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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B Reactivation
• Intervention / Treatment: Drug: Tenofovir alafenamide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Po-Yueh Chen, MD; Phone Number: 5275 +886-5-2765041; Email: hdilwy7@gmail.com

Study Locations

• Taiwan
  • Chiayi City, Taiwan, 600
    • Recruiting
    • Dalin Tzu Chi General Hospital
    • Contact: Kuo-Chi Tseng, MD
    • Principal Investigator: Kuo-Chi Tseng, MD
  • Chiayi City, Taiwan, 600
    • Recruiting
    • Ditmanson Medical Foundation Chiayi Christian Hospital
    • Contact: Po-Yueh Chen, MD; Phone Number: 5275 +886-5-2765041; Email: hdilwy7@gmail.com
    • Sub-Investigator: Chi-Yi Chen, MD
    • Sub-Investigator: Chu-Kuang Chou, MD
    • Sub-Investigator: Li-Jen Chang, MD
    • Principal Investigator: Po-Yueh Chen, MD
  • Chiayi City, Taiwan, 600
    • Recruiting
    • St. Martin De Porress Hospital
    • Contact: Ching-Chu Lo, MD
    • Principal Investigator: Ching-Chu Lo, MD
  • Tainan, Taiwan
    • Recruiting
    • Chi Mei Medical Hospital
    • Contact: Jyh-Jou Chen, MD
    • Principal Investigator: Jyh-Jou Chen, MD
  • Yun-Lin, Taiwan
    • Recruiting
    • National Taiwan University Hospital, Yun-Lin Branch
    • Contact: Yu-Jen Fang, MD
    • Principal Investigator: Yu-Jen Fang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital
• Collaborators: Chi Mei Medical Hospital; Dalin Tzu Chi General Hospital; National Taiwan University Hospital, Yun-Lin Branch; St. Martin De Porress Hospital
• Investigators: Principal Investigator: Po-Yueh Chen, MD, Ditmanson Medical Foundation Chiayi Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; TAF; cancer patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: IRB2020091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No