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( Myeong Jun Song ),( Jung Hyun Kwon ),( Soon Woo Nam ),( Tae Hee Lee ),( Young Woo Kang ),( Ji Woong Jang ),( Seok Hyun Kim ),( Byung Seok Lee5 ),( Sea Hwan Lee ),( Hong Soo Kim ),( Ji Hoon Kim ),( S 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: We aimed to evaluate the efficacy and safety of Daclatasvir (DAV) and Asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) and chronic renal failure (CRF). Methods: 22 chronic hemodialysis patients with HCV infection at 12 medical centers have prospectively enrolled from Feb, 2016 to Feb, 2017 (NCT02580474). Of those, 9 patients who were followed 12 weeks after treatment ended were included. We evaluated the virological responses at each week 4, 12, 24 and the 12-week sustained virologic response (SVR12). The tolerability and safety of patients were also evaluated. Results: Of these 20 patients, there had no resistance-associated variant of NS5A (NS5A RAVs) and 2 patients showed indeterminate NS5A RAVs. 12 patients (54.5%) completed the 24 weeks treatment of DAV and ASV. 6 patients (27.2%) have continued, but 4 patients discontinued study prior to 12 weeks. Overall, all patients (n=9) achieved SVR12. Virologic response at week 4, 12 and 24 showed 94.4% (17/18), 93.3% (14/15), and 100% (12/12) respectively. DCV and ASV were well tolerated among the majority of patients and discontinuation of the treatment due to adverse events (hypertension, bradycardia, leukemia) was occurred in 3 patients. In two patients with indeterminate NS5A RAVs, one achieved SVR12 but the other showed viral breakthrough and discontinued treatment. Conclusions: In this study, DAV and ASV combination therapy for chronic hemodialysis patients with HCV infection achieved high sustained virological response with few adverse events. Close monitoring of safety and tolerability may be necessary when treating chronic hepatitis C patients with CRF receiving DCV and ASV.