Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Low-Dose Tablet Receives the US FDA’s Approval for Expanded Indication to Treat HIV-1

October 19, 2021 Auto Bot approval, FDA, Gilead, regulatory 0

Shots:

  • The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed or new to antiretroviral therapy
  • The results showed that Biktarvy low-dose tablets were found to be effective & well-tolerated @24wks. After switching to Biktarvy, 91% of patients remained virologically suppressed @24wks. & mean change in CD4 % from baseline was 0.2%
  • The sNDA approval expands the indication for the use of Biktarvy in younger children living with HIV-1 infection. In Feb’18, the US FDA has approved Biktarvy as a single-tablet regimen for HIV-1 infection in adults

Click here to­ read the full press release/ article | Ref: Gilead | Image: GeneOnline

The post Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Low-Dose Tablet Receives the US FDA’s Approval for Expanded Indication to Treat HIV-1 first appeared on PharmaShots.