Baracle® vs Baraclude® for 48 weeks in patients with treatment-naïve chronic hepatitis B: A comparison of efficacy and safety

Do Young Kim, Ju Hyun Kim, Won Young Tak, Jong Eun Yeon, Joon Hyeok Lee, Jung Hwan Yoon, Youn Jae Lee, Byung Seok Lee, Byung Hoon Han, Han Chu Lee

Research output: Contribution to journalArticle

Abstract

Background and objective: Entecavir (ETV) is a standard of care for chronic hepatitis B (CHB). In a bioequivalence study, ETV from Dong-A ST (Baracle®) was found to have a pharmacokinetic profile equivalent to ETV from Bristol-Myers Squibb (BMS) (Baraclude®). The present study was conducted to evaluate the antiviral activity and safety of ETV from Dong-A ST in comparison to ETV from BMS in patients with CHB. Methods: In this multicenter, double-blind, active-controlled, stratified-randomized, parallel group, comparative trial, 118 treatment-naïve patients with CHB were randomly assigned to receive either 0.5 mg of ETV from Dong-A ST or ETV from BMS once daily for 48 weeks. The primary efficacy endpoint was virologic improvement (a mean reduction from baseline in serum HBV DNA levels) at 24 weeks. Secondary efficacy endpoints included a mean reduction in serum HBV DNA levels at 48 weeks, proportion of patients with undetectable levels of serum HBV DNA, rates of hepatitis B e antigen (HBeAg) loss and seroconversion, rates of HBsAg loss and seroconversion, and rates of normalization of alanine aminotransferase (ALT) levels. Results: From baseline to week 24, HBV DNA levels (log10) decreased by 4.81 and 4.63 with ETV from Dong-A ST and with ETV from BMS, respectively. The upper limit of two-sided 95% confidence intervals (CI) (equivalent to one-sided 97.5% CIs) for the difference between the treatment groups was 0.208, which was below the noninferiority margin of 1, thus supporting the noninferiority of ETV from Dong-A ST in comparison to ETV from BMS. No statistically significant differences were noted between the treatment groups in all secondary and tertiary efficacy endpoints. Safety profiles were also similar between the two groups. Conclusion: In patients with previously untreated HBeAg-positive or negative HBV infection, the efficacy of ETV from Dong-A ST was noninferior to that of ETV from BMS, and there were no significant differences in efficacy or safety between two groups.

Original languageEnglish
Pages (from-to)3145-3152
Number of pages8
JournalDrug Design, Development and Therapy
Volume11
DOIs
Publication statusPublished - 2017 Oct 31

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery

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    Kim, D. Y., Kim, J. H., Tak, W. Y., Yeon, J. E., Lee, J. H., Yoon, J. H., Lee, Y. J., Lee, B. S., Han, B. H., & Lee, H. C. (2017). Baracle® vs Baraclude® for 48 weeks in patients with treatment-naïve chronic hepatitis B: A comparison of efficacy and safety. Drug Design, Development and Therapy, 11, 3145-3152. https://doi.org/10.2147/DDDT.S149199