EU license for injectable cabotegravir/rilpivirine injections expanded to include adolescents >12 years old

31 January 2025. Related: Other news.

Simon Collins, HIV i-Base

On 31 January 2025, the European Commission extended the license for long-acting cabotegravir and rilpivirine to include adolescents aged 12 and over.

Individuals need to already be undetectable on their current ART, and to weigh >35 kgs.

The extension was supported by week 24 data in 144 adolescents from the ongoing phase1/2  IMPAACT 2017 MOCHA study, presented at CROI 2024. [2, 3]

This open-label, non-comparative study reported that 139/144 participants (96.5%) remained virologically suppressed <50 copies/mL with no new safety concerns. Nearly all participants expressed preference for the injections compared to oral ART.

Reference

1. ViiV Healthcare. European Commission authorises ViiV Healthcare’s long-acting injectable cabotegravir + rilpivirine for HIV treatment in adolescents. (31 January 2025).
   viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/january/long-acting-injectable-vocabria-rekambys-for-hiv-treatment/
2. Gaur A et al. Long-acting cabotegravir plus rilpivirine in adolescents with HIV: Week 24 IMPAACT 2017(MOCHA) Study. CROI 2024, abstract 188.
   www.croiconference.org/abstract/long-acting-cabotegravir-plus-rilpivirine-in-adolescents-with-hiv-week-24-impaact-2017mocha-study/
3. Lowenthal ED et al. IMPAACT 2017 adolescent/parent experiences with LA cabotegravir plus rilpivirine for HIV treatment. CROI 2024, abstract 949. Available at: https://www.croiconference.org/abstract/impaact-2017-adolescent-parent-experiences-with-la-cabotegravir-plus-rilpivirine-for-hiv-treatment.