Zobair M Younossi1,2, Maria Stepanova3, Linda Henry3, Fatema Nader3, Sharon Hunt3. 1. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia, USA. 2. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia, USA. 3. Center for Outcomes Research in Liver Diseases, Washington DC, USA.
Abstract
OBJECTIVES: Interferon- and ribavirin (RBV)-containing regimens negatively impact patients' experience. The aim of this study was to quantify the impact of different anti-viral regimens for hepatitis C on patients' work productivity, fatigue, and other patient-reported outcomes (PROs). METHODS: The PRO data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or RBV were retrospectively used. Treatment regimens were classified as interferon+RBV-containing, interferon-free RBV-containing, and interferon-free RBV-free. Four PRO instruments (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP) were administered to subjects at baseline, during, and up to 24 weeks after treatment. RESULTS: We included 3,425 subjects with chronic hepatitis C infection with PRO data. Patients were 62.8% male, 62.2% treatment naive, 18.1% with cirrhosis, and 72.9% with HCV genotype 1. Of the study participants, 546 received interferon+RBV+sofosbuvir, 1,721 received sofosbuvir+RBV, and 1,158 received interferon- and RBV-free ledipasvir+sofosbuvir. At baseline, there were no difference in PROs between treatment groups (all P>0.01). During treatment, the decrements in PROs were up to -23.6% for the interferon+RBV group, up to -7.0% in the sofosbuvir+RBV group, whereas there was an improvement of up to +11.6% in the interferon-free RBV-free group (all P<0.0001). In multivariate analysis, the use of interferon was independently associated with up to -26.0% worsening of the PRO scores during treatment and the use of RBV with up to -9.0% worsening. After 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up. CONCLUSIONS: The use of interferon- and RBV-free regimens for HCV is associated with better patients' experience and work productivity during treatment.
OBJECTIVES: Interferon- and ribavirin (RBV)-containing regimens negatively impact patients' experience. The aim of this study was to quantify the impact of different anti-viral regimens for hepatitis C on patients' work productivity, fatigue, and other patient-reported outcomes (PROs). METHODS: The PRO data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or RBV were retrospectively used. Treatment regimens were classified as interferon+RBV-containing, interferon-free RBV-containing, and interferon-free RBV-free. Four PRO instruments (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP) were administered to subjects at baseline, during, and up to 24 weeks after treatment. RESULTS: We included 3,425 subjects with chronic hepatitis C infection with PRO data. Patients were 62.8% male, 62.2% treatment naive, 18.1% with cirrhosis, and 72.9% with HCV genotype 1. Of the study participants, 546 received interferon+RBV+sofosbuvir, 1,721 received sofosbuvir+RBV, and 1,158 received interferon- and RBV-free ledipasvir+sofosbuvir. At baseline, there were no difference in PROs between treatment groups (all P>0.01). During treatment, the decrements in PROs were up to -23.6% for the interferon+RBV group, up to -7.0% in the sofosbuvir+RBV group, whereas there was an improvement of up to +11.6% in the interferon-free RBV-free group (all P<0.0001). In multivariate analysis, the use of interferon was independently associated with up to -26.0% worsening of the PRO scores during treatment and the use of RBV with up to -9.0% worsening. After 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up. CONCLUSIONS: The use of interferon- and RBV-free regimens for HCV is associated with better patients' experience and work productivity during treatment.
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