Trial | NCT04619082  Report issue

Title

TAF to Prevent HBV Reactivation in Cancer Patients
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    150
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.
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.
Study Started
Jul 01
2021
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Apr 28
2022

Drug Tenofovir alafenamide

Tenofovir alafenamide 25 mg once per day for one year

TAF prophylaxis Experimental

Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients

Criteria 

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
No Results Posted