- 期刊
Switching From Branded to Generic Entecavir in Patients With Treatment-Naïve Chronic Hepatitis B: Experience of a Single Tertiary Medical Center
摘要
Entecavir (ETV) is the standard treatment for the suppression of chronic hepatitis B virus. In terms of nucleotide/nucleoside analogs, generic ETV made by China Chemical & Pharmaceutical Co. Ltd. (Envir®) was found to have a pharmacokinetic profile equivalent to branded ETV developed by Bristol-Myers Squibb (Baraclude®). The aim of the study was to evaluate the antiviral efficacy and safety of shifting from branded to generic ETV in our hospital. In this single-center, retrospective study, treatment-naïve hepatitis B patients who received branded ETV for at least 2 years and had switched to generic ETV for at least 48 weeks were included for analysis. The primary endpoint was to assess the liver biochemical status and viral suppression after drug switching, and the secondary endpoint was to assess the rate of viral breakthrough after drug switching. A total of 169 patients were included in this analysis. The mean age of the patients was 61.0 ± 10.8 years, and the male sex was predominant (68.6%). The mean treatment period was 1,146 (768-2,441) days for branded ETV and 946 (890-964) days for generic ETV. Forty-eight weeks after drug switches, there were no significant changes in the rate of complete viral suppression, liver biochemistry normalization, or renal function. Three patients (1.78%) developed viral breakthrough during the therapy, and 2 patients were not compliant with the drug. In patients with treatment-naïve hepatitis B, the antiviral efficacy and safety profiles were not affected by switching from branded to generic ETV.