PPT Slide
In the study of Marcellin et al., 515 patients from 78 medical centers worldwide who had HBeAg-positive chronic HBV infection, at least 1 million copies of HBV DNA per milliliter, and an elevated serum alanine aminotransferase level were randomly assigned to placebo, to 10 mg of adefovir, or to 30 mg of adefovir for 48 weeks.
Slightly greater suppression of HBV DNA as compared with placebo was observed with 30 mg of adefovir than with 10 mg of adefovir (decrease, 4.76 vs. 3.52 log copies per milliliter). Percentages of patients with histologic or biochemical improvement (normalization of the serum alanine aminotransferase level) were similar with the two doses (59 percent vs. 53 percent and 55 percent vs. 48 percent, respectively). Mild nephrotoxicity was evident only at the 30-mg dose, with an increase of 0.5 mg per deciliter (44 µmol per liter) or greater in the serum creatinine concentration occurring in 8 percent of patients.
Mailliard & Gollan, N. Engl. J. Med. 348, 848-850 (2003)
“Suppressing Hepatitis B without Resistance – So Far, So Good”