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RISS 인기검색어
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- 저자 : ( Bruce Kreter ) (검색결과 1 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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