最低的成本生产丙型肝炎直接作用的抗病毒药，用于在发展

StephenW

> www.natap.org
>
> AASLD: Minimum costs to produce Hepatitis C Direct Acting Antivirals for access programs in developing countries - (12/20/13)
> Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries
> Clinical Infectious Diseases Advance Access published January 6, 2014

> Abstract
>
> Background.  Several combinations of two or three Direct Acting Antivirals (DAAs) can cure HCV in the majority of treatment-naïve patients. DAAs for HCV infection have similar mechanisms of action and chemical structures to antiretrovirals for HIV infection. Generic antiretrovirals are currently manufactured at very low prices, to treat 10 million people with HIV/AIDS in developing countries.
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> Methods. Four HCV DAAs, currently either in Phase III development or recent approval (daclatasvir, sofosbuvir, simeprevir, faldaprevir) and ribavirin were classified by chemical structure, molecular weight, total daily dose and complexity of synthesis. The likely range of manufacturing costs per gram of DAA were then projected as formulated product cost, based upon treating a minimum of one million patients annually (to arrive at volume demand) combined with an analysis of the complexity of synthesis and a 40% margin for formulation. Projections were then compared with actual costs of antiretrovirals with similar structures.
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> Results. Minimum manufacturing costs of antiretrovirals were US$0.2-2.1/g. The complexity of chemical synthesis for HCV DAAs was ranked from lowest to highest: ribavirin, daclatasvir, sofosbuvir, faldaprevir and simeprevir. Predicted manufacturing costs for 12-week courses of HCV DAAs were: US$21-63 for ribavirin, US$10-30 for daclatasvir, US$68-136 for sofosbuvir, US$100-210 for faldaprevir, and US$130-270 for simeprevir.
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> Conclusions.  Within the next 15 years, large-scale manufacture of two or three drug combinations of HCV DAAs is feasible, with minimum target prices of US$100-250 per 12 week treatment course. These low prices could make widespread access to HCV treatment in low and middle income countries a realistic goal.                 

StephenW

> www.natap.org
>
> AASLD ：最低的成本生产丙型肝炎的直接作用的抗病毒药对发展中国家接入方案 - （ 13年12月20日）
>最低的成本生产丙型肝炎直接作用的抗病毒药，用于在发展中国家大规模获得治疗程序中使用
>临床传染病提前访问发布2014年1月6日

>摘要
>
>背景。两个或三个直接作用抗病毒药物（的DAA ）的几种组合可以在大多数治疗初治患者的治愈丙型肝炎。的DAA为HCV感染者的行动和化学结构的抗逆转录病毒药物对HIV感染类似的机制。通用的抗逆转录病毒药物在非常低的价格，目前生产，对待1000万人感染艾滋病毒/艾滋病在发展中国家。
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>方法。四丙型肝炎病毒的DAA ，目前无论是在第三阶段的发展或近期批准（ daclatasvir ， sofosbuvir ， simeprevir ， faldaprevir ）和利巴韦林进行分类，化学结构，分子量，每日总剂量和合成的复杂性。每克DAA的制造成本可能范围，然后投影作为制定产品成本，根据每年治疗至少百万患者（以容积需求到达）结合的合成的复杂性进行分析，并有40 ％，余量为配方。预测，然后用抗逆转录病毒药物具有相似结构的实际成本进行比较。
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>业绩。抗逆转录病毒药物的最小的制造成本约为0.2-2.1 /克。化学合成的丙型肝炎病毒的DAA的复杂性被排从最低到最高：利巴韦林， daclatasvir ， sofosbuvir ， faldaprevir和simeprevir 。丙型肝炎病毒的DAA的12周的课程，预计生产成本为：US $ 21-63为利巴韦林，约为10-30 daclatasvir ，约为68-136的sofosbuvir ，约为100-210为faldaprevir ，以及美元,130-270为simeprevir 。
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>结论。在接下来的15年中，丙型肝炎病毒的DAA两个或三个药物组合大型制造是可行的，与美元100-250每页显示12周的治疗过程中的最低目标价格。这些低价格可以使广泛利用在低收入和中等收入国家的HCV治疗一个现实的目标。