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 evaluated 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.