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RISS 인기검색어
- 검색키워드
- 저자 : ( Luisa Stamm ) (검색결과 2 건)
- 무료
- 기관 내 무료
- 유료
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( Eric Lawitz ),( Michael Manns ),( Marc Bourliere ),( Sooji Lee ),( Nelson Cheinquer ),( Luisa Stamm ),( Robert H. Hyland ),( Liyun Ni ),( Hadas Dvory-sobol ),( Diana Brainard ),( Mani Subramanian ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: The pangenotypic fixed-dose combination (FDC) of sofosbuvir (SOF), a HCV NS5B inhibitor, velpatasvir (VEL), a HCV NS5A inhibitor, and voxilaprevir (VOX), a HCV NS3/4A protease inhibitor, is an salvage regimen for direct acting antiviral (DAA)-experienced patients based on the safety and efficacy demonstrated in Phase 2 and Phase 3 trials in this population. Methods: This was a retrospective analysis of data from 454 NS5A inhibitor-experienced patients treated with SOF/VEL FDC+VOX or SOF/VEL/VOX FDC in the Phase 2 and Phase 3 trials. Efficacy was assessed by SVR12 and relapse rates. Safety was assessed by treatment-emergent adverse events (AEs) and laboratory abnormalities. Results: Of 454 NS5A inhibitor-experienced patients treated, 77% were male, 41% had compensated cirrhosis, 86% had NS5A and NS3 baseline resistance-associated substitutions (RASs), 74% had genotype 1 HCV infection. Most patients (53%) had previously been exposed to NS5A inhibitor+NS5B inhibitor, with 39% exposed to NS5A inhibitor+NS3/4A protease inhibitor±NS5B inhibitor and 8% exposed to NS5A inhibitor±another DAA. Overall, the SVR12 rate was 97% with a relapse rate of 2%. The SVR12 rate in patients with compensated cirrhosis was 95% and in patients with baseline RASs was 97%. The SVR12 rates by prior regimen were: NS5A inhibitor+NS5B inhibitor 95%; NS5A inhibitor+NS3/4A protease inhibitor±NS5B inhibitor 99%; and NS5A inhibitor±another DAA 100%. Treatment-emergent RASs were uncommon, present in 3 of 10 patients who relapsed. Only 1 patient (0.2%) discontinued treatment due to an AE. No serious adverse events attributed to study medication were reported. Conclusions: Results in over 450 NS5A inhibitor-experienced patients enrolled in Phase 2 or Phase 3 trials demonstrate that the 3-DAA combination of SOF, VEL and VOX for 12 weeks is a safe, well tolerated and effective treatment for patients who previously failed an NS5A inhibitor-containing regimen, irrespective of the other drugs in the prior treatment.
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( Edward J. Gane ),( Marc Bourliere ),( Stuart C. Gordon ),( Alnoor Ramji ),( Natarajan Ravendhran ),( Tram T. Tran ),( Rob H. Hyland ),( Jie Zhang ),( Hadas Dvory-sobol ),( Luisa M. Stamm ),( Diana M 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: NS5A inhibitors are potent DAAs which are key components of HCV treatment regimens. In combination with other DAAs, NS5A inhibitors provide cure to over 90% of patients. For patients who have failed a regimen with an NS5A inhibitor, there is concern about long-lasting NS5A RASs and currently no approved retreatment option. Sofosbuvir (SOF) and velpatasvir (VEL) are pangenotypic inhibitors of the NS5B and NS5A proteins, respectively, and voxilaprevir (VOX) is a pangenotypic NS3/4A protease inhibitor. This study evaluates treatment with a SOF/VEL/VOX for 12 weeks in patients who previously received an NS5A inhibitor. Methods: Eligible patients received at least 4 weeks of a prior NS5A inhibitor-containing. Those with HCV GT1 were randomized 1:1 to receive SOF/VEL/VOX (400mg/100 mg/100 mg) or matching placebo daily for 12 weeks, stratified by the presence or absence of cirrhosis. Patients of all other GTs were assigned to receive SOF/VEL/VOX for 12 weeks. Those patients assigned to receive placebo were offered deferred treatment with SOF/VEL/VOX for 12 weeks. The primary endpoint evaluated the superiority of SVR12 to a performance goal of 85%. Results: Of 415 patients enrolled and treated with SOF/VEL/VOX, 76% were male, 80% were white, 46% had compensated cirrhosis, and 57% had GT 1infection. The majority of patients had DAA experience with an NS5A inhibitor given in combination with an NS5B inhibitor, and the most common prior NS5A inhibitor was ledipasvir (50%). Treatment with SOF/VEL/VOX was well tolerated. No serious adverse events attributed to study medication were reported. Overall, 253/263 (96%) of patients treated with SOF/VEL/VOX achieved SVR12, which was superior to the prespecified goal of 85% (p<0.001). High SVR12 was achieved across HCV GTs and regardless of selected baseline factors such as cirrhosisand RASs at any position. Conclusions: SOF/VEL/VOX for 12 weeks is a safe, well-tolerated and effective treatment for patients previously failed an NS5A inhibitor-containing DAA regimen, a group that currently has no retreatment option.
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