Treatment with the first Russian direct-acting antiviral drug in patients with chronic hepatitis C


DOI: https://dx.doi.org/10.18565/epidem.2019.9.4.77-83

Ponezheva Zh.B., Makashova V.V.

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia
The review paper analyzes the latest data on the efficiency of narlaprevir in different antiviral treatment regimens for chronic hepatitis C (CHC). It presents the results of large-scale randomized trials in an extensive cohort of Russian patients using narlaprevir in combination with ritonavir in the interferon-containing and interferon-free regimens, by assessing its pharmacokinetics and profile of adverse events. The paper shows the stages of researches on the first Russian antiviral drug for the treatment of CHC. It gives combinations of narlaprevir with other drugs, its doses, and the duration of its treatment cycle in different antiviral therapy regimens.
Keywords: narlaprevir, direct-acting antiviral drug, hepatitis C, efficacy, antiviral therapy
Read entire article

Literature

  1. World Health Organization 2017, Global hepatitis report, 2017. Publication date: April 2017 Languages: English ISBN: 978-92-4-156545-5. http://www.who.int/ hepatitis/publications/global-hepatitis-report2017/en

  2. Maleev V.V., Sitnikov I.G., Bokhonov M.S. [Topical issues of modern Hepatology]. Moscow–Yaroslavl: YarMediaGru 2013; 246. (In Russ.).

  3. Mittal S., El-Serag H.B., Sada Y.H., Kanwal F., Duan Z., Temple S. et al. Hepatocellular Carcinoma in the Absence of Cirrhosis in United States Veterans is Associated With Nonalcoholic Fatty Liver Disease. Clin. Hepatol. 2016; 14(1): 124–31. DOI: 10.1016/j.cgh.2015.07.019

  4. WHO. International Agency for Research on Cancer, editor. IARC monographs on the evaluation of carcinogenic risks to humans. Volume 100: A review of human carcinogens. Part B: Biological agents. Lyon, 2012.

  5. Pimenov N.N., Komarova S.V., Karandashova I.V., Tsapkova N.N., Volchkova E.V., Chulanov V.P. [Hepatitis С and its outcomes in Russia: analysis of incidence, prevalence and mortality rates before the start of the programme of infection elimination]. Infektsionnye Bolezni 2018; 16(3): 37–45. (In Russ.). DOI: 10.20953/1729-9225-2018-3-37-45

  6. Soriano1 V. Report from the International Conference on Viral Hepatitis – 2017/ Vicente Soriano1, Benjamin Young and Nancy Reau. AIDS reviews January 2018 DOI: 10.24875/AIDSRev. M17000012.

  7. Global Health Sector Strategy on viral hepatitis, 2016–2021. Geneva: World Health Organization, 2016. http://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en

  8. AASLD/ IDSA HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. http://hcvguidelines.org/

  9. EASL Recommendations on Treatment of Hepatitis C 2018. J. Hepatol. 2018; 69(2): 461–511.

  10. Yushchuk N.D. [Recommendations for diagnosis and treatment of adult patients with hepatitis C]. Мoscow: GEOTAR-Media, 2017. 96 p. (In Russ.).

  11. Bakulin I., Pasechnikov V., Varlamicheva A., Sannikova I. NS3 protease inhibitors for treatment of chronic hepatitis C: efficacy and safety. World J. Hepatol. 2014; 6(5): 326–39.

