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( Ki Tae Yoon ),( Seto Wai-kay ),( Kao Jia-horng ),( Lim Seng-gee ),( Peng Cheng-yuan ),( Kwan Soo Byun ),( Inokuma Tetsuro ),( June Sung Lee ),( Flaherty John ),( Yee Leland J ),( Jump Belinda ),( Se 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Background: Tenofovir alafenamide (TAF) has shown similar efficacy to tenofovir disoproxil fumarate (TDF) with better bone and renal safety in 2 Phase 3 trials through 96 weeks. After a protocol amendment, some TDF patients received 96 weeks while others received 144 weeks of TDF treatment before rolling over to open-label (OL) TAF. Aim: To examine whether duration of prior TDF treatment impacted changes in bone and renal parameters after 48 weeks of OL TAF treatment in the subset of East Asian (EA) patients with chronic HBV. Methods: Among 190 EAs randomized to TDF, changes in bone mineral density (BMD) by DXA scans and renal parameters were assessed from OL baseline to Week 48 following switch to OL TAF. Results: At Week 48, mean (SD) percent changes from OL baseline in hip-BMD were +0.92 (2.32) and +0.79 (2.47) and in spine-BMD were +1.52 (2.68) and +2.27 (3.51) for DB-TDF-144wks and DB-TDF-96wks, respectively. Similarly, median (Q1, Q3) changes from OL baseline in creatinine clearance (eGFR<sub>CG</sub>) were +2.4 (-4.2, +10.8) and +3.0 (-3.0, +8.4) mL/min for DB-TDF-144wks and DBTDF-96wks, respectively. Similar trends in BMD and eGFR<sub>CG</sub> changes were seen in non-EAs. Following switching to OL TAF, improvements in bone and renal biomarkers were also observed. Conclusions: In EA patients who switched to TAF from TDF, improvements were seen in bone and renal parameters.