Clinical study of lamivudine and Biejia Xiaozheng pill combination therapy for chronic hepatitis B

Objective To investigate whether supplementation of Biejia Xiaozheng pill increased the therapeutic benefit of lamivudine (LAM) nucleoside analogue drug treatment in patients with chronic hepatitis B virus (HBV) infection.Methods Between June 2009 and June 2012, adult patients (18-60 years old) with mild to moderate chronic hepatitis B (CHB) were recruited for study according to findings of: serum HBV DNA ≥105 copies/ml, alanine aminotransferase (ALT) and asparatate aminotransferase (AST) increased<10 times="" the="" upper="" limit="" of="" normal="" total="" bilirubin="">5 times the ULN, and no previous treatment with antiviral and immunomodulatory agents.The 72 enrollees were randomly assigned to receive LAM alone for 24 weeks (control group, n=30) or LAM combined with Biejia Xiaozheng pill for 24 weeks followed by peresistant Biejia Xiaozheng pill (combination therapy group, n=42) .The baseline levels of serum ALT, TBil, and HBV DNA were compared between the two groups at weeks 12, 24 and 48 after treatment initiation.The overall efficacy was evaluated at weeks 24 and 48, and classified as: complete response, when ALT and TBil returned to normal level and HBV DNA was undetectable;partial response, when ALT and TBil showed ≥50% reduction and HBV DNA was reduced to ≥2log10 copies/ml;non-response: ALT and TBil ≤50% reduction and HBV DNA was reduced to ≤2log10 copies/ml or increased.The sigifinficance of differences between the control and combination therapy groups was assessed by Chi-squared test or t-test.Results At week 24 of treatment, a significantly higher percentage of the combined treatment group than the control group had achieved complete response (80.95 vs.56.67%, P<0.05) 48="" but="" at="" week="" the="" two="" groups="" showed="" similar="" percentages="" of="" complete="" response="" 83.33="" p="">0.05) .A similar trend of significant reduction in HBV DNA quantity was observed at 24 weeks of treatment (2.53±0.61 vs.3.12±0.54, P<0.01) 48="" and="" not="" at="" weeks="" of="" treatment="" 0.85="" p="">0.05) .ALT level was also significantly improved in the combination therapy group at 24 weeks compared to the control group (32.24±6.42 vs.45.10±5.44 U/L, P<0.01) 48="" but="" not="" at="" weeks="" of="" treatment="" p="">0.05) .However, the combination therapy group showed significantly improved TBil levels at both week 24 of treatment (12.66±3.41 vs.15.42±5.76 μmol/L, P<0.01) and week 48 of treatment (11.22±3.62 vs.13.86±4.88 μmol/L, P<0.01) .Conclusion Supplementation of Biejia Xiaozheng pill to the standard LAM therapy can enhance the early and rapid virological response rate, and may help to reduce the occurrence of LAM resistance.