LIM S, CHANG T, TONG M, MARCELLIN P, SIEVERT W, SCHIFFMAN M, JEFFERS L, GOODMAN Z, MA J, JAMES C, FRY J, BROSGART C; THE GS-98-437 STUDY GROUP; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. LB-20.

National University Hospital, Singapore, Singapore.

BACKGROUND: Chronic HBV infection is a leading cause of cirrhosis and hepatocellular carcinoma. ADV is a nucleotide analogue with potent antiviral activity against wild-type and lamivudine resistant HBV. Methods: We evaluated the antiviral activity of ADV 10 mg compared to PLB at week 48 with respect to 1)liver histology, HBV DNA, ALT and HBeAg seroconversion 2) safety and tolerability. At baseline patients (pts) with HBsAg for >/= 6 months, HBV DNA >/= 10[6] copies/mL, and ALT 1.2-10 x ULN were randomized in a 1:1:1 ratio to ADV 10 mg, ADV 30 mg or PLB. Biopsies were scored (Knodell) by a blinded histopathologist. RESULTS: 515 HBeAg+ pts were enrolled: 380 males (74%), 135 females (26%); median age 33 years. Ethnicity: 306 Asian (59%),185 Caucasian (36%), 24 other (4%). 442 pts (86%) had paired baseline and week 48 biopsies. 53% of ADV 10 mg pts demonstrated improvement in liver histology compared to 25% of PLB pts (p<0.001). At week 48 ADV 10 mg pts had a median 3.52 log[10] copies/mL reduction in HBV DNA levels compared to 0.55 log[10] reduction in the PLB group(p<0.001). 12% of ADV pts serocoverted compared to 6% in PLB group(p<0.05). 48% of ADV 10 mg pts had a normal ALT level at week 48 compared to 16% of PLB pts (p<0.001). Premature discontinuation of study medication and adverse events were similar between ADV 10 mg and PLB. CONCLUSION: ADV 10 mg demonstrated significant antiviral activity, with liver histology improvements, increased HBeAg seroconversion rates, and decreases in HBV DNA and ALT levels. The safety profile was similar to placebo.

Publication Types:

• Meeting Abstracts

Keywords:

• Adenine
• Alanine Transaminase
• Antiviral Agents
• Communicable Diseases
• Female
• Hepatitis B
• Hepatitis B e Antigens
• Hepatitis B virus
• Hepatitis B, Chronic
• Humans
• Infection
• Lamivudine
• Liver
• Liver Function Tests
• Male
• Phosphonic Acids
• adefovir dipivoxil
• immunology

Other ID:

• GWAIDS0029970

UI: 102269602

From Meeting Abstracts