dm+d

35641711000001106

New Medicines

BiktarvyHIV infection in children and adolescents aged over 6 years - and new lower strength tablet formulation

Information

Biktarvy
New formulation and licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

None
Recommended for approval (Positive opinion)
Launched
Sep 22EU positive opinion granted recommending a licence change to include use in children aged 2 years and older (previously licensed only for use in adults). The proposed new indication is use for “the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir”. CHMP also recommend addition of a 30mg/120mg/15mg film-coated tablet [10].
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 - and new lower strength tablet formulation
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