Cabotegravir (2) – Vocabria®

• Clinical trials
  • The pharmaceutical manufacturer does not consider the single-arm IMPAACT 2017 trial, which formed the basis for marketing authorisation, to be relevant for the assessment of additional benefit due to the lack of comparison with the appropriate comparator therapy.

Adolescents aged 12 to 17 years and weighing at least 35 kg with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen (HIV-1 RNA < 50 copies/ml) with no current or historically documented resistance to the NNRTI or INI classes and no history of virological failure with active ingredients from the NNRTI and INI classes

• An additional benefit is not proven.
• Overall, the pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of cabotegravir in combination with rilpivirine compared with the appropriate comparator therapy for the indicated therapeutic indication.
• An additional benefit of cabotegravir in combination with rilpivirine compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.