Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B

L. Jeffers, C. J. Van Rensburg, A. Banks, M. Schechter, S. J. Schmidt, W. Hu, C. Llamoso, R. Parana

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

This single-arm, open-label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide-naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(-) compensated CHB of self-described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on-treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.

Original languageEnglish (US)
Pages (from-to)74-76
Number of pages3
JournalJournal of viral hepatitis
Volume21
Issue number1
DOIs
StatePublished - Jan 1 2014

Keywords

  • antiviral therapy
  • hepatitis B e antigen
  • hepatitis B virus DNA
  • nucleos(t)ide analogue

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

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    Jeffers, L., Van Rensburg, C. J., Banks, A., Schechter, M., Schmidt, S. J., Hu, W., Llamoso, C., & Parana, R. (2014). Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B. Journal of viral hepatitis, 21(1), 74-76. https://doi.org/10.1111/jvh.12144