dm+d

35641711000001106

New Medicines

BiktarvyHIV infection in children and adolescents aged over 6 years

Information

Biktarvy
Licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

None
None
Launched
Oct 21 Approved in US for use in children weighing ≥14kg [8]
Dec 20Not yet licensed in this age group. PIII trial ongoing until mid-2022. [6,7]
Jun 19Approved in US - population expanded to include HIV-1 infected pediatric patients weighing at least 25 kg. [5]

Category

A fixed-dose combination product comprising bictegravir (HIV-1 integrase inhibitor), emtricitabine (nucleoside reverse transcriptase inhibitor), and tenofovir alafenamide, a prodrug of tenofovir (nucleotide reverse transcriptase inhibitor).
In 2016, 41 children were newly diagnosed with HIV – down from 131 in 2005. Of these, 36 were born abroad and arrived in the UK at an older age [1].
HIV infection in children and adolescents aged over 6 years
Oral

Trial or other data

Jan 22PII/III study (NCT02881320) now has an estimated primary completion date of May 2023. [10]
Dec 20PII/III study (NCT02881320) still recruiting with an estimated primary completion date of July 2022.
Dec 19PII/III study (NCT02881320) still recruiting with an estimated primary completion date of July 2020. [4]
Feb 19PII/III study (NCT02881320) is recruiting [3].
Sep 16PII/III study to evaluate the pharmacokinetics and safety/tolerability of Biktarvy starts (NCT02881320). Two strengths will be assessed - B/F/TAF 30/120/15mg FDC and B/F/TAF 50/200/25mg FDC. 125 children aged 2 years to 17 years will be recruited in the US, South Africa, Thailand and Uganda. Collection of primary outcome data is due to complete Oct 19 [2,3].

Evidence based evaluations