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Treatment with ledipasvir and sofosbuvir improves patient‐reported outcomes: Results from the ION‐1, ‐2, and ‐3 clinical trials

Treatment with interferon (IFN) and ribavirin (RBV) significantly impairs quality of life and other patient‐reported outcomes (PROs). Patient experience with IFN‐ and RBV‐free anti‐HCV (hepatitis C virus) regimens has not been reported. We assessed PROs in patients treated with ledipasvir and sofosbuvir (LDV/SOF) with and without RBV. Four different PRO questionnaires were administered at baseline, during, and post‐treatment in HCV genotype 1 patients treated with LDV/SOF±RBV (ION‐1, ‐2, and ‐3). A total of 1,952 patients were enrolled to be treated for 8 (N = 431), 12 (N = 867), or 24 weeks (N = 654) with LDV/SOF (N = 1,080) or LDV/SOF+RBV (N = 872). Baseline demographics and psychiatric disorders were similar between treatment groups (all P > 0.05). Patients receiving LDV/SOF regimens showed significant improvement of PRO scores during treatment (up to +7.4%, +7.0%, and +6.7% on a normalized 0%‐100% scale in the 8‐, 12‐, and 24‐week‐long treatment groups, respectively (all P < 0.0001). These PRO improvements coincided with early viral suppression after 2 weeks of treatment and maximized by the end of treatment. On the other hand, during treatment with LDV/SOF+RBV, PRO scores declined (up to −5.5% regardless of treatment duration; P < 0.0001). Receiving RBV was an independent predictor of PRO impairment in multivariate analysis (beta up to −5.9%; P < 0.0001). Patients who achieved sustained virological response at 12 weeks showed significant improvement of their PROs post‐treatment (up to +8.3%; P < 0.0001). Conclusion: IFN‐ and RBV‐free regimens with LDV/SOF result in early HCV suppression with simultaneous improvement in PROs that continued throughout the duration of treatment and post‐treatment. (Hepatology 2015;61:1798‐1808)