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丙型肝炎:真实世界中的疗效和安全性。

Hepatitis C: efficacy and safety in real life.

机构信息

Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.

Department of Pediatrics, Gastroenterology and Allergology, Medical University of Białystok, Białystok, Poland.

出版信息

Liver Int. 2017 Jan;37 Suppl 1:26-32. doi: 10.1111/liv.13293.

Abstract

Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis. In a number of recently published real-world studies evaluating ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV, the SVR rate was between 92% and 100%. The SVR rate of the 4260 patients included in the studies in this paper was 97% and the rate was the same in the 1647 patients with cirrhosis. Recently, data evaluating SOF/simeprevir±RBV showed an SVR rate >90%, while in combination with daclatasvir this rate reached approximately 95%. The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies. Because of the similar efficacy and safety, real-world data support the use of either the LDV/SOF±RBV or OBV/PTV/r±DSV±RBV regimen in patients with genotypes 1 or 4. There is still not enough real-world data in patients with genotype 3 and other genotypes.

摘要

无干扰素联合方案于 2014 年和 2015 年注册用于治疗慢性 HCV 感染。因此,过去一年积累了真实世界的经验,本文介绍了截至 2016 年 9 月的数据。关于 ledipasvir/sofosbuvir(LDV/SOF)±利巴韦林(RBV)方案疗效的真实世界研究显示,持续病毒学应答(SVR)率在 91%至 98%之间。本文纳入的 13858 例患者的 SVR 率为 94%,肝硬化患者为 92%。在最近发表的几项评估 ombitasvir/paritaprevir/ritonavir(OBV/PTV/r)±达沙布韦(DSV)±RBV 的真实世界研究中,SVR 率在 92%至 100%之间。本文纳入的 4260 例患者的 SVR 率为 97%,肝硬化患者为 97%。最近,评估 SOF/simeprevir±RBV 的数据显示 SVR 率>90%,而与达卡他韦联合使用时,这一比率达到了 95%左右。LDV/SOF±RBV 和 OBV/PTV/r±DSV±RBV 的可用安全性数据表明,因不良反应而停药的患者不超过 3%,严重不良反应的发生率在 0 至 11%之间,特别是在真实世界研究中。由于疗效和安全性相似,真实世界的数据支持在基因型 1 或 4 的患者中使用 LDV/SOF±RBV 或 OBV/PTV/r±DSV±RBV 方案。在基因型 3 和其他基因型的患者中,仍然没有足够的真实世界数据。

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