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?
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.
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?
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.
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?
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.
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.