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RISS 인기검색어
- 검색키워드
- 저자 : ( Annette Bruchfeld ) (검색결과 2 건)
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( K. Rajender Reddy ),( David Roth ),( Annette Bruchfeld ),( Peggy Hwang ),( Barbara Haber ),( Bach-yen T. Nguyen ),( Eliav Barr ),( Janice Wahl ),( Wayne Greaves ),( Youngmi Eun ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Decreased estimated glomerular filtration rate (eGFR) has been reported in patients with HCV infection receiving direct-acting antiviral agents. EBR/GZR was safe and efficacious in patients with chronic kidney disease stage 4/5 (CKD 4/5) in the C-SURFER study. The aim of this analysis was to evaluate the impact of EBR/GZR on eGFR in patients with less severe CKD. Methods: We analyzed a pooled dataset of 1689 patients who received EBR/GZR (50 mg/100 mg) with or without ribavirin (RBV) for 8 (n=91, 5%), 12 (n=1238, 73%), 16 (n=211, 12%), or 18 (n=149, 9%) weeks (656 patients [39%] received RBV). Patients were treatment-naïve or treatment-experienced, and included cirrhotics and those with HIV co-infection. Creatinine values were assessed at baseline and ≥1 post-baseline timepoint. eGFR was calculated using the Modified Diet in Renal Disease equation at baseline, end of treatment, and 12 weeks post-therapy. Results: Of the 1689 patients evaluated, 32 had CKD 3 (eGFR < 60 mL/min/1.73 m2 to ≥30 mL/min/1.73 m2) and 1657 had eGFR >60 mL/min/1.73 m2 (Table). Demographics were similar in both groups except for a higher proportion of HIV-co-infected patients in the CKD 3 group (41% vs. 17%). Patients with CKD 3 and those with eGFR >60 mL/min/1.73 m2 at baseline did not show any decrease in eGFR during treatment or follow-up. Conclusions: EBR/GZR did not affect eGFR in patients with pre-existing eGFR >60 mL/min/1.73 m2 or those with CKD3. Treatment duration, RBV co-administration, cirrhosis, or HIV coinfection did not adversely affect renal outcome.
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( Marcello Persico ),( Robert Flisiak ),( Manal Abunimeh ),( Meghan Sise ),( Jun Yong Park ),( Marwan Kaskas ),( Annette Bruchfeld ),( Marcus-alexander Worns ),( Andrea Aglitti ),( Zhenyi Xue ),( Jane 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: The direct acting-antivirals (DAA) glecaprevir (NS3/4A protease inhibitor; developed by AbbVie and Enanta) and pibrentasvir (NS5A inhibitor), coformulated as G/P, are a once-daily, all-oral treatment regimen with high rates of sus tained virologic response at 12 weeks post-treatment (SVR12) and a favourable safety profile indicated for use in patients at any stage of chronic kidney disease (CKD). Here we report pre liminary data from a Phase 3b study assessing the efficacy and safety of 8, 12, and 16 weeks of G/P treatment in patients with chronic hepatitis C virus (HCV) genotype (GT) 1-6 infection and CKD Stage 3b, 4, or 5, including those on dialysis. This study aims: to provide further evidence supporting G/P’s labeled reg imen among patients with moderate or severe CKD, including efficacy of an 8-week G/P treatment duration for patients who are treatment naive and non-cirrhotic. Methods: EXPEDITION-5 (NCT03069365) is an ongoing, Phase 3b, multicenter study evaluating the efficacy and safety of G/P in patients without cirrhosis or with compensated cirrhosis and with CKD. Patients were either treatment-naive or -experienced with interferon (IFN), pegIFN ± ribavirin (RBV), or sofosbuvir (SOF) + RBV ± pegIFN. Prior treatment with a DAA other than SOF was not permitted. Patients had an estimated glomerular filtration rate (eGFR)<45mL/min/1.73 m2 without a history of acute renal failure within 3 months prior to screening. Patients were treated with label (U.S. and E.U.) indicated treatment du ration. Efficacy was evaluated by the percent of patients achiev ing SVR12 (HCV RNA<lower limit of quantification). Safety was assessed in all patients. Results: In total, 101 patients were enrolled with 84, 13, and 4 patients receiving G/P for 8, 12, and 16 weeks, respectively. Demographics for the first 99 patients are as follows: 41 (41%) were female, 72 (73%) were white and 13 (13%) had compen sated cirrhosis. At screening, 7 (7%), 17 (17%), and 75 (76%) patients had CKD stage 3b, 4, and 5, respectively; 73 (74%) patients required dialysis. Safety information identified pruritus, occurring in 14%, as the only adverse events (AEs) reported in ≥ 5% of patients. Grade ≥3 serious and non-serious treat ment-emergent AEs were reported in 5% of patients; none of which were related to G/P or led to treatment discontinuation. To date, 81/84 patients treated with G/P for 8 weeks have achieved SVR12 (2 d/c, 1 missing SVR 12). Overall mITT SVR12 rate of 100 %(98/98). Conclusions: safety data suggest that G/P was safe and well-tolerated. Data confirms the 8-weeks use of G/P in CKD patient with no virologic failures
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