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Gilead launches combination HIV pill in UK and Germany

Stribild is approved in EU as once-daily single tablet

Gilead Sciences Stribild HIV package

Gilead Sciences has launched its combination HIV pill Stribild in the UK and Germany following approval from the European Commission (EC).

The once-daily drug, which combines four separate treatments each working in a different way, offers HIV patients in Europe a less complicated treatment option than taking multiple pills a day and expectations are that it will support improved adherence.

Stribild is already making inroads in the US following its FDA approval in August 2012, and the medicine made more than $92m during the first quarter of 2013 despite what some commentators see as a prohibitive price tag of $28,000 per year.

Gilead will be hoping for similar strong uptake in the EU, where 2.3 million people are thought to live with HIV.

This includes 96,000 people in the UK, which according to a Gilead spokesperson was chosen alongside Germany as the launch market “based on pricing and reimbursement procedures”.

“We are now working expeditiously with national authorities to confirm pricing arrangements for Stribild as quickly as possible,” the spokesperson added, while launches in Austria, the Nordics, Italy and Spain are expected over the coming weeks and months.

Dr Anton Pozniak, Director, HIV Service, Chelsea and Westminster Hospital, London, commented on the drug’s potential in the UK.

He said: “Treatment guidelines from the British HIV Association recommend HIV regimen simplification to help enhance patient adherence. This can keep the virus under control, which may improve long-term health benefits for patients.”

The EC approval for Stribild follows the recommendation from the European Medicines Agency (EMA) and covers the drug’s use as a treatment of HIV in adults who have not previously received antiretroviral treatment or whose HIV has not mutated to resist to any of the three antiretroviral agents in Stribild.

These agents include emtricitabine and tenofovir disoproxil, which are already approved as the combination therapy Truvada.

In addition to these agents, Stribild contains the integrase inhibitor elvitegravir and cobicistat, which doesn’t tackle the virus itself, but supports the effect of other medicines by boosting the body’s metabolism.

Neither elvitegravir and cobicistat is recommended for individual use in Europe, and both were recently turned down as monotherapies by the US FDA.

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