Clinical Trial Design Issues for Chronic Hepatitis B
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Clinical Trial Design Issues for Chronic Hepatitis B U
Yeong-liong Lin, MD Medical Reviewer, the Center for Drug Evaluation. Taipei
Key Words Nucleoside analogue; Design; Hepatitis B Correspondence Address Yeong-Liang Lin. MD. Center for Drug Evaluation, I F , No I S - I , Section I , Hangjou S Road, Taipei, Taiwan I00 (e-mail :[email protected]).
INTRODUCTION More than 350 million people worldwide are infected with hepatitis B virus (1).Complications of chronic hepatitis B include cirrhosis, hepatocellular carcinoma, and end-stage liver disease. Hyperendemic regions include Southeastern Asia where about 10%to 20% of the population are chronic carriers, compared to a carrier rate of 0.1%to 2% of the population in North American and Western Europe (2). Recently, several nucleoside analogues, including lamivudine and adefovir dipivoxil, were authorized to treat patients with chronic hepatitis B. Although evidence of efficacy and safety provided by clinical trials of these agents was adequate to back their licensing authorization, there is room to improve the design of clinical trials in chronic hepatitis B (3).This recently prompted the United States Food and Drug Administration to convene a meeting on issues in clinical trial design. These issues include: Durable response to anti-viral agents, Optimal treatment duration, Active controlled versus placebo controlled study design, and Optimal follow-up period.
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In recentyean, several nucleoside analogues have been authorized to treat patients with chronic hepatitis B. Evidence of eficaq and safety provided by clinical trials with these agents was adequate to back their licensing authorization. Without question, howevec there is room to improve trial design iffuture pivotal trials are to provide more informative data than those derived from the trials of authorized nucleoside analogues. In response to a call to reexamine trial design for chronic hepatitis B, the author presents personal thoughts in hopes that data derived )?om future trials may provide more robust eficaq and safety evidence and, therefore, provide clinicians with informative instructions on the use of these drugs, which should be an important consideration in granting licensing authorization.
The purpose of this article is to address these chronic hepatitis B trial-related issues. By presenting his personal thoughts regarding appropriate trial design, the author hopes to improve the scientific merit of future trials, thereby enabling trial data to provide clinicians with informative instructions on the use of nucleoside analogues in clinical practice.
D U R A B L E RESPONSE TO A N T I - V I R A L AGENTS Since chronic hepatitis B is an infectious disease caused by a virus, the ultimate goal of major clinical trials is to demonstrate a difference in clinical outcome between treatment groups, that is, a lower incidence of the complications of chronic hepatitis B such as cirrhosis, hepatocellular carcinoma, and end-stage liver disease, after receiving anti-viral treatment. The long-term nature of t
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