Table 4.

Safety outcomes by baseline renal function in RBV-free regimen (SOF/SMV)

Safety outcome	All patients, N = 718	eGFR ≤45, N = 39	eGFR >45, N = 679	P-value
Early treatment discontinuation, n (%)	37(5)	3 (8)	34(5)	0.45
Early treatment discontinuation because of AE, n (%) Common AEs, n (%)	21 (3)	3 (8)	18 (3)	0.10
Fatigue	76(25)	9 (23)	167(25)	1.00
Headache	112(16)	4(11)	108(16)	0.50
Nausea	92(13)	5(13)	87(13)	1.00
Anaemia AE, n (%)	121 (17)	12(31)	109 (16)	0.03
Required transfusion(s)	9 (1)	3 (8)	6 (1)	0.01
Erythropoietin stimulating drug started on treatment, n (%)	0 (0)	0 (0)	0 (0)	1.00
Worsening renal function*, n (%)	13(2)	4(10)	9 (1)	0.004
Any serious AEs, n (%)	41 (6)	7(18)	34(5)	0.005
Cardiac serious AEs, n (%)	2 (<0.5)	0 (0)	2 (<0.5)	0.73
Death, n (%)	6 (1)	1 (3)†	5 (1)	0.28

^*Outcome abstracted from HCV TARGET database as reported by investigators; includes test terms of acute kidney failure, acute kidney injury, renal insufficiency, renal failure, azotemia, acute renal failure, acute renal failure, anuric renal failure and impaired renal function.

^†The patient with eGFR ≤45 who died was a liver transplant recipient with baseline MELD of 26 who died from worsening renal failure and hepatic decompensation.

Bold text signifies statistically significant differences.

AE, adverse event; HCV, hepatitis C virus; RBV, ribavirin; SMV, simeprevir; SOF, sofosbuvir.