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( S Fung ),( P Kwan ),( A Horban ),( M Pelemis ),( P Husa ),( H W Hann ),( Jf Flaherty ),( B Massetto ),( P Dinh ),( A Corsa ),( K Kitrinos ),( Jg Mchutchison ),( M Fabri ),( E Gane ) 대한간학회 2013 춘·추계 학술대회 (KASL) Vol.2013 No.1
Background: Efficacy and safety of tenofovir DF (TDF) have been demonstrated over 6 years in pivotal HBV studies, but have yet to be established in lamivudine-resistant (LAM-R) patients in a prospective, randomized trial. Methods: Phase 3b, double-blind, randomized (1:1) comparison of TDF and emtricitabine (FTC)/TDF in chronic HBV patients on LAM at screening with HBV DNA ≥103 IU/mL and documented LAM-R (rtM204V/I±rtL180M; INNO-LiPA HBV v2/ v3). Patients were stratified by ALT (≥ or <2×ULN) and HBeAg status. Efficacy and safety, including bone mineral density (BMD) monitoring by DXA were assessed over 96 weeks. Results: Of 280 randomized and treated patients, 133/141 (94%) and 125/139 (90%) in TDF and FTC/TDF groups completed 96 weeks. Groups were well matched: mean age 47 years, 75% males, 34% Asian, 47% HBeAg+, 42% ALT <ULN; HBV genotypes: 22% A, 14% B, 19% C, and 45% D. By ITT analysis, missing=failure, 89% and 86% receiving TDF and FTC/TDF, respectively, had HBV DNA <400 copies/mL at Week 96 (P =0.43); 70% in each arm had normal ALT. HBeAg loss was observed in 10/65 (15%) and 9/68 (13%) in TDF and FTC/TDF arms, respectively. One patient (FTC/TDF) had HBsAg loss without seroconversion. Both treatments were well tolerated with 1% (3/280) discontinuing for adverse event (1 TDF, 2 FTC/TDF). No patients had confirmed increase in serum creatinine of ≥0.5 mg/dL, and 1% (2 TDF) had serum phosphorus <2 mg/dL. BMD of spine and hip revealed no clinically relevant bone loss, and there were no non-traumatic fractures reported. No TDF resistance was detected through 96 weeks. Conclusions: A high rate of HBV DNA suppression with no detectable TDF resistance was achieved with TDF monotherapy in LAM?R patients through 96 weeks. TDF was safe and well tolerated, with a low rate of renal events and no evidence of clinically relevant bone loss.
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