P1026s EVG data used to change Stribild® and Genvoya® labels

IMPAACT P1026s has now enrolled over 1000 pregnant/postpartum women for intensive pharmacokinetic (PK) sampling of HIV, TB and contraceptive medications and is a widely recognized repository of pregnancy pharmacokinetic data. IMPAACT P1026s has published data describing the safety and PK of over 20 antiretrovirals and its data have served as a key source in dosing recommendations issued by perinatal HIV guidelines committees, including the US Perinatal HIV Guidelines Committee and WHO. The IMPAACT P1026s elvitegravir/cobicistat arm recently published the first data describing the safety and PK of elvitegravir/cobicistat during pregnancy. These data were used as the basis for a recent FDA change in licensing for elvitegravir/cobicistat drugs that includes the recommendation that these drugs not be used in pregnancy due to low drug exposures.

Recent P1026s Abstracts and Presentations:

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.