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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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

Hepatology International, 08/02/2011 Clinical Article

Xie W et al. – Adefovir dipivoxil plus bicyclol combination therapy is a safe

and superior treatment regimen for patients with HbeAg-positive chronic

hepatitis B(CHB) when compared with adefovir dipivoxil(ADV) monotherapy.

Methods• Total of 250 patients with HBeAg-positive CHB were randomized to ADV

plus bicyclol combination group and ADV monotherapy group.

• 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.

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

conducted before and after therapy.

Results• Serum aminotransferase levels were decreased significantly in both

groups.

• Serum aminotransferase level in ADV plus bicyclol combination therapy group

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

• 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.