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- 저자 : ( Audrey Lau ) (검색결과 3 건)
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( Brunetto ),( Carla Coffin ),( Audrey Lau ),( Shuyuan Mo ),( John F. Flaherty ),( Anuj Gaggar ),( G Mani Subramanian ),( Mindie H. Nguyen ),( Selim Gurel ),( Alexander Thompson ),( Edward J. Gane ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Suppression of the HBV in women of childbearing potential (WOCBP) has important implications in preventing transmission of HBV from mother to infant. Antiviral therapy that reduces HBV DNA to < 2x105 IU/mL at delivery in mothers can substantially reduce the risk of perinatal transmission. We evaluated the viral kinetics of TAF and TDF in WOCBP. Methods: : In two Phase 3 studies (HBeAg positive and negative patients), 1301 patients (37% female) were randomized (2:1) to receive TAF 25 mg QD or TDF 300 mg QD. All patients were required to have HBV DNA >2x104 IU/mL at screening and serum ALT >2 times AASLD criteria.WOCBP were defined as nonmenopausal females 18 years or older without history of hysterectomy, bilateral oophorectomy, or ovarian failure. For this subanalysis, patients were stratified by baseline HBV DNA levelsand the endpoints were virologic suppression to HBV DNA <29 IU/mL or < 2x105 IU/mL. Results: 365(76%) female were identified as WOCBP with 118 (32%) having HBV DNA >1x108 IU/mL at baseline. Suppression rates were generally similar between TAF and TDF groups and within viral load strata for HBeAg positive and negative patients. After 12 weeks of treatment with TAF or TDF, 77% of WOCBP with baseline HBV DNA <2x105 IU/mL had full suppression to <29 IU/mL compared to 1% of those at the highest baseline viral load (Figure A). By Week 24, 54% of all WOCBP had achieved complete viral suppression. Of WOCBP with baseline viral load ≥2x105 IU/mL (n=305), 76%, 89%, and 93% achieved viral load reduction to <2x105 IU/mL by Weeks 4, 8, and 12, respectively (Figure B). Conclusions: After 12 weeks of treatment the majority of WOCBP had HBV DNA to <2x105 IU/mL. In women with higher baseline viral loads, longer treatment duration may be necessary to achieve viral suppression below recommended thresholds.
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( Scott Fung ),( Wan Long Chuang ),( Shuhei Nishiguchi ),( Wai Kay Seto ),( Won Young Tak ),( Elke M. Erne ),( Maciej,Jablkowski ),( Vyacheslav Morozov ),( Audrey H. Lau ),( Vithika Suri ),( John F. F 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Compared with TDF, smaller declines in bone mineral density (BMD) were demonstrated with TAF vs. TDF over 48 weeks. Presented here are bone safety results at Week 96. Methods: In two Phase 3 studies, 1301 patients were randomized (2:1) to receive TAF 25 mg QD or TDF 300 mg QD. Dual energy X-ray absorptiometry (DXA) scans were evaluated for mean percent change from baseline and by the proportion with >3% declines in hip and spine BMD. BMD changes were also assessed in the subset of patients at higher risk for bone loss (females, advanced age [≥ 50 y], Asian race, eGFR <90 mL/min). Serum markers of bone resorption (CTX) and formation (osteocalcin, bone-specific alkaline phosphatase, P1NP) were also assessed serially. Results: Patients with TAF experienced lesser declines in hip and spine BMD over 96 weeks(Table, p< 0.001). A higher proportion of subjects treated with TDF also experienced >3% declines in hip and spine BMD compared with TAF-treated patients (Table, p < 0.0001). Greater declines in BMD were seen in patients with >1 risk factor for bone loss at baseline; however, in comparison to TDF, the proportion with >3% declines in hip and spine BMD were lower in the TAF group (p<0.0001 for all) and were less impacted by the presence of multiple risk factors (Table, p< 0.005 for all). By multivariate analysis baseline predictors for >3% decline in hip or spine BMD at Week 96 were: treatment with TDF, female gender, and older age. The smaller changes in BMD seen with TAF were associated with minimal changes in markers of bone turnover compared with TDF. Conclusions: Through 96 weeks, TAF was associated with had less impact on BMD and bone parameters compared to TDF. The magnitude of these differences was most pronounced in those at higher risk for bone loss.
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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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