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- 저자 : ( Bibin George ) (검색결과 1 건)
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( Anuj Gaggar ),( Bibin George ),( Stephen Munn ),( Hongyuan Wang ),( Vithika Suri ),( John Flaherty ),( Ed Gane ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Chronic Hepatitis B(CHB) remains a leading indication for orthotopic liver transplantation(OLT) worldwide. Common complications following OLT include renal dysfunction second ary to perioperative renal injury and post-operative nephrotox icity from calcineurin inhibitors; osteoporosis is also observed secondary to preoperative malnutrition and post-operative corticosteroids. In this setting, antiviral prophylaxis to prevent recurrent HBV infection with TAF may have advantages over TDF due to its improved renal and bone safety profile. Methods: In this Phase 2 study (NCT02862548), LT recipients with stage 2 or greater CKD and receiving antiviral prophylaxis with TDF were randomized 1:1 to either receive TAF 25 mg or continue TDF . The primary efficacy analysis was the percent of patients who maintained viral suppression at Week 24. Key pre-specified secondary safety endpoints were changes in hip and spine BMD, changes in sCr, estimated GFR and direct GFR assessment over 48 weeks. Results: 51 patients were randomized and treated at a single site in New Zealand. Baseline characteristics included: mean age 60 years, 75% males, 53% Pacific Islander and mean baseline eGFRCKD-EPI 52mL/min/1.73m2 with 53% of patients with <50mL/min/1.73m2. The median baseline surface area corrected GFRCr-EDTA was 58 mL/min/1.73m2. The median interval since transplantation was approximately 9 years. Of the 47 patients that have reached Week 12, all patients maintained viral suppression. There were no treatment discontinuations and serious adverse events were numerically lower in TAF arm compared to the TDF arm. Switching to TAF treatment resulted in a trend toward improved sCr levels (median change: -0.07 for TAF vs. -0.02 for TDF; P=0.09) and improved eGFRCKD-EPI (median change: 2.7 for TAF vs. 0.8 for TDF; P=0.14) as early as week 12 (Figure 1). Conclusions: Early after switching from TDF to TAF in LT recip ients, viral suppression is maintained while smaller changes in renal function were observed.
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