K D ; van der Meer, J T M ; Depla, A C T M ; Tuynman, H ; van Nieuwkerk, C M J ; Schinkel, C J ; Kwa, D ; Reesink, H W ; van der Valk, M. / Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life. In: Journal of Viral Hepatology. 2016 ; Vol. 23, No. 12. pp. 950-954.
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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 na{\"i}ve 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.",
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Willemse, SB, Baak, LC, Kuiken, SD, van der Sluys Veer, A, Lettinga, KD, van der Meer, JTM, Depla, ACTM, Tuynman, H, van Nieuwkerk, CMJ, Schinkel, CJ, Kwa, D, Reesink, HW & van der Valk, M 2016, 'Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life' Journal of Viral Hepatology, vol. 23, no. 12, pp. 950-954. https://doi.org/10.1111/jvh.12567

Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life. / Willemse, S B; Baak, L C; Kuiken, S D; van der Sluys Veer, A; Lettinga, K D; van der Meer, J T M; Depla, A C T M; Tuynman, H; van Nieuwkerk, C M J; Schinkel, C J; Kwa, D; Reesink, H W; van der Valk, M.

In: Journal of Viral Hepatology, Vol. 23, No. 12, 12.2016, p. 950-954.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - Sofosbuvir plus simeprevir for the treatment of HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis is highly efficacious in real life

AU - Willemse, S B

AU - Baak, L C

AU - Kuiken, S D

AU - van der Sluys Veer, A

AU - Lettinga, K D

AU - van der Meer, J T M

AU - Depla, A C T M

AU - Tuynman, H

AU - van Nieuwkerk, C M J

AU - Schinkel, C J

AU - Kwa, D

AU - Reesink, H W

AU - van der Valk, M

N1 - © 2016 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.

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N2 - 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.

AB - 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.

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DO - 10.1111/jvh.12567

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JO - Journal of Viral Hepatology

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