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Telbivudine vs. Lamivudine for Chronic Hepatitis B

In a large double-blind trial, telbivudine was superior to lamivudine, particularly in HBeAg-positive patients.

Lamivudine is the antiviral most widely prescribed worldwide for chronic hepatitis B. Other agents available for use include interferon alfa, adefovir dipivoxil, entecavir, and telbivudine. Trials directly comparing the efficacy and safety of these agents are needed.

Now, in a manufacturer-sponsored, phase III, randomized, double-blind trial, researchers have compared telbivudine (600 mg daily) with lamivudine (100 mg daily) in adults with chronic hepatitis B. Conducted at 112 medical centers in 20 countries, the trial involved 1370 participants aged 16 to 70. Duration of follow-up was 52 weeks. The primary endpoint was therapeutic response; the main secondary endpoint was histologic response. Subgroup analyses were performed based on patients’ hepatitis B e antigen (HBeAg) status.

Telbivudine was deemed noninferior to lamivudine on all study endpoints and was then examined for superiority. Among HBeAg-positive patients, telbivudine was superior to lamivudine for the primary and the main secondary endpoints. Among HBeAg-negative patients, the two drugs were equivalent with respect to these endpoints. Telbivudine had better antiviral activity than did lamivudine, regardless of the patients’ HBeAg status, and was associated with lower rates of drug resistance. The safety profiles of the two antivirals were similar overall. Creatine kinase elevations (transient in most cases) were more common with telbivudine than with lamivudine; on-treatment aminotransferase flares were more common with lamivudine. One telbivudine recipient developed myopathy.

Comment: Telbivudine seems to represent an advance in the therapy of chronic hepatitis B. Based on analyses of efficacy, safety, and likelihood of selection for viral resistance, telbivudine proved a better choice in this comparative trial, particularly for HBeAg-positive patients.

— Larry M. Baddour, MD

Published in Journal Watch Infectious Diseases December 19, 2007

Citation(s):

Lai CL et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007 Dec 20; 357:2576.

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