Table 2.

Safety and Tolerability

Event	Without Cirrhosis	With Cirrhosis
	8 wk	12 wk
	(n = 137)	(n = 16)
Any AE	86 (63)	8 (50)
Grade 1 (mild)	52 (60)	3 (38)
Serious AE	3 (2)a	1 (6)b
DAA-related serious AE	0	0
AE leading to discontinuation	0	1 (6)b
AEs occurring in ≥5% of overall patients
Fatigue	18 (13)	0
Nausea	12 (9)	1 (6)
Headache	12 (9)	0
Nasopharyngitis	12 (9)	0
Laboratory abnormalities
ALT, grade ≥3 (>5 × ULN)	0	0
AST, grade ≥3 (>5 × ULN)	0	0
Total bilirubin, grade ≥3 (>3 × ULN)	1 (0.7)	0

Data are given as no. (%).

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DAA, direct-acting antiviral; ULN, upper limit of normal.

^aUpper gastrointestinal hemorrhage, obliterating arteriopathy, and urolithiasis in 1 patient each, all unrelated to glecaprevir/pibrentasvir.

^bCerebrovascular accident and cerebral hemorrhage, both unrelated to glecaprevir/pibrentasvir.