A Randomized Controlled Trial on the Efficacy of Tenofovir Disoproxil Fumarate (TDF)-Switch Therapy in Chronic Hepatitis B Patients With Incomplete Response to Entecavir

Launched by CHINESE UNIVERSITY OF HONG KONG · Aug 6, 2013

Keywords

ClinConnect Summary

Chronic hepatitis B virus (HBV) infection affects approximately 400 million people worldwide, and three-quarter of them are from Asia-Pacific region \[1-3\]. Nucleos(t)ide analogs treatment can suppress viral replication, delay cirrhotic complications and reduce the risk of hepatocellular carcinoma (HCC) \[4-5\].

Currently, five nucleos(t)ide analogs are approved for the treatment of chronic hepatitis B, namely lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil fumarate (TDF). ETV and TDF are recommended as first-line therapy by all regional guidelines du...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 or above
• • Positive hepatitis B surface antigen for at least 6 months
• • On ETV monotherapy as anti-viral treatment for at least 52 weeks
• • HBV DNA (\>20 IU/ml) at week 52 or more of ETV treatment
• • Written informed consent obtained
• Exclusion Criteria:
• • Concurrent use of other antiviral treatment (including oral nucleos(t)ide analogs, interferon or pegylated interferon) for chronic hepatitis B.
• • Concurrent use of steroids or immunosuppressive agents more than two week consecutively
• • Co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• • Features suggestive of concomitant chronic liver diseases: positive anti-nuclear antibody (ANA) titer above 1/160, positive anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (SMA), abnormal serum ceruloplasmin or iron profile, or histological features of alternative chronic liver disease
• • Pregnancy or breast feeding.
• • Inability or unwillingness to give informed consent or abide by the requirements of the study.
• • History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
• • Patients with baseline significant impaired renal function with creatinine clearance \<30 ml/min or receiving dialysis for end stage renal disease.