Phase 4
Completed N=10
Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
Hepatitis C · HIV Coinfection
Source: ClinicalTrials.gov NCT03126370 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks — 3466; 743; 868 ng*h/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]), and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to participate.
The study will consist of five visits: a screening visit, three abbreviated 4-hour pharmacokinetic visits, and one end-of-study follow-up visit.
Subjects will also be asked to use a Wisepill device, which will track medication adherence throughout the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks |
3466; 743; 868 | — |
| PRIMARY Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks |
83.0; 926; 1129 | — |
| SECONDARY Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) |
36014; 6735; 6100 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR |
86.7; 91.0; 88.1 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR |
134; 118; 97.3 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio |
419; 224; 178; 436; 242; 146 | — |
Eligibility Criteria
Inclusion Criteria
- Between 18-70 years of age
- Have been taking TDF and a ritonavir- or cobicistat-boosted protease inhibitor as part of standard care for treatment of HIV
Exclusion Criteria
- eGFR < 30 mL/min
- Pregnant or planning pregnancy
- Breastfeeding
- Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes
- Signs or symptoms of decompensated liver disease
- Hepatitis B infection
- Medications that may cause unwanted drug interactions with ledipasvir/sofosbuvir or emtricitabine/tenofovir alafenamide
- Unwillingness or inability to comply with study procedures
- Chronic hepatitis C infection
Data sourced from ClinicalTrials.gov (NCT03126370). 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.