Gilead’s Biktarvy has previously been approved by the FDA as HIV treatment in both adult and paediatric (weighing at least 14kg) populations. Image Credit: Michael Vi / Shutterstock.

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg).

The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1.

All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower plasma exposures observed during pregnancy compared to postpartum. All 29 newborn participants had negative or nondetectable HIV-1 polymerase chain reaction (PCR) results at birth and/or at four to eight weeks postbirth.

In addition, the trial did not identify any new safety or tolerability concerns for people who use Biktarvy during pregnancy and postpartum. The overall incidence and types of adverse events observed were consistent with those expected for the population studied, as per Gilead.

See Also:

Biktarvy is recommended as an alternative complete regimen for use in pregnancy and for people who are trying to conceive by the US Department of Health and Human Services (DHHS) perinatal guidelines.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Biktarvy is a top revenue-generating therapy in Gilead’s portfolio and pulled in $2.9bn in sales in Q1 this year, as per the company’s financials. The sales for the therapy are expected to increase to $15.5bn in 2030, as per GlobalData analysis.

GlobalData is the parent company of Clinical Trials Arena.

Another HIV therapy in Gilead’s portfolio is Sunlenca (lenacapavir), an FDA-approved multidrug-resistant HIV treatment. The company is evaluating Sunlenca in combination with Merck & Co’s islatravir as a long-acting HIV treatment for virologically suppressed people living with HIV.