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      • Post Marketing Surveillance of Daclatasvir/Asunaprevir in Japanese Patients with Chronic Hepatitis C: An Interim Report

        ( 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.

      • A Study on Modality Adaptation Support for Migrating Services

        Kiyotaka Takahashi,Tetsuo Yamabe,Etsuya Shibayama 보안공학연구지원센터 2008 International Journal of Multimedia and Ubiquitous Vol.3 No.2

        This paper presents our work on a service framework for supporting pervasive computing systems. In our vision, a novel mobile service based on pervasive computing requires to provide high accessibility regardless of computing platform and user context. From that point of view, user interface is one of key issues to achieve the vision. Therefore, we discuss technical challenge such as adaptation and context-awareness in terms of user interface. In this paper, we described the requirements and design for the service framework, and its application through explaining a possible scenario. Then we identified diverse modality as a technical challenge for achieving such mobile service and applied media conversion for adapting data representation to each particular modality. Besides, we carried out user trial using an experimental prototype. The results of the trial show the proposed approach for modality adaptation is beneficial to users in some aspect through usability and feasibility analyses.

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