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.

Table 2 Sustained virological response by genotype and treatment regimen

Treatment regimen	Patients in each	SVR
Genotype 1
SMV and SOF	149 (41.2)	139 (93.3)
SMV and DCV	7 (1.9)	7 (100)
SOF and DCV	15 (4.1)	15 (100)
OMV, PTV/r, and DSV	91 (25.1)	86 (94.5)
SOF and LDV	100 (27.6)	95 (95.0)
Total	362 (100)	342 (94.5)
Genotype 2
SOF and DCV	5 (45.5)	5 (100)
SOF	5 (45.5)	5 (100)
SOF and LDV	1 (9.1)	1 (100)
Total	11 (100)	11 (100)
Genotype 3
SOF and DCV	37 (82.2)	34 (91.9)
SOF	5 (11.1)	5 (100)
SOF and LDV	3 (6.7)	3 (100)
Total	45 (100)	42 (93.3)
Genotype 4
SMV and SOF	19 (43.2)	18 (94.7)
SOF	1 (2.3)	1 (100)
OMV and PTV/r	13 (29.5)	12 (92.3)
SOF and LDV	11 (25.0)	11 (100)
Total	44 (100)	42 (95.5)

SVR: Sustained virological response; SMV: Simeprevir; SOF: Sofosbuvir; DCV: Daclatasvir; LDV: Ledipasvir; OMV: Ombitasvir; PTV/r: Paritraprevir/ritonavir; DSV: Dasabuvir.

Table 3 Safety profile n (%)

Patients	n = 462
Severe AEs
Any AE1	11 (2.4)
AEs	321 (69.5)
Fatigue	104 (22.5)
Headache	55 (11.7)
Anemia	52 (11.3)
Insomnia	23 (5.0)
Infection	20 (4.3)
Arthralgia, myalgia	19 (4.1)
Dyspepsia	15 (3.2)
Rash	14 (3.0)
Deaths	0 (0.0)

¹Adverse events (AEs) occurring during treatment or follow-up in ≥ 3% patients.