ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: TH-PO1131

Effect of Ledipasvir and Sofosbuvir (LDV/SOF) on Kidney Function and Urinary Biomarkers in Patients (Pts) with Proteinuric CKD

Session Information

Category: CKD (Non-Dialysis)

  • 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Sise, Meghan E., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Chute, Donald F., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Gustafson, Jenna L., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Waikar, Sushrut S., Harvard Medical School, Boston, Massachusetts, United States
  • Chung, Raymond T., Massachusetts General Hospital, Boston, Massachusetts, United States
Background

HCV infection is associated with CKD incidence and progression. HCV may lead to immune-complex mediated glomerulonephritis, however HCV also promotes atherosclerosis, insulin resistance and chronic inflammation. We sought to determine whether HCV treatment improves kidney function, as assessed by biomarkers of kidney disease.

Methods

NCT02503735 was an investigator-initiated pilot trial that used SOF/LDV to treat pts with HCV genotype 1 or 4 and proteinuria (>300mg proteinuria/g Cr). Baseline proteinuria, cystatin-c, and creatinine were compared to on treatment values and post-therapy values. Insulin resistance (IR) was calculated by HOMA-IR. Urine biomarkers were measured by Luminex. The primary outcome was change in natural log proteinuria-to-creatinine (UPC) ratio from baseline to 12-weeks post SOF/LDV compared by paired t-test.

Results

10 pts began 12-weeks of LDV/SOF mean age 64 (SD 10), 70% male, 60% White, 30% Black, 10% Native American. 4/10 had cirrhosis. 8/10 were cured of HCV, 2 relapsed. Baseline eGFR was 63.2 mL/min/1.73m2 (SD 26.2), baseline proteinuria was 1.05g/g (SD 0.95). Baseline to post-treatment values are in Table 1. Non-diabetic pts cured of HCV (pts 1-4) all had improvement in proteinuria: 1.8g/g, (SD 1.6) to 0.69g/g (SD 0.7g/g) (p=0.01). Diabetic pts and pts with HCV relapse had worsening proteinuria 0.77g/g, (SD 0.3) to 2.2g/g (SD 1.4) (p=0.05). Complement and cryoglobulins normalized in the majority, IR decreased slightly.

Conclusion

Non-diabetic pts with HCV-associated CKD had substantial improvement in proteinuria when HCV was eradicated with SOF/LDV.

PtViral OutcomeDiabetesBaselineFollow-Up 12 Weeks After SOF/LDV
CreatinineCystatin CProteinuria UPC RatioCryocritLow C4CRPHoma-IRCreatinineCystatin CProteinuria UPC RatioCryocritLow C4CRPHoma-IR
1CuredNo1.001.433.564%Yes1.74.30.931.371.78NoneNo11.83.7
2CuredNo1.352.140.501%Yes164.71.452.110.122%Yes9.22.5
3CuredNo0.780.801.443%Yes0.91.70.790.760.761%No5.01.9
4CuredNo1.301.020.39NoneNo0.13.61.661.030.11NoneNo0.65.4
5CuredYes1.221.090.84NoneNo0.36.71.230.872.18NoneNo0.59.3
6CuredYes1.030.641.133%Yes1.519.80.700.561.00NoneNo1.917.2
7CuredYes1.532.421.151%No0.55.51.912.752.01NoneNo4.13.7
8CuredYes1.682.000.682%No0.22.22.022.144.36NoneNo0.11.2
9RelapsedNo1.421.840.312%No32.81.481.630.35NDNo9.12.4
10RelapsedNo0.770.670.53NoneNo0.34.80.690.712.18NoneNo0.46.7

Abbreviations: Pt = patient, UPC = urine protein to creatinine, CRP = c-reactive protein, HOMA-IR = homeostatic model assessment of insulin resistance

Funding

  • Commercial Support