Epidemiology and Infectious Diseases » Efficacy of a direct-acting antiviral drug in children with chronic hepatitis C

Efficacy of a direct-acting antiviral drug in children with chronic hepatitis C

DOI: https://dx.doi.org/10.18565/epidem.2024.14.1.102-7

Churbakova O.V., Akimkin V.G., Makashova V.V., Chernova O.E., Pechkurov D.V.
1) Samara State Medical University, Ministry of Health of Russia, Samara, Russia; 2) Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; 3) Samara Regional Clinical Center for the Prevention and Control of AIDS, Samara, Russia

Objective. Evaluation of the effectiveness and safety of treatment of children with chronic hepatitis C (CHC) with the direct-acting antiviral drug Maviret in real clinical practice.
Materials and methods. The study included 38 children with CHC aged 12 to 17 years (mean age 14.7 ± 1.9 years). The patients were followed-up in the Children’s Infectious Diseases Department of the N.A. Semashko City Clinical Hospital. Of these, 13 had previously received antiviral therapy (AVT) (interferon alfa-2b + rebetol or peginterferon alfa-2b + rebetol), the remaining 25 children did not receive AVT. All 38 patients were prescribed Maviret (treatment was carried out at the Samara Regional Clinical Center for the Prevention and Control of AIDS). The duration of follow-up of patients after the end of combination therapy according to the interferon alfa-2b + rebetol regimen was 7–14 years (mean 6.4 ± 3.9 years), and immediately before the prescription of a direct-acting antiviral drug was 3–15 years (7. 6 ± 4.1 years). General and biochemical blood tests were performed, and the HCV RNA level was determined by PCR (sensitivity – 10–15 IU/ml).
Results. The dynamics of clinical, biochemical and virological parameters in children with CHC after IFN therapy, before and after the end of treatment with Maviret were considered. The duration of therapy was 8 weeks in 37 patients, and in one child with HCV genotype 3–16 weeks, since a virological response was not obtained to the previously administered combination therapy. At the end of the course of therapy, the children’s biochemical parameters normalized and a virological response was obtained after 12 weeks after completion of treatment, a sustained virological response was observed in 100% of patients. During the treatment of children with CHC with a direct-acting antiviral drug, no serious adverse events were registered.
Conclusion. Therapy with a direct-acting antiviral drug in children with CHC has shown high efficiency and safety.

Keywords: clinical syndromes, Keуwords: chronic hepatitis C, direct-acting antiviral drug, children

Read entire article

Literature

1. Ягудина Р.И., Куликов А.Ю, Крылов В.А. Анализ «влияния на бюджет» применения препаратов прямого противовирусного действия у взрослых пациентов с хроническим гепатитом С (генотип 1b) в условиях российского здравоохранения. Инфекционные болезни 2020; 18(1): 116–25. DOI: 10.20953/1729-9225-2020-1-116-125.

Yagudina R.I., Kulikov А.Yu., Krylov V.А. (Analysis of the «budget impact» of using direct-acting antiviral drugs in adult patients with chronic hepatitis С (genotype 1b) under the Russian healthcare system). Infectious diseases 2020; 18(1): 116–25. (In Russ.). DOI 10.20953/1729-9225-2020-1-116-125.

2. Global health sector strategy on viral hepatitis 2016–2021. Towards ending viral hepatitis) World Health Organization, 2016. WHO/HIV/2016.06.

3. Razavi H., Elkhoury A.C., Elbasha E., Estes C., Pasini K., Poynard T. et al. Chronic hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology 2013; 57(6): 2164–70. DOI 10.1002/геп.26218

4. Gower E., Estes C., Blach S., Razavi-Shearer K., Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J. Hepatol. 2014; 61(1 Suppl): 45–57. DOI:10.1016/i.ihep/2014/07/027.

5. Hedskog C., Bhardwaj N., Chang S. Parhy В., MartinR. et al. Identification of novel HCV genotype and subtypes in patients treated with sofosbuvir based regimens. Hepatology 2017; 66: 121A. DOI 10.1093/ofid/ofz076.

