Experience with narlaprevir in the treatment of chronic hepatitis C


DOI: https://dx.doi.org/10.18565/epidem.2020.2.76-83

Ponezheva Zh.B., Makashova V.V., Sannikova I.V., Titorenko M.V., Mannanova I.V., Patlusov E.V., Kambieva L.F., Ivanova M.R.

1) Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Customer Rights Protection and Human Well-Being, Moscow, Russia 2) Stavropol State Medical University, Stavropol, Russia; 3) Military Clinical Hospital Five, National Guard Forces Command of Russia, Yekaterinburg, Russia; 4) Center for Prevention and Control of AIDS and Infectious Diseases, Ministry of Health of the Kabardino-Balkarian Republic, Nalchik, Russia
Objective. To evaluate the efficacy and safety of the Russian NS3-protease inhibitor narlaprevir used with ritonavir (NVR/RTV) in combination with Peg-IFN and ribavirin (RBV) in patients with chronic hepatitis C (CHC), who were infected with HCV genotype 1b, as well as in combination with daclatasvir (DAC) in those with CHC who have not received antiviral therapy.
Subjects and methods. The investigators analyzed the case records of 42 patients aged 18 to 70 years with CHC infected with CHV genotype 1b, who were not found to have NS5A drug resistance-associated amino acid substitutions (Y93C/H/N/S and/or L31F/M/V/I). Two groups were formed according to the treatment regimen. Group 1 patients (n = 26) received triple therapy: NVR 200 mg once daily, RTV 100 mg once daily in combination with Peg-IFN) and RBV for 12 weeks with interferon therapy continuation for up to 24 weeks. Group 2 patients (n = 16) had 12-week interferon-free therapy: NVR 200 mg once daily, RTV 100 mg once daily in combination with DAC 60 mg once daily. The proportion of patients who had achieved a sustained virologic response (SVR) was a main efficiency indicator.
Results. SVR at 24 weeks after therapy (SVR24) could be achieved in 5 out of 6 patients who relapsed after the previous Peg-IFN + RBV treatment cycle. Primary patients who received NVR/RTV therapy achieved SVR24 in 93% of those who had the initial degree of liver fibrosis F0–F2 (according to the METAVIR scoring system). In Groups 1 and 2, SVR24 was recorded in 21 (81%) and 15 (94%) patients, respectively.
Conclusion. A combination of NVR/RTV + DAC compared to that of NVT/RTV + Peg-IFN + RBV showed a higher efficiency (94% vs. 81%) and safety, ease of use and good tolerability.
Keywords: chronic hepatitis C, antiviral therapy, narlaprevir

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About the Autors


Information about the authors:
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: http://orcid.org/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: http://orcid.org/0000-0002-3820-2586
Irina V. Sannikova, MD, Professor, Department of Infectious Diseases and Epidemiology, Stavropol State Medical University, Stavropol, Russia; e-mail: dr.sannikova@gmail.com; ORCID: http://orcid.org/0000-0002- 2840-1848
Marina V. Titorenko, Cand. Med. Sci., Associate Professor, Department of Infectious Diseases and Epidemiology with Course of Advanced Professional Education, Stavropol State Medical University, Ministry of Health of Russia, Stavropol, Russia; e-mail: marititorenko@gmail.com; ORCID: http://orcid.org/0000-0002-1182-0683
Irina V. Mannanova, Junior 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; e-mail: irinasemenova07@rambler.ru, ORCID: http://orcid.org/ 0000-0002-3612-1889
Evgeny P. Patlusov, Colonel of Medical Service, Head, Infectious Diseases Department, Military Clinical Hospital Five, National Guard Forces Command of Russia, Yekaterinburg, Russia; е-mail: patl73@mail.ru; ORCID: http://orcid.org/0000-0001-8649-8660
Lyudmila F. Kambieva, Cand. Med. Sci., Infectiologist, Center for Prevention and Control of AIDS and Infectious Diseases, Ministry of Health of the Kabardino-Balkarian Republic, Nalchik, Russia; е-mail: sana-01@mail.ru; ORCID: http://orcid.org/0000-0002-3205-4762
Marina R. Ivanova MD, Head Physician, Center for Prevention and Control of AIDS and Infectious Diseases, Ministry of Health of the Kabardino-Balkarian Republic, Nalchik, Russia; е-mail: marina19692003@list.ru; ORCID: http://orcid. org/0000-0003-2878-0312


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