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2 . 2016

Сlinical practice of triple therapy with Cepeginterferon alfa-2b, simeprevir and ribavirin in patients with chronic hepatitis C virus genotype 1 infection

Abstract

The objective. To study the efficacy and safety of triple therapy with simeprevir, cepeginterferon alfa-2b and ribavirin in chronic hepatitis C (CHC) genotype 1 patients in order to additional safety data collection of simeprevir based triple therapy.
Material and methods. Data was collected from medical reports provided by request. Treatment data were collected of HCV infected patients receiving triple therapy with simeprevir 150 mg once daily in combination with cepeginterferon alfa-2b 1.5 μg/kg/week and ribavirin 800-1400 mg daily (weight based) for 12 weeks, followed by cepeginterferon alfa-2b/ribavirin therapy for 12-36 weeks. Treatment efficacy was assessed by the rate of sustained virologic response (SVR) on 12/24 week after completion of antiviral therapy. Safety assessment including adverse events and laboratory abnormalities was carried out throughout the treatment period and follow up.
Results. Data are available for 37 patients with CHC genotype 1: 21 (56.76%) women, 16 (43.24%) men (mean age - 41.92±8.77 years). The majority of patients (75.68%, n=28) were treatment naive. At the time of analysis 34 patients completed treatment and follow-up. SVR was observed in 94.12% (n=32) of patients. In 2 patients treatment was not effective. 1 patient at the end of treatment had HCV RNA level 52 000 IU/ml, the second patient had the relapse of HCV infection on week 4 of follow up. Now 2 patients continue treatment and 1 patient is in the follow up period. These patients had negative PCR for HCV RNA in intermediate time points. Registered adverse events were expected and common for interferon alfa/ribavirin based therapy. In most cases, adverse reactions were moderate and matched grade 1-2 of CTCAE.
Conclusion. The results of the study confirm the efficacy and safety of triple therapy with simeprevir, cepeginterferon alfa-2b and ribavirin in patients with chronic hepatitis C genotype 1 in everyday practice.

Keywords:chronic hepatitis C, antiviral therapy, cepeginterferon alfa-2b, simeprevir

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CHIEF EDITOR
Aleksandr V. Gorelov
Academician of the Russian Academy of Sciences, MD, Head of Infection Diseases and Epidemiology Department of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko ofRussian University of Medicine, Ministry of Health of the Russian Federation, Professor of the Department of Childhood Diseases, Clinical Institute of Children's Health named after N.F. Filatov, Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Deputy Director for Research, Central Research Institute of Epidemiology, Rospotrebnadzor (Moscow, Russian Federation)

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