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RISS 인기검색어
- 검색키워드
- 저자 : ( Peter Buggisch ) (검색결과 3 건)
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( Peter Buggisch ),( Jorg Peterson ),( Stefan Mauss ),( Kris Kowdley ),( Micheal Curry ),( Peter Ruane ),( Dani Ain ),( Naoky Tsai ),( Yoori Lee ),( Edward Eggleton ),( Macky Natha ),( Bruce Kreter ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The optimal duration of therapy to achieve SVR depends on multiple factors. In a post-hoc analysis of the Phase 3 ION-3 (treatment-naive (TN), non-cirrhotic (NC) patients) 8 week of LDV/SOF data, a viral load (VL) <6M was shown to be the best predictor of SVR. Real world effectiveness (RWE) is often different from Phase III trials and there is a need to understand real-world 8 week regimens in a broader spectrum of patients. Methods: RWE 8 week LDV/SOF data is emerging from multiple single- center and multicenter retrospective and prospective cohorts. In this analysis, the phase-3 ION-3 data is compared with data from several diverse real world populations and one post-marketing investigator sponsored HIV/HCV trial. Patient demographics, characteristics, SVR12 and discontinuation data has been compared. Results: The ION-3 post-hoc analysis reported 123 patients who were TN, NC and VL<6M and treated with 8 weeks of LDV/SOF. Mean age was 52, 22% black, 72% GT1a; the SVR12 was 97% (119/123). The overall SVR12 rate from six diverse real world and post marketing cohorts was also 97% (638/658). There was no significant impact of HCV genotypes or subtypes (GT1a, 1b versus GT4), prior treatment history, presence or absence of cirrhosis, high viral load (HCV VL>6M), or HIV/HCV co-infection. All response rates are detailed in Figure1. Conclusions: LDV/SOF for 8 weeks yielded high SVR rates in ION-3. Analysis of RWE data from several diverse and heterogeneous cohorts from the US & EU show SVR outcomes that were consistent with the ION-3 results and supports the use of 8 weeks LDV/SOF in treatment- naive, non-cirrhotic GT1 patients with a baseline HCV VL <6M and possibly in other populations including HIV/HCV co-infected patients. Discontinuation rates were low despite diverse patients and clinical settings. Data from the TARGET and TRIO cohorts also suggests that the 8-week regimen is underutilized.
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( Peter Buggisch ),( Ana Moreno ),( Vasily Isakov ),( Lisa Backus ),( Dani Ain ),( Peter Ruane ),( Juan Gonzalez ),( Sooji Lee ),( Sarjita Naik ),( Swarup Mehta ),( Jina Lee ),( Michael Mertens ),( Ma 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: The AASLD/IDSA/IAS-USA Guidance and EASL Recommendations on Treatment of Hepatitis C state that HIV/HCV coinfection should be treated the same as HCV monoinfection with careful monitoring of antiretrovirals. Real world cohorts (RWC) have demonstrated excellent efficacy of LDV/SOF for 8weeks in HCV monoinfected patients. The aim of this study was to describe the effectiveness of the STR of LDV/SOF for 8 weeks in HCV GT 1 patients with HIV/HCV coinfection in RWC. Methods: Real world effectiveness data of LDV/SOF for 8weeks in HIV/HCV coinfection is emerging from multiple cohorts. In this descriptive analysis, data from two prospective studies, one investigator- sponsored, 1 registrational trial, and three retrospective RWC of LDV/SOF for 8weeks in HIV/HCV co-infected patients were compared. The prospective trials include data from Ain et al (investigator sponsored) and Isakov et al (registrational trial). The RWC include the Deutsches Hepatitis C-Register, Madrid Coinfection Registry (Madrid-CoRe), and Veterans Affairs HCV Registry. Baseline characteristics and efficacy were analyzed. Results: The majority of the 279 patients included in this descriptive analysis were GT1, treatment naive (TN), noncirrhotic (NC), and had a HCV viral load <6million. The prospective cohorts enrolled 79 patients with the following baseline characteristics: mean age (43 years), male (74%), white (78%), and GT1a (55%). The RWC studies assessed enrolled 200 patients with the following overall baseline characteristics: mean age (53 years) male (79%), white (98%), and GT1a (82%) in those that reported demographics. The overall SVR12 from five diverse real world and post-marketing cohorts was 94% (263/279). The individual study results are presented in Table 1. Conclusions: This analysis of diverse cohorts from the EU and US yielded high SVR rates similar to SVR rates seen in multiple RW moninfected cohorts and supports the use of 8 weeks of LDV/SOF in TN, NC GT 1 HIV/HCV coinfected patients with a baseline HCV viral load <6 million.
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( Paul Kwo ),( Stefan Zeuzem ),( Steven L. Flamm ),( Myron Tong ),( John M Vierling ),( Stephen Pianko ),( Peter Buggisch ),( Victor de Lédinghen ),( Robert H. Hyland ),( Xiaoru Wu ),( Evguenia S. Sva 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: DAAs provide safe and highly efficacious therapies for HCV infection. However, the small proportion of patients who do not achieve a sustained virologic response with DAA-based regimens represent a population with an unmet medical need. Sofosbuvir(SOF) and velpatasvir(VEL) are pangenotypic inhibitors of the HCV NS5B and NS5A proteins, respectively, and voxilaprevir(VOX) is a pangenotypic HCV NS3/4A protease inhibitor. This study evaluates treatment with a SOF/VEL/VOX for 12weeks and a SOF/VEL for 12weeks as salvage regimens in DAA-experienced patients who had not previously received an NS5A inhibitor. Methods: Patients with genotypes 1-3 were randomized 1:1 to receive open-label SOF/VEL/VOX or SOF/VEL for 12weeks, stratified according to genotype and cirrhosis status. Patients of all other genotypes were assigned to receive SOF/VEL/VOX for 12weeks. DAA-experienced patients who previously were treated with an NS5A inhibitor or with only an NS3/4A protease inhibitor in combination with ribavirin and Peg-IFN were excluded. The primary endpoint evaluates the superiority of the SVR12 of each treatment to a prespecified goal of 85%. Results: Of the 333 patients who were randomized and treated, 77% were male, 19% had the IL28B CC genotype, 46% had compensated cirrhosis and 43% had genotype 1 infection. Most patients had prior DAA experience with either an NS5B inhibitor alone(73%) or an N5SB inhibitor and an NS3/4A protease inhibitor(25%); the most common prior treatment regimens were SOF with ribavirin ±Peg-IFN and SOF combined with simeprevir. Treatment was well tolerated.No SAE was assessed to be attributable to study drug. Overall, SVR12 was achieved in 97%(177/182) of patients treated with SOF/VEL/VOX and 90%(136/151) patients treated with SOF/VEL. SOF/VEL/VOX met the prespecified 85% SVR12 performance goal(p<0.001); SOF/VEL did not. Conclusions: SOF/VEL/VOX for 12 weeks provides a safe, well tolerated and effective retreatment options for patients who did not previously achieve SVR following treatment with non-NS5A inhibitor-containing DAA regimens.
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