6. Мескина Е.Р., Галкина Л.А., Целипанова Е.Е., Одинаева Н.Д. Каскад медицинской помощи детям с инфекцией, вызванной вирусом гепатита С, в Московской области. Журнал микробиологии, эпидемиологии и иммунобиологии 2022; 99(5): 525–39. DOI 10.36233/0372-9311-330

Meskina E.R., Galkina L.A., Tselipanova E.E., Odinaeva N.D. (Hepatitis C virus care cascade for children in Moscow Region). Journal of microbiology, epidemiology and immunobiology 2022; 99(5): 525–39. (In Russ.). DOI 10.36233/0372-9311-330

7. Schmelzer J., Dugan E., Blach S., Coleman S., Cai Z., DePaola M. et al. Global prevalence of hepatitis C virus in children in 2018: a modelling study. Lancet Gastroenterol. Hepatol. 2020; 5(4): 374–92. DOI 10.1016/S2468-1253(19)30385-1.

8. Басина В.В., Сухорук А.А., Арсентьева Н.А, Любимова Н.Е., Семенов А.В., Эсауленко Е.В. и др. Клинико-иммунологическая характеристика пациентов с хроническим гепатитом C во время противовирусной терапии в безинтерфероновом режиме. Казанский мед. ж. 2018; 99(5): 760–5. DOI 10.17816/KMJ2018-760

Basina V.V., Sukhoruk A.A., Arsentieva N.A., Lyubimova N.E., Semenov A.V., Esaulenko E.V. et al. (Clinical and immunological characteristics of patients with chronic hepatitis C during antiviral therapy in interferon-free regimen). Kazan Medical Journal 2018; 99(5): 760–5 (In Russ.). DOI10.17816/KMJ2018-760

9. Angeli P., Bernardi M., Villanueva C., Francoz C., Mookerjee R.P. , Trebicka J., et al. (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of patients with decompensated cirrhosis). J. Hepatol. 2018; 69(2): 406–60. DOI 10.1016/j.jhep.2018.03.024.

10. Валутите Д.Э., Семенов А.В., Останкова Ю.В., Козлов К.В., Борисов А.Г., Назаров В.Д. и др. Выявление мутаций лекарственной устойчивости вируса гепатита С у пациентов с неэффективной терапией препаратами прямого противовирусного действия. Журнал микробиологии, эпидемиологии и иммунобиологии 2021; 98(1): 18–27. DOI 10.36233/0372-9311-47.

11. Valutite D.E., Semenov A.V., Ostankova Yu.V., Kozlov K.V., Borisov A.G., Nazarov V.D., et al. (Detection drug resistance mutations of hepatitis C virus in patients with failure of the treatment with direct acting antivirals). Journal of microbiology, epidemiology and immunobiology 2021; 98(1): 18–27. (In Russ). DOI 10.36233/0372-9311-47.

12. Есмембетов К.И., Есмембетова Н.И. Противовирусная терапия цирроза печени в исходе хронического гепатита С препаратами интерферона. Клиническая медицина Казахстана 2015; 4(38): 21–34.

Yesmembetov K. , Yesmembetova N. (Antiviral therapy of liver cirrhosis due to chronic hepatitis C with interferon). Clinical Medicine of Kazakhstan 2015; 4 (38): 21–4. (In Russ).

13. Сулима Д., Лиознов Д., Яковлев А., Смирнов А., Ларионов В., Бацких А. и др. Первый в России опыт применения GLE/PIB для лечения HCV-инфекции генотипа 3а с криоглобулинемией и сопутствующей HBV-инфекцией у пациента с ХБП С5д, леченного гемодиализом и ожидающего трансплантации почки. Врач 2019; 30(2): 3–13. DOI 10.29296/25877305-2019-02-01

Sulima D., Lioznov D., Yakovlev A., Smirnov A., Larionov V., Batskikh A. et al. (The first experience in Russia of using GLE/PIB for the treatment of HCV infection genotype 3a with cryoglobulinemia and concomitant HBV infection in a patient with C5d CKD treated with hemodialysis and awaiting kidney transplantation). Doctor 2019; 30(2): 3–13. (In Russ). DOI 10.29296/25877305-2019-02-01

14. Волынец Г.В., Хавкин А.И. Современный взгляд на лечение хронического гепатита С у детей и подростков. Российский вестник перинатологии и педиатрии 2019; 64(6): 11–9. DOI: 10.21508/1027-4065-2019-64-6-11-19

Volynets G.V., Khavkin A.I. (A modern view on the treatment of chronic hepatitis C in children and adolescents). Russian Bulletin of perinatology and pediatrics 2019; 64(6): 11–9. (In Russ). DOI: 10.21508/1027-4065-2019-64-6-11-19

15. Jonas M.M., Squires R.H., Rhee S.M., Lin C.W., Bessho K., Feiterna-Sperling C. et al. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Patients with Genotypes 1–6 Chronic HCV Infection: Part 1 of the Dora Study. Hepatology 2018; 68(Suppl): 1347A–1348A. DOI: 10.1002/hep.30840

16. Горячева Л.Г., Венцловайте Н.Д., Грешнякова В.А. Вирусные гепатиты у детей: состояние и перспективы решения проблемы. Детские инфекции 2021; 20(4): 35-41. DOI: 10.22627/2072-8107-2021-20-4-35-41

Goriacheva L.G., Ventslovayte N.D., Greshnyakova V.A. (Viral hepatitis in children: state and prospects for solving the problem). Children’s Infections 2021; 20(4): 35–41. (In Russ). DOI: 10.22627/2072-8107-2021-20-4-35-41

17. Фомичева А.А., Мамонова Н.А., Пименов Н.Н., Комарова С.В., Уртиков А.В., Горячева Л.Г. и др. Состояние и перспективы терапии хронического гепатита С у детей в Российской Федерации. Журнал Инфектологии 2021; 13(1): 50–7. DOI: 10.22625/2072-6732-2021-13-1-50-57

Fomicheva A.A., Mamonova N.A., Pimenov N.N., Komarova S.V., Urtikov A.V., Goriacheva L.G., et al. (State and prospects of therapeutic treatment of children with chronic hepatitis C in the Russian Federation). Journal Infectology 2021; 13(1): 50–7. (In Russ.). DOI: 10.22625/2072-6732-2021-13-1-50-57

18. Эсауленко Е.В., Новак К.Е., Басина В.В., Дземова А.А., Ганченко Р.А. Распространенность коморбидности при хроническом вирусном гепатите С. Медицинский алфавит 2021; (1): 66–70. DOI: 10.26442/20751753.2021.5.200909

Esaulenko E.V., Novak K.E., Basina V.V., Dzemova A.A., Ganchenko R.A. (Prevalence of comorbidity in chronic HCV-infection). Medical Alphabet 2021; (1): 66–70. (In Russ.). DOI: 10.26442/20751753.2021.5.200909

19. Krishnan P., Pilot-Matias T., Schnell G., Tripathi R., Ng T.I., Reisch T. et al. Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials. Antimicrob. Agents Chemother. 2018; 62(10): 1249–18. DOI: 10.1128/AAC.01249-18.

20. Puoti M., Foster G.R., Wang S., Mutimer D., Gane E., Moreno C. et al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1-6 patients without cirrhosis. J. Hepatol. 2018; 69(2): 293–300. DOI: 10.1016/j.jhep.2018.03.007

21. Jonas M.M., Squires R.H., Rhee S.M., Lin C.W., Bessho K., Feiterna-Sperling C. et al. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. Hepatology 2020; 71(2): 456–62. DOI: 10.1002/hep.30840.

22. Никитин И.Г. Современные подходы к безинтерфероновой противовирусной терапии хронического вирусного гепатита С. Лечебное дело 2021; (2): 121–8. DOI: 10.24412/2071-5315-2021-12339

Nikitin I.G. (Modern Approaches to Interferon-free Antiviral Therapy of Chronic Viral Hepatitis C. Medical business). Medical business 2021; (2): 121–8. (In Russ.). DOI: 10.24412/2071-5315-2021-12339

23. Макашова В.В., Понежева Ж.Б. Эффективность безинтерфероновых схем терапии у больных хроническим гепатитом С. Эпидемиол. инфекц. болезни. Актуал. вопр. 2017; (6): 31–4. DOI: 10.31618/ESU.2413-9335.2019.1.65.257

Makashova V.V., Ponezheva Zh.B. (Effectiveness of interferon-free therapy regimens in patients with chronic hepatitis C). Epidemiology and infectious diseases. Current issues 2017; (6): 31–4. (In Russ.). DOI: 10.31618/ESU.2413-9335.2019.1.65.257

24. Венцловайте Н.Д., Горячева Л.Г., Грешнякова В.А., Ефремова Н.А., Шилова И.В. Опыт терапии хронического вирусного гепатита С у детей старше 12 лет комбинированным препаратом прямого противовирусного действия, содержащим глекапревир и пибрентасвир. Инфекционные болезни: новости, мнения, обучение 2021; 10(3): 57–66. DOI: 10.33029/2305-3496-2021-10-3-57-66

