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Long-Term Patient Centered Outcomes in Cirrhotic Patients with Chronic Hepatitis C After Achieving Sustained Virologic Response |
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Clin Gastroenterol Hepatol. 2021 Jan 22;S1542-3565(21)00076-8.doi:10.1016/j.cgh.2021.01.026. Online ahead of print.
Zobair M Younossi 1, Andrei Racila 2, Andrew Muir 3, Marc Bourliere 4, Alessandra Mangia 5, Rafael Esteban 6, Stefan Zeuzem 7, Massimo Colombo 8, Michael Manns 9, George V Papatheodoridis 10, Maria Buti 6, Anand Chokkalingam 11, Anuj Gaggar 11, Fatema Nader 12, Issah Younossi 12, Linda Henry 12, Maria Stepanova 12
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Author information
- 1Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; Inova Medicine, Inova Health System, Falls Church, VA, USA. Electronic address: Zobair.Younossi@inova.org.
- 2Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; Inova Medicine, Inova Health System, Falls Church, VA, USA.
- 3Duke University Medical Center, Department of Medicine, Durham, NC, United States.
- 4Department of Hepato- Gastroenterology, Hospital Saint Joseph, Marseille, France.
- 5IRCCS Casa Sollievo della Sofferenza Hospital, Liver Unit, Medical Sciences, San Giovanni Rotondo, Italy.
- 6Liver Unit, Hospital Universitari Vall d'Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain.
- 7Department of Medicine I at the Goethe University Hospital, Frankfurt, Germany.
- 8Liver Center for Translational Research, IRCCS Humanitas, Milan, Italy.
- 9Hannover Medical School (MHH), Hannover, Germany.
- 10Academic Gastroenterology Department of Laiko Hospital of Athens, Greece.
- 11Gilead Sciences, Foster City, CA, United States.
- 12Center for Outcomes Research in Liver Disease, Washington DC, United States.
Abstract
Objective: Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis.
Design: Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAA's) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV.
Results: Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p<0.05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pre-treatment levels in 11/20 domains for those with DCC (+4% to +21%) and 19/20 PRO domains in patients with CC (+3% to +17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P<0.05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2.
Conclusion: Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after two years.
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