Phase 3
Completed N=490
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
Source: ClinicalTrials.gov NCT02979613 ↗Enrolled (actual)
490
Serious AEs
2.8%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm — 0.4; 0.4 percentage of participants
◆ Published Evidence
Highly cited
139citations · ~23 / year
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
Linked Publications
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Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm |
0.4; 0.4 | — |
| SECONDARY Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm |
0.4; 0.4 | 0.9953 |
| SECONDARY Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48 |
96.3; 96.3 | 0.98 |
| SECONDARY Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48 |
63.4; 62.0; 32.9; 34.3; 65.5; 64.1 | — |
| SECONDARY Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96 |
94.7; 93.9 | 0.6863 |
| SECONDARY Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96 |
65.8; 66.1; 28.8; 27.8; 69.3; 70.1 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48 |
7.7; 6.4 | 0.7258 |
| SECONDARY Percentage of Participants With HBeAg Seroconversion at Week 48 |
2.6; 0.0 | 0.1348 |
| SECONDARY Percentage of Participants With HBeAg Loss at Week 96 |
17.9; 9.0 | 0.1005 |
| SECONDARY Percentage of Participants With HBeAg Seroconversion at Week 96 |
5.1; 2.6 | 0.4154 |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 |
0.0; 2.0 | 0.0281 sig |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Week 48 |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 96 |
1.6; 2.4 | 0.5373 |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Week 96 |
0.8; 0.4 | 0.5845 |
| SECONDARY Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria) |
89.3; 84.9; 79.0; 75.1 | 0.1405 |
| SECONDARY Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria) |
50.0; 36.8; 50.0; 26.4 | 0.3381 |
| SECONDARY Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria) |
88.5; 91.4; 80.7; 86.5 | 0.2803 |
| SECONDARY Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria) |
56.3; 78.9; 55.8; 73.6 | 0.0880 |
| SECONDARY Change From Baseline in FibroTest® Score at Week 48 |
-0.02; -0.01 | 0.0186 sig |
| SECONDARY Change From Baseline in FibroTest® Score at Week 96 |
-0.03; -0.03 | 0.6956 |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 |
0.659; -0.507 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 96 |
1.157; 0.180 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
1.743; -0.138 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 96 |
2.330; 1.726 | 0.0970 |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48 |
2.240; -1.722 | < 0.0001 sig |
| SECONDARY Change From Baseline in eGFR-CG at Week 96 |
1.626; 0.544 | 0.7535 |
Eligibility Criteria
Key Inclusion Criteria
- Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Adult male and non-pregnant, non-lactating females
- Documented evidence of chronic hepatitis B virus (HBV) infection previously
- Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA 5 × upper limit of the normal (ULN)
- Albumin 1.5 × ULN (unless stable on anticoagulant regimen)
- Total bilirubin > 2.5 × ULN
- Received solid organ or bone marrow transplant
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
- Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
- Use of investigational agents within 3 months of screening, unless allowed by the sponsor
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02979613) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.