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- 저자 : ( Gregory Camus ) (검색결과 2 건)
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( Christoph Sarrazin ),( Curtis L. Cooper ),( Michael P. Manns ),( Rajender Reddy ),( Kris Kowdley ),( Sooji Lee ),( Hadas Dvory-Sobol ),( Evguenia Svarovskia ),( Ross Martin ),( Gregory Camus ),( Bri 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: The pangenotypic combination of sofosbuvir (SOF) /velpatasvir (VEL)/voxilaprevir(VOX), inhibit distinct HCV targets, the NS5B polymerase, the NS5A protein, and NS3/4A protease, respectively. In Phase 3 studies, SOF/VEL/VOX administered for 12weeks demonstrated a 96% SVR12 rate in NS5A inhibitor-experienced patients in POLARIS-1, and a 97% SVR12 rate in DAA-experienced patient who had not previously received an NS5A inhibitor in POLARIS-4. Here, we evaluate the effect of baseline resistance associated substitutions (RASs) on treatment outcome and the emergence of RASs in patients who experienced virologic failure. Methods: NS3, NS5A, and NS5B deep sequencing was performed at baseline for all patients and at the time of virologic failure. NS3 and NS5A class RASs as well as VOX or VEL-specific RASs that confer >2.5-fold changes in EC50 were evaluated. Results: In POLARIS-1, 79% of NS5A inhibitor-experienced patients (205/260) had baseline NS3 and/or NS5A class RASs. Of these, 75% (196/260) had baseline NS5A RASs, the most common RASs. The SVR12 rates were similar in subjects with or without NS3 and/or NS5A class RASs, and with or without VOX or VEL-specific RASs(Table 1). RASs at NS5A position Y93 were present in 25% of patients, of whom 63(95%) achieved SVR12; all patients with ≥2 NS5A RASs achieved SVR12 (n=77). 95%(18/19) of patients with NS5B nucleoside inhibitor(NI) RASs achieved SVR12; 2 patients had S282T at baseline and achieved SVR12. In POLARIS-4, the overall prevalence of baseline NS3 and/or NS5A class RASs was 47%(83/178) and all achieved SVR12. All patients with. Conclusions: Baseline RASs had no impact on response in DAA-experienced patients following treatment with SOF/VEL/VOX for 12 weeks. Viral relapse was not associated with emergence of viral resistance.
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( Chun-Jen Liu ),( Wan-Long Chuang ),( I-Shyan Sheen ),( Horng-Yuan Wang ),( Chi-Yi Chen ),( Kuo-Chih Tseng ),( Ting-Tsung Chang ),( Benede tta Massetto ),( Jenny Yang ),( Gregory Camus ),( Fangqiu Zh 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Patients co-infected with HCV and HBV have more rapid progression and worse outcomes than mono-infected patients. Taiwan has among the highest prevalence of chronic HCV/HBV coinfection in Southeast Asia. This study evaluated the safety and efficacy of an all-oral treatment with ledipasvir(LDV)/sofosbuvir(SOF) for 12 weeks in chronic HCV and HBV coinfection. Methods: Patients with or without compensated cirrhosis chronic HCV GT1/GT2 and HBV (HBsAg+) treatment naïve were enrolled into open-label, receiving LDV 90 mg/SOF 400 mg(QD) for 12 weeks. The primary efficacy endpoint is SVR12. HBV DNA was monitored at all study visits and it will be monitored for 2 years post-treatment. Results: A total of 111 patients (68[61%] with GT1 and 43[39%] with GT2) were enrolled and treated. The majority were female(62%), treatment naive(67%), and non-cirrhotic(85%), with a mean age of 55 years and mean BMI of 24.5kg/m2. All but one was HBeAg negative. Mean baseline HBV DNA was 2.1 log10IU/mL. SVR4 was 100%(111/111). The mean change in HBV DNA ranged from -0.06 log10IU/mL at week 1 to +0.49 log10IU/mL at follow-up visit 4; HBV DNA kinetics are shown in Fig 1. 60(54%) patients had an increase in HBV DNA> 10 x BL or became HBV DNA > LLOQ. No patients had ALT ≥ 2 X baseline. No patients discontinued treatment due to adverse events (AEs). Three patients had serious AEs(optic neuritis, post procedural bleeding and duodenal ulcer bleeding; none was considered drug related). Conclusions: In chronic HCV/HBV infection patients, LDV/SOF for 12 weeks resulted in an SVR4 rate of 100%. Although most patients had an increase in HBV DNA during treatment, this was not associated with ALT elevations ≥2 X baseline, and no patients started HBV therapy to date. This all-oral, interferon-free regimen was well tolerated, supporting its potential as a treatment option for HCV/HBV co-infected patients.
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