Symtuza

Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged over 12 years and weighing at least 40 kg). HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).

Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.

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

Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide. The recommended dose is one tablet a day, taken with food.

For further information, see the package leaflet.

Symtuza contains four active substances which work in different ways against HIV:

• Darunavir is a type of antiviral agent called a ‘protease inhibitor’. It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected. By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
• Cobicistat acts as a ‘booster’ to enhance the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging the time it acts in the body.
• Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
• Emtricitabine is a reverse transcriptase inhibitor and it works in the same way as tenofovir.

Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

Darunavir and cobicistat are authorised as Rezolsta. Emtricitabine and tenofovir alafenamide are authorised as Descovy.

Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood to the active substances given separately.

In addition, one main study was carried out to compare Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated. Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml. Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was comparable to the 74% (37 of 50) of patients who achieved it with the comparator.

The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), tiredness, headache and rash. For the full list of side effects reported with Symtuza, see the package leaflet.

Symtuza must not be taken by patients with severely reduced liver function. It must also not be taken with certain medicines that may reduce the effectiveness of Symtuza, as well as medicines that may increase the risk of serious side effects. For more information on the medicines that should not be taken with Symtuza, see the package leaflet.

The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment. Symtuza has also been shown to be as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide. Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.

The Agency decided that Symtuza’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symtuza have been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Symtuza on 21 September 2017.

For more information about treatment with Symtuza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.