BioCentury
ARTICLE | Clinical News

More Phase III data for adefovir

September 19, 2001 7:00 AM UTC

GILD said that 64% of patients with precore mutant chronic hepatitis B virus (HBV) infection had improved liver histology after receiving adefovir dipivoxil 10 mg once daily as a monotherapy for 48 weeks versus 33% of patients receiving placebo (p= 0.0002). Liver histology was the primary endpoint of the 185-patient Phase III study, and is a marker of disease progression in HBV infection, according to GILD. Precore mutant HBV is a strain of HBV virus with a mutation in the viral genome that destroys the ability of the virus to produce the "e" antigen. The study's secondary efficacy endpoint of a change in HBV viral load also was achieved. In addition, 72% of patients treated with 10 mg adefovir dipivoxil achieved normalization of ALT levels, compared to 29% of patients receiving placebo(p<0.0001). ...