Analysis of a randomized, double-blind, double-dummy, controlled, multicenter study confirmed the similar therapeutic efficacies of entecavir maleate and entecavir for treatment of HBeAg-positive chronic hepatitis B / 中华肝脏病杂志

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of entecavir maleate (ETV) versus ETV in Chinese patients with hepatitis B e antigen(HBeAg)-positive chronic hepatitis B(CHB).</p><p><b>METHODS</b>The patient population of this previously published randomized, double-blind, double-dummy, controlled, multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group (total n = 110) and patients in the 0.5 mg/day ETV group (total n = 108). At treatment weeks 12, 24 and 48, hepatitis B virus (HBV) DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay. Adverse events (AE) were recorded.</p><p><b>RESULTS</b>As in the original analysis, the two treatment groups showed similar characteristics at baseline. In addition, the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis, including the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12, 24, and 48 (ETV by 4.28, 5.00, and 5.53 log10 IU/ml vs. ETV maleate by 4.46, 4.99, and 5.51 log10 IU/ml, respectively; all vs. baseline P more than 0.05), achievement of undetectable levels of serum HBV DNA ( less than 20 IU/ml) at week 48 (ETV 38.18% vs. ETV maleate 35.19%; P more than 0.05), HBeAg loss rates at week 48 (ETV 10.91% vs. ETV maleate 12.96%; P more than 0.05), HBeAg seroconversion rates at week 48 (ETV 7.77% vs. ETV maleate 10.38%; P more than 0.05), normalization of alanine aminotransferase at week 48 (ETV 75.47% vs. ETV maleate 82.86%; P more than 0.05), and overall incidence of AE (ETV 18.02% vs. ETV maleate 17.43%; P more than 0.05).</p><p><b>CONCLUSION</b>Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB.</p>