An In-Depth Analysis of Patient-Reported Outcomes in Patients With Chronic Hepatitis C Treated With Different Anti-Viral Regimens.

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.