PE-071 : Sofosbuvir and Ledipasvir is Associated with High Sustained Virologic Response and Improvement of Health- Related Quality-of-Life in East-Asians with Hepatitis C

Aims: We aim to assess HRQL in east Asian (EA) HCV patients treated with different anti-HCV sofosbuvir (SOF)-based regimens. Methods: 1070 EA HCV subjects were enrolled in two phase 3 clinical trials [China: 55.6%, S. Korea: 20.7%, Taiwan: 16.1%, Vietnam: 4.7%, and Hong Kong: 2.9%]. Patients received IFN+SOF+RBV for 12 weeks (n=155, GT 1 and 6) or SOF+RBV for 12-24 weeks (n=531, GT 1, 2, 3 and 6) or IFN-free RBV-free LDV/SOF (n=384, GT1 only). The SVR-12 rates were 95.5%, 96.0%, and 99.2%, respectively (P=0.008). EA HCV patients completed Short Form-36 before, during, and after treatment and HRQL scores compared between regimens. Results: Baseline HRQL scores were similar between treatment groups. After 2 weeks of treatment, HRQL scores for the IFN+RBV- containing regimen became significantly lower as compared to the IFN-free regimens (average decline up to -11.2 points, P<0.0001). By the end of treatment, IFN-treated group experienced significant declines in most HRQL scores (up to -13.3 points, P<0.02 for 7/8 HRQL scales). Patients on SOF+RBV had milder HRQL impairments (up to -5.4 points, P<0.05 for 5/8 scales). However, patients receiving LDV/SOF had improvement in their HRQL scores (up to +4.3 points by the end of treatment, P<0.001 for 3/8 scales). Achieving SVR-12 with IFN+RBV+ SOF and SOF+RBV was associated with improvement in General Health (GH) and Vitality (VT) (up to +2.9 points, P<0.05), while SVR-12 with LDV/SOF was associated with improvement in Physical Functioning, GH, VT, Mental Health, and Role Emotional (up to +5.9 points, P<0.03). In multivariate analysis, receiving IFN was independently associated with HRQL impairment during treatment (β: -10.4 to -17.3 points, P<0.0001). Conclusions: Treatment of EA HCV patients with IFN or RBV containing regimens is associated with HRQL impairment, while treatment with LDV/SOF is associated with improvement of HRQL during treatment. SVR-12 was associated with greater improvements in HRQL.