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Research

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 and Carla S. Coffin
January 05, 2018 6 (1) E12-E18; DOI: https://doi.org/10.9778/cmajo.20170059
Alex I. Aspinall
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Abdel A. Shaheen
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Golasa S. Kochaksaraei
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Breean Haslam
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Samuel S. Lee
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Gisela Macphail
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Jeff Kapler
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Oscar E. Larios
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Kelly W. Burak
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Mark G. Swain
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Meredith A. Borman
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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Carla S. Coffin
Calgary Liver Unit (Aspinall, Shaheen, Kochaksaraei, Haslam, Lee, Burak, Swain, Borman, Coffin), Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary; Calgary Urban Project Society (Macphail); Southern Alberta Clinic (Kapler, Larios, Coffin), Alberta Health Services, Calgary, Alta.
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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
    CharacteristicNo. (%) of patients*p value
    Achieved SVR
    n = 326
    Did not achieve SVR
    n = 25
    Age at treatment, median (IQR), yr57 (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), kPa10.2 (6.7-20.4)12.5 (7.6-26.3)0.1
    HCV RNA level at baseline, median (IQR), IU/mL701 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/min94 (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
      RegimenNo. (%) of patientsp value
      Achieved SVR
      n = 326
      Did not achieve SVR
      n = 25
      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.

        • View popup
        Table 3: Predictors of achieving an SVR among all patients
        VariableUnivariate analysis
         OR (95% CI)
        Multivariate analysis
        adjusted OR (95% CI)
        Age0.95 (0.90-0.99)0.95 (0.90-1.00)
        Male sex0.28 (0.10-0.84)0.30 (0.10-0.89)
        Previous treatment0.82 (0.34-1.97)-
        Genotype 1a1.34 (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 baseline0.39 (0.17-0.91)0.56 (0.23-1.36)
        Treated according to guidelines1.09 (0.36-3.32)-
        Previous history of hepatocellular carcinoma0.27 (0.08-0.88)0.37 (0.11-1.28)
        MELD score at baseline1.76 (0.35-8.97)-
        MELD with sodium score at baseline1.01 (0.78-1.31)-

        Note: CI = confidence interval, MELD = model for end-stage liver disease, OR = odds ratio, SVR = sustained viral response.

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        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
        Jan 2018, 6 (1) E12-E18; DOI: 10.9778/cmajo.20170059

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        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
        Jan 2018, 6 (1) E12-E18; DOI: 10.9778/cmajo.20170059
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