丙型肝炎治疗的费用可能低至卢比67

StephenW

Hepatitis C cure may cost as low as Rs 67khttp://timesofindia.indiatimes.com/home/science/Hepatitis-C-cure-may-cost-as-low-as-Rs-67k/articleshow/49966218.cms


NEW DELHI: In a move that comes as a huge relief to patients of chronic Hepatitis C, the apex committee of the Central Drugs Standard Control Organisation (CDSCO) has granted a waiver of local trials for crucial new direct-acting antiviral drugs treating the disease.

The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir is expected to bring the generic version of these drugs, which cost a fraction of the branded versions, into the Indian market within weeks. Some patients facing a threat to life currently import these drugs at a huge cost.

According to the World Health Organisation, about 12 million people are infected with Hepatitis C in India. India is now one of the few countries where generics are available for interferon-free treatment. Pegylated interferon is an old, expensive, injectable chemotherapy drug with serious side effects used to treat Hep C in combination with sofosbuvir and ribavirin.

The interferon-free treatment, which costs over $90,000 in the US (from Jules: in realty now its $50k in US after price reductions and rebates over the past year). and over 50,000 euros in the EU will be available to Indian patients for about Rs 55,000 or about $1,000 or even less thanks to competition between generic manufacturers.

Indian generics are expected to revolutionise Hep C treatment in the region and all across the world as they did in the case of HIV/AIDS. People from countries where treatment is being rationed by the governments, such as in Australia, many European countries, the US, and Canada, already come to India to get treated and this trend is only likely to continue.

Several patient groups, including International Treatment Preparedness Coalition - South Asia, the Delhi Network of Positive People, thalassemic patients' groups and Medecins Sans Frontieres (MSF) or Doctors Without Borders have been petitioning the health ministry and the Drug Controller General of India (DCGI) seeking a clinical trial waiver for these drugs. Over a dozen patient groups and access-to-medicine activists from Indonesia, Thailand, Malaysia, Nepal and Vietnam too had sent similar appeals. "The requirement for a local clinical trial in India will delay the introduction of the new HCV drug daclatasvir in the country, and also in other high-burden countries in the region," stated the appeals.

HCV Patients with advanced liver disease, thalassemics, those with HIV co-infection or those with kidney disease undergoing dialysis who have hepatitis C need daclatasvir in combination with sofosbuvir for effective treatment. They cannot tolerate interferon and/or ribavirin and treatment with sofosbuvir alone was not possible for them. Hence they were left with no treatment option when the manufacturer of daclatasvir, Bristol Myers Squibbs (BMS), was not willing to bring the drug to India or other developing countries.

Sofosbuvir was registered in India in January 2015 and daclatasvir was registered this month. The combo is seen as a very potent cure with about 90% cure rate and for no other disease has such a short-time cure become available, that too in a generic version.

According to the recommendations of a high level committee, waiver of clinical trials in India for approval of a new drug that has already been approved outside India can be considered only in cases of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy. This was hampering the waiver that millions of Hep C patients were petitioning for.

However, the technical committee, after examining the case of sofosbuvir, said that it was the only drug which could be safely used in several categories of Hepatitis C patients. In the case of daclatasvir, the committee said that the drug in combination with other medicinal products became imperative to expedite the treatment of all types (genotypes) of Hepatitis C and hence recommended the waiver.

"We welcome the availability of a pan-genotypic directly acting anti-viral (DAA) combination in India, which is a big step towards interferon free treatment for chronic HCV patients, many of whom urgently need treatment as they have advanced liver disease," said Leena Menghaney, head of MSF's South Asia Access Campaign.

StephenW

丙型肝炎治疗的费用可能低至卢比67K
http://timesofindia.indiatimes.c ... leshow/49966218.cms

新德里：在此之际，一个巨大的安慰慢性丙型肝炎患者的举动，中央药品标准控制组织（CDSCO）的顶点委员会已批准豁免的地方试验的关键新的直接作用的抗病毒药物治疗疾病。

该豁免索非布韦和ledipasvir共配制和daclatasvir有望带来这些药物，这花费了品牌版本的一小部分，进入印度市场周内的通用版本。面对生命的威胁有些患者目前处于巨大的成本进口这些药物。

据世界卫生组织（WHO），约12亿人感染丙型肝炎在印度。印度目前是少数国家的仿制药可用于干扰素的待遇之一。长效干扰素是一个古老的，昂贵的，注射化疗药物与用于治疗丙肝与索非布韦和利巴韦林联合严重的副作用。

干扰素免费治疗，花费超过$ 90,000美国（从朱：在房地产现在的$ 50K在美国降价和回扣在过去的一年）。和超过50,000欧元，欧盟将提供给印度的病人约55,000卢比，或约$ 1,000或甚至更少的仿制药生产商之间的竞争感谢。

印度仿制药有望彻底改变丙肝治疗的区域和所有在世界各地，他们在艾滋病毒/艾滋病的情况下做到了。从那里治疗被配给由政府，比如在澳大利亚，许多欧洲国家，美国和加拿大国家的人民，已经来到印度得到处理，这种趋势只可能会继续下去。

一些患者群体，包括国际治疗准备联盟 - 南亚，积极人民德里网络，地中海贫血患者团体和无国界医生组织（MSF）和无国界医生组织一直(敏感词)卫生部和印度药品管理总局（DCGI ）寻求临床试验豁免这些药物。过了十几个病人团体和访问，以医药活动家来自印尼，泰国，马来西亚，尼泊尔和越南也派出类似的呼吁。 “对于本地的临床试验在印度的需求将推迟推出新的HCV药物daclatasvir在国内，而且在其他的高负担国家在该地区，”说上诉。

丙肝晚期患者的肝脏疾病，thalassemics，那些与艾滋病双重感染或那些与肾脏疾病接受透析谁患有丙型肝炎需要结合daclatasvir与索非布韦进行有效的治疗。他们不能耐受干扰素和/或利巴韦林和治疗与索非布韦单独是不可能的它们。因此，他们留下了没有治疗方案时daclatasvir的制造商，布里斯托尔迈尔斯Squibbs（BMS），不愿意把药给印度或其他发展中国家。

索非布韦注册于印度在2015年一月daclatasvir于本月注册。该组合被看作是一种非常有效的固化，约90％的治愈率和没有其它疾病已经如此短的时间固化变得可用，即得在一个宽泛的版本。

据一个高级别委员会的建议，放弃对新药的审批已被批准印度以外的印度临床试验可以被认为只有在国家紧急状态，极端紧迫性，流行性的案件和孤儿药稀有疾病和药物表示为其中没有治疗的条件/疾病。这是阻碍了数百万丙肝患者进行了(敏感词)的豁免。

然而，技术委员会，审查索非布韦的情况后，他说，这是它可以安全地用于几个类别丙型肝炎患者的唯一药物。在daclatasvir的情况下，该委员会表示，与其他医药产品的组合药物成为迫切需要加快各类（基因型）丙型肝炎的治疗，因此建议豁免。

“我们欢迎泛基因型直接作用的抗病毒（DAA）在印度的组合，这是对干扰素免费治疗慢性丙型肝炎患者，其中许多人迫切需要治疗，因为他们拥有先进的肝脏疾病迈出了一大步的可用性。”说的Leena Menghaney，无国界医生的南亚访问活动负责人。

hengyin

67K还是67卢比？67卢比等于6.7人民币

StephenW

回复 hengyin 的帖子

Rs 55,000.

hengyin

回复 StephenW 的帖子

5500RMB相比国内还是便宜了很多了！