Preveon adefovir dipivoxil nucleotide analog: Phase II data; Phase II/III

GILD reported results of Phase II trials of adefovir in patients with chronic hepatitis B. In one trial, 11 patients with normal liver enzyme (ALT) levels were treated with 30 mg adefovir daily for 12 weeks, and in the second trial, 39 patients with elevated liver enzymes received either 5, 30 or 60 mg daily. In each trial, 17 patients received placebo. During treatment, all dose levels reduced serum HBV levels versus placebo (p<0.001). In patients followed for up to 36 weeks, hepatitis Be antigen loss and seroconversion rates were higher in the 30 and 60 mg dose groups than in placebo among patients with elevated liver enzymes at baseline. HBeAg seroconversion did not occur in any of the 11 treated patients with normal enzyme levels.

A separate trial tested extended therapy in patients who had previously received 4 weeks of adefovir. Patients received either 60 or 120 mg daily adefovir for 24 weeks. Among 15 patients, 4 had undetectable HBV DNA at the end of treatment, with a median decrease of 4.3 log, and 3 patients also were negative for HBeAg. ...