Hepatology Digest: In 2014, AASLD update guideline of hepatitis c online. In the new guideline, sofosbuvir is recommended to treat patients with HCV genotype 1-6. But FDA approved indications of sofosbuvir are HCV genotype 1-4. Would you like tell us about the reason?
《国际肝病》：随着新型抗HCV药物的不断上市，AASLD也加快了指南更新的脚步。2014年，AASLD在线更新丙型肝炎指南。该指南推荐的治疗适应证超过了药物批准的适应证，例如FDA批准的SOF适应证为基因1-4型HCV感染者，但是AASLD指南推荐的是基因1-6型患者。为什么会出现这种超适应证推荐？
Prof. Schinazi:I work for Emory University in Atlanta, Georgia, so I can’t speak for the FDA. But what we do know is that there was sufficient data to support the approval of sofosbuvir (Sovaldi) for the treatment of hepatitis C even as a monotherapy. Obviously, when you use it as a monotherapy, it is not as effective as when used in combination. They approved it for genotypes 1 through 4 because they had enough patients studied in terms of safety as the primary concern and secondly, in terms of efficacy. They didn’t have any data for 5 and 6 at the time with very limited number of patients treated for 5 and 6 so were unable to approve it.
Schinazi教授：我在亚特兰大埃默里大学工作，所以不能代表FDA发言。但是我们所知道的是已有相当充足的数据支持sofosbuvir用于治疗丙型肝炎，甚至是单药治疗。当然，sofosbuvir单药治疗的疗效不如联合治疗。FDA批准sofosbuvir用于治疗基因1～4型HCV感染者，也是因为该药物治疗基因1～4型患者的安全性和疗效已在足够多的病例中得到验证，而基因5～6型患者的数据非常有限，因此FDA未批准这两种基因型的治疗。
Hepatology Digest: With increasing of hepatitis c cure rate, clinical doctors will also face a variety of treatment options. What factors determine doctor’ s drug selection?
《国际肝病》：丙型肝炎大量新药物上市，丙型肝炎治愈率提高的同时，临床医生面临多种治疗方案的选择。选择哪种药物或方案治疗，由哪些因素决定？
Prof. Schinazi:I think the most important factors are probably adverse events and drug-drug interactions. All the drugs we have today and especially the combinations of drugs are very effective but they do have side effects. The side effects are going to determine which drugs are going to be used. Of course, if you have a drug that has some side effects, then the price will also be lower due to the demands of the market. But safety, efficacy and convenience of use will demand which drug should be used, assuming there is equal pricing.
Schinazi教授：我认为最重要的因素是可能存在的药物不良反应和药物药物间的相互作用。目前已有的新的抗HCV药物，特别是联合治疗非常有效，但是也同时伴随有副作用。药物的副作用将决定哪些药物可以应用。当然，有一些药物有副作用，其价格也会低一些，这是由市场需求而决定的。如果价格相当，那么安全性、疗效和使用的便利性将是选择用药的主要决定因素。
Hepatology Digest: The price is the main influencing factor of new drug application. In the United States, whether the price influence hepatitis C new drug application?
《国际肝病》：新的药物的应用的一个重要影响因素是价格问题，在美国价格问题是否影响了丙型肝炎患者接受新的治疗？
Prof. Schinazi: I don’t think price is considered by the US FDA. They only look at efficacy and safety. Price may influence the patient and the doctor but we should always be offering the best drugs to our patients irrespective of price.
Schinazi教授：我认为价格不是FDA批准药物上市所考虑的因素。FDA仅关注药物的疗效和安全性。价格可能影响患者和医生，但是作为医生，我们应该提供给患者最好的治疗药物，而不是受到价格的影响。
Hepatology Digest: Whether the high cure rate of hepatitis C has changed the scope of "difficult to treat" populations? Now what patients are still "difficult to treat" patients?
《国际肝病》：丙型肝炎治愈率的提高是否改变了难治性丙型肝炎的概念？目前还有哪些属于难治性患者？
Prof. Schinazi: Interestingly, when we first started out, we thought patients with HIV/HCV co-infections would be difficult to treat, but it has been proven otherwise. These patients can be treated just as effectively as those who do not have HIV. That is one example. Basically today, we are thinking we can treat everybody with the more modern fixed-dose combinations that we have as a single pill. These work against all genotypes and more so as new drugs emerge. Right now, we have very good drugs for genotypes 1 and 2 and an excellent drug for genotype 4. We don’t have much data on 3, 5 and 6, but we are able to treat almost everybody, even cirrhotic patients up to a point, very effectively. It is important to be treating before the necessity for a liver transplant due to cirrhosis. But I think, we will see with time, that the number of liver transplants will be reduced significantly with increasing access to the drugs we have today.
Schinazi教授：我们最初认为HIV/HCV合并感染患者属于难治性患者，但是事实证明并非如此。HIV/HCV合并感染患者与HCV单独感染者的治疗效果相当。这仅是其中一个例子。目前，我们正在考虑实现用固定剂量的单片复方制剂来治疗所有患者。这种复方制剂对所有基因型有效，并会作为新的药物出现。现在，我们有很好的药物可以用于治疗基因1、2和4型HCV感染者。但是对于基因3、5和6型患者的数据还不足够，但是我们已经能够治疗几乎所有的患者，甚至包括肝硬化患者也有很好的疗效。肝硬化患者在发展至不得不接受肝移植之前进行治疗非常重要。但是，我认为我们将会看到由于应用了现有的这些药物，肝移植数量显著降低。