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      • A Phase 3 Study Comparing Tenofovir Alafenamide (TAF) to Tenofovir Disoproxil Fumarate (TDF) in HBeAg-Negative CHB Patients at Week 96

        ( Seung Kew Yoon ),( Maurizia Brunetto ),( Young Suk Lim ),( Ed Gane ),( Wai Kay Seto ),( Marina Osipenko ),( Sang Hoon Ahn ),( Harry L. Janssen ),( Akash Shukla ),( Wan Long Chuang ),( Huy Trinh ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: In this randomized, double blind study in HBeAg- negative patients comparing TAF to TDF, the efficacy of TAF was demonstrated to be noninferior to that of TDF at Week 48 in the proportion with HBV DNA <29 IU/mL with improved bone and renal effects. Here we present the results after two years of treatment. Methods: 425 patients were randomized to receive TAF 25 mg QD (n=285) or TDF 300 mg QD (n=140) and treated for 144 weeks.. Efficacy analyses at Week 96 included virologic (HBV DNA <29 IU/mL), and biochemical (ALT normalization) responses; key secondary safety endpoints were changes in hip and spine bone mineral density (BMD), and changes in serum creatinine and estimated GFR by Cockcroft- Gault method (eGFRCG). Serum markers of bone turnover and urine markers of renal tubular function were also assessed. Results: Baseline characteristics included: mean age 46 years, 61% males, 72% Asians, genotypes A through D (5%, 24%, 38%, 31%); 19% had HBV DNA ≥ 7 log10 IU/mL, and 21% were previously treated with nucleos(t)ides. Efficacy and safety results are summarized in the Table. At Week 96, virologic response rates were similar in the TAF and TDF groups.A greater percentage of TAF patients achieved normalization of serum ALT valuesPatients receiving TAF showed smaller declines in hip and spine BMD compared with TDF patients through Week 96. The smaller decline in eGFRCG and smaller changes in renal tubular markers observed with TAF. The rates of treatment discontinuations for adverse events (<2%) and serious adverse events were (≤11%) were similar. Conclusions: At Week 96, high rates of virologic suppression were maintained with a higher rate of ALT normalization seen in TAF patients relative to TDF and continued improved bone and renal safety with TAF compared with TDF.

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