Tenofovir alafenamide: Tenofovir alafenamide 25 mg once per day for one year
Study 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
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
Primary outcome measure(s)
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
Trial sites (5)
Facility
City
Region
Status
Dalin Tzu Chi General Hospital
Chiayi City
Taiwan
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City
Taiwan
St. Martin De Porress Hospital
Chiayi City
Taiwan
National Taiwan University Hospital, Yun-Lin Branch
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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