Hepsera in Treating HBeAg Negative HBV Patients

yuer

Hepsera (adefovir dipivoxil) Proves Safe and Effective in Treating HBeAg Negative HBV Patients By Brian Boyle, MD Treatment for chronic hepatitis B virus (HBV) is advancing rapidly. There are now 3 therapies approved for the treatment of HBV, including interferon, Epivir-HBV (lamivudine) and Hepsera (adefovir). Hepsera, the last agent to be approved, has a somewhat checkered past, with it failing to obtain approval for the treatment of HIV infection in large part due to the risk of renal tubular dysfunction. Fortunately, Hepsera is effective against HBV at much lower doses than those required for HIV therapy and studies to date have failed to show significant rates of toxicity at the 10mg per day dose used in the treatment of HBV. In a study published in The New England journal of Medicine, the efficacy and safety of Hepsera in the treatment of hepatitis B e antigen (HBeAg) negative chronic HBV was evaluated. The prospective, placebo-controlled study enrolled 185 patients who were randomized to receive either 10 mg of Hepsera or placebo once daily for 48 weeks. The investigators found that at week 48 the patients that received Hepsera had a significantly higher rate of improvement in histologic liver abnormalities than patients who received placebo (64% vs. 33%, P<0.001). Further, serum HBV DNA levels were reduced to <400 copies/mL in 51% and 0% of the patients treated with Hepsera or placebo, respectively (P<0.001) and the median decrease in HBV DNA levels was greater with Hepsera than placebo (3.91 vs. 1.35 log copies per milliliter, P<0.001). At week 48, alanine aminotransferase (ALT) levels normalized in 72% of Hepsera patients and only 29% of those receiving placebo (P<0.001) and no patient developed resistance to Hepsera. Finally, the safety and tolerability of Hepsera were quite remarkable with the safety profile of Hepsera similar to that of placebo. The authors conclude, "In patients with HBeAg-negative chronic hepatitis B, 48 weeks of adefovir dipivoxil treatment resulted in significant histologic, virologic, and biochemical improvement, with an adverse-event profile similar to that of placebo. There was no evidence of the emergence of adefovir-resistant HBV polymerase mutations." 02/28/03 Reference S Hadziyannis and others. Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Negative Chronic Hepatitis B. The New England Journal of Medicine 2003;348:800-807.