Cobicistat and elvitegravir approved in the US as single pills
1 October 2014. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 24 September 2014, the FDA approved separate formulations of cobicistat (Tybost) 150 mg tablets and elvitegravir (Vitekta) 85 mg and 150 mg tablets. [1, 2]
Cobicistat is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other ARVs as part of an HIV combination. Cobicistat is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data and is not recommended with these drugs.
Cobicistat and elvitegravir were approved in the EU last year – in September 2013 and November 2013, respectively.
Comment
Since EU approval, UK access to separate evitegravir has been restricted to getting this directly from Gilead.
References:
- FDA. Approval of Tybost (cobicistat) 150 mg tablets. (24 September 2014).
http://content.govdelivery.com/accounts/USFDA/bulletins/d16150 - FDA. Approval of Vitekta (elvitegravir) 85 mg and 150 mg tablets. (24 September 2014).
http://content.govdelivery.com/accounts/USFDA/bulletins/d162bb