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A comparative study of chronic hepatitis B subjects treated with entecavir plus tenofovir combination therapy vs entecavir monotherapy in adults who are treatment-naïve to nucleosides and nucleotides: the BE-LOW study (BMS AI463110) (HUM 12655)
The purpose of this research study is to determine if combination therapy of entecavir 0.5 mg plus tenofovir 300 mg has superior antiviral activity compared with entecavir monotherapy 0.5 mg in adults with chronic hepatitis B infection who are treatment-naïve to nucleosides and nucleotides.
Study Design
This is a comparative, randomized, open-label, multi-center study. Subjects will be randomized 1:1 to receive entecavir plus tenofovir combination therapy or entecavir monotherapy for a duration of 100 weeks.
Main Inclusion Criteria
- Adult males and females
- Chronic HBV infection (HBeAg positive or HBeAg negative)
- Nucleoside- and nucleotide-naïve (no prior oral HBV antiviral therapy)
- Compensated liver function
- ALT of ≥ 1.3 x ULN
- All subjects must be willing to use adequate birth control for duration of treatment and follow-up
Main Exclusion Criteria
- Decompensated liver disease (variceal hemorrhage, hepatic encephalopathy, or ascites)
- Women who are pregnant or breastfeeding
- Lab results of serum creatinine >1.5 mg/dL, hemoglobin <10.0 g/dL, platelets <70,000/mm3, neutrophils <1500 cells/mm3, AFP level > 100 ng/mL
- Coinfection with HIV
- Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
Study Visits
- Liver biopsy not required
- Study visits every 4–12 weeks
Note: All study related activities (medications, labs and study visits) are covered by the study.
Questions or referrals: please contact Tess Bonham at (734) 615-0158 or tbonham@umich.edu or Anna Lok, MD at aslok@med.umich.edu. |
