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RISS 인기검색어
- 검색키워드
- 저자 : ( Claire Fournier ) (검색결과 2 건)
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( Jeong Heo ),( Harry L.A. Janssen ),( Young-suk Lim ),( Edward J. Gane ),( Claire Fournier ),( Sang Hoon Ahn ),( Owen Tsang ),( Wan-long Chuang ),( Aric Josun Hui ),( Magdy Elkhashab ),( Chi-yi Chen 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: TAF, a novel tenofovir prodrug, has demonstrated noninferior efficacy to TDF with superior bone and renal safety in virally suppressed CHB patients with eGFR (by Cockcroft-Gault; eGFR<sub>CG</sub>) ³50 mL/min when switched from TDF. The efficacy and safety of virally suppressed patients on TDF with renal impairment who were switched to TAF were evaluated in this Phase 2 study. Methods: CHB patients with renal impairment taking TDF for ³48 weeks and virally suppressed for ³6 months with HBV DNA <20 IU/mL at screening were enrolled into 2 cohorts: 1) moderate-severe renal impairment (eGFR<sub>CG</sub> 15 to <60mL/min) and 2) ESRD (eGFR<sub>CG</sub> <15 mL/min) patients on chronic HD. All patients were switched to TAF 25 mg QD for 96 weeks. Co-primary endpoints were proportion with HBV DNA <20 IU/mL and graded adverse events (AEs)/lab abnormalities at Week 24. Results: 93 patients (Mod-severe impairment 78; ESRD 15) were enrolled from 26 sites in 8 countries. Median age was 65 years, 74% male, 77% Asian, 83% HBeAg-negative, up to 60% had low BMD at hip and/or spine, and 60% and 24% had a history of HTN and/or diabetes, respectively. Key efficacy/safety results at Week 24 are summarized in the Table. All patients on treatment at Week 24 maintained HBV DNA <20 IU/mL and a high proportion had normal ALT levels. Relative to baseline levels, switching to TAF from TDF resulted in increases in hip/spine BMD, decreases in bone turnover markers, as well as increases in eGFR<sub>CG</sub> and decreases in renal tubular markers. TAF was well tolerated with few having Grade 3 or 4 AEs (8%) and no discontinuations due to AEs. Conclusions: In renally-impaired CHB patients, including ESRD patients on HD, viral suppression was well maintained and the bone and renal safety were improved 24 weeks after switching from TDF to TAF.
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( Sang Hoon Ahn ),( Young-Suk Lim ),( Pietro Lampertico ),( Ho Bae ),( Wan-Long Chuang ),( Jeong Heo ),( Yi-Hsiang Huang ),( Aric Josun Hui ),( Chun-Yen Lin ),( Claire Fournier ),( Chien-Hung Chen ),( 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: TAF, a novel tenofovir (TFV) prodrug, has greater plasma stability, more targeted delivery of TFV to hepatocytes, and reduced circulating levels of TFV compared to TDF. We evaluated efficacy and safety when virally suppressed CHB (Chronic Hepatitis B) patients with hepatic impairment were switched to TAF. Methods: In this Phase 2 study (NCT03180619) CHB patients with a ChildTurcottePugh (CTP) score of ³7 and £12 at screening (or past history of CTP ³7 and any score £12 at screening) who were taking TDF and/or other OAVs for ³48 weeks, with HBV DNA <LLOQ for ³24 weeks and <20 IU/mL at screening were eligible. All patients were switched to TAF 25 mg QD and treated for 96 weeks. The co-primary endpoints were proportion with HBV DNA <20 IU/mL and graded adverse events (AEs)/lab abnormalities at Week 24. Results: 31 patients were enrolled at 18 sites in 7 countries. At baseline, 19 (61%), 9 (29%) and 3 (10%) were CTP Class A, B, or C, respectively. Median age was 57 y (19% ³65 y), 68% male, 81% Asian, 90% HBeAg-negative, median fibrotest score 0.81, and median eGFR<sub>CG</sub> 98 mL/min; up to 48% had low BMD at hip and/or spine, and 68% had prior TDF exposure. Key efficacy/safety results at Week 24 are summarized in the Table. All patients had HBV DNA <20 IU/mL and a high proportion had normal ALT. Switching to TAF resulted in increases in hip/spine BMD, decreases in bone turnover markers, an increase in eGFR<sub>CG</sub> with decreases in tubular markers. TAF was well tolerated with few having Grade 3 or 4 AEs (2 patients) and no discontinuations for and AE. <sup>a</sup>HBV DNA results are missing=failure. <sup>b</sup>ALT normal is the proportion with ALT ≤ULN at Week 48, regardless of baseline ALT level; <sup>c</sup>ULN 35 U/L males, 25 U/L females; <sup>d</sup>Patients with ALT >ULN at baseline; <sup>e</sup>HBeAg-positive at baseline. <sup>f</sup>Serum C-type collagen sequence (bone resorption marker); <sup>g</sup>Serum procollagen type 1 N-terminal propeptide (bone formation marker); <sup>h</sup>Urine retinol binding protein/creatinine (tubular marker); <sup>i</sup>Urine beta-2 microglobulin/creatinine (tubular marker). BMD, bone mineral density by DXA scan; sCr, serum creatinine; PO<sub>4</sub>, serum phosphorus; eGFR<sub>CG</sub>, estimated creatinine clearance (Cockcroft-Gault method) Conclusions: In CHB patients with hepatic impairment switched to TAF from TDF or other OAVs, viral suppression was well maintained and improved bone and renal safety was seen at Week 24.
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