Real-world effectiveness and safety of direct-acting antivirals in hepatitis C virus patients with mental disorders

Table 5 Safety of direct-acting antiviral treatment in chronic hepatitis C patients with (group A) and without (group B) psychiatric disorders, %, n

Parameter	All patients (n = 14272)	Group A (n = 942)	Group B (n = 13330)	P value
Treatment course
According to schedule	97.5 (13848)	96.8 (907)	97.6 (12941)	0.164 (χ2 = 1.9)
Therapy discontinuation	1.1 (157)	1.4 (13)	1.1 (144)	0.394 (χ2 = 0.7)
Therapy modification	1.4 (194)	1.8 (17)	1.3 (177)	0.222 (χ2 = 1.5)
No data	0.5 (73)	0.5 (5)	0.5 (68)	0.813
Death	0.5 (71)	0.4 (4)	0.5 (67)	1.0
SAE	1.0 (145)	1.6 (15)	0.97 (130)	0.068 (χ2 = 3.3)
Psychiatric complications
New incidence of depression	0.1 (8)	0.2 (2)	0.05 (6)	0.093
New incidence of schizophrenia	0.0 (1)	0.0 (0)	0.0 (1)	1.0
New incidence of sleep disorders	1.8 (262)	3.3 (31)	1.7 (231)	0.001 (χ2 = 10.4)
New incidence of anxiety	0.0 (1)	0.1 (1)	0.0 (0)	1.0
Drinking binge	0.0 (1)	0.1 (1)	0.0 (0)	1.0
Exacerbation of psychiatric disease		0.6 (6)
Depression		0.5 (5)
Schizophrenia		0.1 (1)

The reported P value relates to Pearson’s chi-square test or Fisher’s exact test if the number of observations in the category was less than 10. SAEs: Serious adverse events.