EU recommends approval of dispersible abacavir/lamivudine/dolutegravir FDC for children weighing 14 to >25 kg
1 December 2022. Related: Antiretrovirals, Paediatric care.
Simon Collins, HIV i-Base
On 16 December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to approve Triumeq PD as a dispersible fixed dose combination (FDC) for children weighing 14 to <25 kg. [1]
The committee also lowered the minimum weight for using the adult non-dispersible tablet from 40 kg to 25 kg.
Triumeq PD is a dispersible tablet formulation of the fixed dose combination of abacavir, lamivudine and doluteravir.
This dispersible formulation was approved by the US FDA in March 2022. [2]
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Paediatric HIV remains one of the global areas of unmet need. Only 52% of children (880k/1.3 million) are on ART and only 40% on ART are undetectable. [3]
WHO-preferred first-line ART is already ViiV’s fixed dose dispersible paediatric formulation of abacavir/lamivudine/dolutegravir (pALD), given without genetic HLA testing for abacavir hypersensitivity. This is approved for weight 10 to 25 kg, with a plan to file for 6 kg lower weight. The US FDA approved different weight eligibility to the EU (down to 10 kg in US).
Originator products are rarely introduced in LMIC but CHAI and ViiV are working with generic manufacturers. Last I heard was filings are expected in the new year + tentative approval mid 2023. [3]
Given the wide use of dual ART without abacavir, the D3 study (PENTA 21) is also investigating DTG/3TC in children.
https://penta-id.org/hiv/d3
Reference
- ViiV press release. ViiV Healthcare announces CHMP positive opinion for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV in Europe. (16 December 2022).
viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/december/viiv-healthcare-announces-chmp-positive-opinion-for-triumeq-pd - FDA approves dispersible dolutegravir/abacavir/3TC for children. HTB May 2022.
i-base.info/htb/42815 - CHAI. Highlighting the latest updates in HIV treatment, prevention, and diagnostics