A randomized, double-blind, double-dummy, controlled, multicenter study of entecavir maleate versus entecavir for treatment of HBeAg-negative chronic hepatitis B: results at week 48.
- Author:
Jing-hang XU
1
;
Yan-yan YU
;
Chong-wen SI
;
Zheng ZENG
;
Da-zhi ZHANG
Author Information
- Publication Type:Journal Article
- MeSH: Adult; Antiviral Agents; adverse effects; therapeutic use; Double-Blind Method; Female; Guanine; adverse effects; analogs & derivatives; therapeutic use; Hepatitis B e Antigens; blood; Hepatitis B, Chronic; blood; drug therapy; Humans; Male; Maleates; adverse effects; therapeutic use; Middle Aged; Treatment Outcome
- From: Chinese Journal of Hepatology 2012;20(7):512-516
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the efficacy and safety of entecavir (ETV) maleate versus ETV in Chinese patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB).
METHODSThis was a randomized, double-blind, double-dummy, controlled, multicenter study. Patients were randomly assigned to receive 48 weeks of treatment with 0.5 mg/day ETV (group A; n = 26) or 0.5 mg/day ETV maleate (n = 31). Hepatitis B virus (HBV) DNA levels were measured at weeks 12, 24, and 48 by the Roche Cobas Ampliprep/Taqman PCR assay. Adverse events (AE) were recorded.
RESULTSBaseline characteristics were similar between the two groups. At weeks 12, 24, and 48, the mean HBV DNA level had similarly decreased from baseline in both groups (A: by 4.24, 4.61 and 4.88 log10 IU/mL vs. B: 4.01, 4.50 and 4.99 log10 IU/mL, respectively; all P more than 0.05). Patients who achieved undetectable levels of serum HBV DNA (less than 20 IU/mL) at week 48 were similar in the two groups (A: 69.23% vs. B: 80.65%; P more than 0.05). Both groups achieved similar normalization of ALT at week 48 (A: 96.00% vs. B: 83.87%; P more than 0.05). The overall AE incidence was similar for the two groups (A: 22.22% vs. B: 9.38%; P more than 0.05).
CONCLUSIONEntecavir maleate and entecavir showed similar efficacy and safety in patients with HBeAg-negative CHB.
