Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States

Archived Drugs

Delavirdine (Rescriptor, DLV)

Delavirdine is classified as FDA pregnancy category C and is no longer available in the United States.

Animal Studies

Carcinogenicity
In vitro screening tests for carcinogenicity have been negative. In rats, delavirdine was noncarcinogenic at all doses studied. In mice, delavirdine was associated with an increase in hepatocellular adenoma and carcinoma in both males and females and urinary bladder tumors in males at systemic exposures 0.5- to 3-fold higher than human exposure at therapeutic doses for female mice and at exposures 0.2- to 4-fold higher in male mice.

Reproduction/Fertility
Delavirdine does not impair fertility in rodents.

Teratogenicity/Adverse Pregnancy Outcomes
Delavirdine is teratogenic in rats; doses of 50 to 200 mg/kg/day during organogenesis caused ventricular septal defects.

Exposure of rats to doses approximately 5 times human therapeutic exposure resulted in marked maternal toxicity, embryotoxicity, fetal developmental delay, and reduced pup survival.

Abortions, embryotoxicity, and maternal toxicity were observed in rabbits at doses approximately 6 times human therapeutic exposure.

Placental and Breast Milk Passage
Whether delavirdine crosses the placenta is unknown. Delavirdine is excreted in the milk of lactating rats; however, it is unknown if the drug is excreted in human breast milk.

Human Studies in Pregnancy

Delavirdine has not been evaluated in HIV-infected pregnant women. In premarketing clinical studies, the outcomes of seven unplanned pregnancies were reported: three resulted in ectopic pregnancies, three resulted in healthy live births, and one infant was born prematurely with a small muscular ventricular septal defect to a patient who received approximately 6 weeks of treatment with delavirdine and zidovudine early in the course of pregnancy.