在上周末举行的国际肝病会议(ILC)上，丙型肝炎病毒(HCV)感染的无干扰素治疗方案有突出表现，雅培生命、默沙东及吉利德相继报道了他们试验药物的最新数据。三家公司均报道了其试验药物用于晚期肝脏疾病HCV患者令人鼓舞的试验结果，临床试验受试者为已发生并发症的患者，如肝硬化，这类患者众所周知是难以有效治疗的。

雅培生命报道了其全口服方案的一项关键3期临床试验结果，结果显示经过12周治疗后，除已确定的肝脏疾病之外，大约92%难治性基因型1(GT1)病毒株HCV患者获得了持续的病毒学应答(SVR)，在第12周时SVR上升到96%。

该方案包括ABT-450/利托那韦与NS5A抑制剂Ombitasvir (ABT-267)，日服一次，同时服用250mg剂量的NS5B RNA聚合酶抑制剂Dasabuvir，每天服用两次。该公司称打算于未来几周推进提交这款混合物的上市申报资料。

默沙东在ILC上宣布了一项正在进行的2期试验的中期结果，该试验是评价其两药复方药物的有效性及安全性，该复方药物由NS3/4A蛋白酶抑制剂MK-5172和NS5A复制复合物抑制剂MK-8742组成，加或不加利巴韦林，用于肝硬化GT1 HCV患者。

在之前尚未治疗的HCV感染患者中，SVR率在第12周时高达97%，甚至对HCV与HIV并发感染的患者，SVR率也超过了90%，而这类患者是一个特别难以治疗的群体。默沙东最近启动了其复方药物的3期临床研究项目。

最后，吉利德报道了两项2期试验结果，这些试验目的在于观察其最近推出的NS5B聚合酶抑制剂Sovaldi (sofosbuvir)与利巴韦林治疗晚期肝脏疾病HCV患者的有效性

所有三项研究显示，该药物方案在60%至95%的患者中抑制了病毒水平，有良好的耐受性，巩固了这款在上市第一年就准备成为销售额达几十亿美元重磅炸弹级产品的临床证据，但其在美国每12周疗程8.4万美元的昂贵价格受到批评。

上周末，据报道吉利德已与无国界医生组织(MSF)达成一项协议，使这款药物在肯尼亚、莫桑比克、缅甸和印度等国家仅以900美元即可获得一疗程的药物。

Oral hepatitis C regimens tackle advanced liver disease

 New data released at the International Liver Congress by AbbVie, Merck & Co and Gilead

Interferon-free treatment regimens for hepatitis C virus (HCV) infection featured prominently at the International Liver Congress (ILC) over the weekend, with new data from AbbVie, Merck & Co and Gilead Sciences.

All three companies reported encouraging new clinical results in HCV patients with advanced liver disease that had progressed to complications such as cirrhosis, who are notoriously difficult to treat effectively.

AbbVie reported data from a pivotal phase III trial of its all-oral regimen, revealing that after 12 weeks around 92 per cent of HCV patients with the hard-to-treat genotype 1 (GT1) strain of the virus as well as established liver disease had a sustained virologic response (SVR), rising to 96 per cent at 12 weeks.

The regimen includes ABT-450/ritonavir co-formulated with NS5A inhibitor ombitasvir (ABT-267) given once-daily, alongside NS5B RNA polymerase inhibitor dasabuvir (ABT-333) 250mg dosed twice-daily. The company now says it intends to press ahead with a regulatory filing for the cocktail within the next few weeks.

Merck announced interim results from an ongoing phase II trial at the ILC that eva1uated the efficacy and safety of its two-drug regimen based on NS3/4A protease inhibitor MK-5172 and NS5A replication complex inhibitor MK-8742, given with or without ribavirin, in GT1 HCV patients with cirrhosis.

SVR rates were as high as 97 per cent at 12 weeks among patients who had not been treated for HCV infection before, and above 90 per cent even for patients with HCV and HIV co-infection, a particularly hard-to-treat group. Merck recently started its phase III programme for the combination.

Finally, Gilead reported the results of two phase II trials and data from a compassionate use programme which looked at the effectiveness of its recently-launched NS5B polymerase inhibitor Sovaldi (sofosbuvir) with ribavirin in HCV patients with advanced liver disease.

All three studies showed that the regimen suppressed virus levels in 60 to 95 per cent of patients and was well tolerated, cementing the clinical evidence for a drug that is already set to become a mega blockbuster in its first year on the market despite criticism of its hefty price tag of $84,000 per 12-week course in the US.

Late last week, it was reported that Gilead has reached a deal with Medecins sans Frontieres (MSF) to make the drug available at just $900 per course to countries such as Kenya, Mozambique, Myanmar and India.

免责声明： 

      本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。 

      如有侵权，请联系我们删除