(Last updated: March 28, 2014; last reviewed: March 28, 2014)
Animal Carcinogenicity StudiesElvitegravir was not genotoxic or mutagenic in vitro. No carcinogenicity was detected in long-term studies in mice at exposures up to 14-fold and rats at exposures up to 27-fold that achieved human systemic exposure at the recommended dose. Cobicistat was not genotoxic or mutagenic in vitro. Long-term carcinogenicity testing is ongoing for cobicistat.
Reproduction/Fertility Animal StudiesElvitegravir did not affect fertility in male and female rats at approximately 16- and 30-fold higher exposures than in humans at standard dosing. Fertility was normal in offspring. Cobicistat did not affect fertility in male and female rats at exposures approximately 4-fold higher than in humans. Fertility was normal in exposed offspring.
Teratogenicity/Developmental Toxicity Animal StudiesStudies in rats and rabbits have shown no evidence of teratogenicity or effect on reproductive function with elvitegravir or cobicistat.
Placental and Breast Milk PassageStudies in rats have demonstrated that elvitegravir and cobicistat are secreted in milk. No human data are available for either drug. No data on placental passage are available for elvitegravir or cobicistat.
Human Studies in PregnancyNo studies of elvitegravir/cobicistat use in human pregnancy have been reported. How to Cite the Guidelines