ationwide Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive and/or Anticancer Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
- Conditions
- HBV carriers and HBV-infected patients
- Registration Number
- JPRN-UMIN000002859
- Lead Sponsor
- Saitama Medical University
- Brief Summary
A total of 325 patients were enrolled; 36 patients (11.1%) were positive for serum HBs-antigen, while 289 patients (88.9%) were negative for serum HBs-antigen, but positive for serum anti-HBc and/or anti-HBs antibodies. In 36 HBV carriers, preemptive entecavir administration was done before treatment. Consequently, none of these patients developed an elevated serum ALT level. In 289 patients with previously resolved HBV infection, the serum HBV-DNA levels were less than 1.3 Log IU/mL at baseline in all the patients, but were qualitatively detectable in 6 patients (2.1%). Serum HBV-DNA became detectable in 20 patients (6.9%) following the initiation of therapy. Among these patients, the serum HBV-DNA levels increased to 1.3 Log IU/mL or more in 11 patients (3.8%). Among the 11 patients with serum HBV-DNA levels of 1.3 Log IU/mL or more, entecavir (0.5 mg/day) was administered immediately after the diagnosis of HBV reactivation in 10 patients; consequently, none of these patients developed an elevated serum ALT level. In the remaining 1 patient, serum HBV-DNA level increased to 1.5 Log IU/mL at 34 months, but was decreased to less than 1.3 Log IU/mL at 1 month thereafter, so preemptive entecavir administration was not done.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 530
Not provided
The patients receiving rituximab.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method