Real-world treatment of hepatitis C with second-generation direct-acting antivirals: initial results from a multicentre Canadian retrospective cohort of diverse patients

Alex I. Aspinall; Abdel A. Shaheen; Golasa S. Kochaksaraei; Breean Haslam; Samuel S. Lee; Gisela Macphail; Jeff Kapler; Oscar E. Larios; Kelly W. Burak; Mark G. Swain; Meredith A. Borman; Carla S. Coffin

doi:10.9778/cmajo.20170059

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Figure 1
Flow diagram showing patients with data available for analysis. Note: HCV = hepatitis C virus, SVR = sustained viral response.

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Table 1: Demographic, clinical and laboratory characteristics of patients infected with hepatitis C virus according to SVR status

Characteristic	No. (%) of patients*		p value
Characteristic	Achieved SVR n = 326	Did not achieve SVR n = 25	p value
Age at treatment, median (IQR), yr	57 (50-61)	60 (56-64)	0.02
Sex
Male (n = 216)	195 (90.3)	21 (9.7)	0.02
Female (n = 135)	131 (97.0)	4 (3.0)
Had previous treatment (n = 99)	91 (91.9)	8 (8.1)	0.6
Genotype (n = 350)†
1a (n = 206)	193 (93.7)	13 (6.3)	0.5
1b (n = 59)	57 (96.6)	2 (3.4)	0.3
2 (n = 25)	22 (88.0)	3 (12.0)	0.4
3 (n = 51)	44 (86.3)	7 (13.7)	0.1
4 and 6 (n = 9)	9 (100.0)	0 (0.0)	1.0
FibroScan measurement at baseline, median (IQR), kPa	10.2 (6.7-20.4)	12.5 (7.6-26.3)	0.1
HCV RNA level at baseline, median (IQR), IU/mL	701 684 (158 376-1 677 684)	500 000 (94 082-1 500 000)	0.5
Chronic kidney disease at baseline (n = 16)	16 (100.0)	0 (0.0)	0.6
Estimated glomerular filtration rate at baseline, median (IQR), mL/min	94 (81-101)	96 (83-99)	0.6
Coinfection with HIV (n = 12)	12 (100.0)	0 (0.0)	1.0
Coinfection with HBV (n = 1)	1 (100.0)	0 (0.0)	1.0
Cirrhosis at baseline (n = 350)
Yes (n = 149)	133 (89.3)	16 (10.7)	0.03
No (n = 201)	192 (95.5)	9 (4.5)
Previous history of hepatocellular carcinoma (n = 20)	16 (80.0)	4 (20.0)	0.04
Liver transplantation (n = 9)	9 (100.0)	0 (0.0)	1.0
Site
1 (n = 11)	11 (100.0)	0 (0.0)
2 (n = 40)	37 (92.5)	3 (7.5)	0.7
3 (n = 110)	100 (90.9)	10 (9.1)
4 (n = 190)	178 (93.7)	12 (6.3)
Died during follow-up (n = 6)	3 (50.0)	3 (50.0)	< 0.01
Development of hepatocellular carcinoma during follow-up (n = 12)	11 (91.7)	1 (8.3)	0.6
MELD score, median (IQR)	6 (6-6)	6 (6-6)	1.0
MELD with sodium score, median (IQR)	7 (5-8)	6 (5-8)	0.9

Note: HBV = hepatitis B virus, HCV = hepatitis C virus, IQR = interquartile range, MELD = model for end-stage liver disease, SVR = sustained viral response.

*Except where noted otherwise.

†One patient was treated without an identified genotype and achieved an SVR.

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Table 2: Sustained viral response status by genotype and treatment regimen

Regimen	No. (%) of patients		p value
Regimen	Achieved SVR n = 326	Did not achieve SVR n = 25	p value
Genotype 1a (n = 206)	193 (93.7)	13 (6.3)	0.5
Sofosbuvir-ledipasvir (n = 158)	147 (93.0)	11 (7.0)
Sofosbuvir-ledipasvir + ribavirin (n = 13)	12 (92.3)	1 (7.7)
Simeprevir-sofosbuvir (n = 17)	17 (100.0)	0 (0.0)	0.8
Pegylated interferon + direct-acting antiviral (n = 13)	12 (92.3)	1 (7.7)
Ombitasvir-paritaprevir-ritonavir and dasabuvir ± ribavirin (n = 5)	5 (100.0)	0 (0.0)
Genotype 1b (n = 59)	57 (96.6)	2 (3.4)	0.2
Sofosbuvir-ledipasvir (n = 48)	46 (95.8)	2 (4.2)
Sofosbuvir-ledipasvir + ribavirin (n = 1)	1 (100.0)	0 (0.0)
Simeprevir-sofosbuvir (n = 2)	2 (100.0)	0 (0.0)	1.0
Pegylated interferon + direct-acting antiviral (n = 3)	3 (100.0)	0 (0.0)
Ombitasvir-paritaprevir-ritonavir and dasabuvir ± ribavirin (n = 5)	5 (100.0)	0 (0.0)
Genotype 2 (n = 25)	22 (88.0)	3 (12.0)	0.4
Sofosbuvir + ribavirin (n = 23)	20 (87.0)	3 (13.0)
Pegylated interferon + direct-acting antiviral (n = 2)	2 (100.0)	0 (0.0)
Genotype 3 (n = 51)	44 (86.3)	7 (13.7)	0.1
Sofosbuvir-ledipasvir + ribavirin (n = 1)	1 (100.0)	0
Sofosbuvir + ribavirin (n = 45)	38 (84.4)	7 (15.6)
Pegylated interferon + direct-acting antiviral (n = 5)	5 (100.0)	0 (0.0)
Other (n = 9)	9 (100.0)	0 (0.0)	1.0
Sofosbuvir-ledipasvir (n = 4)	4 (100.0)	0 (0.0)
Sofosbuvir-ledipasvir + ribavirin (n = 1)	1 (100.0)	0 (0.0)
Sofosbuvir + ribavirin (n = 2)	2 (100.0)	0 (0.0)	1.0
Pegylated interferon + direct-acting antiviral (n = 1)	1 (100.0)	0 (0.0)
Ombitasvir-paritaprevir-ritonavir and dasabuvir ± ribavirin (n = 1)	1 (100.0)	0 (0.0)

Note: SVR = sustained viral response.

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Table 3: Predictors of achieving an SVR among all patients

Variable	Univariate analysis OR (95% CI)	Multivariate analysis adjusted OR (95% CI)
Age	0.95 (0.90-0.99)	0.95 (0.90-1.00)
Male sex	0.28 (0.10-0.84)	0.30 (0.10-0.89)
Previous treatment	0.82 (0.34-1.97)	-
Genotype 1a	1.34 (0.59-3.03)	-
FibroScan measurement at baseline (per kPa)	0.99 (0.97-1.02)	-
Viremia (per 1000 IU)	1.00 (0.99-1.02)	-
Cirrhosis at baseline	0.39 (0.17-0.91)	0.56 (0.23-1.36)
Treated according to guidelines	1.09 (0.36-3.32)	-
Previous history of hepatocellular carcinoma	0.27 (0.08-0.88)	0.37 (0.11-1.28)
MELD score at baseline	1.76 (0.35-8.97)	-
MELD with sodium score at baseline	1.01 (0.78-1.31)	-