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Hepatitis B Resource Center
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The hepatitis B virus (HBV) is transmitted hematogenously and sexually. The outcome of this infection is a complicated viral-host interaction resulting in either an acute symptomatic disease or an asymptomatic disease. Patients may become immune to HBV or may develop a chronic carrier state. Later consequences are cirrhosis and the development of hepatocellular carcinoma. Antiviral treatment may be effective in approximately one third of the patients who receive it, and for selected candidates, liver transplantation currently seems to be the only viable treatment for the latest stages of this disease. |
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Acute liver failure (ALF) is an uncommon condition in which the rapid deterioration of liver function results in coagulopathy and alteration in the mental status of a previously healthy individual. ALF often affects young people and carries a very high mortality. The term ALF is used to describe the development of coagulopathy, usually an international normalized ratio (INR) of greater than 1.5, and any degree of mental alteration (encephalopathy) in a patient without preexisting cirrhosis and with an illness of less than 26 weeks' duration |
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Cirrhosis is defined histologically as a diffuse hepatic process characterized by fibrosis and the conversion of normal liver architecture into structurally abnormal nodules. The progression of liver injury to cirrhosis may occur over weeks to years. Indeed, patients with hepatitis C may have chronic hepatitis for as long as 40 years before progressing to cirrhosis. |
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HBV is transmitted hematogenously and sexually. The outcome of this infection is a complicated viral-host interaction resulting in either an acute symptomatic disease or an asymptomatic disease. Patients may become immune to HBV or may develop a chronic carrier state. Later consequences are cirrhosis and the development of hepatocellular carcinoma (HCC). Antiviral treatment may be effective in approximately one third of the patients who receive it, and for selected candidates, liver transplantation currently seems to be the only viable treatment for the latest stages of this disease. |
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Hepatitis B is a viral disease with a high incidence and prevalence worldwide. Hepatitis B can cause acute and chronic liver disease. The clinical presentation ranges from subclinical hepatitis to symptomatic hepatitis and, in rare instances, fulminant hepatitis. Long-term complications of hepatitis B include cirrhosis and hepatocellular carcinoma. |
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Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation |
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This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized. |
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Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
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The purpose of this clinical research study is to provide entecavir to subjects with chronic hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.
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Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
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The purpose of this study is to evaluate the effectiveness of entecavir plus tenofovir combination therapy compared with entecavir monotherapy. Safety will also be studied.
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Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
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The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
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Lim SG, Marcellin P, Tassopoulos N, Hadziyannis S, Chang TT, Tong M, et al. Clinical trial: effects of adefovir dipivoxil therapy in Asian and Caucasian patients with chronic hepatitis B. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1419-28. |
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Hui CK, Lau GK. Treatment of Hepatitis B e Antigen-negative Patients. Curr Treat Options Gastroenterol. 2007 Dec;10(6):474-82. |
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Palumbo E. Entecavir for chronic hepatitis B: a review. Ther Drug Monit. 2008 Feb;30(1):1-4. |
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Pawlotsky JM, Dusheiko G, Hatzakis A, Lau D, Lau G, Liang TJ, et al. Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: recommendations for a standardized approach. Gastroenterology. 2008 Feb;134(2):405-15. |
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Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, et al. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54. |
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Chan HL, Wang H, Niu J, Chim AM, Sung JJ. Two-year lamivudine treatment for hepatitis B e antigen-negative chronic hepatitis B: a double-blind, placebo-controlled trial. Antivir Ther. 2007;12(3):345-53. |
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Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, et al. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. |
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Yuan Y, Iloeje UH, Hay J, Saab S. Evaluation of the Cost-Effectiveness of Entecavir Versus Lamivudine in Hepatitis BeAg-Positive Chronic Hepatitis B Patients. J Manag Care Pharm. 2008 Jan;14(1):21-33. |
