What is Descovy - Emtricitabine / Tenofovir alafenamide used for?
Descovy is an antiviral medicine used in combination with other medicines to treat subjects with human immunodeficiency virus type 1 (HIV-1) infection, a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents over 12 years of age and with a body weight of at least 35 kg.
Descovy contains the active substances emtricitabine and tenofovir alafenamide.
How is Descovy - Emtricitabine / Tenofovir alafenamide used?
Descovy can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Descovy is available as tablets, each containing 200 mg of emtricitabine and or 10 or 25 mg of tenofovir alafenamide. The recommended dose is one tablet a day, and the concentration of the Descovy tablet chosen by the doctor depends on which other medicines are taken. For more information, see the summary of product characteristics (included with EPAR).
How does Descovy - Emtricitabine / Tenofovir alafenamide work?
Tenofovir alafenamide is a "prodrug" of tenofovir, ie it is converted into the active substance tenofovir within the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, an enzyme produced by the virus that allows it to reproduce in the cells it has infected. By inhibiting reverse transcriptase, Descovy reduces the amount of HIV present in the blood and keeps it at low levels. It does not cure HIV infection or AIDS, but it can delay the damage to the immune system and can prevent the development of infections and diseases associated with AIDS.
What benefit has Descovy - Emtricitabine / Tenofovir alafenamide shown during the studies?
The active ingredients of Descovy (emtricitabine and tonofovir alafenamide) are already approved for the treatment of HIV infection together with two other active substances (elvitegravir and cobicistat) as part of the combination drug Genvoya. The company therefore presented data from the previously used studies for the approval of Genvoya, including 2 studies of 1, 733 previously untreated adults, in which approximately 90% of patients responded to treatment, and another study which shows the benefits that were maintained when patients treated with other effective combinations switched to Genvoya.
The company also provided data from supportive studies including studies observing how Descovy was absorbed by the body. These studies showed that Descovy produces levels of emtricitabine and tenofovir alafenamide in the body similar to Genvoya.
What is the risk associated with Descovy - Emtricitabine / Tenofovir alafenamide?
The most common side effect of Descovy (which may affect more than 1 in 10 people) is nausea. Other common side effects are diarrhea and headache. For the full list of all side effects and restrictions with Descovy, see the package leaflet.
Why has Descovy - Emtricitabine / Tenofovir alafenamide been approved?
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 commonly used tenofovir disoproxil medicine and offers the possibility of reducing side effects. Like Genvoya, Descovy offers an alternative solution to the administration of emtricitabine with tenofovir disoproxil
What measures are being taken to ensure the safe and effective use of Descovy - Emtricitabine / Tenofovir alafenamide?
A risk management plan has been developed to ensure that Descovy is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Descovy, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Descovy - Emtricitabine / Tenofovir alafenamide
The full EPAR for Descovy can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Descovy therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