  12. De Bruijne J., Bergmann J.F., Reesin H.W., Weegink C.J., Molenkamp R., Schinkel J. et al. Antiviral activity of narlaprevir combined with ritonavir and pegylated interferon in chronic hepatitis С patients. Hepatology 2010; 52(5): 1590–9. DOI: 10.1002/hep.23899

  13. Tong X., Arasappan A., Bennett F., Chase R., Feld B., Guo Z. et al. Preclinical characterization of the antiviral activity of SCH 900518 (narlaprevir), a novel mechanismbased inhibitor of hepatitis C virus NS3 protease. Antimicrob. Agents Chemother. 2010; 54: 2365–70. DOI: 10.1128/AAC.00135-10

  14. Arasappan A., Bennett F., Bogen S.L. et al. Discovery of Narlaprevir (SCH 900518): A Potent, Second Generation HCV NS3 Serine Protease Inhibitor. ACS Med. Chem. Lett. 2010; 1(2): 64–9. DOI: 10.1021/ml9000276

  15. Burnevich E.Z., Tikhonova N.Yu., Shchanitsina S.E. [Ritonavir-boosted clinical case, in a combination with pegilated interferon-α and ribavirin for chronic hepatitis C treatment]. Klinicheskaya farmakologiya i terapiya 2014; 23(5): 34–9. (In Russ.).

  16. Isakov V., Koloda D., Tikhonova N., Kikalishvili T., Krasavina E., Lekishvili K., Malaya I., Ryska M., Samsonov M., Tolkacheva V. Pharmacokinetics of the New Hepatitis C Virus NS3 Protease Inhibitor Narlaprevir following Single-Dose Use with or without Ritonavir in Patients with Liver Cirrhosis. Antimicrob. Agents and Chemother. 2016; 60(12): 7098–104. DOI: 10.1128/AAC.01044-16

  17. Reesink H., Bergmann J., de Bruijne J., Weegink C., Van Lier J., Van Vliet A. et al. Safety and antiviral activity of SCH 900518 administered as monotherapy and in combination with peginterferon alfa-2b to naive and treatmentexperienced HCV-1-infected patients. J. Hepatol. 2009; 50: S35–6.

  18. Vierling J.M., Poordad F.F., Lawitz E., Ghalib R.H., Lee W.M., Ravendhran N. et al. Once daily Narlaprevir (NVR; SCH 900518) and Ritonavir (RTV) in combination with peginterferon alfa-2b/ribavirin (PR) for 12 weeks plus 12 weeks PR in treatment-naive patients with HCV genotype 1 (G1): SVR results from NEXT-1, a phase 2 study. Hepatology 2011; 54: 1437A.

  19. Bakulin I.G. [Narlaprevir – domestic direct antiviral agent for chronic hepatitis C treatment. PIONEER study results]. Poliklinika. Gastroenterologiya 2016; (4): 52–4. (In Russ.).

  20. Abdurakhmanov D.T., Bakulin I.G., Bogomolov P.O. Final results from a phase III study of the Narlaprevir, a novel Russian protease inhibitor in treatment-naive and previously treated patients with genotype 1 chronic hepatitis C (the PIONEER trial). Hepatol. Int. 2017; 11(Suppl. 1): S305–6.

  21. Mayevskaya M.V., Ivashkin V.T., Znoyko О.О., Klimova E.A.. Abdurakhmanov D.T.. Bakulin I.G.. Bogomolov P.O.. Burnevich E.Z.. Galushko M.Yu.. Geyvandova N.I.. Zhdanov K.V.. Esaulenko E.V.. Kizhlo S.H.. Konstantinov D Yu.. Mironova N.I.. Morozov V.G.. Strebkova E.A.. Nikitin I.G.. Osipenko M.F.. Pasechnikov V.D.. Sagalova O.I.. Khayertynova I.M.. Chulanov V.P.. Yakovlev A.A.. Vasyutin I.A.. Tarkhova E.P.. Krasavina E.N.. Samsonov M.Yu. [Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study)]. Rossiyskiy zhurnal gastroenterologii, gepatologii i koloproktologii 2017; 27(6): 41–51. (In Russ.).

  22. Hill A., Saleem J., Heath K., Simmons B. Effects of sustained virological response (SVR) on the risk of liver transplant, hepatocellular carcinoma, death and re-infection: Meta-analysis of 129 studies in 23,309 patients with Hepatitis C infection. In Proceedings of the AASLD2014, Boston, MA, USA, 7–11 November 2014 American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting. Boston, MA, 2014. Abstract 44.

