https://scholars.lib.ntu.edu.tw/handle/123456789/568287
標題: | Twelve weeks of ledipasvir/sofosbuvir all-oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials | 作者: | Asahina Y. CHUN-JEN LIU Gane E. Itoh Y. Kawada N. Ueno Y. Youn J. Wang C.-Y. Llewellyn J. Matsuda T. Gaggar A. Mo H. Dvory-Sobol H. Crans G. Chuang W.-L. PEI-JER CHEN Enomoto N. |
公開日期: | 2020 | 出版社: | Blackwell Publishing Ltd | 卷: | 50 | 期: | 10 | 起(迄)頁: | 1109-1117 | 來源出版物: | Hepatology Research | 摘要: | Aim: The combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for the treatment of various hepatitis C virus (HCV) genotypes across many countries. This article presents an integrated analysis of three prospective phase II/III trials in the Asia-Pacific region to evaluate the efficacy and safety of 12?weeks of LDV/SOF in HCV genotype 2 patients without cirrhosis or with compensated cirrhosis. Methods: A total of 200 patients were included in the integrated analysis. The primary end-point was the rate of sustained virologic response for 12?weeks after the end of therapy (SVR12), analyzed by fibrosis stage, treatment history, HCV genotype subtype, and presence of baseline resistance-associated substitutions (RAS). Safety was evaluated by adverse events and laboratory abnormalities. Results: Twelve weeks of treatment with LDV/SOF was associated with high SVR12 rates (overall 98%) in patients with genotype 2 HCV, irrespective of fibrosis stage, treatment history, genotype 2 subtype, and presence of baseline non-structural protein 5A resistance-associated substitution (NS5A RAS), and LDV/SOF was well tolerated. Conclusions: Twelve weeks of treatment with LDV/SOF provides a highly effective and safe treatment for patients with genotype 2 HCV, including those with advanced fibrosis. As a ribavirin-free and protease inhibitor-free regimen with minimal on-treatment monitoring requirements, LDV/SOF can potentially play a crucial role in achieving the WHO's goal of HCV elimination. ? 2020 The Authors. Hepatology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Hepatology |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85089292743&doi=10.1111%2fhepr.13546&partnerID=40&md5=4effe542895a7e17e332c7aaf1461c86 https://scholars.lib.ntu.edu.tw/handle/123456789/568287 |
ISSN: | 1386-6346 | DOI: | 10.1111/hepr.13546 | SDG/關鍵字: | ledipasvir; sofosbuvir; adult; Article; Child Pugh score; chronic hepatitis B; chronic hepatitis C; controlled study; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; female; genotype; headache; Hepatitis C virus genotype 2; human; limit of quantitation; liver fibrosis; major clinical study; male; middle aged; multicenter study; nausea; phase 3 clinical trial; priority journal; randomized controlled trial; relapse; rheumatoid arthritis; rhinopharyngitis; sustained virologic response |
顯示於: | 臨床醫學研究所 |
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