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RISS 인기검색어
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- 저자 : ( E. Z. Burnevich ) (검색결과 1 건)
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( L. Wei ),( F. Wang ),( M. Zhang ),( J. Jia ),( A.A. Yakovlev ),( W. Xie ),( E.Z. Burnevich ),( J. Niu ),( Y.J. Jung ),( X. Jiang ),( M. Xu ),( X. Chen ),( Q. Xie ),( J. Li ),( J. Hou ),( H. Tang ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Background/Aims: Treatment-naive GT 1b-infected patients from mainland China, South Korea and Russia were assessed for SVR at follow-up week 12 (SVR12) after receiving daclatasvir (60 mg, QD) and asunaprevir (100 mg, BID) (DCV+ASV). Methods: Patients were randomized 3:1 to receive DCV+ASV (24 weeks; immediate treatment [IM]) or 12 weeks of placebo followed by DCV+ASV (24 weeks; placebo-deferred treatment [PD]). The primary endpoint was to evaluate SVR12 in the IM arm to the historical rate for peginterferon/ribavirin (70%). Secondary endpoints included overall safety and safety comparisons between the treatment arms during the first 12 weeks. Results: 207 patients were randomized to IM (n=155) or PD (n=52); Asian (86%), female (59%), IL28B CC genotype (68%) and median age 49 (range 18-73) years; cirrhosis (13%), HCV RNA ≥6x106 IU/mL (53%). SVR12 in the IM arm was 92% and broadly unaffected by most baseline factors assessed (Figure); SVR12 was higher in patients without (96%) baseline NS5A-L31M/V or Y93H polymorphisms. There were 6 virologic breakthroughs, 6 relapses and 1 detectable HCV RNA at end-of-treatment in the IM arm. Safety was mostly comparable between the two arms during the first 12 weeks. The most frequent adverse events (AEs; ≥5%) during DCV+ASV (24 weeks) treatment in both arms were aminotransferase, bilirubin and INR elevations, hypertension, fatigue and respiratory tract infections; the most frequent treatment-emergent grade 3/4 laboratory abnormalities were aminotransferase (≤4.5%) and hematologic, lipase and total bilirubin abnormalities (≤2%); one patient (IM) discontinued DCV+ASV for aminotransferase elevations, nausea and jaundice (all reversible); one patient PD) discontinued DCV+ASV for a fatal AE unrelated to treatment. Conclusions: These data demonstrate that DCV+ASV is a highly efficacious and well tolerated treatment for treatment-naive HCV GT 1b-infected patients. Those treated immediately with DCV+ASV achieved a 92% SVR12 rate which was unaffected by factors known to attenuate response to interferon.
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