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Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States

Appendix B: Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy

Protease Inhibitors

Glossary of Terms for Supplement

Carcinogenic: Producing or tending to produce cancer
Some agents, such as certain chemicals or forms of radiation, are both mutagenic and clastogenic.
Genetic mutations and/or chromosomal damage can contribute to cancer formation.

Clastogenic: Causing disruption of or breakages in chromosomes
Genotoxic: Damaging to genetic material such as DNA and chromosomes
Mutagenic: Inducing or capable of inducing genetic mutation
Teratogenic: Interfering with fetal development and resulting in birth defects


Ten protease inhibitors (PIs) are currently approved (amprenavir is no longer available in the United States). Data are available from clinical trials in human pregnancy for atazanavir, ritonavir-boosted lopinavir fixed-dose drug formulation, nelfinavir, ritonavir, and saquinavir. Data in pregnancy are limited for darunavir, fosamprenavir, and indinavir. Very limited data in pregnancy are available for tipranavir.

For information regarding the PI class of drugs and potential metabolic complications during pregnancy and pregnancy outcome, see Combination Antiretroviral Drug Regimens and Pregnancy Outcome


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