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New Treatment for Chronic Hepatitis B

Adefovir dipivoxil provides clinicians with an alternative to lamivudine or interferon.

Until recently, interferon and lamivudine were the only proven therapies for chronic hepatitis B virus (HBV) infection. But, many patients cannot tolerate interferon, and drug resistance develops frequently with lamivudine. Now we have a third option, the nucleotide analogue adefovir dipivoxil (Hepsera), which was evaluated in these 2 industry-sponsored, multicenter, randomized trials.

In one trial, 515 hepatitis B e-antigen-positive viremic patients received daily oral doses of adefovir (30 mg or 10 mg) or placebo. At 48 weeks, patients in both adefovir groups were significantly more likely than patients in the placebo group to have histologic improvement on liver biopsy (59% and 53% vs. 25%), undetectable serum HBV DNA levels (39% and 21% vs. 0%), and normal serum transaminase levels. The 30-mg dose was associated with mild renal toxicity.

In a second trial, 185 e-antigen-negative viremic patients, who often harbor HBV mutations, received daily doses of adefovir (10 mg) or placebo. At 48 weeks, adefovir recipients were significantly more likely than placebo recipients to have histologic improvement (64% vs. 33%), undetectable HBV DNA levels (51% vs. 0%), and normal transaminase levels. There were no major side effects.

Comment: The findings of these 2 studies document that adefovir induces histologic, virologic, and biochemical improvements in patients with chronic HBV infection. The FDA-approved daily dose is 10 mg, because the 30-mg dose was only slightly more effective and carried a higher risk for nephrotoxicity. Importantly, no drug resistance was noted. Longer-term results will tell us whether sustained or additional improvements occur with continuation of therapy.

— Allan S. Brett, MD

Published in Journal Watch General Medicine March 7, 2003

Citation(s):

Marcellin P et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003 Feb 27; 348:808-16.

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• Medline abstract (Free)

Hadziyannis SJ et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med 2003 Feb 27; 348:800-7.

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• Medline abstract (Free)