Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study
The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.
Exposure to Hepatitis B Virus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- HBV reactivation (defined as detectable HBV DNA > 20 IU/mL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]From date of rituximab commencement up to 2 years
Biospecimen Retention: Samples Without DNA
Serum and plasma for hepatitis B virus genotypic, virologic and serologic testing
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
HBsAg-negative, anti-HBc-positive subjects undergoing rituximab-containing chemotherapy
Occult hepatitis B virus (HBV) reactivation has been documented in patients undergoing rituximab-containing chemotherapy who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 70 such patients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.
|Department of Medicine, The University of Hong Kong, Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Man-Fung Yuen, FRCP||The University of Hong Kong|