Dolutegravir / Abacavir / Lamivudin (2) – Triumeq®
HIV infection, ≥ 14 kg to < 12 years
Characteristics
| Start date | 01.03.2023 – Marketing authorisation: 20.02.2023 |
|---|---|
| Resolution | 17.08.2023 |
| INN | Dolutegravir/Abacavir/Lamivudin |
| Brand name | Triumeq® |
| Pharm. company | ViiV Healthcare GmbH |
| G-BA Procedure ID | D-907 |
| ATC code | J05AR13 Antivirals for treatment of HIV infections, combinations (J05AR) |
| ICD-10 codes (AIS) | B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status |
| Alpha-ID codes (AIS) | I24822HIV infection, I29605HIV disease |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Triumeq is indicated for the treatment of human immunodeficiency virus (HIV) infections in children weighing at least virus (HIV) in children weighing at least 14 kg up to < 12 years. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Therapy-naive children with HIV-1 infection ≥ 14 kg to < 6 years of age. | Abacavir + lamivudine or abacavir + emtricitabine, in each case in combination with – lopinavir/ritonavir or – raltegravir or – nevirapine or – atazanavir + ritonavir or – darunavir + ritonavir or dolutegravir + abacavir + emtricitabine |
| b) | Therapy-naive children with HIV-1 infection ≥ 14 kg from 6 to < 12 years of age. | Abacavir + lamivudine or abacavir + emtricitabine, each in combination with – atazanavir + ritonavir or – darunavir + ritonavir or dolutegravir + abacavir + emtricitabine |
| c) | Treatment-experienced children with HIV-1 infection ≥ 14 kg to < 12 years of age. | Patient-specific antiretroviral therapy with selection of approved agents; taking into account previous therapy(ies) and reason for change of therapy, especially therapy failure due to virological failure and any associated development of resistance or due to side effects |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Age |
- 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.
Associated procedures
| Dolutegravir / Abacavir / Lamivudin (2) | Triumeq® | ViiV Healthcare GmbH | HIV infection, ