Эффективность и безопасность длительной терапии хронического гепатита В нуклеозидными и нуклеотидными аналогами
Эффективность и безопасность длительной терапии хронического гепатита В нуклеозидными и нуклеотидными аналогами
Ибрагимов Э.К., Абдурахманов Д.Т., Розина Т.П. и др. Эффективность и безопасность длительной терапии хронического гепатита В нуклеозидными и нуклеотидными аналогами. Терапевтический архив. 2019; 91 (2): 8–47. DOI: 10.26442/ 00403660.2019.02.000073
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Аннотация
Аналоги нуклеоз(т)идов (АН) наиболее часто применяются в лечении хронического гепатита В. Однако необходимая длительность, эффективность и безопасность лечения АН остаются предметом дискуссии.
Цель исследования. Изучение эффективности и безопасности длительной терапии АН больных хроническим гепатитом В (ХГВ).
Материалы и методы. В исследование включены больные ХГВ (n=101), которые за период с 2008 по 2017 г. получали лечение тенофовиром, энтекавиром и телбивудином в течение как минимум 3 лет (максимально – в течение 9 лет).
Результаты и обсуждение. При длительном лечении энтекавиром и тенофовиром увеличивается кумулятивная частота авиремии (более 95% после 3 лет терапии), сероконковерсии HBeAg (93 и 67%, соответственно) и нормализации активности аланинаминотрансферазы (в 95% случаев). Частота развития резистентности при длительном лечении тенофовиром, энтекавиром и телбивудином составила 0; 3,1 и 43,5%, соответственно. При длительном лечении АН наблюдается регресс фиброза печени (с 8,92 до 7,18 кПа; р<0,0001) и уменьшение доли больных с выраженным фиброзом (с 48,1 до 13,8%; р<0,0001).
Заключение. Энтекавир и тенофовир могут рассматриваться как наиболее эффективные и безопасные препараты при длительном лечении ХГВ.
Ключевые слова: хронический гепатит В, аналоги нуклеоз(т)идов, вирусологический ответ, сероконверсия HBeAg, клиренс HBsAg, нормализация аланинаминотрансферазы, безопасность.
Aim. To assess the efficacy and safety of long-term treatment with nucleos(t)ide analogues in patients with chronic hepatitis B.
Materials and methods. We conducted an observational study in 101 chronic hepatitis B (HBeAg-negative and HBeAg-positive) patients treated (≥3 years) with entecavir, tenofovir or telbivudine.
Results and discussion. Treatment with entecavir and tenofovir was associated with high rate of virologic and biochemical response (>95%) and HBeAg seroconversion (93% and 67%, respectively). Cumulative rate of virologic resistance was 0; 3.1% and 43.5% for tenofovir, entecavir and telbivudine, respectively. Long-term nucleos(t)ide analogues treatment resulted in a regress of liver fibrosis (from 8.92 to 7.18 kPa, р<0.0001) and reduction in the number of patients with advanced fibrosis (from 48.1% to 13.8%, р<0.0001). Entecavir and tenofovir were safe and well tolerated, while treatment with telbivudine was associated with development of myopathy in 13% of cases.
Conclusion. Entecavir and tenofovir might be recommended for the treatment of chronic hepatitis B because of having potent antiviral effect, high genetic barriers against resistance and good safety.
Key words: chronic hepatitis B, nucleos(t)ide analogues, virologic response, HBeAg seroconversion, HBsAg clearance, ALT normalization, safety.
Цель исследования. Изучение эффективности и безопасности длительной терапии АН больных хроническим гепатитом В (ХГВ).
Материалы и методы. В исследование включены больные ХГВ (n=101), которые за период с 2008 по 2017 г. получали лечение тенофовиром, энтекавиром и телбивудином в течение как минимум 3 лет (максимально – в течение 9 лет).
