FDA Revises Certain Antiretroviral Drug Labeling to Not Recommend Cobicistat During Pregnancy

The U.S. Food and Drug Administration (FDA) recently revised labeling to state the following cobicistat-containing drugs are not recommended for initiation or continued use during pregnancy:

  • GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate)
  • STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)
  • TYBOST (cobicistat) when coadministered with either atazanavir or darunavir

These labeling changes were made due to substantially lower exposures of cobicistat, elvitegravir, and darunavir during the second and third trimesters of pregnancy that were observed in pharmacokinetic studies of darunavir/cobicistat and elvitegravir/cobicistat in pregnant women. Decreased antiretroviral concentrations may lead to loss of therapeutic effect and possible development of resistance.

The pharmacokinetics and antiviral activity of darunavir/cobicistat- and elvitegravir/cobicistat-containing antiretroviral regimens in pregnant women living with HIV in the second or third trimesters of pregnancy and through 6 to 12 weeks postpartum were evaluated in two prospective studies. Details regarding these studies can be found in the full prescribing information linked below.

Full prescribing information for GENVOYA is available at https://go.usa.gov/xPvYx.

Full prescribing information for STRIBILD is available at https://go.usa.gov/xPvYa.

Full prescribing information for TYBOST is available at https://go.usa.gov/xPVR6.

Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

A non-comprehensive list of examples of clinical substrates, inhibitors and inducers for metabolic and transporter system related interactions may be found at https://go.usa.gov/xXY9C.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.