Selecting an Initial ART Regimen
Editor’s Note: This section is currently under revision. Please refer to the DHHS guideline What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient for the most current information on preferred initial ART regimens, alternative initial ART regimens, considerations for prescribing initial ART in the setting of specific clinical scenarios, and advantages and disadvantages of antiretroviral components recommended as initial ART.
Appendix C: FDA Pregnancy Categories
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 there is no evidence of risk during later trimesters).
Category B. Animal reproduction studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted.
Category C. Animal reproduction studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted.
Category D. Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.