Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort

Lucia Macken, William Gelson, Matthew Priest, George Abouda, Stephen Barclay, Andrew Fraser, Brendan Healey, Will Irving, Sumita Verma

Research output: Contribution to journal › Article

Abstract

Direct-acting antivirals (DAAs) have revolutionised the management of chronic hepatitisC virus (HCV) infection. We describe UK real-world DAA experience. Individualscommencing HCV treatment containing a DAA regimen (Mar 2014-Nov 2016),participating in the National HCV Research UK (HCVRUK) Cohort Study were recruitedfrom 33 UK HCV centers. The data were prospectively entered at sites onto acentralised database. The data were reported as median (Q1-Q3). Of the 1448 treatedpatients, 1054 (73%) were males, the median age being 54 years (47-60), 900 (62%)being genotype 1 and 455 (31%) genotype 3. The majority, 887 (61%) had cirrhosis, and590 (41%) were treatment-experienced. DAA regimens utilised: genotype1 sofosbuvir(SOF)/Ledipasvir/±Ribavirin (625/900, 69%) and Ombitasvir/Paritaprevir/Dasabuvir/±RBV (220/900, 24%), and in genotype 3 SOF/Daclatasvir + RBV (256/455, 56%) andSOF/pegylated interferon/RBV (157/455, 35%). Overall, 1321 (91%) achieved sustainedvirological response (SVR12), genotype 1 vs 3, 93% vs 87%, P < .001. Prior treatment,presence of cirrhosis and treatment regimen did not impact SVR12. Predictors oftreatment failure were genotype 3 infection, OR, 2.015 (95% CI: 1.279-3.176, P = .003),and male sex, OR, 1.878 (95% CI: 1.071-3.291, P = .028). Of those with hepaticdecompensation at baseline (n = 39), 51% (n = 20) recompensated post-treatment, lowerbaseline serum creatinine being associated with recompensation (P = .029). There weretwo liver-related deaths, both having decompensated disease. This real-world UK data,comprising of a predominantly cirrhotic HCV genotype 1/3 cohort, confirms DAAefficacy with an overall 91% SVR12, with 51% recompensating post-treatment.Genotype 3 infection was a predictor of treatment failure.
Original languageEnglish
Pages (from-to)1979-1988
Number of pages10
JournalJournal of Medical Virology
Volume91
Issue number11
Early online date22 Jul 2019
DOIs
Publication statusPublished - Nov 2019

Fingerprint

Antiviral Agents
Genotype
Viruses
Fibrosis
Mars
Ribavirin
Virus Diseases
Infection
Treatment Failure
Interferons
Creatinine
Cohort Studies
Databases
Liver
Serum
Research

Keywords

  • genotype 1
  • genotype 3
  • hepatic decompensation
  • hepatic recompensation
  • SVR12
  • treatment failure
  • Hepatitis C

