Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Table 1 Baseline characteristics of patients receiving direct-acting antiviral agents: Overall patients, patients subgroup clinical trial-met and clinical trial-unmet

Characteristics	Total n = 462	CT-met n = 289	CT-unmet n = 173	P value
Sex, male	311 (67.3)	196 (67.8)	115 (66.5)	0.765
Age, yr	54 (15-87)	53 (30-69)	59 (15-87)	1
BMI, kg/m2, n = 368	26.4 (17.6-47)	26.2 (17.6-47)	26 (18.6-40.6)	0.132
IL28B genotype CC/CT/TT, n = 367	80/231/56	39/153/34	41/78/22	0.021
HCV genotype 1/2/3/4	78.4/2.4/9.7/9.5	76.1/2.1/10.4/11.4	82.1/2.9/8.7/6.4	0.5492
HCV genotype 1a/1b/1	31.2/66.6/2.2	40.1/58.6/2.7	16.2/78.9/1.4	0.0003
Baseline HCV RNA, log10 IU/mL	6.1 (3.0-7.8)	6.5 (4.2-7.6)	6.4 (3.0-7.8)	1
HCV antiviral treatment history				0.233
Naïve	186 (40.0)	112 (38.8)	74 (42.8)
Non-responders	211 (45.7)	131 (45.6)	80 (46.2)
Relapsers	64 (13.9)	46 (15.9)	18 (10.4)
Fibrosis stage, n (%)				0
F0-1	26 (5.6)	21 (7.3)	5 (2.9)
F2	100 (21.6)	83 (28.7)	17 (9.8)
F3	77 (16.7)	59 (20.4)	15 (8.7)
F4	259 (56.1)	126 (43.6)	136 (78.6)
Transient elastography, kPa, n = 435	13.5 (2.8-65)	10.9 (2.8-75)	18.2 (3.5-75)	0
Cirrhosis
No	200 (43.3)	163 (56.4)	37 (21.4)	0
Yes	262 (56.7)	126 (43.6)	136 (78.6)
Child−Pugh Score, n = 209				1
A	180 (86.1)	116 (100)	64 (68.8)
B	22 (10.5)	0 (0.0)	22 (23.7)
C	7 (3.3)	0 (0.0)	7 (7.5)
MELD score, n = 229	8.1 (6–29)	6.9 (6-11)	9.4 (6-29)	1
Hemoglobin level, g/dL,	15.3 (11-19.1)	14.3 (8-19.5)	15 (8-19.5)	1
Platelets, /mm³, n = 446	158666 (23000-457000)	177301 (50000-457000)	124363 (23000-436000)	1
ALT, IU/L, n = 461	81 (64)	71.8 (43.9)	97.6 (79.8)	1
Bilirubin > 1 mg/dL, n = 243	94 (38.7)	19 (15.3)	75 (63.0)	1
Albumin < 3.5 g/dL, n = 239	25 (10.3)	0 (0.0)	25 (21.2)	1
INR	1.1 (0.7-2.9)	1.0 (0.7-1.3)	1.1 (0.9-2.9)	1
Treatment prescribed				0.0244
SMV and SOF	168 (36.4)	90 (31.1)	78 (45.1)
SMV and DCV	7 (1.5)	1 (0.3)	6 (3.5)
SOF and DCV	56 (12.1)	40 (13.8)	17 (9.8)
SOF	11 (2.4)	9 (3.1)	2 (1.2)
OMV and PTV/r	13 (2.8)	10 (3.5)	3 (1.7)
OMV, PTV/r, and DSV	92 (19.9)	60 (20.8)	31 (17.9)
SOF and LDV	115 (24.9)	79 (27.3)	36 (20.8)
+ RBV	198 (42.9)	131 (45.3)	67 (38.7)	165
Treatment duration				0.9735
8 wk	12 (2.6)	9 (3.1)	3 (1.7)
12 wk	407 (88.1)	253 (87.5)	154 (89.0)
24 wk	43 (9.3)	27 (9.3)	16 (9.2)
Treatment at University Hospital	395 (85.5)	259 (89.6)	136 (78.6)	0.001

¹The P value was not calculated because the variable was part of inclusion criteria in the C-met group;

²Genotype 3 vs the rest;

³1a vs 1b;

⁴To calculate the P value the SMV and DCV, SOF and OMV and PTV/r groups were excluded because of a low n;

⁵8 plus 12 wk vs 24 wk. Continuous variables reported as median (range). Categorical variables reported as n and/or %. DDAs: Direct-acting antiviral agents; CT: Clinical trial; BMI: Body mass index; PEG: Pegylated interferon; PIs: Protease inhibitors; ALT: Alanine aminotransferase; SMV: Simeprevir; SOF: Sofosbuvir; DCV: Daclatasvir; LDV: Ledipasvir; OMV: Ombitasvir; PTV/r: Paritraprevir/ritonavir; DSV: Dasabuvir; RBV: Ribavirin.