Table 1.
Demographics, clinical characteristics and follow-up of patients with severe renal insufficiency or ESRD treated with sofosbuvir-based regimens
| 1 | 2 | 3 | 4 | 5 | 6 | |
|---|---|---|---|---|---|---|
| Age/gender | 78 M | 61 M | 56 F | 69 M | 58 M | 37 M |
| Race | White | White | White | White | Black | White |
| Pre-treatment serum HCV Viral load (IU/mL) | 3200000 | 9640000 | 2780000 | 330000 | 4770000 | 79600 |
| HCV genotype | 1a | 1a | 1b | 1 non-subtypeable | 1a | 1 non-subtypeable |
| Duration of HCV infection (years) | 30 | 28 | 30 | 35 | 25 | 35 |
| Cirrhosis | Yes | No | Yes | Yes | No | No |
| Prior transplantation | No | No | Liver for HCC | No | Kidney, failed | No |
| Prior antiviral therapy | None | Peg-IFN/RBV discontinued early due to anemia | Peg-IFN/RBV relapse | None | Standard IFN monotherapy relapse | None |
| Baseline seum Cr (mg/dL) | 2.34 | 2.3 | 1.8 | 2.47 | HD | HD |
| Baseline eGFR (mL/min) | 27 | 29 | 29 | 26 | HD | HD |
| Baseline Hgb (g/dL) | 12.9 | 11.4 | 9.5 | 12.1 | 10.8 | 12.5 |
| Cause of renal disease | Unknown | Diabetes | Unknown | Cryoglobulinemic MPGN | Diabetes s/p transplant with graft failure | Autosomal Recessive Polycystic Kidney Disease |
| Antiviral regimen | Sofosbuvir 400 mg daily + Simeprevir 150 mg daily | Sofosbuvir 400 mg daily + Ribavirin 600 mg twice daily + PEG-IFN 180 mcg SC weekly | Sofosbuvir 400 mg daily + Ribavirin 200 mg twice daily | Sofosbuvir 400 mg daily + Simeprevir 150 mg daily | Sofosbuvir 400 mg daily + Simeprevir 150 mg daily | Sofosbuvir 400 mg daily + Ribavirin 200 mg twice daily |
| Ribavirin dose reduction during treatment | N/A | Yes, to 400 mg twice daily | Yes, to 200 mg daily | N/A | N/A | No |
| Treatment duration (weeks) | 12 | 12, stopped 4 days early due to anemia and leukopenia | 24 | 12 | 12 | 24 |
| Treatment Indication | Advanced cirrhosis with prior HCC | Potential future renal transplant | HCV recurrence in transplanted liver | Cryoglobulinemic MPGN | Listing for renal transplant | Listing for renal transplant |
| SVR12 | Yes | Yes | No | No | Yes | Yes |
| Nadir serum Cr on treatment (mg/dL) | 2.22 | 2.4 | 3.09 | 2.53 | HD | HD |
| Nadir eGFR on treatment (mL/min) | 31 | 28 | 16 | 25 | HD | HD |
| Serum Cr at SVR12 (mg/dL) | 1.78 | 2.3 | 1.05 | 2.50 | HD | HD |
| eGFR at SVR12 (mL/min) | 39 | 29 | 54 | 26 | HD | HD |
| Nadir Hgb on treatment (g/dL) | 13.1 | 6.7 | 8.4 | 11.1 | Unknown | 9.3 |
| Hgb at SVR12 (g/dL) | 13.5 | 10.2 | 9.2 | 12.1 | Unknown | 11.9 |
| Use of ESAs | None | Epoetin increased from monthly pre-treatment to weekly during antiviral treatment | Stable weekly epoetin dose before and during antiviral treatment | None | None | Stable epoetin dose before and during antiviral treatment |
| Adverse effects | None | 1. Anemia (requiring epoetin and RBC transfusions) 2. Leukopenia (requiring filgrastim) |
1. AKI: lupus-like immune complex disease and tubulointerstitial nephritis on renal biopsy specimen. Treated with prednisone and MMF with improvement. 2. Anemia (mild) |
None | None | Anemia |
Legend: AKI = acute kidney injury, Cr = creatinine, eGFR = estimated glomerular filtration rate, ESA = erythropoietin stimulating agent, HCC = hepatocellular carcinoma, HCV = hepatitis C virus, HD = hemodialysis, Hgb = hemoglobin, IFN = interferon, IU = international units, MMF = mycophenolate mofitil, MPGN = membranoproliferative glomerulonephritis, N/A = not applicable, Peg-IFN = pegylated interferon, PO = by mouth, RBC = red blood cell, s/p = status post, SVR12 = sustained virologic response at 12 weeks post-treatment