Cite this

Macken, Lucia ; Gelson, William ; Priest, Matthew ; Abouda, George ; Barclay, Stephen ; Fraser, Andrew ; Healey, Brendan ; Irving, Will ; Verma, Sumita. / Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort. In: Journal of Medical Virology. 2019 ; Vol. 91, No. 11. pp. 1979-1988.
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title = "Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort",
abstract = "Direct-acting antivirals (DAAs) have revolutionised the management of chronic hepatitisC virus (HCV) infection. We describe UK real-world DAA experience. Individualscommencing HCV treatment containing a DAA regimen (Mar 2014-Nov 2016),participating in the National HCV Research UK (HCVRUK) Cohort Study were recruitedfrom 33 UK HCV centers. The data were prospectively entered at sites onto acentralised database. The data were reported as median (Q1-Q3). Of the 1448 treatedpatients, 1054 (73{\%}) were males, the median age being 54 years (47-60), 900 (62{\%})being genotype 1 and 455 (31{\%}) genotype 3. The majority, 887 (61{\%}) had cirrhosis, and590 (41{\%}) were treatment-experienced. DAA regimens utilised: genotype1 sofosbuvir(SOF)/Ledipasvir/±Ribavirin (625/900, 69{\%}) and Ombitasvir/Paritaprevir/Dasabuvir/±RBV (220/900, 24{\%}), and in genotype 3 SOF/Daclatasvir + RBV (256/455, 56{\%}) andSOF/pegylated interferon/RBV (157/455, 35{\%}). Overall, 1321 (91{\%}) achieved sustainedvirological response (SVR12), genotype 1 vs 3, 93{\%} vs 87{\%}, P < .001. Prior treatment,presence of cirrhosis and treatment regimen did not impact SVR12. Predictors oftreatment failure were genotype 3 infection, OR, 2.015 (95{\%} CI: 1.279-3.176, P = .003),and male sex, OR, 1.878 (95{\%} CI: 1.071-3.291, P = .028). Of those with hepaticdecompensation at baseline (n = 39), 51{\%} (n = 20) recompensated post-treatment, lowerbaseline serum creatinine being associated with recompensation (P = .029). There weretwo liver-related deaths, both having decompensated disease. This real-world UK data,comprising of a predominantly cirrhotic HCV genotype 1/3 cohort, confirms DAAefficacy with an overall 91{\%} SVR12, with 51{\%} recompensating post-treatment.Genotype 3 infection was a predictor of treatment failure.",
keywords = "genotype 1, genotype 3, hepatic decompensation, hepatic recompensation , SVR12, treatment failure, Hepatitis C",
author = "Lucia Macken and William Gelson and Matthew Priest and George Abouda and Stephen Barclay and Andrew Fraser and Brendan Healey and Will Irving and Sumita Verma",
note = "Acceptance from webpage AAM requested 26/8/19 (file uploaded by author is VoR). ET and 13/9/19 ET Applied 'no exception' as no (AAM) file available. ET 8/11/19",
year = "2019",
month = "11",
doi = "10.1002/jmv.25552",
language = "English",
volume = "91",
pages = "1979--1988",
journal = "Journal of Medical Virology",
issn = "0146-6615",
publisher = "John Wiley & Sons",
number = "11",

}

Macken, L, Gelson, W, Priest, M, Abouda, G, Barclay, S, Fraser, A, Healey, B, Irving, W & Verma, S 2019, 'Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort', Journal of Medical Virology, vol. 91, no. 11, pp. 1979-1988. https://doi.org/10.1002/jmv.25552

Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort. / Macken, Lucia; Gelson, William; Priest, Matthew ; Abouda, George; Barclay, Stephen; Fraser, Andrew; Healey, Brendan; Irving, Will; Verma, Sumita.

In: Journal of Medical Virology, Vol. 91, No. 11, 11.2019, p. 1979-1988.

Research output: Contribution to journal › Article

TY - JOUR

T1 - Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort

AU - Macken, Lucia

AU - Gelson, William

AU - Priest, Matthew

AU - Abouda, George

AU - Barclay, Stephen

AU - Fraser, Andrew

AU - Healey, Brendan

AU - Irving, Will

AU - Verma, Sumita

N1 - Acceptance from webpage AAM requested 26/8/19 (file uploaded by author is VoR). ET and 13/9/19 ET Applied 'no exception' as no (AAM) file available. ET 8/11/19

