https://scholars.lib.ntu.edu.tw/handle/123456789/582073
標題: | Entecavir: A review of its use in the treatment of chronic hepatitis B in patients with decompensated liver disease | 作者: | Keating G.M. Buti M. Gadano A. JIA-HORNG KAO Lee C.-M. Peng C.-Y. Schiff E.R. Tanwandee T. |
關鍵字: | Adis-Drug-Evaluations; Entecavir; Hepatitis-B | 公開日期: | 2011 | 出版社: | Springer International Publishing | 卷: | 71 | 期: | 18 | 起(迄)頁: | 2511-2529 | 來源出版物: | Drugs | 摘要: | The oral deoxyguanosine nucleoside analogue entecavir (Baraclude?) has potent activity against hepatitis B virus (HBV) and a high genetic barrier to resistance. This article reviews the clinical efficacy and tolerability of entecavir in the treatment of chronic hepatitis B in patients with decompensated liver disease, as well as summarizing its pharmacological properties.Entecavir 1mgday was more effective than adefovir dipivoxil 10mgday in the treatment of patients with chronic hepatitis B and decompensated liver disease, according to the results of a randomized, open-label, multicentre trial. Patients were either nucleos(t)ide naive or lamivudine experienced. The reduction from baseline in HBV DNA levels at week 24 (primary endpoint) was significantly greater with entecavir than with adefovir dipivoxil. The proportion of patients with HBV DNA levels of <300 copiesmL was also significantly greater with entecavir than with adefovir dipivoxil at weeks 24, 48 and 96, as was the proportion of patients with ALT normalization.Entecavir 0.5 or 1mgday, tenofovir disoproxil fumarate 300mgday and a fixed-dose combination of emtricitabinetenofovir disoproxil fumarate 200mg300mg per day were effective in the treatment of chronic hepatitis B in patients with decompensated liver disease, according to the 48-week analysis of a randomized, double-blind, multicentre trial, primarily designed to examine tolerability endpoints. In this trial, over one-third of patients had received previous therapy with lamivudine for ?6 months.The efficacy of entecavir in treatment-naive patients with HBV-related decompensated cirrhosis did not significantly differ from that seen in patients with chronic hepatitis B or compensated cirrhosis (compensated group), according to the results of a prospective, nonrandomized study. After 6 or 12 months of entecavir treatment, there were no significant differences between the decompensated and compensated groups in virological, biochemical or serological endpoints. In patients with decompensated cirrhosis, significant improvements from baseline in liver function were seen after 12 months of entecavir therapy.Oral entecavir was generally well tolerated in patients with chronic hepatitis B and decompensated liver disease, with most of the reported treatment-emergent adverse events consistent with decompensated liver disease. In the trial primarily designed to examine tolerability endpoints, there was no significant difference between patients receiving entecavir and those receiving tenofovir disoproxil fumarate with or without emtricitabine in terms of the proportion of patients experiencing tolerability failure or the proportion of patients with confirmed increases in serum creatinine levels of ?0.5mgdL above baseline or confirmed serum phosphorus levels of <2.0mgdL at week 48 (co-primary endpoints).It has been suggested that the risk of lactic acidosis associated with oral nucleos(t)ide analogue therapy is increased in patients with highly impaired liver function. However, only one case of lactic acidosis was reported among entecavir recipients across two clinical trials in patients with chronic hepatitis B and decompensated liver disease. Moreover, small studies found that the risk of lactic acidosis was not increased in patients with chronic hepatitis B and decompensated liver disease who received entecavir, compared with patients with non-HBV decompensated liver disease.In conclusion, entecavir is a valuable agent for the first-line treatment of chronic hepatitis B in patients with decompensated liver disease. ? 2011 Adis Data Information BV. All rights reserved. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-82955172930&doi=10.2165%2f11208510-000000000-00000&partnerID=40&md5=367a0a6656a1ab81a54163a394ebc303 https://scholars.lib.ntu.edu.tw/handle/123456789/582073 |
ISSN: | 0012-6667 | DOI: | 10.2165/11208510-000000000-00000 | SDG/關鍵字: | adefovir dipivoxil; creatinine; DNA polymerase; emtricitabine plus tenofovir disoproxil; entecavir; lamivudine; peginterferon alpha; telbivudine; tenofovir disoproxil; abdominal distension; abdominal pain; allergic reaction; amylase blood level; antiviral activity; area under the curve; ascites; asthenia; chronic hepatitis; creatine kinase blood level; creatinine blood level; decompensated liver cirrhosis; dizziness; drug absorption; drug bioavailability; drug distribution; drug dose reduction; drug excretion; drug fatality; drug metabolism; drug tolerability; fever; glucose urine level; gynecomastia; hepatic encephalopathy; hepatitis B; hepatorenal syndrome; Herpes simplex virus; human; hyperamylasemia; hypersensitivity; Influenza virus; lactic acidosis; liver cell carcinoma; liver failure; myalgia; nausea; nausea and vomiting; peripheral edema; pruritus; rash; review; side effect; triacylglycerol lipase blood level; upper respiratory tract infection; Varicella zoster virus |
顯示於: | 臨床醫學研究所 |
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