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Gilead gets EU nod for TAF-based triple therapy for HIV

Once-daily, single-tablet Odefsey reduces risks of side effects such as renal and bone toxicity
Gilead Sciences

Gilead Sciences has added to its portfolio of HIV drugs in Europe after getting EMA approval for Odefsey, a three-drug combination based on its new tenofovir alafenamide (TAF) drug.

The once-daily, single-tablet combines TAF with emtricitabine - a dual therapy sold as Descovy - with Johnson & Johnson's Edurant (rilpivirine). It is a follow up to Gilead's $1.4bn Complera, which contains emtricitabine, rilpivirine and tenofovir disoproxil fumarate (TDF) and is among the most prescribed HIV drugs.

TAF is a new salt form of TDF that is ten-fold more potent and can be delivered at a much lower dose, reducing the risk of side effects such as renal and bone toxicity.

Gilead is in the process of replacing all of its TDF-based HIV products with TAF and in addition to Descovy - which forms the backbone of its new HIV drugs - has also bagged approval for four-drug Genvoya (elvitegravir, emtricitabine, cobicistat and TAF), an updated version of the company's $1.8bn Stribild brand. Odefsey was approved in the US - its first market - in March.

Gilead has great expectations for the new TAF-based products and early signs are that this confidence is well-placed. In the first 18 weeks from launch in the US last November, Genvoya's uptake is outpacing Gilead's other products and is its most successful launch since it rolled out Atripla in 20016. Since then, Atripla has grown into a $3bn-plus product.

"People living with HIV today are increasingly likely to be receiving treatment for other conditions - such as heart and liver disease - because they are living longer than ever before," commented Andy Ustianowski, an HIV specialist at North Manchester General Hospital in the UK.
Patients typically are exposed to the virus and antiretroviral treatment for longer, he added, so there is a need for "new treatment options that are not only efficacious but also tolerable, and with convenient dosing”.

Integrase inhibitor
Gilead also reported preliminary, first-in-human data from a study of another new HIV treatment, its HIV integrase inhibitor bictegravir (GS-9883), at the recent American Society of Microbiology (ASM) Microbe 2016 Conference in Boston this month. The studies examined the antiviral potency, resistance profile, pharmacokinetics and safety of the drug.

Bictegravir - an improved follow-up to elvitegravir - is currently in phase III trials in a single-tablet regimen in combination with TAF and emtricitabine.

24th June 2016

From: Regulatory

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