Phase 2
Completed N=51
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
Source: ClinicalTrials.gov NCT02862548 ↗Enrolled (actual)
51
Serious AEs
25.7%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation — 2.13; 1.87 mL/min/1.73 m^2
Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation |
2.13; 1.87 | — |
| PRIMARY Percentage of Participants With HBV DNA < 20 IU/mL at Week 24 |
100.0; 100.0 | — |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24 |
0.478; 0.452 | — |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 48 |
1.253; -0.413 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 24 |
0.799; -0.188 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
1.454; -1.082 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 24 |
-0.043; -0.040 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 48 |
-0.052; -0.058 | — |
| SECONDARY Change From Baseline in Serum eGFR_CKD-EPI at Week 48 |
3.01; 2.09 | — |
| SECONDARY Percentage of Participants With HBV DNA < 20 IU/mL at Week 48 |
100.0; 88.0 | — |
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
- Documented evidence of chronic HBV infection prior to transplantation
- Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
- Liver Transplant ≥ 12 weeks prior to screening
- Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment
- Have been on approved HBV oral antiviral (OAV) treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA 10 × the upper limit of normal (ULN)
- International normalized ratio (INR) > 1.5 × ULN unless the participant is stable on anticoagulant regimen affecting INR
- Albumin < 3.0 g/dL
- Direct bilirubin ≥ 4 × ULN
- Platelet count < 50,000/mL
- Co-infection with HIV or hepatitis C virus (HCV)
- Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
- Use of any prohibited medications listed within 28 days of the Baseline/Day 1 visit
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer, etc.) or hepatocellular carcinoma. Participants under evaluation for possible malignancy are not eligible
- Significant cardiovascular, pulmonary, or neurological disease
- Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
- Use of any prohibited medications
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- Lactating females or those who may wish to become pregnant during the course of the study
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02862548). 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.