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( Young-Suk Lim ),( Si-Hyun Bae ),( Sang Hoon Ahn ),( Hyung Joon Kim ),( Won Young Tak ),( Kwan Sik Lee ),( Maria Buti ),( Edward Gane ),( Wai Kay Seto ),( Henry LY Chan ),( Wan-Long Chuang ),( Tatjan 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV),is more stable in plasma and enhances delivery of TFV into hepatocytes while lowering circulating levels of TFV by approximately 90% compared to tenofovir disoproxil fumarate (TDF). Methods: In this Phase 3 study, patients with HBeAg-negative chronic hepatitis B (CHB) were randomized 2:1 to TAF 25 mg QD or TDF 300 mg QD and treated for 96 weeks. After Week 96, patients receive open label TAF for 48 weeks. The primary efficacy analysis was the percent of patients with HBV DNA <29 IU/mL at Week 48. Key secondary safety endpoints were assessed sequentially: changes in hip and spine bone mineral density (BMD), changes in serum creatinine (sCr), and dipstick proteinuria. Markers of bone formation and resorption, and renal tubular function were also assessed. Results: 425 patients were randomized and treated at 105 sites in 17 countries. Baseline characteristics included: mean age 46 years, 61% males, 72% Asians; 19% had HBV DNA ≥ 7 log10 IU/mL, and 21% were previously treated with nucleos(t)ides. At Week 48, TAF was non-inferior in efficacy to TDF with virologic response of 94.0% with TAF and 92.9% with TDF. A greater percentage of patients treated with TAF also achieved normalization of serum ALT values. Patients on TAF experienced significantly less declines in hip and spine BMD than TDF. No differences were seen in sCr change and proteinuria; however, smaller declines in eGFRCG and smaller changes in renal tubular markers were observed in the TAF arm. No viral resistance was observed in the 4 patients (2 per group) who qualified for testing. Conclusions: Compared to TDF 300 mg, the efficacy of TAF 25 mg in patients with HBeAg-negative CHB was noninferior. Safety was also improved, with less change in bone and renal parameters.
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