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( Fumitaka Suzuki ),( Naoya Hatanaka ),( Etsuya Bando ),( Akira Komoto ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Daclatasvir (DCV) combined with asunaprevir (ASV) was the first all-oral treatment to be approved in Japan for chronic hepatitis C virus (HCV) serogroup 1 infection in patients with/without compensated cirrhosis. We report interim findings of a post-marketing survey of DCV+ASV in Japanese patients treated in the routine clinical setting. Methods: The survey aimed to register a total of 3000 HCV-infected patients, including 1000 patients with compensated cirrhosis, between September 2014 and August 2015. All patients received oral DCV 60mg once daily + ASV 100 mg twice daily for 24 weeks. This report includes safety data collected up to 3 July 2016. Results: Of the 3089 patients registered, 2165 (70.0%) patients (female, n=1233 [57.0%]; mean age, 69.1 years [range: 21-92]; compensated cirrhosis, n=862 [39.8%]) are included in the safety set; 1874 (86.6%) patients have completed the treatment period. The main reasons for discontinuation in the safety set were adverse events (n=146 [6.7%]) and lack of efficacy (n=86 [4.0%]). A total of 538 patients (24.85%) in the safety set experienced a total of 811 adverse drug reactions (ADRs). Events corresponding to the composite ADR term ‘hepatic function disorder’ occurred in 315 patients (14.55%). Common ADRs were: hepatic function abnormal (n=133 [6.14%]), increased eosinophil count (n=67 [3.09%]), increased alanine aminotransferase (n=63 [2.91%]), increased aspartate aminotransferase (n=61 [2.82%]), liver disorder (n=58 [2.68%]) and pyrexia (n=53 [2.45%]); rates of ADRs in patients with/without compensated cirrhosis were generally comparable (Table). Serious ADRs which occurred in two or more patients were liver disorder (n=5 [0.23%]), pyrexia (n=4 [0.18%]); hepatic function abnormal (n=3 [0.14%]) hepatic hepatic encephalopathy (n=2 [0.09%]) and jaundice (n=2 [0.09%]); all serious ADRs have/are resolved/resolving and all patients have/are recovered/recovering. No deaths have been reported. Conclusions: DCV + ASV was generally well tolerated in this interim analysis of real-world data.