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RISS 인기검색어
- 검색키워드
- 저자 : ( Mingxiang Zhang ) (검색결과 2 건)
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( Lai Wei ),( Mingxiang Zhang ),( Min Xu ),( Wan-Long Chuang ),( Wei Lu ),( Wen Xie ),( Zhansheng Jia ),( Guozhong Gong ),( Yueqi Li ),( Si Hyun Bae ),( Yong-Feng Yang ),( Qing Xie ),( Shumei Lin ),( 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The efficacy/safety of daclatasvir (pan-genotypic NS5A inhibitor) plus asunaprevir (NS3 protease inhibitor) in interferon (± ribavirin)- ineligible/intolerant patients with chronic HCV genotype-1b infection from mainland China, Korea and Taiwan was investigated in a phase 3, open-label study. Methods: Patients received daclatasvir 60 mg (tablet) once daily plus asunaprevir 100 mg (soft capsule) twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment Week 24 (SVR24). Results: This study treated 159 patients from mainland China (80%), Korea (11%) and Taiwan (9%), including patients with cirrhosis (33%), IL28B non-CC genotypes (40%), and aged ≥70 years (4%). SVR24 was achieved by 91% of patients (100% concordance with SVR12) and was similarly high in all subgroups, e.g. cirrhotic patients (90%), and in patients from mainland China (91%), Korea (94%) and Taiwan (87%). SVR24 was higher in patients without baseline NS5A (L31M/Y93H) resistance-associated variants (RAVs) (n=137/139 [99%]), regardless of the presence (98%) or absence (99%) of cirrhosis, and lower in patients with baseline NS5A RAVs (n=8/19 [42%]). All serious adverse events (AEs) (n=5/159 [3.1%]), grade 4 laboratory abnormalities (n=3/159 [1.9%]) and deaths (n=1/159 [0.6%]) that occurred on-treatment were unrelated to the study drugs; two patients discontinued due to AEs. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a high SVR24 rate of 91%, rising to 99% in patients without baseline NS5A RAVs, and was generally well tolerated in cirrhotic and non-cirrhotic interferon (± ribavirin)-ineligible/intolerant patients with HCV genotype-1b infection from mainland China, Korea and Taiwan.
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( Wan-long Chuang ),( Yan Luo ),( Jeong Heo ),( Gui-qing Wang ),( Ming-lung Yu ),( Yoon Jun Kim ),( Qing Xie ),( Cheng-yuan Peng ),( Mingxiang Zhang ),( Yan Huang ),( Wenjing Lu ),( Linda M. Fredrick 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Hepatoprotective medications (HPMs) are commonly used in patients with chronic liver disease, especially across Asia. The phase 3 ONYX-I and ONYX-II studies evaluated the safety and efficacy of the 3-DAA regimen of ombitasvir and paritaprevir/ritonavir (OBV/PTV/r) plus dasabuvir (DSV) ± ribavirin (RBV) in an exclusively HCV GT1b-infected Asian population. This post-hoc analysis evaluated the impact of HPM use in patients treated with OBV/PTV/r + DSV ± RBV in these studies. Methods: ONYX-I and ONYX-II enrolled patients in China, South Korea and Taiwan. SVR12, treatment-emergent adverse events (AEs), and alanine transaminase (ALT) normalization, as well as mean changes in ALT over time were assessed in patients using vs not using HPMs. HPM use defined as all medications administered during any treatment period. Results: Overall, 11% (36/325) of non-cirrhotic and 57% (59/104) of cirrhotic patients were receiving HPMs, with ursodeoxycholic acid being the most commonly used in both non-cirrhotic (5.2% [17/325]) and cirrhotic (14.4% [15/104]) patients. SVR12 rates were high (99.7- 100%) in both non-cirrhotic and cirrhotic patients irrespective of HPM use. The regimen was generally well tolerated, with low rates of SAEs and AEs leading to treatment discontinuation (Table). Of patients with ALT above normal at baseline (BL), 100% vs 95% of non-cirrhotic and 98% vs 89% of cirrhotic patients using or not using HPMs, respectively, had normal ALT values at end of treatment (EOT). Mean ALT levels during treatment declined rapidly and similarly with and without HPM use; mean changes from BL to EOT were -38.8 and -37.0 U/L, respectively, in non-cirrhotic and -54.2 and -66.6 U/L, respectively, in cirrhotic patients. Conclusions: OBV/PTV/r + DSV ± RBV achieved high SVR12 and was generally well tolerated regardless of HPM use. HPM use had no impact on the safety profile of OBV/PTV/r + DSV therapy in Asian HCV infected subjects.
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