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- 저자 : ( M Pelemis ) (검색결과 2 건)
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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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( Florence Wong ),( Scott Fung ),( Hie-won Hann ),( Magdy Elkhashab ),( Thomas Berg ),( Milotka J. Fabri ),( Andrzej Horban ),( Mijomir Pelemis ),( Ioan Sporea ),( John F. Flaherty ),( Benedetta Masse 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: In CHB patients with LAM-R, TDF has shown efficacy comparableto FTC/TDF and no detectable TDF resistance at 2 years. The final5 year efficacy and safety results from this trial are presented.Methods: CHB patients on LAM with HBV DNA >3 log10 IU/mL andwith documented LAM-R were randomized (1:1) to TDF or FTC/TDFand followed for 5 years.Results: Two hundred eighty patients were randomized; 232 (83%)completed 5 years of treatment. At baseline, mean age was 47 years,most were male (75%) and non-Asian (66%); 53% were HBeAgnegative. Mean HBV DNA was 5.7 log10 IU/mL and 42% had ALT≤ULN at baseline. At Year 5, virologic, serologic, and biochemicalresponses were similar among groups, and remained stable. Ninepatients (4-TDF, 5-FTC/TDF) discontinued due to an adverse event,including increased serum creatinine in 1 patient. For both groupscombined, confirmed renal safety endpoints over 5 years were: CrCL<50 mL/min in 19 (6.8%) patients (12 requiring dose modification),increases in serum creatinine of ≥0.3 and ≥0.5 mg/dL from baselinein 21 (7.5%) and 2 (0.7%) patients, respectively, and serum phosphorus<2 mg/dL in 3 (1.1%) patients. Mean declines in BMD (g/cm2)from baseline for hip and spine BMD, respectively, were 1.7% and1.5% at Year 2, and 2.5%, and 1% at Year 5. Seven patientsexperienced fracture (all except 1 were trauma-related). No TDF resistancewas detected through 5 years by population sequencing.Conclusions: In LAM R patients with CHB treated for 5 years withTDF, a high rate of HBV DNA suppression was achieved and maintainedwith no detectable TDF resistance. There is no apparent ad advantageof combination FTC/TDF in this population. Renal eventsassociated with TDF occurred in up to 7.5% of patients, and averagelosses in bone mineral density of 1 2.5% were observed.
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