Gilead Sciences, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy. The new label now includes extra data that reinforces the safety and effectiveness of the medication for treating HIV-1 in pregnant individuals with suppressed viral loads.
The additional data originated from Study 5310. This research evaluated the pharmacokinetics (the movement of drugs within the body), safety, and efficacy of Biktarvy in treating pregnant individuals with suppressed viral loads. The study focussed on those who have no known resistance to any components of the medication in their second and third trimesters, and for up to 16 weeks postpartum on average.
This new information makes Biktarvy the only single-tablet regimen (STR) based on a second-generation integrase strand transfer inhibitor (INSTI) that has both in-label clinical trial data and FDA approval for use in virologically-suppressed pregnant adults.
Furthermore, the updated label has led the U.S. Department of Health and Human Services (DHHS) to list Biktarvy as having enough data to support its recommendation as an alternative complete regimen for use both during pregnancy and by those attempting to conceive. The guidelines also suggest continuing Biktarvy for individuals already on the treatment who are successfully suppressing the virus and tolerating the treatment well, including those who may become pregnant.
The updated label now includes additional data from Study 5310, a Phase 1b, open-label, single-centre clinical trial. The study assessed the pharmacokinetics, safety, and efficacy of Biktarvy in pregnant individuals who were successfully suppressing the virus and had no known resistance to the components of the medication.
