The FDA on Friday approved a label update on Biktarvy, Gilead’s blockbuster HIV drug, to include more data on the drug’s safety and efficacy for pregnant people with HIV.
The additional data reflected on the label are supported by positive results from Gilead’s Study 5310, which evaluated Biktarvy in pregnant people with HIV-1 who have suppressed viral loads, meaning that they have a low level of virus in their bodies. The study evaluated people in their second and third trimesters through a median of 16 weeks postpartum.
Jared Baeten“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant people with HIV, an often understudied and most vulnerable community in clinical research,” Jared Baeten, Gilead’s vice president of HIV clinical development, said in a statement. “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.”
HHS guidelines recognize Biktarvy as an alternative complete regimen people with HIV can take during pregnancy and for people trying to conceive. The guidelines also recommend the medication for pregnant people with HIV who are tolerating their existing treatment well and may become pregnant, Gilead noted.
The study did not glean any new safety or tolerability concerns and adverse events were consistent with what was expected for the population.
Biktarvy was Gilead’s most lucrative product last year, bringing in $11.8 billion in 2023, according to the company’s earnings report.