Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

Table 2 Baseline characteristics of cases and controls

	Categorical: n (%)			P value1
	Continuous: median (IQR)
	Total	Case (n = 13)	Controls (n = 29)
Demographics and clinical characteristics
Age (yr)	60 (56-65)	64 (56-68)	60 (57-64)	0.97
Gender, female	14 (33)	6 (46)	8 (28)	0.15
Race, black	4 (9)	1 (7)	3 (10)	1.00
Ethnicity, Hispanic	9 (21)	1 (7)	8 (28)	0.23
Weight (lbs)	163 (146-182)	155 (122-168)	170 (147-193)	0.04
BMI (kg/m2)	26.4 (22.6-28.7)	25.6 (21.6-27.8)	26.7 (24.6-29.0)	0.12
Years since Transplant	5.4 (2.1–8.8)	4.98 (1.7-7.5)	5.6 (2.7-8.8)	0.52
Comorbidities
Hepatocellular Carcinoma	16 (38)	5 (38)	11 (38)	1.00
Diabetes	21 (50)	6 (46)	15 (52)	1.00
Hypertension	27 (64)	9 (69)	18 (62)	0.74
Depression	5 (12)	1 (8)	4 (14)	1.00
Liver disease severity
Cirrhosis	8 (19)	3 (23)	5 (17)	0.69
FIB-4	4.81 (3.00-7.02)	6.57 (3.12-8.94)	4.49 (2.78-6.71)	0.24
FIB-4, ≥ 3.25	28 (67)	9 (69)	19 (65)	1.00
Treatment naïve	9 (21)	3 (23)	6 (21)	1.00
Treatment Regimen
SOF/RBV	38 (90)	12 (92)	26 (90)	1.00
SOF/PEG/RBV	4 (10)	1 (8)	3 (10)	1.00
Genotype
1	31 (74)	8 (62)	23 (79)	0.27
2	3 (7)	2 (15)	1 (3)	0.22
3	5 (12)	2 (15)	3 (10)	0.64
4	2 (5)	1 (8)	1 (3)	0.53
Labs
Hemoglobin (g/dL) (Ref: 13.9-16.3 g/dL)	12.7 (10.8-14.2)	11.3 (9.6-12.4)	12.9 (12.2-14.5)	0.01
Platelets (× 103/μL) (Ref: 150-450 × 103/μL)	117 (82-148)	113 (85-138)	121 (81-150)	0.21
HCV viral load (log10) (IU/mL) (Ref: 15-108 IU/mL)	6.53 (6.27-6.72)	6.59 (6.07-6.70)	6.53 (6.32-6.76)	0.81
Serum creatinine (mg/dL) (Ref: 0.70-1.40 mg/dL)	1.44 (1.10-1.72)	1.60 (1.33-1.86)	1.23 (1.04-1.60)	0.06
eGFR (mL/min per 1.73 m2 Albumin, g/dL) (Ref: 3.5-4.9 g/dL)	49 (41-67)	42 (32-49)	56 (44-70)	0.01
	3.8 (3.5-4.1)	3.6 (2.9-3.9)	3.8 (3.6-4.1)	0.23
ALT (U/L) (Ref: 1-53 U/L)	59 (39-82)	43 (33-72)	65 (42-89)	0.15
AST (U/L) (Ref: 1-50 U/L)	62 (49-92)	61 (53-77)	64 (41-93)	0.95
INR	1.0 (1.0-1.2)	1.0 (0.9-1.3)	1.0 (1.0-1.1)	0.852
Total bilirubin (mg/dL) (Ref: 0.1-1.2 mg/dL)	0.7 (0.5-1.1)	0.8 (0.6-2.2)	0.7 (0.5-1.0)	0.10
Alpha fetoprotein (ng/mL) (Ref: 0.0-9.0 ng/mL)	5.0 (3.1-9.2)	5.0 (3.5-12.1)	5.0 (3.0-8.2)	0.40

¹Student t test unless noted otherwise;

²Mann-Whitney. BMI: Body mass index; SOF: Sofosbuvir; RBV: Ribavirin; PEG: Pegylated interferon; eGFR: Estimated glomerular filtration rate; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; INR: International normalized ratio.