Switching to Tenofovir Alafenamide for Chronic Hepatitis B Treatment
A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy
This study is testing if switching chronic hepatitis B patients from their current medication to a new one called tenofovir alafenamide can make them happier with their treatment and help them stick to it better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 1 site (Taichung, Taiwan) |
| Trial ID | NCT05583006 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the satisfaction and adherence of chronic hepatitis B patients who switch from entecavir therapy to tenofovir alafenamide (TAF). TAF is known for its convenience, requiring no dietary restrictions and less frequent dosage adjustments compared to entecavir. The study will assess improvements in patient satisfaction and adherence, as well as the efficacy of TAF therapy through changes in novel biomarkers like HBV core-related antigen. The goal is to determine if switching to TAF can enhance treatment outcomes for patients dissatisfied with their current therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with chronic hepatitis B who are currently on entecavir therapy and are dissatisfied with its efficacy or convenience.
Not a fit: Patients with end-stage renal disease, active malignancies, or those co-infected with other viruses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient satisfaction and adherence to hepatitis B treatment, leading to better health outcomes.
How similar studies have performed: Previous studies have shown positive outcomes with TAF in chronic hepatitis B treatment, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taichung, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Teng-Yu Lee, MD, PhD — Taichung Veterans General Hospital
- Study coordinator: Teng-Yu Lee, MD, PhD
- Email: tylee@vghtc.gov.tw
- Phone: +886423592525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.