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RISS 인기검색어
- 검색키워드
- 저자 : Rohit Talwani (검색결과 2 건)
- 무료
- 기관 내 무료
- 유료
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( Do Young Kim ),( Youn Jae Lee ),( Jeong Heo ),( Woo Jin Chung ),( Won Young Tak ),( Yoon Jun Kim ),( Seung Woon Paik ),( Eungeol Sim ),( Susila Kulasingam ),( Rohit Talwani ),( Barbara Haber ),( Peg 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: All-oral direct-acting antiviral medications have trans formed the treatment of hepatitis C virus (HCV) infection; how ever, local evidence is limited in some regions, including Korea. We conducted an integrated analysis of the efficacy of elbasvir (EBR)/grazoprevir (GZR) in Korean participants with HCV infec tion enrolled in EBR/GZR phase 3 clinical studies. Methods: Participants with HCV GT1b infection enrolled at Korean study centers who received EBR/GZR 50 mg/100 mg for 12 weeks were included. The primary endpoint of all stud ies was sustained virologic response (HCV RNA < 15 IU/mL) 12 weeks after end of therapy (SVR12) in the full analysis set (all participants who received ≥1 dose of study medication). Results: A total of 74 Korean participants were included. Mean age was 55 years (SD, 11 years), 25 (33.8%) had cirrhosis, and 70 (94.6%) were treatment-naïve. There were no participants with HCV/HIV coinfection. SVR12 was achieved by 73 of 74 (98.6%) participants; and only 1 participant, who withdrew consent, failed to achieve SVR12. Therefore, in the modified full analysis set (excluding participants who discontinued for rea sons unrelated to study medication), SVR12 was 100% (73/73). SVR remined high among participants with cirrhosis (25/25, 100%), baseline viral load >2,000,000 IU/mL (34/34 (100%), and age >65 years (16/16, 100%). Baseline NS5A resistance associated substitutions (RASs) were detected in 16 of 73 participants (22%) who had a treatment outcome of SVR or virologic failure; all 16 achieved SVR12. Rates of SVR12 among Korean participants in this analysis (73/74, 98.6%) were similar to those in non-Korean Asian participants with GT1b infection (378/388, 97.4%), and to non-Asian participants with GT1b infection (589/608, 96.9%) enrolled in phase 2/3 EBR/GZR clinical trials. Conclusions: The combination of EBR/GZR was highly effective in Korean participants with HCV GT1b infection, with high rates of SVR12 across all subgroups examined, including those with NS5A RASs.
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Youn Jae Lee,Jeong Heo,Do Young Kim,Woo Jin Chung,Won Young Tak,Yoon Jun Kim4,백승운,Eungeol Sim,Susila Kulasingam,Rohit Talwani,Barbara Haber,Peggy Hwang 대한간학회 2019 Clinical and Molecular Hepatology(대한간학회지) Vol.25 No.4
Background/Aims: In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies. Methods: This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or Child- Pugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL). Results: SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs. Conclusions: In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.
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