TAF to Prevent HBV Reactivation in Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy

Conditions
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Hepatitis B Reactivation

Intervention / Treatment
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* Drug: Tenofovir alafenamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAF prophylaxis<br>Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients | Drug: Tenofovir alafenamide<br>* Tenofovir alafenamide 25 mg once per day for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of HBV reactivation during TAF prophylaxis | Definition of HBV reactivation : HBV DNA increase 2 log (100-fold) compared to the baseline level HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level HBV DNA 4 log (10,000) IU/mL if the baseline level is not available | after 48 weeks of TAF use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dynamic change of eGFR during TAF prophylaxis | record the dynamic change of eGFR from baseline to 48 weeks after TAF | after 48 weeks of TAF use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAF, cancer patients, chemotherapy