https://scholars.lib.ntu.edu.tw/handle/123456789/581837
標題: | Twelve-week ravidasvir plus ritonavir-boosted danoprevir and ribavirin for non-cirrhotic HCV genotype 1 patients: A phase 2 study | 作者: | JIA-HORNG KAO Yu M.-L. Chen C.-Y. Peng C.-Y. Chen M.-Y. Tang H. Chen Q. Wu J.J. |
關鍵字: | danoprevir; efficacy; hepatitis C; interferon free; ravidasvir | 公開日期: | 2018 | 出版社: | Blackwell Publishing | 卷: | 33 | 期: | 8 | 起(迄)頁: | 1507-1510 | 來源出版物: | Journal of Gastroenterology and Hepatology (Australia) | 摘要: | Background and Aim: The need for all-oral hepatitis C virus (HCV) treatments with higher response rates, improved tolerability, and lower pill burden compared with interferon-inclusive regimen has led to the development of new direct-acting antiviral agents. Ravidasvir (RDV) is a second-generation, pan-genotypic NS5A inhibitor with high barrier to resistance. The aim of this phase 2 study (EVEREST study) was to assess the efficacy and safety of interferon-free, 12-week RDV plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimen for treatment-na?ve Asian HCV genotype 1 (GT1) patients without cirrhosis. Methods: A total of 38 treatment-na?ve, non-cirrhotic adult HCV GT1 patients were enrolled in this multicenter, open-label, single-arm phase 2 study (NCT03020095). All patients received a combination of RDV 200?mg once daily (q.d.) plus DNVr 100?mg/100?mg twice daily (b.i.d.) and oral RBV 1000/1200?mg/day (body weight 75/??75?kg) for 12?weeks. The primary endpoint was the rate of sustained virologic response 12?weeks after the end of treatment (SVR12). Results: Of 38 patients, all (100%) achieved SVR12. During the study, no treatment-related serious adverse events, no patients discontinued treatment due to adverse events, and no deaths were reported. Six of 37 (16%) patients with available sequences had HCV NS5A resistance-associated variants at baseline. All patients (6/6) with baseline NS5A resistance-associated variants achieved SVR12. Conclusions: Twelve-week RDV and DNVr in combination with RBV for 12?weeks achieves the SVR12 rate of 100% in treatment-na?ve non-cirrhotic Asian patients with HCV GT1 infection. This interferon-free regimen is also safe and well tolerated. ? 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85043576587&doi=10.1111%2fjgh.14096&partnerID=40&md5=42d64dc9e502b572facc62552c63a86f https://scholars.lib.ntu.edu.tw/handle/123456789/581837 |
ISSN: | 0815-9319 | DOI: | 10.1111/jgh.14096 | SDG/關鍵字: | danoprevir; ravidasvir; ribavirin; ritonavir; antivirus agent; danoprevir; lactam; ribavirin; ritonavir; sulfonamide; aged; anemia; antiviral therapy; Article; Asian; clinical article; coughing; diarrhea; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; female; hepatitis C; Hepatitis C virus genotype 1; human; male; multicenter study; nonhuman; open study; phase 2 clinical trial; priority journal; rash; sustained virologic response; treatment duration; upper respiratory tract infection; adult; Asian continental ancestry group; chronic hepatitis C; clinical trial; combination drug therapy; drug administration; genetics; genotype; Hepacivirus; intraocular drug administration; liver cirrhosis; middle aged; time factor; treatment outcome; very elderly; virology; Administration, Ophthalmic; Adult; Aged; Aged, 80 and over; Antiviral Agents; Asian Continental Ancestry Group; Drug Administration Schedule; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Lactams; Liver Cirrhosis; Male; Middle Aged; Ribavirin; Ritonavir; Sulfonamides; Time Factors; Treatment Outcome |
顯示於: | 臨床醫學研究所 |
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