Table 3.

Safety Outcomes in Patients Treated with Simeprevir Plus Sofosbuvir

Safety Outcome	CP Class B/C (n = 55)	CP Class A (n = 101)	p-value
CP score change from baseline to end of treatment, median (range)	0 (−2–5)	0 (−1–2)	0.46
MELD score change from baseline to end of treatment, median (range)	0 (−4–7)	0 (−3–8)	0.36
Early treatment discontinuation, no (%)	6 (11)	1 (1)	<0.01
Early treatment discontinuation due to adverse event, no (%)	5 (9)	1 (1)	0.01
Hospitalization due to adverse event, no (%)	12 (22)	2 (2)	<0.01
Infection requiring antibiotics, no (%)	11 (20)	1 (1)	<0.01
Hepatic decompensation, no (%)	11 (20)	3 (3)	<0.01
Death, no (%)	1 (2)*	1 (1)§	0.66

^*liver-related death

^§not liver-related death

CP = Child-Pugh; Model for End-Stage Liver Disease = MELD