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发表于 2004-4-17 03:30
Treatment of Chronic HBV Patients with Adefovir Monotherapy Results in Loss of HBsAg, Undetectable HBV DNA and Normalization of ALT
Clearance of circulating hepatitis B surface antigen (HBsAg) and appearance of antibody to HBsAg (anti-HBs) are generally accepted as evidence of clinical and serologic recovery from chronic hepatitis B virus infection.
The objective of the current study was to describe the frequency of HBsAg loss and seroconversion to anti-HBs in patients who were treated with adefovir dipivoxil/ ADV (Hepsera) monotherapy in clinical trials.
A retrospective analysis of all patients who received at least 4 weeks of ADV monotherapy in four clinical trials conducted between 1999 - 2001 was evaluated.
HBsAg seroconversion was defined as loss of HBsAg and appearance of anti-HBs at a single time point. Baseline characteristics, HBV DNA, ALT, and HBV genotype were analyzed.
Results
Nine of 578 patients treated (1.6%) with ADV monotherapy achieved HBsAg seroconversion after a median of 72.6 weeks. Seven patients were HBeAg+ and 2 patients were HBeAg- at baseline.
Baseline median HBV DNA was of 8.57 log10 copies/mL (range, 4.27- 9.78); median ALT was 112 IU/L (range, 52-324). At the time of HBsAg seroconversion, serum HBV DNA was undetectable by Roche Amplicor MonitorTM PCR (LLQ < 1,000 copies/mL) and serum ALT was within normal limits in all patients.
Of the 7 HBeAg+ patients, the median time from loss of HBeAg to HBsAg seroconversion was 32 weeks (range, 16-88). Six of the nine patients were genotype A.
In conclusion, the authors note, "HBsAg seroconversion was observed in patients receiving ADV monotherapy and was associated with loss of HBV DNA and ALT normalization. Further surveillance in long-term studies out to 5 years is ongoing.
04/16/04
Reference
M Shiffman and others. HBsAg Seroconversion in Adefovir Dipivoxil Treated Chronic Hepatitis B Patients. Abstract 45 (oral). 39th EASL. April 14-18, 2004. Berlin, Germany.
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