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Information about Symtuza▼

What is it and what is it used for?

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 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.

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 was first approved for use in the EU in 2017. Symtuza is manufactured by Janssen-Cilag.

What are the benefits?

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.

What are main side effects?

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

Who should avoid taking it?

Symtuza should not be initiated during pregnancy. Treatment with darunavir/cobicistat (two of the components of Symtuza) during pregnancy results in low darunavir exposure. Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen 

Low darunavir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child

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 (link in External Resources).

What studies have been done?

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.

Sources

EMA website for Symtuza.  Accessed on 25/10/17. 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).