Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid (new indication: HIV infection, patients aged 2 to < 6 years)



  • Active Substance: Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid 
  • Name: Genvoya®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH


Time table:

  • Start: 01.11.2022
  • Publication of assessment: 01.02.2023
  • End of public hearing: 22.02.2023
  • Final decision by G-BA: middle of April 2023


Comparative therapy:

  1. Therapy-naive children: Abacavir + lamivudine OR abacavir + emtricitabine, in each case in combination with
    - dolutegravir OR
    - lopinavir/ritonavir
    - raltegravir OR
    - nevirapine OR
    - atazanavir/ritonavir OR
    - darunavir/ritonavir
  2. Therapy-experienced children: A patient-individual anti-retroviral therapy depending on approved agents; taking into account previous therapies and reason for change of therapy, in particular therapy failure due to virological failure and any associated development of resistance due to side effects.