Результаты и обсуждение. При длительном лечении энтекавиром и тенофовиром увеличивается кумулятивная частота авиремии (более 95% после 3 лет терапии), сероконковерсии HBeAg (93 и 67%, соответственно) и нормализации активности аланинаминотрансферазы (в 95% случаев). Частота развития резистентности при длительном лечении тенофовиром, энтекавиром и телбивудином составила 0; 3,1 и 43,5%, соответственно. При длительном лечении АН наблюдается регресс фиброза печени (с 8,92 до 7,18 кПа; р<0,0001) и уменьшение доли больных с выраженным фиброзом (с 48,1 до 13,8%; р<0,0001).
Заключение. Энтекавир и тенофовир могут рассматриваться как наиболее эффективные и безопасные препараты при длительном лечении ХГВ.
Ключевые слова: хронический гепатит В, аналоги нуклеоз(т)идов, вирусологический ответ, сероконверсия HBeAg, клиренс HBsAg, нормализация аланинаминотрансферазы, безопасность.
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Aim. To assess the efficacy and safety of long-term treatment with nucleos(t)ide analogues in patients with chronic hepatitis B.
Materials and methods. We conducted an observational study in 101 chronic hepatitis B (HBeAg-negative and HBeAg-positive) patients treated (≥3 years) with entecavir, tenofovir or telbivudine.
Results and discussion. Treatment with entecavir and tenofovir was associated with high rate of virologic and biochemical response (>95%) and HBeAg seroconversion (93% and 67%, respectively). Cumulative rate of virologic resistance was 0; 3.1% and 43.5% for tenofovir, entecavir and telbivudine, respectively. Long-term nucleos(t)ide analogues treatment resulted in a regress of liver fibrosis (from 8.92 to 7.18 kPa, р<0.0001) and reduction in the number of patients with advanced fibrosis (from 48.1% to 13.8%, р<0.0001). Entecavir and tenofovir were safe and well tolerated, while treatment with telbivudine was associated with development of myopathy in 13% of cases.
Conclusion. Entecavir and tenofovir might be recommended for the treatment of chronic hepatitis B because of having potent antiviral effect, high genetic barriers against resistance and good safety.
Key words: chronic hepatitis B, nucleos(t)ide analogues, virologic response, HBeAg seroconversion, HBsAg clearance, ALT normalization, safety.
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21. Pan HY, Pan HY, Song WY, Zheng W, Tong YX, Yang DH, Dai YN, Chen MJ, Wang MS, Huang YC, Zhang JJ, Huang HJ. Long-term outcome of telbivudine versus entecavir in treating higher viral load chronic hepatitis B patients without cirrhosis. J Viral Hepat. 2017;24(suppl 1):29-35. doi: 10.1111/jvh.12794
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34. Chulanov VP. Resistance to antiviral drugs in chronic hepatitis В. Farmateka. 2010;(4):20-6 (In Russ.)
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36. Kim SS, Hwang JC, Lim SG, Ahn SJ, Cheong JY, Cho SW. Effect of virological response to entecavir on the development of hepatocellular carcinoma in hepatitis B viral cirrhotic patients: comparison between compensated and decompensated cirrhosis. Am J Gastroenterol. 2014;109(8):1223-33. doi: 10.1038/ajg.2014.145
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39. Marcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gure S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials: 229. Hepatology. 2014;60:313A-314A. doi: 10.1002/hep.27486
Авторы
Э.К. Ибрагимов1, Д.Т. Абдурахманов1, Т.П. Розина1,2, Е.Н. Никулкина1, Е.Л. Танащук1, А.В. Одинцов1, С.В. Паневкина2, С.В. Моисеев1,2
1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
2 ФГБОУ ВО «Московский государственный университет им. М.В. Ломоносова», Москва, Россия
1 I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia;
2 M.V. Lomonosov Moscow State University, Moscow, Russia
1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
2 ФГБОУ ВО «Московский государственный университет им. М.В. Ломоносова», Москва, Россия
________________________________________________
1 I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia;
2 M.V. Lomonosov Moscow State University, Moscow, Russia
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