A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection

Table 3 Summary of AEs

	SVR at LPVPS N = 200	No SVR at LPVPS N = 49	Total N = 249
36-month study period
Any AE, n (%)	10 (5.0)	1 (2.0)	11 (4.4)
Worst Grade 1 or 2	2 (1.0)	1 (2.0)	3 (1.2)
Worst Grade 3 or 4	8 (4.0)	0	8 (3.2)
Any SAE, n (%)	10 (5.0)	0	10 (4.0)
SAE at least possibly related to the study drug	0	0	0
Any AE with a fatal outcome, n (%)	3 (1.5)^a	0	3 (1.2)^a
AE for which study procedure was permanently stopped, n (%)	1 (0.5)^b	0	1 (0.4)^b
AE of hepatocellular carcinoma type, n (%)	3 (1.5)	0	3 (1.2)
Patients on disallowed medication ^c	n = 0	n = 8	n = 8
Any AE, n (%)
Worst Grade 1 or 2	0	1 (12.5)	1 (12.5)
Worst Grade 3 or 4	0	1 (12.5)	1 (12.5)
Any SAE, n (%)	0	1 (12.5)	1 (12.5)
SAE at least possibly related to the study drug	0	0	0
Any AE with a fatal outcome, n (%)	0	0	0
AE for which study procedure was permanently stopped, n (%)	0	0	0
AE of hepatocellular carcinoma type, n (%)	0	1 (12.5)	1 (12.5)

AE adverse event, HCV hepatitis C virus, LPVPS last post-therapy follow-up visit of the parent study, SAE serious adverse event, SVR sustained virologic response
^aGrade 4 cholangitis and pancreatic carcinoma, Grade 3 hepatic neoplasm malignant and Grade 4 myocardial infarction
^bGrade 3 hepatic neoplasm malignant
^cAEs reported for patients who started disallowed HCV medication are presented separately from the time this medication was started

ISSN: 1743-422X