Burden of disease in patients with chronic hepatitis C in the Austrian REAL study

Michael Gschwantler; Thomas Bamberger; Ivo Graziadei; Andreas Maieron; Nives Katalinic; Rudolf Stauber

doi:10.1007/s00508-018-1404-2

Burden of disease in patients with chronic hepatitis C in the Austrian REAL study

Michael Gschwantler, Thomas Bamberger, Ivo Graziadei, Andreas Maieron, Nives Katalinic, Rudolf Stauber

Division of Internal Medicine 2 (University Hospital St. Pölten)

Research output: Journal article (peer-reviewed) › Journal article

Abstract

BACKGROUND: The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs).

METHODS: Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.

RESULTS: A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.

CONCLUSIONS: These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.

Original language	English
Pages (from-to)	8-16
Number of pages	9
Journal	Wiener Klinische Wochenschrift
Volume	131
Issue number	1-2
DOIs	https://doi.org/10.1007/s00508-018-1404-2
Publication status	Published - 01 Jan 2019

Keywords

Antiviral Agents/therapeutic use
Austria
Cost of Illness
Drug Therapy, Combination
Female
Genotype
Hepacivirus
Hepatitis C, Chronic/drug therapy
Humans
Male
Middle Aged
Prospective Studies
Quality of Life
Ribavirin
Treatment Outcome
Dasabuvir
Chronic hepatitis C
Patient-reported outcome measures
Ombitasvir/paritaprevir/ritonavir
Direct-acting antivirals

ASJC Scopus subject areas

General Medicine

Access to Document

10.1007/s00508-018-1404-2

Cite this

@article{84b5793ffde745b486a1705493c65a65,

title = "Burden of disease in patients with chronic hepatitis C in the Austrian REAL study",

abstract = "BACKGROUND: The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs).METHODS: Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.RESULTS: A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.CONCLUSIONS: These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.",

keywords = "Antiviral Agents/therapeutic use, Austria, Cost of Illness, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Chronic/drug therapy, Humans, Male, Middle Aged, Prospective Studies, Quality of Life, Ribavirin, Treatment Outcome, Dasabuvir, Chronic hepatitis C, Patient-reported outcome measures, Ombitasvir/paritaprevir/ritonavir, Direct-acting antivirals",

author = "Michael Gschwantler and Thomas Bamberger and Ivo Graziadei and Andreas Maieron and Nives Katalinic and Rudolf Stauber",

note = "Funding Information: Acknowledgements Statistical support was provided by Ina Burghaus, PhD, of Prometris GmbH, Mannheim, Germany, and medical writing support was provided by Ulrike Hauf-Zachariou, MD, of IST GmbH, Mannheim, Germany, both funded by AbbVie. The authors would like to express their gratitude to the study participants, investigators, and coordinators who made this study possible. Funding Information: Conflict of interest AbbVie sponsored this study and contributed to the design, study conduct, and analysis. Abb-Vie participated in the interpretation of data, review, and approval of the manuscript. All authors had access to all relevant data. M. Gschwantler: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from Abb-Vie, Gilead, BMS, MSD, and Janssen; grants from AbbVie, Gilead and MSD. T. Bamberger: advisor for AbbVie, BMS, and MSD; received speaker fees from AbbVie, Gilead, and BMS. I. Graziadei: advisory board: AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, and MSD. A. Maieron: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, MSD, and Janssen. N. Katalinic: AbbVie employee and may hold AbbVie stock or options. R. Stauber: advisor for AbbVie, BMS, Gilead, and MSD; received speaker fees from AbbVie, BMS, and Gilead; and research grant from AbbVie. Publisher Copyright: {\textcopyright} 2018, Springer-Verlag GmbH Austria, part of Springer Nature.",

year = "2019",

month = jan,

day = "1",

doi = "10.1007/s00508-018-1404-2",

language = "English",

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pages = "8--16",

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TY - JOUR

T1 - Burden of disease in patients with chronic hepatitis C in the Austrian REAL study

AU - Gschwantler, Michael

AU - Bamberger, Thomas

AU - Graziadei, Ivo

AU - Maieron, Andreas

AU - Katalinic, Nives

AU - Stauber, Rudolf

N1 - Funding Information: Acknowledgements Statistical support was provided by Ina Burghaus, PhD, of Prometris GmbH, Mannheim, Germany, and medical writing support was provided by Ulrike Hauf-Zachariou, MD, of IST GmbH, Mannheim, Germany, both funded by AbbVie. The authors would like to express their gratitude to the study participants, investigators, and coordinators who made this study possible. Funding Information: Conflict of interest AbbVie sponsored this study and contributed to the design, study conduct, and analysis. Abb-Vie participated in the interpretation of data, review, and approval of the manuscript. All authors had access to all relevant data. M. Gschwantler: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from Abb-Vie, Gilead, BMS, MSD, and Janssen; grants from AbbVie, Gilead and MSD. T. Bamberger: advisor for AbbVie, BMS, and MSD; received speaker fees from AbbVie, Gilead, and BMS. I. Graziadei: advisory board: AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, and MSD. A. Maieron: advisor for AbbVie, Gilead, BMS, MSD, and Janssen; received speaker fees from AbbVie, Gilead, BMS, MSD, and Janssen. N. Katalinic: AbbVie employee and may hold AbbVie stock or options. R. Stauber: advisor for AbbVie, BMS, Gilead, and MSD; received speaker fees from AbbVie, BMS, and Gilead; and research grant from AbbVie. Publisher Copyright: © 2018, Springer-Verlag GmbH Austria, part of Springer Nature.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - BACKGROUND: The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs).METHODS: Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.RESULTS: A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.CONCLUSIONS: These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.

AB - BACKGROUND: The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs).METHODS: Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs.RESULTS: A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline.CONCLUSIONS: These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.

KW - Antiviral Agents/therapeutic use

KW - Austria

KW - Cost of Illness

KW - Drug Therapy, Combination

KW - Female

KW - Genotype

KW - Hepacivirus

KW - Hepatitis C, Chronic/drug therapy

KW - Humans

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Quality of Life

KW - Ribavirin

KW - Treatment Outcome

KW - Dasabuvir

KW - Chronic hepatitis C

KW - Patient-reported outcome measures

KW - Ombitasvir/paritaprevir/ritonavir

KW - Direct-acting antivirals

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