Hepatitis B Reactivation
Conditions
Keywords
TAF, cancer patients, chemotherapy
Brief summary
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
Detailed description
This prospective single arm study would be conducted in Taiwan. Patients who fulfill the inclusion criteria, will receive TAF before the initiation of systemic chemotherapy. Based on the guidance of NHI in Taiwan, prophylactic anti-viral agent should be prescribed within 7 days before chemotherapy and would be discontinued at 6 months after cessation of chemotherapy. The duration of TAF prophylaxis would be followed the guidance of NHI in Taiwan, however, the end of our observation would be at week 48 after TAF use. Patients will receive regular follow up at week 4, 12, 24, 36 and 48 (for T-bil, AST, ALT, creatinine, HBsAg, HBV DNA) till 1 year and the outcome will be collected. Platelet and HBcrAg would be examined at enrollment, 24 weeks and 48 weeks. HBeAg and anti-HBeAg will be examined at enrollment and 48 weeks.
Interventions
DRUGTenofovir alafenamide
Tenofovir alafenamide 25 mg once per day for one year
Sponsors
St. Martin De Porress Hospital
Dalin Tzu Chi General Hospital
National Taiwan University Hospital, Yun-Lin Branch
Chi Mei Medical Hospital
Chiayi Christian Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy * The presence of HBs antigen should be confirmed within recent two years * The patients who could receive systemic chemotherapy in 4 weeks
Exclusion criteria
* Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70) * Patients with cirrhosis * Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis * Patients had exposure to any NUC or interferon within 6 months before chemotherapy * Patients were co-infected with HCV or HIV * Allergy history to any tenofovir-based medication * Pregnant woman * Unable to sign inform consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of HBV reactivation during TAF prophylaxis | after 48 weeks of TAF use | Definition of HBV reactivation : 1. HBV DNA increase 2 log (100-fold) compared to the baseline level 2. HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level 3. HBV DNA 4 log (10,000) IU/mL if the baseline level is not available |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The dynamic change of eGFR during TAF prophylaxis | after 48 weeks of TAF use | record the dynamic change of eGFR from baseline to 48 weeks after TAF |
Countries
Taiwan
Outcome results
None listed