Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
Department of Pediatrics, Gastroenterology and Allergology, Medical University of Białystok, Białystok, Poland.
Liver Int. 2017 Jan;37 Suppl 1:26-32. doi: 10.1111/liv.13293.
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.
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。
