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( Jeong Heo ),( Lai Wei ),( Konstantin Zhdanov ),( Eduard Burnevich ),( I-Shyan Sheen ),( Van Kinh Nguyen ),( Tawesak Tanwandee ),( Pin-Nan Cheng ),( Do Young Kim ),( Won Young Tak ),( Svetlana Kizhlo 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Hepatitis C virus (HCV) contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. The efficacy and safety of the fixed-dose combination of elbasvir (EBR) 50 mg and grazoprevir (GZR) 100 mg has been demonstrated in a broad population of HCV-infected subjects and supports evaluation in this region where clinical experience with direct-acting antivirals is limited. EBR/GZR is approved in the United States for treatment of HCV GT1 and 4 infection. Methods: C-CORAL is a double-blind placebo-controlled, Phase 3 trial that randomized treatment-naïve HCV GT1, 4 or 6 infected subjects in a 3:1 ratio to an immediate treatment group (ITG; 12 wks of EBR/GZR) or deferred treatment group (DTG; 12 wks of placebo, followed by 12 wks of EBR/GZR). Subjects were enrolled in an ex-China cohort that included subjects from Korea, Taiwan, Vietnam, Thailand, Australia, and Russia; and a second cohort enrolled subjects from China. The primary endpoints include the % of patients in the ITG who achieved SVR12 and a comparison of the safety and tolerability of EBR/GZR in the ITG vs placebo in the DTG. We will present the efficacy results of the ITG and safety results of the ITG and DTG in both cohorts. Results: To date, data from the ex-China cohort are available. In this cohort, a total of 250 subjects were enrolled in the ITG and 86 in the DTG. Mean age (±SD) was 50 ±12 years, 57% were females, 59% were Asian, 74% were GT1b, and 19% were cirrhotic. SVR12 in the ITG was 92.8% (table). Eighteen subjects in the ITG did not achieve SVR12: 11 were relapses, 6 were on-treatment failures (all GT6) and 1 GT1b subject withdrew consent. The incidence of adverse events (AEs) was generally comparable between the ITG vs the DTG including drug-related AEs (21.2% vs 19.8%) and serious AEs (0.8% vs 1.2%; none considered drug-related). During treatment with EBR/GZR or placebo 2/250 (0.8%) subjects in the ITG and 11/86 (12.8%) subjects in the DTG had an ALT value >5x ULN and greater than baseline. One subject in the ITG withdrew after meeting a trial specific discontinuation criterion for elevated ALT, which was not considered drug related. Updated safety and efficacy data will be presented for the ITG for both the ex-China and China study cohorts. Conclusions: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naïve patients in the Asia Pacific/Russia region.
( Do Young Kim ),( Lai Wei ),( Konstantin Zhdanov ),( Eduard Burnevich ),( I-Shyan Sheen ),( Jeong Heo ),( Van Kinh Nguyen ),( Tawesak Tanwandee ),( Pin-Nan Cheng ),( Won Young Tak ),( Svetlana Kizhlo 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: Hepatitis C virus (HCV) contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. The efficacy and safety of the fixed-dose combination of elbasvir (EBR) 50 mg and grazoprevir (GZR) 100 mg has been demonstrated in a broad population of HCV-infected subjects and supports evaluation in this region where clinical experience with direct-acting antivirals is limited. EBR/GZR is approved in the United States for treatment of HCV GT1 and 4 infection. Methods: C-CORAL is a double-blind placebo-controlled, Phase 3 trial that randomized treatment-naive HCV GT1, 4 or 6 infected subjects in a 3:1 ratio to an immediate treatment group (ITG; 12 wks of EBR/GZR) or deferred treatment group (DTG; 12 wks of placebo, followed by 12 wks of EBR/GZR). Subjects were enrolled in an ex-China cohort that included subjects from Korea, Taiwan, Vietnam, Thailand, Australia, and Russia; and a second cohort enrolled subjects from China. The primary endpoints include the % of patients in the ITG who achieved SVR12 and a comparison of the safety and tolerability of EBR/GZR in the ITG vs placebo in the DTG. We will present the efficacy results of the ITG and safety results of the ITG and DTG in both cohorts. Results: To date, data from the ex-China cohort are available. In this cohort, a total of 250 subjects were enrolled in the ITG and 86 in the DTG. Mean age (±SD) was 50 ±12 years, 57% were females, 59% were Asian, 74% were GT1b, and 19% were cirrhotic. SVR12 in the ITG was 92.8% (table). Eighteen subjects in the ITG did not achieve SVR12: 11 were relapses, 6 were on-treatment failures (all GT6) and 1 GT1b subject withdrew consent. The incidence of adverse events (AEs) was generally comparable between the ITG vs the DTG including drug-related AEs (21.2% vs 19.8%) and serious AEs (0.8% vs 1.2%; none considered drug-related). During treatment with EBR/GZR or placebo 2/250 (0.8%) subjects in the ITG and 11/86 (12.8%) subjects in the DTG had an ALT value >5x ULN and greater than baseline. One subject in the ITG withdrew after meeting a trial specific discontinuation criterion for elevated ALT, which was not considered drug related. Updated safety and efficacy data will be presented for the ITG for both the ex-China and China study cohorts. Conclusions: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naive patients in the Asia Pacific/Russia region.
Late Presentation into Care of HIV Disease and Its Associated Factors in Asia: Results of TAHOD
Jeong, Su Jin,Italiano, Claire,Chaiwarith, Romanee,Ng, Oon Tek,Vanar, Sasheela,Jiamsakul, Awachana,Saphonn, Vonthanak,Nguyen, Kinh Van,Kiertiburanakul, Sasisopin,Lee, Man Po,Merati, Tuti Parwati,Pham, MARY ANN LIEBERT INC PUBL 2016 AIDS RESEARCH AND HUMAN RETROVIRUSES Vol.32 No.3