Dolutegravir / Abacavir / Lamivudin (2) – Triumeq®

• Clinical trials
  • The single-arm, marketing authorisation-supporting IMPAACT 2019 trial is not suitable for assessing additional benefit due to the lack of comparison with the appropriate comparator therapy.

a) treatment-naive children with HIV-1 infection weighing ≥ 14 kg and aged < 6 years

• The G-BA identified abacavir with lamivudine or abacavir with emtricitabine – each as an appropriate comparator therapy for dolutegravir/abacavir/lamivudine – in combination with lopinavir/ritonavir or raltegravir or nevirapine or atazanavir + ritonavir or darunavir + ritonavir, as well as combination therapy with dolutegravir and abacavir and emtricitabine.
• The single-arm, registration-supporting IMPAACT 2019 trial is not suitable for assessing additional benefit due to the lack of comparison with the appropriate comparator therapy.
• Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for treatment-naïve children with HIV-1 infection weighing ≥ 14 kg and aged < 6 years.

b) treatment-naive children with HIV-1 infection weighing ≥ 14 kg, aged 6 to < 12 years

• The G-BA considered abacavir with lamivudine or abacavir with emtricitabine, each in combination with atazanavir + ritonavir or darunavir + ritonavir, as well as combination therapy with lamivudine, to be the appropriate comparator therapy for dolutegravir/abacavir/lamivudine, the G-BA has identified abacavir with lamivudine or abacavir with emtricitabine, each in combination with atazanavir + ritonavir or darunavir + ritonavir, as well as the combination therapy of dolutegravir with abacavir and emtricitabine.
• The single-arm, registration-supporting IMPAACT 2019 study is not suitable for assessing additional benefit due to the lack of comparison with the appropriate comparator therapy.
• Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for treatment-naïve children with HIV-1 infection weighing ≥ 14 kg and aged 6 to < 12 years.

c) treatment-experienced children with HIV-1 infection weighing ≥ 14 kg and aged < 12 years

• The G-BA defined the appropriate comparator therapy for dolutegravir/abacavir/lamivudine as a patient-specific antiretroviral regimen selected from the authorised INN active ingredients; taking into account previous treatment(s) and the reason for the change in therapy, in particular treatment failure due to virological failure and any associated development of resistance, or due to side effects.
• The single-arm, marketing authorisation-supporting IMPAACT 2019 study is not suitable for assessing additional benefit due to the lack of comparison with the appropriate comparator therapy.
• Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for treatment-experienced children with HIV-1 infection weighing ≥ 14 kg and aged < 12 years.

Courtesy translation only, please refer to the German original.