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Information about Descovy ▼

What is it and what is it used for?

Descovy is an antiviral medicine used in combination with other medicines to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged over 12 years and who weigh at least 35 kg.

Descovy contains the active substances emtricitabine and tenofovir alafenamide.

How Descovy is used
Descovy can only be obtained with a prescription and treatment should be started by a doctor experienced in managing HIV infection.

Descovy is available as tablets, each containing 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide. The recommended dose is one tablet per day, and the strength of Descovy tablet chosen by the doctor depends on which other medicines it is given with. For further information, see the summary of product characteristics (also part of the EPAR).

How Descovy works
Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected. By blocking reverse transcriptase, Descovy reduces the amount of HIV in the blood and keeps it at a low level. It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

What are the benefits?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Descovy’s benefits are greater than its risks and recommended that it be approved for use in the EU. Descovy contains tenofovir alafenamide which is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects. Similarly to Genvoya, Descovy offers an alternative option to giving emtricitabine with tenofovir disoproxil.

What are main side effects?

The most common side effect with Descovy (which may affect 1 in 10 people) is nausea (feeling sick). Other common side effects include diarrhoea and headache. For the full list of all side effects and restrictions with Descovy, see the package leaflet.

What studies have been done?

The active substances in Descovy (emtricitabine and tenofovir alafenamide) are already approved to treat HIV infection together with two other active substances (elvitegravir and cobicistat) as part of the combination medicine Genvoya. The company therefore presented data from the studies previously used to approve Genvoya, including 2 studies in 1,733 previously untreated adults, where around 90% of patients responded to treatment, and another study showing benefit was maintained when patients treated with other effective combinations were switched to Genvoya.

The company also provided data from supporting studies including studies looking at the way Descovy was absorbed in the body. These studies showed that Descovy produces comparable levels of emtricitabine and tenofovir alafenamide in the body to Genvoya.

Sources

Descovy was first approved for use in the EU in 2016. It is manufactured by Gilead.

European Medicines Agency website page for Descovy (accessed 19/07/18)

Links available in External Resources

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).