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- 검색키워드
- 저자 : ( Cyril Llamoso ) (검색결과 6 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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( Robert G Gish ),( Ting Tsung Chang ),( Ching Lung Lai ),( Robert A De Man ),( Adrian Gadano ),( Song Yu ),( Cyril Llamoso ),( Hong Tang ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: Entecavir (ETV) 0.5 mg demonstrated superior virologic, histologic, and biochemical benefit compared to lamivudine in phase III study ETV-022. Through 96 weeks of treatment and 24 weeks post-treatment follow-up, 5% of the patients achieved HBsAg loss. We present the changes in quantitative HBsAg levels in patients with HBeAg-positive nucleoside naive chronic hepatitis B patients treated with ETV in study ETV-022. Methods: The nucleoside-naive HBeAg-positive patients received ETV 0.5mg daily in study ETV-022. HBsAg levels were assessed qualitatively and quantitatively every 12 weeks. The quantitative HBsAg levels were measured with the Abbott Architect Assay. Mean HBsAg levels were calculated at baseline, week 12, 24, 36 and 48 for the overall cohort and cohorts with HBeAg loss or HBsAg loss. Results: A total of 95 ETV-treated patients from study ETV-022 had available blood samples and were analyzed for quantitative HBsAg levels. Baseline characteristics of patients include mean age 38 years old, mean HBV DNA 9.64 log10 copies/mL and ALT 156.65 U/L. The quantitative HBsAg levels over time in different patient groups are listed below Conclusion: Quantitative HBsAg levels decreased overtime during the first 48 weeks of ETV therapy in HBeAg-positive nucleoside naive patients. A greater declination in quantitative HBsAg value was observed among subjects who had HBeAg loss or HBsAg loss.
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( William Sievert ),( Huy Trinh ),( Giampiero Carosi ),( Ulus Akarca ),( Adrian Gadano ),( Francois Habersetzer ),( David Wong ),( Meghan Lovegren ),( Hui Zhang ),( Cyril Llamoso ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: The aim of this study was to elucidate the antiviral efficacy and safety of telbivudine in Korean treatment-naive chronic hepatitis B (CHB) patients. Methods: A total of 143 treatment-naive patients who had been treated with telbivudine for at least 6 months were consecutively enrolled. We determined the cumulative rates of virologic response (<12 IU/ml by PCR assay), serologic response, biochemical response and monitored any side effects. Results: The median age and follow-up duration were 50.7 years and 16.4 (range 6-24 months) months, respectively. Sixty seven patients (46.9%) were positive for HBeAg and the median serum HBV DNA level was 7.23 (range 4.31-8.26) log IU/ml. In HBeAg positive group, the cumulative probabilities of HBV DNA undetectability were 14.9% , 24.6%, 34.4% and 26.3% at 6, 12, 18 and 24 months, respectively. Partial virologic response at 6 months occurred in 82.1% of patients and inadequate virologic response at 6 months in 3.0%. During the follow-up period, 8 patients achieved HBeAg loss and 3 patients achieved HBeAg seroconversion. Meanwhile, in HBeAg-negative group, the cumulative rates of virologic response were 64.5%, 86.4%, 82.1% and 81.3%, respectively and the cumulative rates of biochemical response were 89.5%, 98.3%, 100% and 100%, respectively. Among the all patients, there were 42 cases of virologic breakthrough and 21 cases of genotypic resistance and virologic breakthrough. There were 46 (32.2%) cases of CK elevation and 2 (1.4%) cases of myopathy. However, there was no clinically significant safety issue. Conclusions: In Korean treatment-naive HBeAg-negative CHB patients, telbivudine therapy induced favorable virologic, serologic and biochemical responses.
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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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Chang Wook Kim,Chang Seop Kim,Hee Yeon Kim,Chang Don Lee,Kyungha Yu,Cyril Llamoso,Heon Ju Lee 대한내과학회 2018 The Korean Journal of Internal Medicine Vol.33 No.1
Background/Aims: Entecavir (ETV) is effective and safe antiviral agent against hepatitis B virus (HBV) in clinical and real-world setting but, most studies were performed in single institute or have limitation in patient’s number. A large-scale nation-wide real-world surveillance study was carried out to investigate safety, efficacy and clinical effectiveness of ETV in Korean patients with chronic hepatitis B (CHB). Methods: Between 2006 and 2012, 3,444 patients were enrolled from 132 Korean institutions. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events (AEs), as well as laboratory abnormalities. Efficacy, which consisted of change in HBV DNA and alanine aminotransferase (ALT), was evaluated in patients who had received at least 16 weeks of ETV treatment. Overall clinical effectiveness, based on improvement of ALT, HBV DNA and patient’s symptoms, was evaluated by physicians. Results: Of the patients, 3,367 were evaluated for safety and 3,115 for efficacy and clinical effectiveness. Three hundred and eighty AEs were reported in 255 cases (7.57%), and 67 adverse drug reactions in 54 cases (1.6%). Serious AEs (SAE) were 19 events in nine cases (0.27%). Serious adverse drug reactions (SADR) were three events in two cases (0.06%), and unexpected SAE/SADR were three events in two cases (0.06%). Medical history and concomitant medications were factors inf luencing incidence rates of AEs. Overall clinical effectiveness rate was 96.53%, which was clinically assessed as marked improved or improved state. Conclusions: This study showed that ETV was well tolerated and clinically effective in Korean patients with CHB in a real-world nation-wide setting.
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( Robert G Gish ),( Ting Tsung Chang ),( Ching Lung Lai ),( Robert A De Man ),( Adrian Gadano ),( Song Yu ),( Cyril Llamoso ),( Hong Tang ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.-
Background: Entecavir (ETV) 0.5 mg demonstrated superior virologic, histologic, and biochemical benefit compared to lamivudine in phase III study ETV-022. Through 96 weeks of treatment and 24 weeks post-treatment follow-up, 5% of the patients achieved HBsAg loss. We present the changes in quantitative HBsAg levels in patients with HBeAg-positive nucleoside naive chronic hepatitis B patients treated with ETV in study ETV-022. Methods: The nucleoside-naive HBeAg-positive patients received ETV 0.5mg daily in study ETV-022. HBsAg levels were assessed qualitatively and quantitatively every 12 weeks. The quantitative HBsAg levels were measured with the Abbott Architect Assay. Mean HBsAg levels were calculated at baseline, week 12, 24, 36 and 48 for the overall cohort and cohorts with HBeAg loss or HBsAg loss. Results: A total of 95 ETV-treated patients from study ETV-022 had available blood samples and were analyzed for quantitative HBsAg levels. Baseline characteristics of patients include mean age 38 years old, mean HBV DNA 9.64 log10 copies/mL and ALT 156.65 U/L. The quantitative HBsAg levels over time in different patient groups are listed below: Conclusion: Quantitative HBsAg levels decreased overtime during the first 48 weeks of ETV therapy in HBeAg-positive nucleoside naive patients. A greater declination in quantitative HBsAg value was observed among subjects who had HBeAg loss or HBsAg loss.
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