Ventslovayte N.D., Goriacheva L.G., Goriacheva V.A., Efremova N.A., Shilova I.V. (HCV treatment experience in children over 12 years old with a combined direct acting antiviral containing glecaprevir and pibrentasvir. Infektsionnye bolezni: novosti, mneniya, obuchenie). Infectious diseases: news, opinions, training 2021; 10(3): 57–66. (In Russ.). DOI: 10.33029/2305-3496-2021-10-3-57-66

25. Jonas M.M., Squires R.H., Rhee S.M., Lin C.W., Bessho K., Feiterna-Sperling C. et al. Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in pediatric patients with genotypes 1–6 chronic HCV infection: Part 1 of the Dora Study. Hepatology 2018; 68(Suppl): 1347A–1348A. DOI: 10.1002/hep.30840

26. Строкова Т.В., Матинян И.А., Павловская Е.В., Багаева М.Э., Таран Н.Н., Зубович А.И. и др. Результаты терапии препаратами прямого противовирусного действия у детей с хроническим гепатитом С. Вопросы практической педиатрии 2021; 16(1): 79–84. DOI: 10.20953/1817-7646-2021-1-79-84

Strokova T.V., Matinyan I.A., Pavlovskaya E.V., Bagaeva M.E., Taran N.N., Zubovich A.I. et al. (Results of therapy with direct-acting antiviral drugs in children with chronic hepatitis C). Clinical Practice in Pediatrics 2021; 16(1): 79–84. (In Russ.). DOI: 10.20953/1817-7646-2021-1-79-84

27. Макашова В.В., Омарова Х.Г., Понежева Ж.Б. Эффективность препаратов прямого противовирусного действия у больных хроническим гепатитом С. Евразийский Союз Ученых (ЕСУ) 2019; 8(65): 47–9. DOI 10.31618/ESU.2413-9335.2019.1.65.257

Makashova V.V., Omarova H.G., Ponezheva Zh.B. (Efficacy of direct antiviral drugs in patients with chronic hepatitis C). Eurasian Union of Scientists (EUS). 2019; 8(65): 47–9. (In Russ.). DOI: 10.31618/ESU.2413-9335.2019.1.65.257

28. Михайлов М.И., Ющук Н.Д., Малинникова Е.Ю., Кюрегян К.К., Исаева О.В., Знойко О.О. и др. Вирусные гепатиты – проблема общественного здоровья в Российской Федерации (проект программы по контролю и ликвидации вирусных гепатитов). Управление здравоохранением: новости, мнения, образование. Вестник ВШОУЗ 2018; (2): 21–9. DOI: 10.24411/2411-8621-2018-12002

Mikhailov M.I., Yushchuk N.D., Malinnikova E.Yu., Kyuregyan K.K., Isaeva O.V., Znoko О.О. et al. (Viral hepatitis is a public health problem in the Russian Federation (draft program for the control and elimination of viral hpatitis) //Healthcare management: news, views, education). Bulletin of the Higher School of Healthcare Organization and Management 2018; (2): 20–9. (In Russ.). DOI: 10.24411/2411-8621-2018-12002

About the Autors

Olga V. Churbakovа, Cand. Med. Sci., Assistant, Department of Childhood Diseases, Samara State Medical University, Ministry of Health of Russia, Samara, Russia; o_churbakova@mail.ru; http://orcid.org/ 0000-0003-3723-1542
Professor Vasiliy G. Akimkin, Academician of the Russian Academy of Sciences, MD, Director, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; vgakimkin@yandex.ru; http://orcid.org/0000-0003-4228-9044
Professor Vera V. Makashova, МD, Leading Researcher, Clinical Department of Infectious Pathology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; veramakashova@yandex.ru; https://orcid.org/0000-0002-0982-3527
Oksana E. Chernova, Cand. Med. Sci., Chief Physician, Samara Regional Clinical Center for the Prevention and Control of AIDS, Samara, Russia; 23oks@mail.ru: https://orcid.org/0009-0009-8629-4591
Professor Dmitry V. Pechkurov, MD, Head, Department of Children’s Diseases, Samara State Medical University, Ministry of Health of Russiaя, Samara, Russia; dmpechkurov@yandex.ru; http://orcid.org/0000-0002-5869-2893

Efficacy of a direct-acting antiviral drug in children with chronic hepatitis C

Literature

About the Autors

Similar Articles