New HIV pill for UK
pharmafile | May 29, 2013 | News story | Sales and Marketing | Gilead, HIV, stribild
Gilead Sciences has launched Stribild, a once-daily single tablet regimen to combat HIV – the virus which causes AIDS – in the UK.
Stribild is a combination of 150mg each of elvitegravir and cobicistat plus 200mg of emtricitabine and 245mg of tenofovir disoproxil.
It was granted a licence by the European Commission recently for the treatment of HIV-1 in adults who have not had antiretroviral treatment, or who are infected without known mutations associated with resistance to any of Stribild’s three antiretroviral agents.
Elvitegravir is an integrase inhibitor, which interferes with HIV replication by blocking the virus’ ability to integrate into the genetic material of human cells, while cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A, an enzyme that metabolises drugs in the body.
Stribild is Gilead’s third single anti-HIV pill in Europe, following Atripla (marketed with Bristol-Myers Squibb and Merck) and Eviplera (with Janssen R&D, Ireland).
As with other diseases, the drive to de-complicate treatments in order to ensure patients actually take them has been key for the development of HIV products.
“Treatment guidelines from the British HIV Association recommend HIV regimen simplification to help enhance patient adherence,” said Anton Pozniak, director, HIV Service at London’s Chelsea and Westminster Hospital. “This can keep the virus under control, which may improve long-term health benefits for patients.”
In two pivotal Phase III studies, Stribild met its primary objective of non-inferiority to Atripla and to a regimen containing ritonavir-boosted atazanavir, plus Gilead’s own Truvada.
In addition to its EU authorisation, the brand also has licences in the US, Canada, Australia, South Korea, Japan and Turkey.
Standalone marketing applications for elvitegravir and cobicistat are under review in Europe, although similar filings have hit a bumpier road in the US – last month the FDA issued Complete Response Letters on the drugs which Gilead is attempting to resolve ‘as quickly as possible’.
Adam Hill
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