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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B
Journal of Viral Hepatitis, Volume 21, No. 1, Year 2014
Notification
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Description
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. © 2013 John Wiley & Sons Ltd.
Authors & Co-Authors
Jeffers, L.
United States, Miami
University of Miami Leonard M. Miller School of Medicine
van Rensburg, Christoffel Johannes
South Africa, Stellenbosch
Stellenbosch University
Banks, A.
United States, College Park
Banks Hepatology Institute pc
Schechter, Mauro T.
Brazil, Rio de Janeiro
Universidade Federal do Rio de Janeiro
Schmidt, S. J.
Unknown Affiliation
Hu, W.
United States, New York
Bristol-myers Squibb
Llamoso, Cyril
United States, New York
Bristol-myers Squibb
Paraná, Raymundo
Brazil, Salvador
Universidade Federal da Bahia
Statistics
Citations: 8
Authors: 8
Affiliations: 6
Identifiers
Doi:
10.1111/jvh.12144
ISSN:
13520504
e-ISSN:
13652893
Research Areas
Genetics And Genomics
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study