Table 3.

Safety outcomes for patients with cirrhosis undergoing PI^* triple therapy

Safety outcome	Compensated Cirrhosis, CP = 5 (n = 85)	Decompensated Cirrhosis, CP ≥6 (n = 75)	P-value
RBV dose reduction, no. (%)	58 (68)	52 (69)	0.88
RBV minimum dose, mg/day, median (IQR)	600 (600–1000)	600 (200–1000)	0.05
Peg-IFN dose reduction, no. (%)	21 (25)	41 (55)	<0.0001
Peg-IFN minimum dose, µg/week, median†	180 (158–180)	135 (90–180)	<0.0001
Growth factor use, no. (%)
Epotein-alfa	48 (56)	47 (63)	0.43
Granulocyte colony-stimulating factor	23 (27)	28 (37)	0.16
Eltrombopag	2 (2)	19 (25)	<0.0001
Received transfusion(s) during treatment, no. (%)	7 (8)	18 (24)	0.006
Adverse event requiring hospitalisation, no. (%)	10 (12)	18 (24)	0.04
Early treatment discontinuation, no. (%)	32 (38)	34 (45)	0.32
Early treatment discontinuation due to adverse event, no. (%)‡	12 (14)	19 (25)	0.07
Early treatment discontinuation due to virological failure, no. (%)	20 (24)	15 (20)	0.94
Futility rule	14 (16)	8 (11)	0.52
Breakthrough	6 (7)	7 (9)	0.48
MELD increase ≥2 upon early treatment discontinuation, no. (%)§	2 (13)	11 (52)	0.02

CP, Child-Pugh; IQR, interquartile range; MELD, model for end-stage liver disease; peg-IFN, peginterferon; RBV, ribavirin.

^*Telaprevir or boceprevir.

^†Among those receiving peg-IFN a2a.

^‡List of adverse events leading to treatment discontinuation is presented in Table S2.

^§Early treatment discontinuation due to either adverse event or virological failure; analysis excluded one site where MELD score upon early treatment discontinuation was unavailable.