Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

Launched by TAICHUNG VETERANS GENERAL HOSPITAL · Oct 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with chronic hepatitis B (CHB) who are currently using a medication called entecavir (ETV) but are not satisfied with it. Many patients find ETV inconvenient because it requires fasting for over two hours and adjusting doses based on kidney function. The researchers want to see if switching to a different medication called tenofovir alafenamide (TAF), which is taken just once a day and doesn't require food restrictions or frequent dose adjustments, can improve patient satisfaction and adherence to treatment. They believe that happier patients will stick to their medication better, leading to improved health outcomes.

To participate in this trial, you must be at least 20 years old, have a detectable hepatitis B virus in your blood, and currently be on ETV therapy but feeling dissatisfied with it. You should expect regular check-ins with the study team to monitor your health as you switch to TAF. It’s important to note that certain conditions, like severe kidney disease or co-infections with other viruses, may prevent you from joining. The goal is to see if this switch can not only make taking medication easier but also help improve your overall health related to hepatitis B.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 20 years of age
• • 2. Detectable serum HBsAg
• • 3. Chronic HBV infection under ETV therapy
• • 4. ETV users who are unsatisfied with the efficacy and/or feel inconvenient of ETV therapy
• • 5. No contraindications for TAF switch therapy
• • 6. HBV antiviral period expectancy for at least 1 year
• Exclusion Criteria:
• • 1. End stage renal disease (estimated glomerular filtration rate \[eGRF\]\< 15 mL/min/1.73m2) without dialysis
• • 2. Co-infected with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
• • 3. Any active malignancies
• • 4. Under immunosuppressants
• • 5. Known allergy to tenofovir-contained regimens