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HIV 101: Preclinical and Clinical Data Relevant to the Use of Antiretrovirals in Pregnancy

May 2004

Antiretroviral DrugFDA Pregnancy Category*Placental Passage (Newborn:Mother Drug Ratio)Long-term Animal Carcino-
genicity Studies
Animal Teratogen Studies
Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors
Abacavir (Ziagen, ABC)CYes (rats)Positive (malignant and non-malignant tumors of liver, thyroid in female rats, and preputial and clitoral gland of mice and rats)Positive (rodent anasarca and skeletal malformations at 1,000 mg/kg (35x human exposure) during organogenesis; not seen in rabbits)
Didanosine (Videx, ddI)BYes (human) [0.5]Negative (no tumors, lifetime rodent study)Negative
Emtricitabine (Emtriva, FTC)BUnknownNot completedNegative
Lamivudine (Epivir, 3TC)CYes (human) [~1.0]Negative (no tumors, lifetime rodent study)Negative
Stavudine (Zerit, d4T)CYes (rhesus monkey) [0.76]Positive (mice and rats, at very high dose exposure, liver and bladder tumors)Negative (but sternal bone calcium decreases in rodents)
Tenofovir DF (Viread)BYes (rat and monkey)Not completedNegative (osteomalacia when given to juvenile animals at high doses)
Zalcitabine (HIVID, ddC)CYes (rhesus monkey) [0.30-0.50]Positive (rodent, thymic lymphomas)Positive (rodent-hydrocephalus at high dose)
Zidovudine (Retrovir, AZT, ZDV)CYes (human) [0.85]Positive (rodent, noninvasive vaginal epithelial tumors)Positive (rodent-near lethal dose)
Non-Nucleoside Reverse Transcriptase Inhibitors
Delavirdine (Rescriptor)CUnknownPositive (hepatocellular adenomas and carcinomas in male and female mice but not rats, bladder tumors in male mice)Positive (rodent-ventricular septal defect)
Efavirenz (Sustiva)CYes (cynomologus monkey, rat, rabbit)[~1.0]Positive (increased hepatocellular adenomas and carcinomas and pulmonary alveolar/bronchiolar adenomas in female but not male mice)Positive (cynomo-
logus monkey-anencephaly, anophthalmia, microophthalmia)
Nevirapine (Viramune)CYes (human)[~1.0]Positive (hepatocellular adenomas and carcinomas in mice and rats)Negative
Protease Inhibitors
Amprenavir (Agenerase)CUnknownPositive (hepatocellular adenomas and carcinomas in male mice and rats)Negative (but deficient ossification and thymic elongation in rats and rabbits)
AtazanavirBUnknownNot CompletedNegative
Fosamprenavir (Lexiva)CUnknownPositive (increased benign and malignant liver tumors in male rodents)Negative (deficient ossification with amprenavir but not fosamprenavir)
Indinavir (Crixivan)CMinimal (humans)Positive (thyroid adenomas in male rats at highest dose)Negative (but extra ribs in rodents)
Ritonavir (Kaletra)
CUnknownNot CompletedNegative (but delayed skeletal ossification and increase in skeletal variations in rats at maternally toxic doses)
Nelfinavir (Viracept)BMinimal (humans)Positive (thyroid follicular adenomas and carcinomas in rats)Negative
Ritonavir (Norvir)BMinimal (humans)Positive (rodent, liver adenomas and carcinomas in male mice)Negative (but cryptorchidism in rodents)
Saquinavir (Fortovase)BMinimal (humans)Not completedNegative
Fusion Inhibitors
Enfuvirtide (Fuzeon)BUnknownNot DoneNegative
* FDA pregnancy categories:

  1. 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);

  2. Animal reproductive studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted;

  3. Safety in human pregnancy has not been determined, animal studies are either 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.

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This article was provided by Brown Medical School. It is a part of the publication HEPP Report.