Efficacy and safety of 8-week combination therapy for chronic hepatitis C with protease inhibitor narlaprevir

Abstract

Aim of investigation - to estimate efficacy and safety of direct-acting antivirus agents narlaprevir/ritonavir and sofosbuvir in non-cirrhotic patients with chronic hepatitis C.

Material and methods. Treatment naive patients with chronic HCV infection GT1 were enrolled at the study (ClinicalTrials.gov ID: NCT04246723). Patients received therapy with the combination of narlaprevir 200 mg QD, ritonavir 100 mg QD and sofosbuvir 400 mg QD. Treatment duration was 12 weeks in group A and 8 weeks in group B. Primary endpoint is sustained virologic response 12 weeks post treatment (SVR12). The results of the study (group B) are presented.

Results and discussion. Most patients from group B (23/25) had fibrosis (F0-F1) and 2 patients had fibrosis F2. All enrolled 25 patients completed therapy and 96.0% (24/25) patients reached SVR12 (95% CI 79.6-99.9%). Virologic failure was confirmed for one patient (697 000 IU/ml on follow-up week 12). In total, 23/24 patients passed FU week 24 and reached SVR24. One patient was discontinued from the study before last visit (FU24) due to COVID-19 outbreak. Adverse events (AEs) were registered in 5 (20%) patients. No serious AEs occurred. In total, therapy of narlaprevir/ritonavir and sofosbuvir for 8 weeks demonstrated good efficacy and safety profile.

Keywords:chronic hepatitis C, hepatitis C virus, narlaprevir, ritonavir, sofosbuvir

Funding. The study is sponsored by the company R-Pharm JSC; the creation of basic documents, conducting research, processing the obtained data, statistical analysis, writing a report is carried out by the Contract Research Organization ALMEDIS.

Conflict of interests. The authors declare no conflict of interests.

Contribution. Concept and design of the study - Gusev D.A., Klimova E.A., Znoyko O.O., Isakov V.A., Kropochev V.S., Zhdanov K.V., Kizhlo S.N., Kozlov K.V., Sukachev V.S., Batskikh S.N., Tarkhova E.P., Krasavina E.N., Samsonov M.Yu., Yushchuk N.D.; collection and processing of data - Gusev D.A., Klimova E.A., Znoyko O.O., Isakov V.A., Kropochev V.S., Zhdanov K.V., Kizhlo S.N., Kozlov K.V., Sukachev V.S., Batskikh S.N.; statistical data processing - Contract Research Organization Almedis LLC; writing - Krasavina E.N., Isakov V.A.; editing - Gusev D.A., Klimova E.A., Znoyko O.O., Isakov V.A., Kizhlo S.N., Batskikh S.N.; approval of the final version -Krasavina E.N., Samsonov M.Yu.; responsibility for the content - Krasavina E.N.

For citation: Gusev D.A., Klimova E.A., Znoyko O.O., Isakov V.A., Kropochev V.S., Zhdanov K.V., KizhLo S.N., Kozlov K.V., Sukachev V.S., Batskikh S.N., Tarkhova E.P., Krasavina E.N., Samsonov M.Yu., Yushchuk N.D. Efficacy and safety of 8-week combination therapy for chronic hepatitis C with protease inhibitor narlaprevir. Infektsionnye boLezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2020; 9 (3): 41-8. DOI: https://doi.org/10.33029/2305-3496-2020-9-3-41-48 (in Russian)

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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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