Curry M P, Tapper E B, Bacon B, Dieterich D, Flamm S L, Guest L, Kowdley K V, Lee Y, Milligan S, Tsai N, Younossi Z, Afdhal N H
Division of Gastroenterology and Hepatology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Aliment Pharmacol Ther. 2017 Sep;46(5):540-548. doi: 10.1111/apt.14204. Epub 2017 Jul 10.
Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCV patients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA <6 million IU/mL can be treated for 8 weeks. This guidance stemmed from a post hoc analysis of the ION 3 clinical trial, which demonstrated similar SVR for patients treated with ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks.
To compare the SVR for 8 weeks vs 12 weeks of ledipasvir and sofosbuvir in HCV infected patients in a real-world setting.
We performed an observational real-world cohort study of treatment success following 8 or 12 weeks of ledipasvir and sofosbuvir for treatment-naïve genotype 1 HCV patients.
A total of 826 patients were treated for either 8 (n=252) or 12 weeks (n=574) with ledipasvir and sofosbuvir and achieved SVR rate of 95.3% and there was no statistical difference in SVR rates in the two groups irrespective of any clinical or virological variables.
In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen.
采用直接作用抗病毒药物联合治疗丙型肝炎病毒1型（HCV）感染，持续病毒学应答（SVR）率非常高。每日服用雷迪帕韦和索磷布韦，疗程12周，已被批准用于治疗1型HCV患者，不过初治、基线HCV RNA＜600万IU/mL的非肝硬化患者可治疗8周。该指导意见源于对ION 3临床试验的事后分析，该试验表明，雷迪帕韦和索磷布韦联合或不联合利巴韦林治疗8周或12周的患者，SVR相似。
在真实临床环境中比较雷迪帕韦和索磷布韦治疗HCV感染患者8周与12周的SVR。
我们开展了一项观察性真实临床队列研究，观察初治1型HCV患者接受雷迪帕韦和索磷布韦治疗8周或12周后的治疗成功率。
共有826例患者接受了雷迪帕韦和索磷布韦8周（n = 252）或12周（n = 574）的治疗，SVR率为95.3%，两组的SVR率无论在任何临床或病毒学变量方面均无统计学差异。
在初治HCV 1型患者中，接受雷迪帕韦和索磷布韦治疗8周或12周的患者SVR率为95%。对于符合该治疗方案的患者，8周的雷迪帕韦和索磷布韦治疗可降低成本且不影响疗效。
