Steatotic liver disease in patients with chronic hepatitis C

Table 5 Safety of direct-acting antiviral therapy in the steatotic liver disease and non-steatotic liver disease groups, n (%)

Parameter	SLD (n = 290)	Non-SLD (n = 398)	P value
Treatment course			0.0784
According to schedule	279 (96.2)	394 (99)
Therapy modification	2 (0.7)	1 (0.2)
Therapy discontinuation	8 (2.8)	3 (0.8)
No data	1 (0.3)	0
Serious adverse events	20 (6.9)	10 (2.5)	0.0054
Liver-related	9 (45)1	2 (20)2	0.2465
Non-liver-related	11 (55)	8 (80)	0.2465
AEs leading to treatment discontinuation	7 (2.4)	3 (0.8)	0.1049
Patients with at least one AE	46 (15.9)	33 (8.3)	0.0021
Weakness/fatigue	16 (5.5)	12 (3)	0.1010
Anemia	1 (0.3)	3 (0.7)	0.6423
Headache	4 (1.4)	1 (0.2)	0.1670
AEs of particular interest
Ascites	10 (3.4)	1 (0.3)	0.0011
Hepatic encephalopathy	10 (3.4)	3 (0.8)	0.0194
Gastrointestinal bleeding	0	0	NA
Death	11 (3.8)	4 (1.0)	0.0168
Liver-related	5 (81.8)3	2 (50)4	> 0.9999
Non-liver-related	6 (18.2)	2 (50)	> 0.9999

¹Five cases of liver decompensation, one case of drug-induced liver injury after bosentan, one case of liver transplantation during direct-acting antiviral therapy, two cases of hepatocellular carcinoma diagnosed simultaneously with hepatitis C virus infection.

²One case of liver decompensation, one case of hepatocellular carcinoma diagnosed simultaneously with hepatitis C virus infection.

³Three cases of liver decompensation, two cases of hepatocellular carcinoma.

⁴One case of liver decompensation, one case of hepatocellular carcinoma.

SLD: Steatotic liver disease; AE: Adverse event.