New Medicines

Tybost · HIV infection in adolescents aged 12 years and older


Licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
Jan 20 · EU positive opinion for a licence change to expand use to adolescents (previously only adults). the proposed new indication is use as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus‑1 (HIV‑1) infected adults and adolescents aged 12 years and older (weighing at least 35 kg co‑administered with atazanavir or weighing at least 40 kg co‑administered with darunavir) [2].


Pharmacoenhancing agent - increases systemic levels of coadministered agents that are metabolised by CYP3A
In 2017, 42 children were newly diagnosed with HIV – down from 131 in 2005. All these children were born in other countries [1].
HIV infection in adolescents aged 12 years and older