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Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)- pregnancy warning update

Stribild, for HIV and AIDS and HIV - Human immunodeficiency virus infection from Gilead

Pregnancy warning update

The product information for Stribild has been updated to advise that the treatment should not be initiated during pregnancy. An alternative regimen for pregnant women should be undertaken. This is based on data from a study which showed that there was lower elvitegravir and cobicistat levels during 2nd and 3rd trimesters compared to after birth. This means that the treatment may be less effective.

Gilead, the manufacturers of HIV infection treatment, a combination of four medicines - emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide fumarate - brand name Stribild, have updated the pregnancy information.

The product information has been updated to advise not to initiate this product during pregnancy, and to switch to alternative regimen for pregnant women. This is based on data from a study which showed that there was lower elvitegravir and cobicistat levels during 2nd and 3rd trimesters compared to after birth. This means that the treatment may be less effective.

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About Stribild
Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV‑1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used only in patients who have not received HIV medicines before or whose disease is not expected to be resistant to any of the antiviral agents in Stribild; it should only be used in patients under 18 years if other HIV medicines not including tenofovir disoproxil cannot be used because of side effects.

Stribild contains four active substances. Elvitegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an HIV-1 enzyme called integrase, which is involved in the virus’s replication, thereby reducing the virus’s ability to replicate normally and slowing down its spread. Cobicistat enhances the effects of elvitegravir, by prolonging the time for which elvitegravir continues to work. Tenofovir disoproxil is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body. By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.

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

Stribild was first made available in the EU in 2013. It is manufactured by Gilead.

Sources
European Medicines Agency website page for Genvoya
Accessed 23/04/19
Links available in full article

EMA information on Stribild

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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