A randomized, multi-central, controlled study of patients with hepatitis B e antigen-positive chronic hepatitis B treated by adefovir dipivoxil or adefovir dipivoxil plus bicyclol

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http://www.springerlink.com/content/2037228772310281/

Hepatology International

DOI: 10.1007/s12072-011-9294-7Online First™Open Access

Original Article

A randomized, multi-central, controlled study of patients with hepatitis B e

antigen-positive chronic hepatitis B treated by adefovir dipivoxil or adefovir

dipivoxil plus bicyclol

Wen Xie, Guangfeng Shi, Hongfei Zhang, Guiming Zhao, Zujiang Yu, Zhenwei Lang,

Hong Zhao, Jie Yan and Jun Cheng

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Abstract

Objective

To evaluate the efficacy and safety profiles of patients with hepatitis B e

antigen (HBeAg)-positive chronic hepatitis B (CHB) treated with adefovir

dipivoxil (ADV) or ADV plus bicyclol, and to optimize the treatment strategy for

CHB patients.

Patients and methods

A total of 250 patients with HBeAg-positive CHB were randomized to ADV plus

bicyclol combination group and ADV monotherapy group. The patients in the ADV

plus bicyclol combination therapy group (n = 125) received ADV 10 mg orally q.d.

and bicyclol 25 mg orally t.i.d. for 48 weeks, and those in the ADV monotherapy

group (n = 125) were administered ADV 10 mg orally q.d. alone for 48 weeks. The

serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb, and liver biopsy were

conducted before and after therapy.

Results

The serum aminotransferase levels were decreased significantly in both groups.

The serum aminotransferase level in ADV plus bicyclol combination therapy group

decreased greater than that in ADV monotherapy group (P < 0.01). The virological

response rate in ADV plus bicyclol combination therapy group was not

significantly different from that in ADV monotherapy group (P > 0.05). After

treatment for 48 weeks, the Knodell necroinflammatory score of the two groups

were all alleviated significantly, and the Knodell score in the combination

group was significantly lower than that in the ADV monotherapy group (P < 0.05).

There were no remarkable adverse events probably related to the drug in this

study.

Conclusion

Adefovir dipivoxil plus bicyclol combination therapy is a safe and superior

treatment regimen for patients with HBeAg-positive CHB when compared with ADV

monotherapy.