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.

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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.

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.

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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.