In addition, 3 years of treatment with 10 mg daily of adefovir dipivoxil was well tolerated, noted Yi-Min Mao, MD, department of gastroenterology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai, People's Republic of China.

The presence of HBeAg in chronic infection generally indicates that hepatitis B virus is actively reproducing, and that there is a higher probability of liver damage.

In a presentation on October 30^th, Dr. Mao discussed the 3 years of data from a 1-year randomised, double-blind, placebo-controlled trial that enrolled 480 patients, and which is currently in the middle of a 4-year open-label extension phase with 474 patients and 456 patients for years 2 and 3, respectively.

The study is taking place at 12 centers across China.

During the first year of the randomised study, one third of subjects received placebo for the first 12 of 52 weeks (PAAA group); another third received placebo for the last 12 of 52 weeks (AAPA group). The final third cohort received continuous adefovir dipivoxil (AAAA group). Subjects had an average age of 30 years, and 83% were male.

At 3 years, 15.4% of 480 achieved protocol-defined durable HBeAg seroconversion. The median off-drug follow-up was 36 weeks in the 62 patients who stopped adefovir therapy once durable HBeAg seroconversion was achieved. Thirteen patients restarted treatment due to virologic breakthrough within 30 weeks.

At this time, 1% of subjects -- all in the AAAA group -- demonstrated HBsAg loss; 4 subjects demonstrated HBsAg seroconversion. Similarly, in the AAAA group, at week 52 adefovir therapy showed significant improvement of quality of life.

There is great concern today over resistance to hepatitis B treatments, noted Dr. Mao, but resistance mutations were identified in only 3% of 456 subjects up to this time (N236T or A181V ADV mutations).

No data indicate any renal safety concerns, although serious adverse events occurred in 5% of all subjects, which Dr. Mao considers to be drug-related. Seven patients discontinued this study due to adverse events before the open-label extension began.


[Presentation title: Efficacy and Safety of Three Years Therapy With Adefovir Dipivoxil (ADV) in Chinese Subjects With HBeAg-Positive Chronic Hepatitis B (CHB). Abstract LB21]

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