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RISS 인기검색어
- 검색키워드
- 저자 : ( Florin A Caruntu ) (검색결과 2 건)
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( Byoung Kuk Jang ),( Edward Gane ),( Wai Kay Seto ),( Harry La Janssen ),( Florin A Caruntu ),( Hyung Joon Kim ),( Dzhamal Abdurakhmanov ),( Shuhei Nishiguchi ),( Andrzej Horban ),( Ho Bae ),( John F 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Tenofovir alafenamide (TAF), a new prodrug of tenofo vir (TFV), is now a preferred treatment in the 2017 EASL HBV Guidelines, and may be particularly useful in patients with risk factors for TDF associated renal and bone effects. We assessed the 1 year safety and efficacy in CHB patients with TDF risk fac tors who were switched from TDF to TAF. Methods: In two identically-designed Phase 3 studies, HBeAg(+) and HBeAg(-)patients were randomized 2:1 to TAF 25 mg or TDF 300 mg and treated in a double- blind fashion for 96 weeks; all patients received open-label (OL) TAF for an additional 48 weeks (through Week 144). Renal and bone safety parameters, and antiviral efficacy (HBV DNA < 29 IU/mL) and ALT normalization were assessed in the subset of switch patients with baseline risk factors for TDF use: Age >60 years, osteoporosis of hip or spine, ³Stage 2 CKD (GFRCG < 90 mL/ min), albuminurina (UACR >30 mg/g), hypophosphatemia (PO4 <2.5 mg/dL), or presence of comorbidities (e.g. HTN, DM). Results: Of 1298 patients randomized and treated in the 2 studies, 540(42%) switched to open- label TAF at Week 96 (TAF<sup>®</sup>TAF 360; TDF<sup>®</sup>TAF 180), of which 284(53%) patients had at least 1 TDF risk factor at baseline; 123(23%) patients had ³2 risk factors. Baseline demographics and disease characteristics were similar between treatment groups. At Week 144, signifi cant improvements in renal (sCr, eGFRCG) parameters, hip and spine BMD were observed and summarized in the table. Anti viral efficacy was maintained at Week 144 in both groups and in TDF patients who switched to TAF, increased rates of ALT normalization were seen. Conclusions: In CHB patients with risk factors for potential TDF toxicity, switching from TDF to TAF resulted in improved bone and renal safety parameters while efficacy was maintained in this subgroup at one year.
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( Hyung Joon Kim ),( Wan Long Chuang ),( Kosh Agarwal ),( Jae Seok Hwang ),( Florin Caruntu ),( Florence Wong ),( Hie Won Hann ),( John Flaherty ),( Audrey Lau ),( Anuj Gaggar ),( Vithika Suri ),( Shu 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: In Phase 3 studies in CHB patients the efficacy of TAF was found smaller changes in renal parameters compared with TDF treatment. This benefit was particularly evident in patients with risk factors for renal impairment.Here, we present renal safety results after 96 weeks of treatment. Methods: In Phase 3 studies (HBeAg positive patients [N=873] and HBeAg negative patients [N=425]), patients were randomized 2:1 to TAF 25 mg QD or TDF 300 mg QD, and treated for 144 weeks. Renal parameters including estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault method were evaluated. Chronic kidney disease (CKD) staging was categorized by the National Kidney Foundation KDOQI guidelines. Evaluated risk factors for kidney disease included older age (age ≥ 50), female gender, renal impairment (eGFR <90mL/min) and presence of comorbidities (hypertension, cardiovascular disease and diabetes). Urine markers of renal glomerular dysfunction (urine protein and albumin to creatinine ratio) and tubular dysfunction (retinol binding protein (RBP) and beta-2 microglobulin [B2M] to creatinine ratio) were serially assessed. Results: Patients treated with TAF continued to show smaller changes in serum creatinine (p=0.001) and eGFRCG (p<0.001) at 96 weeks. Similarly, median percentage changes in renal tubular markers, were also smaller in TAF-treated patients compared with TDF patients at Week 96; RBP/Cr (p<0.0001) and B2M/Cr (p<0.0001). A lower percentage of patients experienced ≥1 stage worsening in NKF CKD stage when treated with TAF compared with TDF at Week 96 overall and when evaluated by risk factors for kidney disease.Furthermore, CKD stage progression increased disproportionately in the TDF group in patients with ≥2 risk factors (Table). Conclusions: Treatment with TAF for 96 weeks continued to be associated with smaller changes in renal parameters compared with TDF treatment. The benefits of TAF are particularly evident in patients with risk factors for kidney disease.
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