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RISS 인기검색어
- 검색키워드
- 저자 : ( Henry Ly Chan ) (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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( Hyung Joon Kim ),( Young-Suk Lim ),( Ki Tae Yoon ),( Won Young Tak ),( Sang Hoon Ahn ),( Jae-Seok Hwang ),( Henry LY Chan ),( Scott Fung ),( Wai Kay Seto ),( Wan-Long Chuang ),( Chi-Yi Chen ),( Aric 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 hepatocyteswhile lowering circulating levels of TFV by approximately 90% comparedto tenofovir disoproxil fumarate (TDF).Methods: In this Phase 3 study, patients with HBeAg-positive chronichepatitis B (CHB) were randomized 2:1 to TAF 25 mg QD or TDF300 mg QD and treated for 96 weeks. After Week 96, patients receiveopen label TAF for 48 weeks. The primary efficacy analysis was thepercent of patients with HBV DNA <29 IU/mL at Week 48. Key secondarysafety endpoints were assessed sequentially: changes in hip andspine 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: 873 patients were randomized and treated at 164 sites in19 countries. Baseline characteristics included: mean age 38 years,83% males, 82% Asians; 47% had HBV DNA ≥ 8 log10 IU/mL, and26% were treated previously with nucleos(t)ides. At Week 48, TAFwas non-inferior in efficacy to TDF with virologic response rates of63.9% with TAF and 66.8% with TDF. A greater percentage of patientstreated with TAF achieved normalization of serum ALT values.Patients on TAF experienced significantly less declines in hip and spineBMD, and a smaller increase in sCr than TDF; eGFRCG, and renaltubular markers also changed less with TAF. No viral resistance wasobserved in 22/581 (3.8%) and 11/292 (3.8%) of TAF and TDF patients,respectively, who qualified for testing.Conclusions: Compared to TDF 300 mg, the efficacy of TAF 25 mgin patients with HBeAg-positive CHB was noninferior. Safety wasalso improved, with less change in bone and renal parameters.
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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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