PY - 2019/11

Y1 - 2019/11

N2 - Direct-acting antivirals (DAAs) have revolutionised the management of chronic hepatitisC virus (HCV) infection. We describe UK real-world DAA experience. Individualscommencing HCV treatment containing a DAA regimen (Mar 2014-Nov 2016),participating in the National HCV Research UK (HCVRUK) Cohort Study were recruitedfrom 33 UK HCV centers. The data were prospectively entered at sites onto acentralised database. The data were reported as median (Q1-Q3). Of the 1448 treatedpatients, 1054 (73%) were males, the median age being 54 years (47-60), 900 (62%)being genotype 1 and 455 (31%) genotype 3. The majority, 887 (61%) had cirrhosis, and590 (41%) were treatment-experienced. DAA regimens utilised: genotype1 sofosbuvir(SOF)/Ledipasvir/±Ribavirin (625/900, 69%) and Ombitasvir/Paritaprevir/Dasabuvir/±RBV (220/900, 24%), and in genotype 3 SOF/Daclatasvir + RBV (256/455, 56%) andSOF/pegylated interferon/RBV (157/455, 35%). Overall, 1321 (91%) achieved sustainedvirological response (SVR12), genotype 1 vs 3, 93% vs 87%, P < .001. Prior treatment,presence of cirrhosis and treatment regimen did not impact SVR12. Predictors oftreatment failure were genotype 3 infection, OR, 2.015 (95% CI: 1.279-3.176, P = .003),and male sex, OR, 1.878 (95% CI: 1.071-3.291, P = .028). Of those with hepaticdecompensation at baseline (n = 39), 51% (n = 20) recompensated post-treatment, lowerbaseline serum creatinine being associated with recompensation (P = .029). There weretwo liver-related deaths, both having decompensated disease. This real-world UK data,comprising of a predominantly cirrhotic HCV genotype 1/3 cohort, confirms DAAefficacy with an overall 91% SVR12, with 51% recompensating post-treatment.Genotype 3 infection was a predictor of treatment failure.

AB - Direct-acting antivirals (DAAs) have revolutionised the management of chronic hepatitisC virus (HCV) infection. We describe UK real-world DAA experience. Individualscommencing HCV treatment containing a DAA regimen (Mar 2014-Nov 2016),participating in the National HCV Research UK (HCVRUK) Cohort Study were recruitedfrom 33 UK HCV centers. The data were prospectively entered at sites onto acentralised database. The data were reported as median (Q1-Q3). Of the 1448 treatedpatients, 1054 (73%) were males, the median age being 54 years (47-60), 900 (62%)being genotype 1 and 455 (31%) genotype 3. The majority, 887 (61%) had cirrhosis, and590 (41%) were treatment-experienced. DAA regimens utilised: genotype1 sofosbuvir(SOF)/Ledipasvir/±Ribavirin (625/900, 69%) and Ombitasvir/Paritaprevir/Dasabuvir/±RBV (220/900, 24%), and in genotype 3 SOF/Daclatasvir + RBV (256/455, 56%) andSOF/pegylated interferon/RBV (157/455, 35%). Overall, 1321 (91%) achieved sustainedvirological response (SVR12), genotype 1 vs 3, 93% vs 87%, P < .001. Prior treatment,presence of cirrhosis and treatment regimen did not impact SVR12. Predictors oftreatment failure were genotype 3 infection, OR, 2.015 (95% CI: 1.279-3.176, P = .003),and male sex, OR, 1.878 (95% CI: 1.071-3.291, P = .028). Of those with hepaticdecompensation at baseline (n = 39), 51% (n = 20) recompensated post-treatment, lowerbaseline serum creatinine being associated with recompensation (P = .029). There weretwo liver-related deaths, both having decompensated disease. This real-world UK data,comprising of a predominantly cirrhotic HCV genotype 1/3 cohort, confirms DAAefficacy with an overall 91% SVR12, with 51% recompensating post-treatment.Genotype 3 infection was a predictor of treatment failure.

KW - genotype 1

KW - genotype 3

KW - hepatic decompensation

KW - hepatic recompensation

KW - SVR12

KW - treatment failure

KW - Hepatitis C

U2 - 10.1002/jmv.25552

DO - 10.1002/jmv.25552

M3 - Article

VL - 91

SP - 1979

EP - 1988

JO - Journal of Medical Virology

JF - Journal of Medical Virology

SN - 0146-6615

IS - 11

ER -

Macken L, Gelson W, Priest M, Abouda G, Barclay S, Fraser A et al. Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort. Journal of Medical Virology. 2019 Nov;91(11):1979-1988. https://doi.org/10.1002/jmv.25552

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