Original articlePancreas, biliary tract, and liverLong-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection
Section snippets
Data Source
The data used in this study came from 2 long-term follow-up registry studies of HCV subjects who had completed treatment with a DAA-based regimen in a clinical trial. Both registries were enrolling patients in 2016 to 2017 in 17 countries in North America, Europe, and the Asia–Pacific region.
The first registry enrolled subjects who had achieved SVR after treatment (NCT01457755). The second registry enrolled subjects who had not achieved SVR after treatment (NCT01457768). The definition of SVR
Results
The study included 4234 patients who achieved SVR and 242 who did not achieve SVR. All patients had clinical and laboratory data as well as pretreatment PRO data. Patients with SVR were less likely to be male, had a lower BMI, were more likely treatment-naive before treatment in a parent study, less cirrhotic, and had fewer instances of HIV co-infection and type 2 diabetes (P < .05) (Table 1).
Before treatment initiation, the PRO scores of both patient groups were similar or higher than those of
Discussion
In this study, we provide evidence about the sustainability of PRO improvement in HCV patients who achieved SVR. In fact, the long-term follow-up evaluation of patients enrolled in the SVR registry showed consistent PRO improvement in all aspects of patients’ well-being as captured by the SF-36 PRO instrument. These changes were not only statistically significant but also clinically meaningful by meeting minimally clinically important difference thresholds, which generally are believed to be
References (26)
- et al.
Trends in burden of cirrhosis and hepatocellular carcinoma by underlying liver disease in US veterans, 2001-2013
Gastroenterology
(2015) - et al.
Hepatitis C infection: a multi-faceted systemic disease with clinical, patient reported and economic consequences
J Hepatol
(2016) - et al.
Manifestations of chronic hepatitis C virus infection beyond the liver
Clin Gastroenterol Hepatol
(2010) - et al.
Extrahepatic manifestations of hepatitis C: a meta-analysis of prevalence, quality of life, and economic burden
Gastroenterology
(2016) - et al.
Health-related quality of life (HRQL) in chronic liver disease
Dig Liver Dis
(2005) - et al.
Anger experiences among hepatitis C patients: relationship to depressive symptoms and health-related quality of life
Psychosomatics
(2007) - et al.
Mental and emotional impairment in patients with hepatitis C is related to lower work productivity
Psychosomatics
(2016) - et al.
Modelling SF-6D health state preference data using a nonparametric Bayesian method
J Health Econ
(2007) - et al.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
J Chronic Dis
(1987) History of HCV-25 years
The impact of hepatitis C burden: an evidence-based approach
Aliment Pharmacol Ther
The comprehensive outcomes of hepatitis C virus infection: a multi-faceted chronic disease
J Viral Hepat
Changing trends in etiology- and ethnicity-based annual mortality rates of cirrhosis and hepatocellular carcinoma in the United States
Hepatology
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Conflicts of interest These authors disclose the following: Zobair M. Younossi has received research funds from Gilead Sciences, Intercept, Bristol-Myers Squibb; served as a consultant for NovoNordisk, AbbVie, Terns, and Viking; Ira M. Jacobson has served as a consultant for: AbbVie, Arbutus, Arrowhead, Assembly, Atea, BMS, Gilead, Intercept, Janssen, Novo Nordisk, Siemens; received research funding from: Assembly, BMS, Durect, Enanta, Janssen, Eli Lilly, Merck, Myr; Peter J. Ruane has received consulting fees and is a shareholder of Gilead Sciences; and Anuj Gaggar and Robert P. Myers are employees of Gilead Sciences. The remaining authors disclose no conflicts.
Funding This project was supported in part by Gilead Sciences.