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Antiviral efficacy of entecavir in nucleos(t)ide‐naïve patients of B lack/ A frican descent with chronic hepatitis B
Author(s) -
Jeffers L.,
Van Rensburg C. J.,
Banks A.,
Schechter M.,
Schmidt S. J.,
Hu W.,
Llamoso C.,
Parana R.
Publication year - 2014
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12144
Subject(s) - entecavir , medicine , seroconversion , clinical endpoint , gastroenterology , hepatitis b virus , hepatitis b , chronic hepatitis , population , clinical trial , virology , virus , lamivudine , environmental health
Summary This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir ( ETV ) in nucleos(t)ide‐naïve B lack/ A frican A merican patients with chronic hepatitis B ( CHB ), a patient population underrepresented in ETV registration trials. Forty patients with HB eAg(+) or HB eAg(−) compensated CHB of self‐described B lack/ A frican A merican 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 HB eAg loss (11/22; 50%) and HB eAg 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 B lack/ A frican A merican patients with CHB , ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and A sian patients in ETV Phase III studies.