Sex-related differences in patients with chronic hepatitis C infection treated with direct-acting antiviral drugs

Table 4 Safety and characteristics of current therapy in women and men depending on age, n (%)

Parameter	Women 15-44 years, n = 3118	Men 15-44 years, n = 4163	P value	Women 45-55 years, n = 1689	Men 45-55 years, n = 2185	P value	Women > 55 years, n = 4650	Men > 55 years, n = 3181	P value
Treatment course			> 0.99			0.078			0.036
According to schedule	3076 (98.65)	4100 (98.49)		1657 (98.11)	2145 (98.17)		4484 (96.43)	3070 (96.51)
Therapy modification	17 (0.55)	33 (0.79)		23 (1.36)	16 (0.73)		102 (2.19)	48 (1.51)
Therapy discontinuation	25 (0.8)	30 (0.72)		9 (0.53)	24 (1.1)		64 (1.38)	63 (1.98)
Patients with at least one AE	457 (14.66)	491 (11.79)	0.001	319 (18.9)	332 (15.19)	0.007	918 (19.74)	544 (17.1)	0.009
Most common AEs (≥ 2%)
Weakness/fatigue	187 (6)	178 (4.28)	0.005	140 (8.29)	143 (6.54)	0.24	349 (7.51)	232 (7.29)	> 0.99
Headache	113 (3.63)	69 (1.66)	< 0.001	55 (3.26)	33 (1.51)	0.0018	118 (2.54)	47 (1.48)	0.0078
Severe AEs1	7 (0.22)	17 (0.41)	0.66	11 (0.65)	19 (0.87)	> 0.99	71 (1.53)	57 (1.79)	> 0.99
AEs of special interest (cirrhotics)
Ascites	8 (0.26)	12 (0.29)	> 0.99	7 (0.41)	19 (0.87)	> 0.99	35 (0.75)	48 (1.51)	0.009
Hepatic encephalopathy	2 (0.06)	9 (0.22)	> 0.99	6 (0.36)	12 (0.55)	> 0.99	17 (0.37)	34 (1.07)	0.001
Gastrointestinal bleeding	1 (0.03)	8 (0.19)	0.79	2 (0.12)	5 (0.23)	> 0.99	8 (0.17)	7 (0.22)	> 0.99
Death	1 (0.03)	10 (0.24)	0.09	6 (0.36)	11 (0.5)	> 0.99	31 (0.67)	54 (1.7)	0.00002

¹Serious adverse events include 5 patients who underwent liver transplantation during direct-acting antiviral treatment or in the 12-week follow-up period.

Two women, 67 years and 53 years and one man, 67 years, due to hepatocellular carcinoma diagnosed before treatment initiation. One man, 32 years, due to decompensation of liver cirrhosis (present before treatment). All four patients underwent the liver transplant in the 12-week follow-up period after the end of treatment. In one female, 38 years, liver transplantation was carried out during therapy after treatment discontinuation. Regardless, all patients achieved sustained virological response.

AE: Adverse event.