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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.