Table 3.
Safety outcomes by baseline renal function
| Safety outcome | All patients, N = 1789 | eGFR ≤45, N = 73 | eGFR >45, N = 1716 | P-value |
|---|---|---|---|---|
| Early treatment discontinuation, n (%) | 79(4) | 5 (7) | 74 (4) | 0.25 |
| Early treatment discontinuation because of AE, n (%) | 46 (3) | 3 (4) | 43 (3) | 0.43 |
| Common AEs, n (%) | ||||
| Fatigue | 621 (35) | 22 (30) | 599 (35) | 0.40 |
| Headache | 303 (17) | 10(14) | 293 (17) | 0.45 |
| Nausea | 291 (16) | 11 (15) | 280(16) | 0.78 |
| Anaemia AE, n (%) | 295 (16) | 22 (30) | 273 (16) | 0.001 |
| Required transfusion(s) | 41 (2) | 7(10) | 34 (2) | 0.001 |
| Erythropoietin stimulating drugs | 73 (4) | 9(12) | 64 (4) | 0.002 |
| started on treatment, n (%) | ||||
| Reduction in RBV due to anaemia*, n/N (%) | 229/1071 (21) | 11/34 (32) | 218/1071 (21) | 0.11 |
| RBV discontinuation*, n/N(%) | 17/1071 (2) | 4/34 (12) | 13/1037(1) | 0.002 |
| Worsening renal function †n(%) | 29 (2) | 11 (15) | 18(1) | <0.001 |
| Any serious AEs, n (%) | 124 (7) | 16 (22) | 108(6) | <0.001 |
| Cardiac serious AEs, n (%) | 64 (4) | 3(4) | 61 (4) | 0.74 |
| Death, n (%) | 13(1) | 1 (1)‡ | 12(1) | 0.42 |
*
Among patients treated with RBV.
†
Outcome abstracted from HCV TARGET database as reported by investigators; includes test terms of acute kidney failure, acute kidney injury, renal failure acute, renal insufficiency, renal failure, azotemia, azotaemia, acute renal failure, acute renal failure, anuric renal failure and impaired renal function.
‡
eGFR ≤45 patient that died: Liver transplant recipient with baseline MELD of 26 who died from worsening renal failure and hepatic decompensation.
AE, adverse event; HCV, hepatitis C virus; RBV, ribavirin.
Bold text signifies statistically significant differences.