dm+d

31145411000001104

New Medicines

GenvoyaHIV infection in children aged 2-5 years

Information

Genvoya
Licence extension / variation and new formulation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

None
Recommended for approval (Positive opinion)
Phase III Clinical Trials
Jul 22EU positive opinion granted recommending a licence change to include use in children aged 2 years of age and older (previously licensed only for in patients 6 years of age and older). The extension to the indication is for “treatment of human immunodeficiency virus 1 (HIV 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in adults and paediatric patients aged from 2 years and with body weight of at least 14 kg”. CHMP also recommend addition of 90mg /90mg /120mg /6 mg film-coated tablets [2].

Category

Once-daily single tablet regimen of elvitegravir 90mg/ cobicistat 90mg / emtricitabine 120mg/ tenofovir alafenamide 6mg
An estimated 105,200 people were living with HIV in 2019 in the UK; about 6% were unaware of their infection. In 2019, 285 children aged <15 years received HIV care [1].
HIV infection in children aged 2-5 years
Oral