Terapevticheskii arkhivTerapevticheskii arkhiv0040-36602309-5342LLC Obyedinennaya Redaktsiya3362110.26442/00403660.2019.08.000384Research ArticleEfficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis CKlimovaE Aelena_klimova_@mail.ruBurnevichE Z-ChulanovV P-GusevD A-ZnoykoO O-BatskikhS N-KizloS N-MamonovaN A-TarkhovaE P-KrasavinaE N-SamsonovM Yu-YushchukN D-Yevdokimov Moscow State University of Medicine and DentistrySechenov First Moscow State Medical University (Sechenov University)City Clinical Hospital №24Central Research Institute of EpidemiologyCentre for the Prevention and Control of AIDS and Infectious DiseasesR-Pharm15082019918677416042020Copyright © 2019, Consilium Medicum2019Aim. Evaluate efficacy and safety of a combination of direct - acting antivirals narlaprevir/ritonavir with daclatasvir in patients with viral hepatitis C. Materials and methods. The study enrolled adult patients with HCV genotype 1b infection without demonstrated NS5A resistance - associated substitutions Y93C/H/N/S and/or L31F/M/V/I. Patients were treated with narlaprevir 200 mg QD, ritonavir 100 mg QD and daclatasvir 60 mg QD. Treatment duration was 12 weeks. Proportion of patients achieving sustained virological response 12 weeks after treatment (SVR12) was the primary efficacy endpoint. Results and discussion. In total, 105 (75.0%) patients were treatment with the study combination. Patients’ age varied from 21 to 69 years, the mean age being 43.2±10.9 years. There were slightly more women (55.2%), and 69 patients (65.7%) had comorbidities. SVR 12 was 89.5% (95% CI 82.0-94.7%). In 10 of 11 patients with treatment failures NS5A resistance - associated substitutions in residues 31 and/or 93 were found, as well as less clinically relevant substitutions L28M, P58S, R30Q, Q62K. Adverse events (AEs) were found in less than one half of patients (45 patients, or 42.9% in the safety population). Almost all recorded AEs were mild to moderate. Conclusion. Efficacy of treatment with a combination of narlaprevir/ritonavir and daclatasvir in treatment - naïve patients with HCV genotype 1b was close to 90%. This combination was found to be safe and well - tolerated.narlaprevirritonavirdaclatasvirchronic hepatitis Cнарлапревирритонавирдаклатасвирхронический гепатит С[World Health Organization 2017, Global hepatitis report, 2017 Publication date: April 2017 Languages: English ISBN: 978-92-4-156545-5][Westbrook R.H, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014;61:S58-68. doi: 10.1016/j.jhep.2014.07.012][Thein H-H, Yi Q, Dore G.J, Krahn M.D. Estimation of stage - specific fibrosis progression rates in chronic hepatitis C virus infection: a meta - analysis and meta - regression. 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