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RISS 인기검색어
- 검색키워드
- 저자 : ( Macky Natha ) (검색결과 2 건)
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( Meghan E. Sise ),( Naim Alkhouri ),( Brian Borg ),( Sooji Lee ),( Thomas Mcquaid ),( Joseph Llewellyn ),( Macky Natha ),( Shampa De-oertel ),( Diana M. Brainard ),( Marc Carp ),( Michael Fuchs ),( H 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Little is known about the safety and efficacy of LDV/SOF in patients with advanced chronic kidney disease (CKD) with eGFR ≤ 30 ml/min or on hemodialysis. Yet, off-label use of LDV/SOF in this population occurs. Methods: Providers proactively reporting such off-label use to Gilead Sciences were asked to submit de-identified case reports. Demographics, clinical characteristics at baseline, during, and after LDV/SOF treatment, and adverse events were collected. Summary statistics and paired sample t-tests are presented. Results: Twenty-one case summaries were submitted. Median Age was 59 (range 26-71). Eleven patients (52%) were black, 20 had genotype 1 (13-1a, 4-1b) and one patient had genotype 3. Median pretreatment viral load was 1,680,000 IU (range 133,000-37,200,000 IU). Twelve patients (56%) were on hemodialysis and 9 had CKD Stage 4 (eGFR 15-29 ml/min), 13 (62%) had cirrhosis, 11 (50%) had diabetes, 5 had history of organ transplantation (4 kidney, 1 liver). All patients received full dose LDV/SOF for 12 weeks with one patient also receiving 200 mg Ribavirin every other day in combination. Eight adverse events were reported; 2 patients (10%) with anemia, 1 case of insomnia, nausea/vomiting, headache, and chest pain (5%) each. Of the 9 patients with CKD stage 4, 2 experienced an increase in eGFR and 5 a decrease in eGFR post treatment. All 21 patients achieved SVR 12 (100%). No patient discontinued treatment due to an adverse event. Conclusions: In this small case series describing the use of ledipasvir/sofosbuvir in Patients with Advanced Chronic Kidney Disease: 62% had cirrhosis, 52% had diabetes mellitus, and 57% were on hemodialysis. All 21 patients achieved SVR12 including 12 patients on hemodialysis. LDV/SOF was relatively well tolerated and there were no treatment discontinuations. Most patients had stable renal function before and after treatment with LDV/SOF.
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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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