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Nucleoside Analog Reverse Transcriptase Inhibitor

TAF for Chronic Hepatitis B

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Study Summary

This trial will compare the effects of two different drugs on people with HBeAg-negative chronic hepatitis B virus infection who have not yet received treatment or who have already received treatment.

Eligible Conditions
  • Chronic Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL
Secondary outcome measures
Change From Baseline in Serum Creatinine at Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Percent Change From Baseline in Spine BMD at Week 48
Other outcome measures
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48

Side effects data

From 2022 Phase 3 trial • 426 Patients • NCT01940341
19%
Headache
14%
Nasopharyngitis
13%
Upper respiratory tract infection
11%
Arthralgia
9%
Cough
7%
Back pain
6%
Diarrhoea
6%
Fatigue
6%
Influenza
6%
Nausea
5%
Pain in extremity
5%
Abdominal pain
4%
Pharyngitis
4%
Dyspepsia
3%
Urinary tract infection
3%
Dizziness
3%
Hypertension
1%
Gastrooesophageal reflux disease
1%
Pancreatic carcinoma
1%
Hepatocellular carcinoma
1%
Ureterolithiasis
1%
Calculus ureteric
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind Phase: TAF 25 mg
Double-blind Phase: TDF 300 mg
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TAF 25 mgExperimental Treatment2 Interventions
TAF + TDF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).
Group II: Open-label TAFExperimental Treatment1 Intervention
All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study. After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.
Group III: TDF 300 mgActive Control2 Interventions
TDF + TAF placebo for 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAF
2015
Completed Phase 3
~2710
TDF Placebo
2015
Completed Phase 3
~2410

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,415 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,409 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of HepatologyJournal
96 Weeks Treatment of Tenofovir Alafenamide Vs. Tenofovir Disoproxil Fumarate for Hepatitis B Virus Infection
Agarwal, Kosh, Maurizia Brunetto, Wai Kay Seto, Young-Suk Lim, Scott Fung, Patrick Marcellin, Sang Hoon Ahn, et al.. 2018. “96 Weeks Treatment of Tenofovir Alafenamide Vs. Tenofovir Disoproxil Fumarate for Hepatitis B Virus Infection”. Journal of Hepatology. Elsevier BV. doi:10.1016/j.jhep.2017.11.039.
The Lancet Gastroenterology & HepatologyJournal
Tenofovir 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
Buti, Maria, Edward Gane, Wai Kay Seto, Henry L Y Chan, Wan-Long Chuang, Tatjana Stepanova, Aric-Josun Hui, et al.. 2016. “Tenofovir 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”. The Lancet Gastroenterology & Hepatology. Elsevier BV. doi:10.1016/s2468-1253(16)30107-8.
Antimicrobial Agents and ChemotherapyJournal
No Resistance to Tenofovir Alafenamide Detected Through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection
Cathcart, Andrea L., Henry Lik-Yuen Chan, Neeru Bhardwaj, Yang Liu, Patrick Marcellin, Calvin Q. Pan, Shalimar, et al.. 2018. “No Resistance to Tenofovir Alafenamide Detected Through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.01064-18.
Clinical Gastroenterology and HepatologyJournal
RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate over 2 Years in Patients with Chronic HBV Infection
Seto, Wai-Kay, Yasuhiro Asahina, Todd T. Brown, Cheng-Yuan Peng, Carol Stanciu, Dzhamal Abdurakhmanov, Fehmi Tabak, et al.. 2018. “RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate over 2 Years in Patients with Chronic HBV Infection”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2018.06.023.
~37 spots leftby Apr 2025
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