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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 A: Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy

Protease Inhibitors

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 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, lopinavir/ritonavir, 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 Protease Inhibitor Therapy and Hyperglycemia and Combination Antiretroviral Therapy and Pregnancy Outcome in the perinatal guidelines.

Amprenavir (Agenerase, APV)
Atazanavir (Reyataz, ATV)
Darunavir (Prezista, DRV)
Fosamprenavir (Lexiva, f-APV)
Indinavir (Crixivan, IDV)
Lopinavir + Ritonavir (Kaletra, LPV/r)
Nelfinavir (Viracept, NFV)
Ritonavir (Norvir, RTV)
Saquinavir (Invirase [Hard Gel Capsule], SQV)
Tipranavir (Aptivus, TPV)