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- 저자 : ( Marinho Rt ) (검색결과 1 건)
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( Welzel Tm ),( Isakov V ),( Trinh R ),( Streinu-cercel A ),( Dufour J-f ),( Marinho Rt ),( Moreno C ),( Liu L ),( Xie W ),( Tatsch F ),( Shulman Ns ),( Craxi A ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Ombitasvir (OBV), paritaprevir with the pharmacokinetic enhancer ritonavir (PTV/r), and dasabuvir (DSV) without ribavirin (RBV) has demonstrated sustained virologic response at 12 weeks post-treatment (SVR12) rates of 99-100% in HCV GT1b-infected patients without cirrhosis. In GT1b-infected patients with cirrhosis, OBV/PTV/r + DSV with RBV for 12 weeks achieved an SVR12 rate of 98.5%. Regimens with RBV are associated with higher rates of adverse events (AEs), primarily anaemia, and a higher pill burden. This post hoc, pooled analysis from 5 Phase 3/3b trials investigated the efficacy and safety of the RBV-free, 12-week regimen of OBV/PTV/r + DSV among HCV GT1b-infected patients with or without compensated cirrhosis. Methods: Data for patients treated without RBV in 5 trials (GT1b-infected patients with cirrhosis: TURQUOISE-III; GT1b-infected patients without cirrhosis: PEARL-II, PEARL-III, TOPAZ-II, MALACHITE-I) were pooled and patients were characterised by the presence or absence of compensated cirrhosis at baseline. Treatment-naive and pegylated interferon/RBV-experienced patients were included in the analysis population. Efficacy and safety were assessed in all patients. Comparisons of safety outcomes between groups were analysed using Fisher’s exact test. Results: The pooled analysis included 60 patients with cirrhosis and 521 patients without cirrhosis: 62% and 48% were male, 87% and 91% were white, and 45% and 74% were treatment-naive, respectively. SVR12 with OBV/PTV/r + DSV for 12 weeks was 100% (60/60) and 99% (515/521) in patients with and without cirrhosis, respectively. Three patients without cirrhosis experienced virologic failure. Treatment-emergent AEs and laboratory abnormalities are provided in the following table. Conclusions: In HCV GT1b-infected patients, SVR12 rates with the RBV-free, 12-week regimen of OBV/PTV/r + DSV were very high in patients with and without compensated cirrhosis (100% and 99%). Treatment was well tolerated, with no discontinuations due to an AE, and there were low rates of serious AEs and grade 3/4 laboratory abnormalities.
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