Dear Doctor Letter (Rote-Hand-Brief) on Genvoya®, Stribild® und Tybost®: increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection
2019.03.26
Active substance: elvitegravir | cobicistat
Affected drugs:
Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide)
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil)
Tybost® (cobicistat)
Gilead Sciences, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to inform that the therapy with elvitegravir- or cobicistat-containing drugs should not be initiated during pregnancy. Women who become pregnant during therapy with elvitegravir- or cobicistat-containing should be switched to an alternative regimen.
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