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( Zobair Younossi ),( Maria Stepanova ),( Linda Henry ),( Kwanghyub Han ),( Sang Ahn ),( Youngsuk Lim ),( Wanloung Chuang ),( Jia Horng Kao ),( Nguyen Kinh ),( Ching Lung Lai ),( Man Fung Yuen ),( Hen 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
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.