TAF to Prevent HBV Reactivation in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Hepatitis B Reactivation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TAF prophylaxis

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

Group Type EXPERIMENTAL

Tenofovir alafenamide

Intervention Type DRUG

Tenofovir alafenamide 25 mg once per day for one year

Interventions

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Tenofovir alafenamide

Tenofovir alafenamide 25 mg once per day for one year

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No