We are looking for Black/African-American or Hispanic adults with chronic HBV infection (HBsAg-positive for ≥6 months) who have not been previously treated.

All patients will be treated with FDA approved doses of Entecavir and drug will be supplied by the sponsor of the study.

Inclusion Criteria

• Black/African-American race or of Hispanic ethnicity
• Chronic HBV infection, with detectable HBsAg for at least 6 months
• HBeAg positive or negative
• No prior treatment for hepatitis B
• Elevated ALT (>1.3 time the upper limit of normal)
• Compensated liver function (ALL) :
• INR ≤1.5
• Albumin ≥3.0 g/dL
• Total bilirubin  ≤2.5 mg/dL
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Decompensated cirrhosis
• Coinfection with HIV or HCV
• Currently abusing illegal drugs or alcohol sufficient to prevent  compliance with study therapy
• Currently taking prednisone or other immunosuppressive agents
• Any serious medical conditions that might preclude completion of this study
• Creatinine >1.5 mg/dL
• Hemoglobin <10.0 g/dL
• Platelet count <70,000/mm3
• Absolute neutrophil count <1200 cells/mm3
• AFP level >100 ng/mL

If you have an eligible patient, please contact

Principal Investigator
Edmund J. Bini, M.D., M.P.H.
Telephone: (212) 686-7500 ext. 3874
E-mail: Edmund.Bini@med.va.gov

Research Coordinator
Stanley L. John, CCRC
Telephone (212) 686-7500 ext. 4477
E-mail: Stanley.John@med.va.gov