Hepatitis B cure: From discovery to regulatory approval.
Anna S Lok, Fabien Zoulim, Geoffrey Dusheiko...
https://pubmed.ncbi.nlm.nih.gov/28778687Actively Recruiting
Age: 20Years +
All Genders
ID05583006
Study of Switching to Tenofovir Alafenamide to Improve Satisfaction and Adherence in Chronic Hepatitis B Patients Unsatisfied with Entecavir Therapy
Led by Taichung Veterans General Hospital · Updated on 2025-01-09
60
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
T
Taichung Veterans General Hospital
Lead Sponsor
I
Institute of Adherence to Medication
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating tenofovir alafenamide (TAF) switch therapy in patients with chronic hepatitis B (CHB) who are unsatisfied with entecavir (ETV) therapy. ETV requires fasting for at least two hours and dose adjustments based on kidney function, which may be inconvenient and affect adherence. TAF is approved as a safe and effective treatment for CHB, taken once daily without regard to food or kidney function. This study aims to assess whether switching from ETV to TAF improves patient satisfaction and drug adherence, and to evaluate potential improvements in treatment efficacy using biomarkers like HBV core-related antigen (HBcrAg). Participants will receive TAF switch therapy and be monitored over 48 weeks. This includes observing changes in renal function, viral load, and patient satisfaction with the new therapy. TAF delivers its active metabolite more efficiently and at lower doses than other treatments, potentially improving kidney health and bone density compared to alternatives. The study focuses on patients who have been on ETV but find it inconvenient or insufficient. Throughout the study, patients will have their kidney function markers and HBV viral load measured at 48 weeks. Satisfaction with TAF therapy, including drug adherence, will also be assessed. Researchers will collect data on biomarkers related to HBV infection to evaluate treatment effects. The total participation involves monitoring over a 48-week period to track safety, efficacy, and patient-reported outcomes.
CONDITIONS
Official Title
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- At least 20 years of age
- Detectable serum hepatitis B surface antigen (HBsAg)
- Chronic hepatitis B infection currently treated with entecavir (ETV)
- Unsatisfied with the efficacy or convenience of ETV therapy
- No contraindications for switching to tenofovir alafenamide (TAF) therapy
- Expect to continue HBV antiviral treatment for at least 1 year
You will not qualify if you...
- End stage renal disease with estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m2 and not on dialysis
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D virus
- Presence of any active cancers
- Currently using immunosuppressant medications
- Known allergy to tenofovir-containing medications
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705
Actively Recruiting
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Research Team
T
Teng-Yu Lee, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Factors associated with non-adherence to HBV antiviral therapy.
Suzanne Sheppard-Law, Iryna Zablotska-Manos, Melissa Kermeen...
https://pubmed.ncbi.nlm.nih.gov/29355830A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction.
Sarah S Lee, Joshua P Havens, Harlan R Sayles...
https://pubmed.ncbi.nlm.nih.gov/29980192Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance.
Norah A Terrault, Anna S F Lok, Brian J McMahon...
https://pubmed.ncbi.nlm.nih.gov/29405329EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection.
European Association for the Study of the Liver
https://pubmed.ncbi.nlm.nih.gov/28427875Significance of switching of the nucleos(t)ide analog used to treat Japanese patients with chronic hepatitis B virus infection from entecavir to tenofovir alafenamide fumarate.
Yoshihito Uchida, Masamitsu Nakao, Shohei Tsuji...
https://pubmed.ncbi.nlm.nih.gov/31777965Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects.
Jing-He Yan, Marc Bifano, Steven Olsen...
https://pubmed.ncbi.nlm.nih.gov/17050790Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
Henry L Y Chan, Scott Fung, Wai Kay Seto...
https://pubmed.ncbi.nlm.nih.gov/28404091Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
Maria Buti, Edward Gane, Wai Kay Seto...
https://pubmed.ncbi.nlm.nih.gov/28404092Switching from entecavir to tenofovir alafenamide for chronic hepatitis B patients with low-level viraemia.
Zhong-Bin Li, Le Li, Xiao-Xia Niu...
https://pubmed.ncbi.nlm.nih.gov/33404182