Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD) who are treated with Harvoni for 12 weeks have improvements in their kidney disease.
The investigators hypothesize that patients with early stage (1-3) CKD caused by HCV infection will have significantly improved proteinuria and eGFR after viral eradication with 12 weeks of treatment Harvoni (LDV/SOF). This trial data will serve as the basis to support further study of LDV/SOF in patients with early CKD. Slowing progression of CKD is a critical goal, as the increasing incidence and prevalence of advanced CKD and end stage renal disease (ESRD) places significant health burden on patients and tremendous costs on our health-care system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
12 weeks treatment with Harvoni
Massachusetts General Hospital
Boston, Massachusetts, United States
The Percent Change in Proteinuria
% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni.
Time frame: Baseline and 24 weeks (12 weeks after completion of Harvoni)
Median Change in eGFR From Baseline to Timepoint Week 24
Median change from baseline (timepoint week 0) to timepoint week 24, which was 12 weeks after completion of Harvoni. Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation. eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \[if female\] × 1.08 \[if black\]
Time frame: 24 weeks
Number of Participants With ≥25% Reduction in Proteinuria
Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni.
Time frame: 24 weeks
Mean Time in Weeks to Maximum Reduction in Proteinuria
This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria.
Time frame: 52 weeks
Median Change in eGFR From Baseline to Timepoint Week 52
Median change from baseline (timepoint week 0) to timepoint week 52, which was 40 weeks after completion of Harvoni. Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation. eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \[if female\] × 1.08 \[if black\]
Time frame: 52 weeks
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Change in Urinary β-2microglobulin Levels Before Therapy
Change in urinary β-2microglobulin levels before therapy with ledipasvir/sofosbuvir fixed dose combination pill. β-2microglobulin (mcg/L) change prior to initiating HCV-treatment. This outcome was not assessed.
Time frame: 24 weeks
Change in Urinary β-2microglobulin Levels After Therapy
Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill β-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR.
Time frame: 24 weeks