Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study

John Lubel, Simone Strasser, Katherine A. Stuart, Gregory Dore, Alexander Thompson, Stephen Pianko, Steven Bollipo, Joanne L. Mitchell, Vincenzo Fragomeli, Tracey Jones, Sarah Chivers, Paul Gow, David Iser, Miriam Levy, Edmund Tse, Alessia Gazzola, Wendy Cheng, Saroj Nazareth, Sam Galhenage, Amanda Wade & 8 others Martin Weltman, Alan Wigg, Gerry MacQuillan, Joe Sasadeusz, Jacob George, Amany Zekry, Stuart K. Roberts, the Australian Liver Association Clinical Research Network (ALA CRN)

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pretreatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. Methods: 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Results: Cirrhosis was present in 340 patients (75.4%). Overall SVR was 95.1% with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7% versus 96.4%). SVR in subgenotypes 1a and 1b was 93.1% and 99.2%, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9% of patients including hepatic decompensation (2.7%) and hepatocellular carcinoma (1.8%). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. Conclusions: In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.

Original languageEnglish
Pages (from-to)699-710
Number of pages12
JournalAntiviral Therapy
Volume22
Issue number8
DOIs
Publication statusPublished - 2017

Cite this

Lubel, John ; Strasser, Simone ; Stuart, Katherine A. ; Dore, Gregory ; Thompson, Alexander ; Pianko, Stephen ; Bollipo, Steven ; Mitchell, Joanne L. ; Fragomeli, Vincenzo ; Jones, Tracey ; Chivers, Sarah ; Gow, Paul ; Iser, David ; Levy, Miriam ; Tse, Edmund ; Gazzola, Alessia ; Cheng, Wendy ; Nazareth, Saroj ; Galhenage, Sam ; Wade, Amanda ; Weltman, Martin ; Wigg, Alan ; MacQuillan, Gerry ; Sasadeusz, Joe ; George, Jacob ; Zekry, Amany ; Roberts, Stuart K. ; the Australian Liver Association Clinical Research Network (ALA CRN). / Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study. In: Antiviral Therapy. 2017 ; Vol. 22, No. 8. pp. 699-710.
@article{889d9cf2ba5342cc92f552fc8b7ae331,
title = "Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study",
abstract = "Background: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pretreatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. Methods: 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Results: Cirrhosis was present in 340 patients (75.4{\%}). Overall SVR was 95.1{\%} with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7{\%} versus 96.4{\%}). SVR in subgenotypes 1a and 1b was 93.1{\%} and 99.2{\%}, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9{\%} of patients including hepatic decompensation (2.7{\%}) and hepatocellular carcinoma (1.8{\%}). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. Conclusions: In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.",
author = "John Lubel and Simone Strasser and Stuart, {Katherine A.} and Gregory Dore and Alexander Thompson and Stephen Pianko and Steven Bollipo and Mitchell, {Joanne L.} and Vincenzo Fragomeli and Tracey Jones and Sarah Chivers and Paul Gow and David Iser and Miriam Levy and Edmund Tse and Alessia Gazzola and Wendy Cheng and Saroj Nazareth and Sam Galhenage and Amanda Wade and Martin Weltman and Alan Wigg and Gerry MacQuillan and Joe Sasadeusz and Jacob George and Amany Zekry and Roberts, {Stuart K.} and {the Australian Liver Association Clinical Research Network (ALA CRN)}",
year = "2017",
doi = "10.3851/IMP3168",
language = "English",
volume = "22",
pages = "699--710",
journal = "Antiviral Therapy",
issn = "1359-6535",
publisher = "International Medical Press",
number = "8",

}

Lubel, J, Strasser, S, Stuart, KA, Dore, G, Thompson, A, Pianko, S, Bollipo, S, Mitchell, JL, Fragomeli, V, Jones, T, Chivers, S, Gow, P, Iser, D, Levy, M, Tse, E, Gazzola, A, Cheng, W, Nazareth, S, Galhenage, S, Wade, A, Weltman, M, Wigg, A, MacQuillan, G, Sasadeusz, J, George, J, Zekry, A, Roberts, SK & the Australian Liver Association Clinical Research Network (ALA CRN) 2017, 'Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study' Antiviral Therapy, vol. 22, no. 8, pp. 699-710. https://doi.org/10.3851/IMP3168

Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study. / Lubel, John; Strasser, Simone; Stuart, Katherine A.; Dore, Gregory; Thompson, Alexander; Pianko, Stephen; Bollipo, Steven; Mitchell, Joanne L.; Fragomeli, Vincenzo; Jones, Tracey; Chivers, Sarah; Gow, Paul; Iser, David; Levy, Miriam; Tse, Edmund; Gazzola, Alessia; Cheng, Wendy; Nazareth, Saroj; Galhenage, Sam; Wade, Amanda; Weltman, Martin; Wigg, Alan; MacQuillan, Gerry; Sasadeusz, Joe; George, Jacob; Zekry, Amany; Roberts, Stuart K.; the Australian Liver Association Clinical Research Network (ALA CRN).

In: Antiviral Therapy, Vol. 22, No. 8, 2017, p. 699-710.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 – final results of the REV1TAL study

AU - Lubel, John

AU - Strasser, Simone

AU - Stuart, Katherine A.

AU - Dore, Gregory

AU - Thompson, Alexander

AU - Pianko, Stephen

AU - Bollipo, Steven

AU - Mitchell, Joanne L.

AU - Fragomeli, Vincenzo

AU - Jones, Tracey

AU - Chivers, Sarah

AU - Gow, Paul

AU - Iser, David

AU - Levy, Miriam

AU - Tse, Edmund

AU - Gazzola, Alessia

AU - Cheng, Wendy

AU - Nazareth, Saroj

AU - Galhenage, Sam

AU - Wade, Amanda

AU - Weltman, Martin

AU - Wigg, Alan

AU - MacQuillan, Gerry

AU - Sasadeusz, Joe

AU - George, Jacob

AU - Zekry, Amany

AU - Roberts, Stuart K.

AU - the Australian Liver Association Clinical Research Network (ALA CRN)

PY - 2017

Y1 - 2017

N2 - Background: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pretreatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. Methods: 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Results: Cirrhosis was present in 340 patients (75.4%). Overall SVR was 95.1% with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7% versus 96.4%). SVR in subgenotypes 1a and 1b was 93.1% and 99.2%, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9% of patients including hepatic decompensation (2.7%) and hepatocellular carcinoma (1.8%). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. Conclusions: In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.

AB - Background: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pretreatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. Methods: 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Results: Cirrhosis was present in 340 patients (75.4%). Overall SVR was 95.1% with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7% versus 96.4%). SVR in subgenotypes 1a and 1b was 93.1% and 99.2%, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9% of patients including hepatic decompensation (2.7%) and hepatocellular carcinoma (1.8%). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. Conclusions: In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.

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U2 - 10.3851/IMP3168

DO - 10.3851/IMP3168

M3 - Article

VL - 22

SP - 699

EP - 710

JO - Antiviral Therapy

JF - Antiviral Therapy

SN - 1359-6535

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