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RISS 인기검색어
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- 저자 : ( Andrzej Horban ) (검색결과 4 건)
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( Jeong Heo ),( Sang Hoon Ahn ),( Young Oh Kweon ),( Byung Ho Kim ),( Henry Ly Chan ),( Andrzej Horban ),( Suchat Wongcharatrawee ),( Cyril Llamoso ),( Kwan Sik Lee ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.-
Background: Unlike the combination of adefovir (ADV) and lamivudine (LVD), currently recommended for treatment of LVD-resistant chronic hepatitis B, both components of an entecavir (ETV)+ADV combination have antiviral activity against LVD-resistant HBV. ETV+ADV may therefore provide antiviral synergy in this challenging population. Methods: In this open-label, multi-center study, 416 HBeAg(+) CHB patients with LVD-resistant HBV were randomized 1:1:1 to receive ETV+ADV (1.0 mg+10 mg), ADV+LDV (10 mg+100 mg) or ETV (1.0 mg) once-daily for 100 weeks. The primary efficacy endpoint was the proportion with HBV DNA <50 IU/mL at Week 48; comparing ETV+ADV to ADV+LVD and ETV monotherapy using the 2-stage Hochberg procedure. At Week 96, the key efficacy endpoint was the difference in proportion <50 IU/ml for ETV+ADV vs ADV+LDV. Subjects who discontinued prior to each analysis were considered failures (NC=F). Results: A total of 415 patients were dosed (76% Korean, 67% male, mean age 44 years). Mean baseline HBV-DNA was 7.4 log10 IU/mL (86% Subtype C, 7% A, 4% B, 3% D, <1% H). At Week 48, proportions <50 IU/mL for ETV+ADV (n=138), ADV+LVD (n=137) and ETV (n=140) were 25.4%, 19.7% and 16.4%, respectively (p=NS). At Week 96, ETV+ADV vs ADV+LDV for <50 IU/mL was 43.5% vs. 28.5% (Difference 15.0%; p=0.0095). Other endpoints are shown in the table below. Conclusions: With 96 weeks of treatment, the antiviral efficacy of ETV+ADV was superior to LVD+ADV. All treatments were well tolerated and had comparable safety profiles.
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( Jeong Heo ),( Sang Hoon Ahn ),( Young Oh Kweon ),( Byung Ho Kim ),( Henry Ly Chan ),( Andrzej Horban ),( Suchat Wongcharatrawee ),( Cyril Llamoso ),( Kwan Sik Lee ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: Unlike the combination of adefovir (ADV) and lamivudine (LVD), currently recommended for treatment of LVD-resistant chronic hepatitis B, both components of an entecavir (ETV)+ADV combination have antiviral activity against LVD-resistant HBV. ETV+ADV may therefore provide antiviral synergy in this challenging population. Methods: In this open-label, multi-center study, 416 HBeAg(+) CHB patients with LVD-resistant HBV were randomized 1:1:1 to receive ETV+ADV (1.0 mg+10 mg), ADV+LDV (10 mg+100 mg) or ETV (1.0 mg) once-daily for 100 weeks. The primary efficacy endpoint was the proportion with HBV DNA <50 IU/mL at Week 48; comparing ETV+ADV to ADV+LVD and ETV monotherapy using the 2-stage Hochberg procedure. At Week 96, the key efficacy endpoint was the difference in proportion <50 IU/ml for ETV+ADV vs ADV+LDV. Subjects who discontinued prior to each analysis were considered failures (NC=F). Results: A total of 415 patients were dosed (76% Korean, 67% male, mean age 44 years). Mean baseline HBV-DNA was 7.4 log10 IU/mL (86% Subtype C, 7% A, 4% B, 3% D, <1% H). At Week 48, proportions <50 IU/mL for ETV+ADV (n=138), ADV+LVD (n=137) and ETV (n=140) were 25.4%, 19.7% and 16.4%, respectively (p=NS). At Week 96, ETV+ADV vs ADV+LDV for <50 IU/mL was 43.5% vs. 28.5% (Difference 15.0%; p=0.0095). Other endpoints are shown in the table below. Conclusions: With 96 weeks of treatment, the antiviral efficacy of ETV+ADV was superior to LVD+ADV. All treatments were well tolerated and had comparable safety profiles.
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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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( Byoung Kuk Jang ),( Edward Gane ),( Wai Kay Seto ),( Harry La Janssen ),( Florin A Caruntu ),( Hyung Joon Kim ),( Dzhamal Abdurakhmanov ),( Shuhei Nishiguchi ),( Andrzej Horban ),( Ho Bae ),( John F 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Tenofovir alafenamide (TAF), a new prodrug of tenofo vir (TFV), is now a preferred treatment in the 2017 EASL HBV Guidelines, and may be particularly useful in patients with risk factors for TDF associated renal and bone effects. We assessed the 1 year safety and efficacy in CHB patients with TDF risk fac tors who were switched from TDF to TAF. Methods: In two identically-designed Phase 3 studies, HBeAg(+) and HBeAg(-)patients were randomized 2:1 to TAF 25 mg or TDF 300 mg and treated in a double- blind fashion for 96 weeks; all patients received open-label (OL) TAF for an additional 48 weeks (through Week 144). Renal and bone safety parameters, and antiviral efficacy (HBV DNA < 29 IU/mL) and ALT normalization were assessed in the subset of switch patients with baseline risk factors for TDF use: Age >60 years, osteoporosis of hip or spine, ³Stage 2 CKD (GFRCG < 90 mL/ min), albuminurina (UACR >30 mg/g), hypophosphatemia (PO4 <2.5 mg/dL), or presence of comorbidities (e.g. HTN, DM). Results: Of 1298 patients randomized and treated in the 2 studies, 540(42%) switched to open- label TAF at Week 96 (TAF<sup>®</sup>TAF 360; TDF<sup>®</sup>TAF 180), of which 284(53%) patients had at least 1 TDF risk factor at baseline; 123(23%) patients had ³2 risk factors. Baseline demographics and disease characteristics were similar between treatment groups. At Week 144, signifi cant improvements in renal (sCr, eGFRCG) parameters, hip and spine BMD were observed and summarized in the table. Anti viral efficacy was maintained at Week 144 in both groups and in TDF patients who switched to TAF, increased rates of ALT normalization were seen. Conclusions: In CHB patients with risk factors for potential TDF toxicity, switching from TDF to TAF resulted in improved bone and renal safety parameters while efficacy was maintained in this subgroup at one year.
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