Genvoya: elvitegravir + cobicistat + emtricitabine + TAF (E/C/F/TAF)

12 April 2016. Related: ARVs, Fixed dose combinations, Integrase inhibitors, Nukes, PK booster.

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Genvoya is a single pill that contains elvitegravir (150 mg) the booster cobicistat (150 mg) emtricitabine (200 mg) and tenofovir alafenamide fumarate (10 mg). It is a white/grey tablet.

Geneva is approved by the EMA in Europe and by the FDA in the US. 

Genvoya is a 4-in-1 single combination pill that is taken once-daily, with food.

The active drugs in Genvoya are:

• 150 mg elvitegravir – an integrase inhibitor.
• 150 mg cobicistat – a “booster” for elvitegravir.
• 10 mg tenofovir alafenamide (TAF)
• 200 mg FTC.

Other important characteristics include:

• Genvoya needs to be taken with food. The amount of type of food is not included in this recommendation but it may be important to include fat. The food interaction study reported that elvitegravir exposure (total drug levels over the dose period, called the AUC) increased by 36% with a light meal (~373 kcal, 20% fat) and by 91% with a high-fat meal (~800 kcal, 50% fat).
• Drug interactions include with antacid medicines which can reduce levels of elvitegravir. Antacids need to be be separated by at least four hours.
• A potential interaction means that multivitamins and elvitegravir need to be separated by at least four hours.
• Drug interactions. Please tell your doctor or pharmacist about any other drugs or supplements before taking them with Genvoya. Drug interactions can also be checked using the online checker at Liverpool University HIV Interaction website:
  https://www.hiv-druginteractions.org/checker
• Genvoya should not be used in people with reduced kidney function defined as having eGRF levels less than 30 mL/minute.
• Genvoya should not be used in people with severe liver impairment.
• The US approval included a second formulation that used a 25 mg dose of TAF. In the US, the 25 mg TAF version is recommended when used in combinations that do not included boosted protease inhibitors.

The European patient leaflet and detailed Product Information for Genvoya are available at this link on the European Medicines Agency (EMA) website.

The Patient Information is a simplified summary: what the drug is, why it is used, results from studies and cautions including side effects.

The Product Information is a detailed technical summary that you can access as a PDF file by clicking the ‘Product Information’ tab. It describes more precisely how the drug works and how it is processed by your body. This includes, for example, reported food interaction studies in terms of calories or fat content. It includes more details of the study results and a full list of side effects and drug interactions.

Link to EU prescribing information. (html pages)

Link to US prescribing information. (PDF document)