First paediatric EC approval of HIV drug

The European Commission (EC) has granted the first paediatric marketing authorisation for Gilead’s new low-dose tablet Biktarvy^® (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in the European Union (EU) to treat human immunodeficiency virus (HIV). The EC has authorised extension for Biktarvy^® to treat HIV-infected children over two years old and weighing at least 14kg.

A milestone in the journey to overcoming HIV

“The European Commission’s approval is a significant milestone,” shared Dr Jared Baeten, PhD, Vice President, HIV Clinical Development at Gilead Sciences. “Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic.”

The marketing authorisation applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.

EC’s extended approval of Gilead’s HIV drug

The extension authorisation is based on an ongoing open-label, 24-week study (NCT02881320), which indicated Biktarvy^® was effective and generally well-tolerated by virologically suppressed adolescents and children with HIV.

Treatment outcomes were evaluated in adolescents between the ages of 12 to less than 18 years weighing at least 35kg (treatment cohort 1, N=50) and in children between the ages of six to less than 12 years old weighing at least 25kg (treatment cohort 2, N=50).

Treatment outcomes were assessed in children over two years old weighing at least 14kg to less than 25kg (treatment cohort 3, N=22). At Week two or Week 4, selected participants were given a pharmacokinetic (PK) evaluation to confirm the dosage that the participants would receive. All participants received Biktarvy^® for 48 weeks. After Week 48, participants could receive Biktarvy^® in an active open-label extension phase for up to 96 weeks.

Effectiveness of Biktarvy^®

Treatment cohort 1

After switching to Biktarvy^®, 98 percent (49/50) of participants in this group remained suppressed (HIV-1 RNA < 50 copies/ml) at Week 48.

Treatment cohort 2

After switching to Biktarvy^®, 98 percent (49/50) of participants remained suppressed (HIV-1 RNA < 50 copies/ml) at Week 48.

Treatment cohort 3

After switching to Biktarvy^®, 91 percent (20/22) of participants  remained virologically suppressed at Week 24. In this study, no new adverse reactions (ARs) have been observed in paediatric subjects aged two years and older living with HIV-1 compared to adults.