Table 7.

Safety during 24 wk of daclatasvir plus asunaprevir treatment in either arm n (%)

Parameter	Immediate treatment, n = 155	Placebo-deferred treatment, n = 511	Overall, n = 206
AEs leading to discontinuation	1 (1)2	1 (2)3	2 (1)
Serious AEs	7 (5)45	1 (2)3	8 (4)
Deaths	0 (0)	1 (2)3	1 (< 1)
AEs (any grade), ≥ 5%
ALT elevation	17 (11)	5 (10)	22 (11)
Upper respiratory tract infection	13(8)	8(16)	21(10)
Hypertension	11 (7)	6 (12)	17 (8)
AST elevation	13 (8)	3 (6)	16 (8)
INR elevation6	11 (7)	2 (4)	13 (6)
Blood bilirubin elevation	12 (8)	0 (0)	12 (6)
Fatigue	5 (3)	6 (12)	11 (5)
On-treatment grade 3-4 laboratory abnormalities
ALT	7 (5)2	2 (4)7	9 (4)
AST	5 (3)2	1 (2)7	6 (3)
Total bilirubin	1 (1)	0 (0)	1 (< 1)
Hemoglobin	3 (2)	0 (0)	3 (1)
Platelets	1 (1)	0 (0)	1 (< 1)
Absolute lymphocyte count	0 (0)	1 (2)	1 (< 1)
Absolute neutrophil count	1 (1)	0 (0)	1 (< 1)
Lipase	3 (2)	0 (0)	3 (1)

¹Excludes the patient who discontinued during the double-blind phase;

²Jaundice and nausea, which followed concomitant but reversible treatment-related ALT, AST and total bilirubin elevations (patient met the biochemical criteria for Hy’s law; aminotransferases, jaundice and nausea resolved off-treatment and patient achieved SVR12);

³Fatality (stab wound) unrelated to treatment;

⁴Treatment related: Study drug overdose (n = 2);

⁵Unrelated to treatment: Ventricular extrasystoles (n = 1), acute cholecystitis (n = 1), intervertebral disc protrusion (n = 1), retinal detachment (n = 1) and appendicitis (n = 1); ⁶No grade 3-4 INR laboratory abnormalities were observed;

⁷One patient experienced vomiting, decreased appetite and myalgia (all resolved), plus grade 3 ALT and AST abnormalities (both reversible), and interrupted DUAL treatment for 2 d (patient achieved SVR12). AE: Adverse event; ALT: Alanine transaminase; AST: Aspartate transaminase; INR: International normalized ratio.