FDA expands approval of Gilead's Biktarvy for HIV-1 treatment in children

October 19, 2021

Biktarvy was originally approved by the US FDA in February 2018 for the treatment of adult HIV-1 patients.

The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences' biktarvy expanded indication for the treatment of human immunodeficiency virus 1 (HIV-1) infection in pediatric subjects.

The low-dose tablets of the drug are suitable for children whose body weight is not less than 14 kg to 25 kg and whose virology is inhibited or who have just received antiretroviral treatment.

Biktarvy is a comprehensive three drug therapy for HIV-1, including bictegravir and ntriptabine / tenofovir, and eiranolamine (descovy).

It is said to be used once a day. Biktarvy is the smallest HIV-1 monolithic regimen based on integrase chain transfer inhibitor (insi).

With the latest approval of the supplementary new drug application (SNDA), biktarvy is now suitable for young HIV-1 patients.

Gilead estimates that new developments will fill the gap between HIV treatment options available to children and adults.

The approval is based on the results of group 3 of an open label, one arm phase II / III clinical trial in 22 virologically inhibited children with HIV-1 weighing at least 14 kg.

The results showed that low-dose biktarvy tablets proved to be effective in these children and were well tolerated within 24 weeks.

No new adverse reactions or laboratory abnormalities were detected in pediatric trials compared with those reported in adult subjects.

Merdad Parsey, chief medical officer of Gillie science, said: "HIV infected children need effective and accessible antiretroviral therapy.

"The approval of sNDA is an important step in fulfilling the goal of Gillie's commitment to bring Biktarvy pediatric preparations to HIV infected children all over the world."

Initially, Gilead received FDA approval in February 2018 for biktarvy to treat HIV-1 in adult patients.

In June 2019, FDA expanded the label of biktarvy to include pediatric subjects weighing at least 25 kg.

In the same year, China's State Drug Administration approved Gilead's biktarvy to treat HIV-1