zurück

Dolutegravir / abacavir / lamivudine (new indication: HIV infection; ≥ 14 kg and < 12 years of age)

 

Subject:

  • Active Substance: Dolutegravir / abacavir / lamivudine
  • Name: Triumeq®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: ViiV Healthcare GmbH

 

Time table:

  • Start: 01.03.2023
  • Publication of assessment: 01.06.2023
  • End of public hearing: 22.06.2023
  • Final decision by G-BA: mddle of August 2023

 

Comparative therapy:

  1. Therapy-naïve children weighing ≥ 14 kg and aged < 6 years: abacavir + lamivudine or abacavir + emtricitabine in combination, respectively, with:

    • lopinavir / ritonavir or raltegravir or nevirapine or atazanavir / ritonavir or darunavir / ritonavir

  2. Therapy-naïve children weighing ≥ 14 kg and aged 6 to < 12 years: abacavir + lamivudine or abacavir + emtricitabine in combination, respectively, with:

    • atazanavir / ritonavir or darunavir / ritonavir

  3. Pre-treated children weighing ≥ 14 kg and aged < 12 years: a patient-individual anti-retroviral therapy choosing from authorized medicinal products, under consideration of pre-treatment(s) and reason for switch of treatment, especially failure of therapy due to virological failure and concomitant development of resistance or due to adverse reactions