Daclatasvir plus asunaprevir in treatment-naïve patients with hepatitis C virus genotype 1b infection

Table 6 Safety during the 12-wk double-blind period n (%)

Parameter	Immediate treatment, n = 155	Placebo-deferred treatment, n = 52
AEs leading to discontinuation	0 (0)	1 (2)1
Serious AEs	5 (3)2	3 (6)13
AEs (any grade), ≥ 5%
ALT elevation	5 (3)	12 (23)
AST elevation	2 (1)	8 (15)
Hypertension	11 (7)	4 (8)
Upper respiratory tract infection	10 (6)	3 (6)
Platelet count decrease	3 (2)	4 (8)
Pyrexia	1 (1)	3 (6)
On-treatment grade 3-4 laboratory abnormalities
ALT	1 (1)	5 (10)
AST	1 (1)	3 (6)
Total bilirubin	1 (1)	0 (0)
Hemoglobin	3 (2)	0 (0)

¹Hepatitis E virus infection and liver injury (n = 1);

²Treatment related: Study drug overdose (n = 2); Unrelated to treatment: Ventricular extrasystoles (n = 1), acute cholecystitis (n = 1) and intervertebral disc protrusion (n = 1);

³ALT elevation (n = 1) and coronary artery disease (n = 1). AE: Adverse event; ALT: Alanine transaminase; AST: Aspartate transaminase.