近日，百时美施贵宝向美国提交了由其HIV药物阿扎那韦与吉利德Cobicistat组成的固定剂量复方药物的上市申请。
这款药物将百时美施贵宝HIV蛋白酶抑制剂硫酸阿扎那韦（Reyataz）与Cobicistat结合在了一起，Cobicistat是一种药代动力学增加剂，已作为许多其它HIV治疗药物的构成成分出售，包括吉利德自己的四药复方药物Stribild及强生最近提交上市申请的达如那韦复方药物。
这是百时美施贵宝在一周时间内向美国提交的第三款抗病毒药物，之前该公司提交了丙型肝炎病毒(HCV)治疗药物Daclatasvir和Asunepravir。这家美国制药巨头正在寻求批准这款日服一次的胶囊剂与其它抗逆转录病毒药物合并用药，治疗HIV-1感染，旨在减少患者每天所服用的药片数量。
据称，阿扎那韦是唯一在前瞻性3期试验中评价与Cobicistat合并使用的蛋白酶抑制剂，该试验在48周的无既往治疗史成人患中，对比了Cobicistat增强的阿扎那韦与利托那韦增强的阿扎那韦的有效性和安全性，结果发现两种方案等效。然而，Cobicistat与利托那韦相比，不太可能引起LDL胆固醇升高，而LDL胆固醇升高预示着心血管疾病风险升高。
“坚持HIV治疗方案对于某些患者来说可能是一种挑战，如果该处方药物不能正常服用，可能会导致治疗失败，”新英格兰社区研究计划的HIV专家Calvin Cohen评论称。
阿扎那韦单独用药已是一款成功的HIV治疗药物，去年其全球销售额超过了15亿美元，其中大约50%来自美国市场。百时美施贵宝称，这款药物是最畅销的蛋白酶抑制剂，自该药物于2003年上市以来，在美国大约有24.5万人使用过该药物。
该公司负责Cobicistat增强的阿扎那韦产品的生产与销售，根据与吉利德于2011年签订的协议条款，百时美施贵宝将向吉利德支付销售提成。
BMS files fixed-dose HIV combination in US
Bristol-Myers Squibb (BMS) has filed for approval of a fixed-dose combination of its HIV drug Reyataz with Gilead Sciences' cobicistat in the US.
The product combines BMS' successful HIV protease inhibitor Reyataz (atazanavir sulphate) with cobicistat, a pharmacokinetics-enhancing agent that is already sold as a constituent of a number of other HIV therapies, including Gilead's own quadruple therapy Stribild and Johnson & Johnson's recently filed Prezista combination.
It is the third antiviral filing for BMS in the US in a week, coming shortly after the company submitted applications for hepatitis C virus (HCV) therapies daclatasvir and asunepravir.
The US pharma major is seeking approval of the once-daily capsule formulation for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, as a means of reducing the number of tablets patients need to take per day.
Reyataz is said to be the only protease inhibitor that has been eva1uated with cobicistat in a prospective phase 3 trial (Study 114), which compared the efficacy and safety of cobicistat-boosted Reyataz versus ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks and found the two regimens were equally effective.
Cobicistat is however less likely than ritonavir to cause elevations in LDL-cholesterol, which could indicate an increased risk of cardiovascular disease.
"Adhering to HIV treatment regimens can be challenging for some patients, and if the prescribed medications are not taken properly, it could result in treatment failure," commented Calvin Cohen, an HIV specialist at the Community Research Initiative of New England.
Reyataz is already a successful HIV therapy in its own right, with worldwide sales of more than $1.5bn last year of which around 50 per cent came from the US market. BMS says it is the best-selling protease inhibitor with around 245,000 patients treated with it in the US since it was first launched in 2003.
The company is responsible for the manufacturing and sale of the cobicistat-boosted Reyataz product and will pay Gilead royalties on sales under the terms of an agreement between the two companies signed in 2011.
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