Antiviral efficacy of entecavir in nucleos(t)ide‐naïve patients of B lack/ A frican descent with chronic hepatitis B

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.