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

• Published in: Journal of viral hepatitis 2014-01, Vol.21 (1), p.74-76
• Main Authors: Jeffers, L., Van Rensburg, C. J., Banks, A., Schechter, M., Schmidt, S. J., Hu, W., Llamoso, C., Parana, R.
• Format: Article
• Language: English
• Subjects: Adult; African Americans; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - pharmacology; antiviral therapy; DNA, Viral - blood; Female; Guanine - administration & dosage; Guanine - adverse effects; Guanine - analogs & derivatives; Guanine - pharmacology; hepatitis B e antigen; Hepatitis B e Antigens - blood; Hepatitis B virus; Hepatitis B virus - drug effects; Hepatitis B virus - isolation & purification; hepatitis B virus DNA; Hepatitis B, Chronic - drug therapy; Humans; Male; Microbial Sensitivity Tests; nucleos(t)ide analogue; Treatment Outcome; Viral Load
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/jvh.12144

Summary 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 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.