Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

Table 7 Safety of antiviral therapy in six-time intervals

Parameter	2015-2016	2017	2018	2019	2020	2021
Number of patients	1199	827	573	438	199	341
Treatment course, n (%)
According to schedule	1073 (89.5)	776 (93.8)	538 (93.9)	428 (97.7)	196 (98.5)	334 (97.9)
Therapy modification	71 (5.9)	21 (2.6)	26 (4.5)	2 (0.5)	0	0
Therapy discontinuation	44 (3.7)	19 (2.3)	9 (1.6)	5 (1.1)	1 (0.5)	6 (1.8)
No data	11 (0.9)	11 (1.3)	0	3 (0.7)	2 (1.0)	1 (0.3)
Patients with at least one AE, n (%)	500 (41.7)	212 (25.6)	139 (24.3)	80 (18.3)	36 (18.1)	66 (19.4)
Serious adverse events, n (%)	48 (4)	11 (1.3)	16 (2.8)	7 (1.6)	4 (2)	3 (0.9)
AEs leading to treatment discontinuation, n (%)	35 (2.9)	16 (1.9)	4 (0.7)	2 (0.5)	1 (0.5)	1 (0.3)
Most common AEs (≥ 2%), n (%)
Weakness/fatigue	242 (20.2)	78 (9.4)	59 (10.3)	28 (6.4)	13 (6.5)	16 (4.7)
Anemia	63 (5.3)	36 (4.4)	17 (3)	2 (0.5)	0	2 (0.6)
Sleep disorders	52 (4.3)	20 (2.4)	20 (3.5)	4 (0.9)	6 (3)	6 (1.8)
Nausea	32 (2.7)	14 (1.7)	3 (0.5)	1 (0.2)	5 (2.5)	6 (1.8)
Abdominal pain	21 (1.8)	7 (0.8)	4 (0.7)	12 (2.7)	5 (2.5)	8 (2.3)
Headaches	50 (4.2)	14 (1.7)	11 (1.9)	7 (1.2)	3 (0.5)	8 (2.3)
Myalgia/arthralgia	18 (1.5)	18 (2.2)	9 (1.6)	6 (1.4)	6 (3)	8 (2.3)
Pruritis	71 (5.9)	19 (2.3)	10 (1.7)	10 (2.3)	7 (3.5)	7 (2.1)
Skin lesions	26 (2.2)	14 (1.7)	7 (1.2)	5 (1.1)	2 (1)	4 (1.2)
Bilirubin, > ULN	44 (3.7)	30 (3.6)	3 (0.5)	3 (0.7)	0	0
AEs of particular interest
Ascites	30 (2.5)	23 (2.8)	12 (2.1)	6 (1.4)	0	13 (3.8)
Hepatic encephalopathy	28 (2.3)	12 (1.5)	6 (1.0)	2 (0.5)	1 (0.5)	6 (1.8)
Gastrointestinal bleeding	9 (0.8)	4 (0.5)	5 (0.9)	1 (0.2)	1 (0.5)	0
Death, n (%)	13 (1.1)	10 (1.2)	10 (1.7)	3 (0.7)	2 (1.0)	7 (2.1)

AE: Adverse event; ULN: Upper limit of normal.