编者按：与很多发达国家不同，发展中国家的人民没有发达国家完善的医疗保险制度，多数情况下必须由个人支付治疗所需的全部费用，因此患者可能因为治疗负担就会难以承受。长期以来，度制药业以实惠的价格成为“世界药房”。 在刚刚结束的第52届EASL年会上，一场有关“丙型肝炎治疗的全球化观点” 的专题会议吸引着众人的目光。会上，来自印度昌迪加尔医学教育研究所Radha K. Dhiman教授分享了有关仿制药与原研药在抗HCV治疗中的疗效比较以及药物经济学观点。

 

目前，我们已经到了抗丙型肝炎药物的时代。在英国或美国等发达国家，一盒索磷布韦需要花费数百甚至数千美元，而印度产的索磷布韦三个月疗程总的成本只有150美元。目前印度制药公司获Gilead授权许，可生产索磷布韦的仿制药。这些药物不仅可以治疗印度的丙型肝炎患者，而且还出口到其他发展中国家，例如，埃及是丙型肝炎患者数量最多的发展中国家。

 

近年来，丙型肝炎的治疗药物取得了突破性发展，新型直接作用抗病毒药物（DAA）给患者带来了治愈的希望。这当中有很多不同类型的药物，如NS5A和NS5B抑制剂，索磷布韦、达卡他韦和雷迪帕韦等等。治疗时这些药物常需联合应用。例如，索磷布韦和雷迪帕韦对于基因1型的患者是100%有效的。类似的，索磷布韦和达卡他韦反应率为95%~100%。这些都是非常有效的药物。

 

关于仿制药与品牌药物的区别，Dhiman教授表示仿制药与品牌药物一样有效，因为它们有类似的配方和制造精度，但仿制药的成本要便宜得多。这些药物也会由各国政府，包括在印度政府在内进行监管。仿制药与品牌药物的成本差异巨大。至于疗效而言，仿制药与品牌药物没有任何区别。Dhiman教授在本次EASL大会上也提供了仿制药效力的数据，证实这些仿制药与原研药之间在疗效上相当。

 

Dhiman教授谈道，向每一位丙型肝炎患者提供有效的治疗药物是丙型肝炎治疗的全球挑战，但更为最重要的是如何通过筛选来发现那些感染了HCV的患者。印度是一个中等流行程度的国家，但其中有些地区的患病率要远高于其他地区。Dhiman教授来自的旁遮普省患病率为3.3%，比例非常之高。这是当前我们面临的最重要的挑战。目前，在丙型肝炎的筛查方面，HCV RNA的诊断测试非常昂贵，因此如何寻找最便宜和最具成本效益的方式去筛选出这些患者也是具有挑战性的难题。一旦确诊为丙型肝炎，就需要尽可能的便宜治疗。因此，找到最便宜且有效的治疗策略也是一个重要问题。上述应该是我们当前面临的关于丙型肝炎防治和最终消除疾病的挑战。

 

Hepatology Digest: India has been referred to as the “pharmacy of developing countries” and can produce inexpensive generic drugs. Can you explain what this means?

 

Dr Dhiman: India produces most of the drugs that are essential for the treatment of certain diseases and is able to do so at a very low cost, making the drugs affordable for patients. The developing countries do not have the medical insurance that is common elsewhere, so everybody has to pay the full price of their treatment. Initially, HIV presented as an excellent example of this. India produced the generic drugs required to treat HIV, making them available much more cheaply. Then there are the examples of cancer drugs, which were otherwise very expensive. Now, we have arrived in the era of ant-hepatitis C drugs. One tablet of sofosbuvir in a developed nation such as the UK or USA can cost hundreds, even thousands of dollars. The entire course of three months of sofosbuvir produced in India costs only $150. This is only possible because of the generics being produced by the Indian companies. The generics produced in India are licensed by the parent company. For example, sofosbuvir is licensed by Gilead. So these drugs are not just being produced for the population of India, but also exported to other countries. Egypt, for example, which has the highest number of hepatitis C patients, is treating their patients with generics that come from India.

 

Hepatology Digest: For the treatment of hepatitis C, how much difference is there between the generic and branded drugs?

 

Dr Dhiman: Treatment of hepatitis has evolved. A few years ago, treatment involved interferon injections and capsules. The peg-interferon injections were not only expensive, but also had many side effects. This was also not very practical. Since then, the oral drugs have arrived and they are very effective. There are different drugs from different categories - NS5A and NS5B inhibitors like sofosbuvir, daclatasvir and ledipasvir and so on. These drugs are given in combinations. For example, a combination of sofosbuvir and ledipasvir for genotype 1 is effective in 100% of patients. Similarly, sofosbuvir and daclatasvir show a response rate of 95-100%. These are very effective drugs. To answer your question regarding the difference between branded and generic drugs, the generic drugs are as effective as the branded drugs because they have a similar formulation and precision of manufacture. But they are being made much more cheaply. Regarding regulation of these drugs, that is done by the government of the respective countries, including in India. The difference in the cost of these drugs is huge, as I outlined earlier. A single tablet of sofosbuvir/daclatasvir costs

 

around $1000 in the US, but the full treatment cost of 12 weeks of sofosbuvir/daclatasvir in India is only $150. As far as efficacy is concerned, there is no difference and I presented data on the efficacy of the generic drugs at this meeting. That efficacy is as good as the branded drugs.

 

Hepatology Digest: From your perspective, what are the global challenges and advances in hepatitis C treatment?

 

Dr Dhiman: The global challenges for the treatment of hepatitis C include the availability of these drugs to each and every person infected with the hepatitis C virus. Most important is to be able to identify those people who are infected with hepatitis C through screening. As far as India is concerned, because it is an intermediate prevalence country, there are some areas where prevalence is higher than other areas. I am from the Punjab Province where the prevalence is 3.3%, which is very high. We need to tackle these challenges by finding out why the prevalence is high, what is the route of transmission and who are at high-risk and then screen them. These are our most important challenges. Once diagnosed, people need to be treated as cheaply as possible. Finding the cheapest and most cost-effective way of identifying these patients is challenging. Performing diagnostic tests for hepatitis C virus RNA is very expensive, so finding the cheapest effective diagnostic strategy is an issue. These are the challenges facing us with regard to hepatitis C treatment and the ultimate elimination of the disease.