Health-Related Quality of Life (HRQL) and Health Utilities (HU) of Patients with Chronic Hepatitis C (CH-C) Treated with an Interferon (IFN)-Free Regimen Containing Ledipasvir (LDV) and Sofosbuvir (SOF)

Abstract

Introduction: HRQL is an important patient-reported outcome while heath utilities measure patients’ preferences and are used for economic analyses. Aim: To assess HRQL and utilities for SOF plus LDVcontaining regimens. Methods: Short form 36 (SF-36) was administered at baseline, during, and post-treatment to HCV genotype 1 patients treated with SOF plus LDV with or without RBV (ION-1, 2, and 3 clinical trials). SF-6D scores were calculated from the SF-36 scores. Results: A total of 1,952 CH-C patients were included. Baseline SF-36 scores were similar across study arms (p>0.05). During treatment, RBV-containing regimens showed minimal decrements in 6 SF-36 scales (up to -5.4% for role physical, all p<0.03); while IFN- and RBV-free arms showed an improvement in all scales (up to +5.1% for vitality, all p<0.02). At the end of follow-up, patients with SVR-12 showed an improvement of the HRQL (up to +7.2% for vitality, all p<0.0001). Baseline SF-6D scores showed no differences between treatment arms (all p>0.05). During treatment with the RBV-containing regimens, decrements in SF6D scores were observed starting as early as week 4 of treatment (-2.0%, p=0.0005) and continued throughout treatment (-3.8% in the 8 weeks arm, -2.6% in 12 weeks, -3.3% in 24 weeks; all p<0.02). On the other hand, patients receiving RBV-free SOF plus LDV regimens showed improvement of their SF-6D scores during treatment (+3.5%, +4.8%, and +4.1% from baseline, respectively; all p<0.001). When compared directly to RBV-containing regimens, RBV-free SOF plus LDV regimen was associated with +5.2% (8 weeks), +5.9% (12 weeks), +5.9% (24 weeks) (all p<0.01) superiority in SF-6D during treatment. Receiving RBV was an independent predictor of on-treatment impairment in multivariate analysis (beta=-5.6±0.9%, p<0.0001). Nevertheless, regardless of the regimen, patients who achieved SVR-12 showed significant improvement of their SF-6D scores by week 12 post-treatment (+4.8%, p<0.0001), although post-SVR improvement in SF-6D in RBV-free arm was still superior: +5.6% vs. +3.9% (p=0.02). Subgroup analysis of patients with cirrhosis showed consistently lower scores (p=0.004 to <0.0001). Despite this, treatment-related and post-treatment changes in scores (decreases in RBV-containing vs. increases in RBV-free, as well as post-SVR increases in all regimens) were similar in cirrhotic and non-cirrhotic patients regardless of the treatment regimen (all p>0.05). Conclusion: RBV-free SOF plus LDV anti-HCV regimens are associated with significant improvement of HRQL and utilities during treatment. Although cirrhosis is associated with lower baseline scores, HCV cirrhotic patients treated with SOF plus LDV had treatment-related and post-treatment effect on HRQL/utilities similar to non-cirrhotics. Disclosure - Drs. Younossi, Afdahl, Kowdley, Marcellin are investigators for Gilead sciences and serve on their advisory board and/or consultants. This research was supported by an industry grant from Gilead Sciences.