New TAF-containing fixed dose combination approved in the US
22 March 2016. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 1st March 2016, the U.S Food and Drug Administration (FDA) approved a new fixed-dose combination (FDC) for adults and adolescents (older than 12 years) that contains a new formulation of tenofovir DF.
The FDC contains rilpivirine (25 mg), emtricitabine (200 mg) and tenofovir alafenamide (TAF) (25 mg). The indication is for initial treatment in people with viral load <100,000 copies/mL.
It is also indicated as a switch treatment for people on stable treatment with undetectable viral load (<50 copies/mL) for more than six months, who do not have a history of previous treatment failure.
Both indications are dependent on not having drug resistance associated with any of the three drugs.
As with other rilpivirine-containing combinations, this FDC also needs to be taken with a meal (>400 kcal).
It is not recommended in patients with CrCl <30 mL/min.
This FDC is manufactured by Gilead and has the brand name Odefsey. The original manufacturers of rilpivirine, Janssen, will have marketing rights in 17 countries.
Please see prescribing information for further details. [2, 3]
Comment
A decision on approval in the EU is expected by 3Q2016.
Last week, the European Medicines Agency (EMA) announced a positive opinion on the two-drug combination of emtricitabine plus TAF, with expected full approval within a few months. [4]
References:
- Gilead press release. U.S. Food and Drug Administration approves Gilead’s second TAF-based single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV-1 infection. (01 March 2016)
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2144886 - Patient Information ODEFSEY (oh-DEF-see) (emtricitabine, rilpivirine and tenofovir alafenamide) tablets
http://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_patient_pi.pdf - Gilead. Odefsey hightlights of prescribing information.
http://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pdf - Gilead press release. European CHMP adopts positive opinion for Gilead’s fixed-dose combination Descovy (emtricitabine/tenofovir alafenamide) for the treatment of HIV. (26 February 2016).
http://www.gilead.com/news/press-releases/2016/2/european-chmp-adopts-positive-opinion-for-gileads-fixeddose-combination-descovy-emtricitabinetenofovir-alafenamide-for-the-treatment-of-hiv