Clinical

Long-term adefovir therapy useful for chronic hepatitis B

Last Updated: 2007-01-30 16:44:57 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Treatment with adefovir dipivoxil for up to 5 years is well tolerated and provides a variety of benefits for patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, new research shows.

Patients with HBeAg-negative chronic hepatitis B are at increased risk for progression to cirrhosis and hepatocellular carcinoma and rarely experience spontaneous, sustained remission. Therefore, continuous antiviral therapy is typically required.

Early research has shown that a 48-week course of adefovir provides clinical improvements in patients with HBeAg-negative chronic hepatitis B. Unfortunately, these benefits disappear upon drug discontinuation. The focus of the present study was to determine the safety and efficacy of adefovir treatment for up to 5 years.

As reported in the December issue of Gastroenterology, Dr. Stephanos J. Hadziyannis, from the Henry Dunant Hospital in Athens, Greece, and colleagues assessed the clinical outcomes of 185 patients who were randomized to receive adefovir or placebo. The duration of adefovir therapy ranged from 48 to 240 weeks.

At 240 weeks, 67% of adefovir-treated patients had serum hepatitis B virus (HBV) DNA levels below 1000 copies/mL and 69% of patients had achieved normal alanine aminotransferase levels.

With long-term adefovir therapy, necroinflammation and fibrosis improved in 83% and 73% of patients, respectively. The percentage of patients with improved fibrosis scores, relative to baseline, was directly related to the duration of adefovir therapy, ranging from 35% after 48 weeks to 71% after 240 weeks.

After 240 weeks of therapy, the cumulative rates of HBV polymerase mutations, virologic resistance, and clinical resistance were 29%, 20%, and 11%, respectively.

Four patients experienced mild elevations in creatinine levels, the investigators point out.

"Treatment with adefovir dipivoxil for up to 240 weeks produces sustained suppression of HBV DNA levels, durable normalization of ALT, and continued improvement in liver histology," the authors conclude.

"With its safety, durable efficacy, and delayed resistance for up to 5 years, adefovir dipivoxil is a primary therapeutic option for the treatment of HBeAg-negative chronic hepatitis B."

Gastroenterology 2006;131:1743-1751.