Safety of protease inhibitors in HIV-infected pregnant women

Figures & data

Figure 1 Concerns raised by the use of protease inhibitors during pregnancy.

Figure 2 Trends for in utero exposure to PI.

Note: Copyright © 2011, Mary Ann Liebert, Inc. publishers. Reproduced with permission from Griner R, williams PL, Read JS, et al. In utero and postnatal exposure to antiretrovirals among HIV-exposed but uninfected children in the United States. AIDS Patient Care STDS. 2011;25(7):385–394.¹¹
Abbreviation: PI, protease inhibitor.

Table 1 Safety classification and placental transfer of PIs for use in pregnancy

FDA pregnancy category	Interpretation	PI	Placental transfer
A	Adequate, well controlled studies in pregnant women have not shown an increased risk of fetal abnormalities in the fetus in any trimester of pregnancy.
B	Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well controlled studies in pregnant women. Or Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.	Ritonavir Saquinavir Atazanavir Nelfinavir Darunavir	Low Low Yes Low ND
C	Animal studies have shown an adverse effect and there are no adequate and well controlled studies in pregnant women. Or No animal studies have been conducted and there are no adequate and well conducted studies in pregnant women.	Indinavir Lopinavir Fosamprenavir Amprenavir Tipranavir	Low Low ND ND ND
D	Adequate well controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
X	Adequate well controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. Use of the product is contraindicated in women who are or may become pregnant.

Abbreviations: ND, no data available; FDA, Food and Drug Administration; PI, protease inhibitor.

GrinerRWilliamsPLReadJSIn utero and postnatal exposure to antiretrovirals among HIV-exposed but uninfected children in the United StatesAIDS Patient Care STDS201125738539421992592

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