FDA Pregnancy Categories for Antiretroviral Therapy 

Updated: Mar 26, 2014
  • Author: Kristina M Jose, MD; Chief Editor: John Bartlett, MD  more...
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FDA Pregnancy Categories

Treatment recommendations for pregnant patients infected with the human immunodeficiency virus (HIV) should be based on providing antiretroviral therapy that has minimal adverse effects on the mother, fetus, and infant. Before initiating treatment, health care providers should review the potential teratogenic effects of antiretroviral treatments on the fetus, as well as any other adverse impacts the therapy could have on the fetus or newborn. [1, 2, 3]

The decision whether to use antiretroviral therapy during pregnancy should be made by the patient after she has discussed with her health care provider the treatment’s known and potential benefits and risks to herself and her fetus.

The US Food and Drug Administration (FDA) requires that any drug that is systemically absorbed contain information on the drug’s teratogenic effects, as well as information on other effects the agent may have on reproduction and pregnancy.

FDA Pregnancy Categories

See the list below:

  • Category A: Adequate and well-controlled studies of pregnant women fail to demonstrate a risk to the fetus during the first trimester of pregnancy (and no evidence exists of risk during later trimesters)
  • Category B: Animal reproduction studies fail to demonstrate a risk to the fetus, and adequate, but well-controlled, studies of pregnant women have not been conducted
  • Category C: Safety in human pregnancy has not been determined; animal studies either are positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus
  • Category D: There is positive evidence of human fetal risk that is based on adverse-reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug in pregnant women might be acceptable despite its potential risks
  • Category X: Studies in animals or reports of adverse reactions have indicated that the risk associated with the use of the drug for pregnant women clearly outweighs any possible benefit

FDA Pregnancy Categories for Antiretroviral Therapy

There are several antiretroviral agents that are used to treat HIV, including nucleoside and nucleotide analogue reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, cellular chemokine receptor (CCR5) antagonists, fusion inhibitors, and integrase inhibitors.

Table. FDA Pregnancy Categories for Antiretroviral Therapy

TD

Table. (Open Table in a new window)

Nucleoside and nucleotide analogue reverse transcriptase inhibitors
Antiretroviral therapy FDA pregnancy category
Abacavir (ABC) C
Didanosine (ddI) B
Emtricitabine (FTC) B
Lamivudine (3TC) C
Stavudine (d4T) C
Tenofovir DF (TDF) B
Zidovudine (ZDV) C
Nonnucleoside reverse transcriptase inhibitors
Antiretroviral therapy FDA pregnancy category
Delavirdine (DLV) C
Efavirenz (EFV) D
Etravirine (ETR) B
Nevirapine (NVP) B
Rilpivirine (RPV) B
Protease inhibitors
Antiretroviral therapy FDA pregnancy category
Atazanavir (ATV) B
Darunavir (DRV) C
Fosamprenavir (f-APV) C
Indinavir (IDV) C
Lopinavir/ritonavir (LPV/r) C
Nelfinavir (NFV) B
Ritonavir (RTV) B
Saquinavir (SQV) B
Tipranavir (TPV) C
Fusion inhibitor
Antiretroviral therapy FDA pregnancy category
Enfuvirtide (T-20) B
Cellular chemokine receptor (CCR5) antagonist
Antiretroviral therapy FDA pregnancy category
Maraviroc (MVC) B
Integrase inhibitor
Antiretroviral therapy FDA pregnancy category
Raltegravir (RAL) C
Elvitegravir (EVG) B
Dolutegravir (DTG) B