← Back to Search

Nucleoside Analog Reverse Transcriptase Inhibitor

TAF for Chronic Hepatitis B

Q: What conditions does TAF typically help alleviate?

TAF is frequently used to treat patients that have been virologically supressed for 3 months. Additionally, TAF can be given to patients that have tenofovir resistance, treatment failure, or are high risk.

Q: Are there precedent studies that have utilized TAF?

TAF was first researched in 2002 by the University of Zurich. Since then, there have been a total of 405 completed clinical trials. As of now, 122 studies are actively recruiting participants with a high number of these being located in Ottawa, Canada.

Q: What is the latest update on TAF's progress towards FDA approval?

TAF has received a score of 3 for safety. This is because TAF is in Phase 3 testing, meaning that there are both efficacy and multiple rounds of safety data supporting its use.

Q: What is the total number of research facilities participating in this project?

This trial has 27 enrolment sites, which include The Ottawa Hospital in Ottawa, Huntington Medical Research Institutes in Pasadena, Tufts Medical Center, Inc in Boston among other locations.

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 effectiveness, safety, and tolerability of two different drugs for treating hepatitis B virus infection in adults.

Eligible Conditions

Chronic Hepatitis B

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

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 at Week 48

Secondary outcome measures

Change From Baseline at Week 48 in Serum Creatinine

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Percent Change From Baseline in Spine BMD at Week 48

+1 more

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

Cough

Back pain

Fatigue

Diarrhoea

Influenza

Nausea

Pain in extremity

Abdominal pain

Pharyngitis

Dyspepsia

Dizziness

Urinary tract infection

Hypertension

Gastrooesophageal reflux disease

Pancreatic carcinoma

Hepatocellular carcinoma

Ureterolithiasis

Calculus ureteric

100%

80%

60%

40%

20%

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

TDF Placebo

2015

Completed Phase 3

~2410

TAF

2015

Completed Phase 3

~2710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

841,966 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

185,960 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does TAF typically help alleviate?

"TAF is frequently used to treat patients that have been virologically supressed for 3 months. Additionally, TAF can be given to patients that have tenofovir resistance, treatment failure, or are high risk."

Answered by AI

Are there precedent studies that have utilized TAF?

"TAF was first researched in 2002 by the University of Zurich. Since then, there have been a total of 405 completed clinical trials. As of now, 122 studies are actively recruiting participants with a high number of these being located in Ottawa, Canada."

Answered by AI

What is the latest update on TAF's progress towards FDA approval?

"TAF has received a score of 3 for safety. This is because TAF is in Phase 3 testing, meaning that there are both efficacy and multiple rounds of safety data supporting its use."

Answered by AI

What is the total number of research facilities participating in this project?

"This trial has 27 enrolment sites, which include The Ottawa Hospital in Ottawa, Huntington Medical Research Institutes in Pasadena, Tufts Medical Center, Inc in Boston among other locations."

Answered by AI

Recent research and studies

The Lancet Gastroenterology & HepatologyJournal

Tenofovir 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

Chan, Henry L Y, Scott Fung, Wai Kay Seto, Wan-Long Chuang, Chi-Yi Chen, Hyung Joon Kim, Aric Josun Hui, et al.. 2016. “Tenofovir 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”. The Lancet Gastroenterology & Hepatology. Elsevier BV. doi:10.1016/s2468-1253(16)30024-3.

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.

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.

Clinical Gastroenterology and HepatologyJournal