根据每人90 $新颖HCV的DAA可以是大量生产的

StephenW

Novel HCV DAAs could be mass-produced under $90 per person
July 26, 2016

   
If international donors place larger orders, novel direct-acting antivirals to treat hepatitis C could be mass-produced for under $90 per person, according to data presented at AIDS 2016.

“A course of treatment to cure hepatitis C could be mass produced for under $90 per person, if we can follow the same methods of production used to treat 17 million people with HIV/AIDS using antiretrovirals,” Andrew Hill, PhD, senior visiting research fellow in the pharmacology department at Liverpool University, told Infectious Disease News. “For this to happen, we need international donors or national health authorities to place large orders for treatment. We would need orders for at least 1 million courses of treatment to achieve the $90-unit price.”

Andrew Hill, PhD

Andrew Hill

Novel DAAs can achieve sustained viral response rates above 90%, according to Hill and colleagues. However, the lowest price for a 12-week course of Sovaldi (sofosbuvir, Gilead Sciences) is $324 and “access” prices are available in countries only covering 50% of the worldwide epidemic, they said.

To measure how prices for novel DAAs are beginning to fall, the researchers extracted data from the first half of 2016 on the per-kilogram prices of exported active pharmaceutical ingredient (API) and exported volumes and determined per-pill API costs according to daily dosage. They estimated a cost of $0.04 per pill for formulation and excipients, $0.35 a month for packaging and a 50% profit margin.

They found that the total exports from India during this period were 10.2 tons of sofosbuvir, which is equivalent to 303,000 12-week treatment courses; 5,443 kg of Daklinza (daclatasvir Bristol-Myers Squibb), which is equivalent to 1,080,000 courses; and 240 kg of ledipasvir (Gilead Sciences), which is equivalent to 32,000 courses.

API prices decreased during this period. At the end of May 2016, the API price was $1,094/kg for sofosbuvir, $998/kg for daclatasvir, $2,441/kg for ledipasvir and between $8,900 and $11,700/kg for velpatasvir. Prices in the United States were 1,355 times higher than the target price for sofosbuvir, 4,500 times higher for daclatasvir, 984 times higher for Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) and between 346 and 413 times higher for Epclusa (sofosbuvir/velpatasvir, Gilead Sciences).

Overall, 12-week treatments of sofosbuvir can be manufactured for $62, sofosbuvir plus ledipasvir for $96, daclatasvir for $14 and sofosbuvir plus velpatasvir for between $181 and $216, all of which include a 50% profit margin.

“Currently, less than 1 million people are being treated for hepatitis C worldwide, according to our analysis of exported raw materials,” Hill said. “By contrast there are an estimated 2 to 4 million new infections with hepatitis C each year. So unless we increase the numbers of people treated, the epidemic of hepatitis C will continue worldwide.” – by Will Offit

Reference:

Gotham D, et al. Abstract A-792-0516-01639. Presented at: AIDS 2016 Annual Meeting; July 18-22, 2016; Durban, South Africa.

Disclosure: The researchers report no relevant financial disclosures.

StephenW

根据每人90 $新颖HCV的DAA可以是大量生产的
2016年7月26日

   
如果国际捐助者把更大的订单，新的直接作用抗病毒药物治疗丙型肝炎的可能是大规模生产下每人$ 90，根据在2016年艾滋病呈现的数据。

“治疗治愈丙型肝炎的课程可以批量生产根据每人$ 90，如果我们可以按照使用使用抗逆转录病毒药物治疗1700万人感染艾滋病毒/艾滋病的生产同样的方法，”安德鲁·希尔博士，高级访问研究在利物浦大学药理系研究员告诉传染病新闻。 “为了做到这一点，我们需要国际捐助者或国家卫生部门大量订货治疗。我们需要订单处理至少有1万个疗程达到$ 90的单价。“

安德鲁·希尔博士

安德鲁•希尔

新的DAA可以实现持续病毒应答率90％以上，根据希尔和他的同事。但是，最低价格Sovaldi（索非布韦，吉利德科学）的12周的课程为$ 324和“准入”的价格是国家只覆盖了全球流行的50％可用，他们说。

为了衡量价格如何为新的DAA都开始下降，研究人员根据每日用量提取从2016年上半年的数据对出口活性药物成分（API）和出口量的每公斤价格和每丸确定API费用。他们估计，每丸$ 0.04为制定和辅料，每月$ 0.35的包装和50％的利润率为代价。

他们发现，从印度出口总量在此期间10.2吨索非布韦，相当于303000 12周疗程的; 5443公斤Daklinza（daclatasvir施贵宝），这相当于108万课程;和240公斤ledipasvir（Gilead Sciences公司），相当于32,000个课程。

API的价格在此期间下降。在2016年5月底，该API价格为$ 1,094 /公斤索非布韦，$ 998张/公斤daclatasvir，$ 2,441 /公斤ledipasvir到$ 8900和$ 11,700 /公斤velpatasvir。在美国的价格高出1355倍，目标价为索非布韦，为daclatasvir高4500倍，高出984倍Harvoni（ledipasvir /索非布韦，吉利德科学）和Epclusa（索非布韦/ velpatasvir，吉利德更高倍346和413之间科学版）。

总体而言，索非布韦的12周的治疗可以为$ 62索非布韦加上ledipasvir为$ 96 daclatasvir为$ 14和索非布韦加velpatasvir介于$ 181和$ 216其中包括所有50％的利润率来制造。

“目前，不到1万人正在接受治疗丙型肝炎全世界，根据我们出口原材料的分析，”希尔说。 “相比之下有丙型肝炎，每年估计有200至400万新感染病例。因此，除非我们增加人们治疗的人数，丙型肝炎疫情将继续全世界。“ - 威尔Offit

参考：

谭D，等。摘要A-792-0516-01639。发表在：2016年艾滋病年度会议; 7月18日至22日，2016年;南非德班举行。