  23. Hüsing A., Kabar I., Schmidt H.H., Heinzow H.S. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine. Int. J. Mol. Sci. 2015; 16(8): 18033–53.

  24. Kravchenko А.V., Zhdanov К.V., Chulanov V.P., Isakov V.A., Erofeeva S.E. Shipaeva E., Krasavina E., Tarkhova E., Samsonov M. A drug interaction study to assess the pharmacokinetics of a potent HCV protease inhibitor Narlaprevir and antiretroviral drugs. Hepatol. Int. 2018; 12 (Suppl 2): S500–1. APASL Annual meeting 2018, March 14–18. New Delhi, India, Abstract HCV-47.

  25. Burnevich E.Z.. Nikulkina E.N.. Shchanitsyna S.E. [Combination of daclatasvir and asunaprevir in the treatment of chronic hepatitis C in patients infected with HCV 1 genotype]. Klinicheskaya farmakologiya i terapiya 2015; (4): 34–8. (In Russ.).

  26. Zeuzem S., Hézode C., Bronowicki J.P., Loustaud-Ratti V., Gea F., Buti M. et al. LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J. Hepatol. 2016; 64(2): 292–300.

  27. Alavian S.M., Rezaee-Zavareh M.S. Daclatasvir-based treatment regimens for hepatitis C virus infection: A systematic review and meta-analysis. Hepat. Mon 2016; 16(9): e41077.

  28. Burnevich E.Z., Gusev D.A., Znoyko O.O., Klimova E.A.. Chulanov V.P.. Batskikh S.N.. Kizhlo S.N.. Mamonova N.A.. Tarkhova E.P.. Krasavina E.N.. Samsonov M.Yu.. Yushchuk N.D. [Efficacy and safety of narlaprevir/ritonavir and daclatasvir combination in the treatment naive, noncirrhotic patients with hepatitis C virus genotype 1b]. Klinicheskaya farmakologiya i terapiya 2018; 27(4): 35–9. (In Russ.).

  29. Chulanov V.P., Gusev D.A., Burnevich E.Z. Narlaprevir/ritonavir and daclatasvir combination in treatment-naïve patients with chronic hepatitis C genotype 1b infection. Hepatol. Int. 2019; 13(Suppl 1): S1–266. DOI: 10.1007/s12072-019-09936-5

  30. Klimova E.A., Burnevich E.Z., Chulanov V.P., Gusev D.A.. Znoyko O.O.. Batskikh S.N.. Kizhlo S.N.. Mamonova N.A.. Tarkhova E.P.. Krasavina E.N.. Samsonov M.Yu.. Yushchuk N.D. [Efficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis C]. Terapevticheskiy arkhiv 2019; 91(8): 67–74. (In Russ.). DOI: 10.26442/00403660. 2019.08.000384

  31. Dietz J., Susser S., Vermehren J., Peiffer K.-H., Grammatikos G, BergerА., Ferenci P. et al. Patterns of Resistance-Associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct-Acting Antivirals. Gastroenterology 2018; 154(4): 976–88. e4. DOI: 10.1053/ j.gastro.2017.11.007

  32. Yushchuk N.D., Klimova E.A. [Treatment of chronic hepatitis C in Russia: current opportunities and immediate prospects]. Infektsionnye Bolezni: novosti, mneniya, obuchenie 2018; 7(4): 8–14. (In Russ.). DOI: 10.24411/2305-3496-2018-14001


About the Autors

Zhanna B. Ponezheva, MD, Head, Clinical Department of Infectious Diseases, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; е-mail: doktorim@mail.ru, ORCID 0000-0002-6539-4878
Prof. Vera V.Makashova, MD, Leading Researcher, Clinical Department of Infectious Diseases, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; е-mail: veramakashova@yandex.ru; ORCID 0000-0002-3612-1889


Similar Articles

Back to Content

Бионика Медиа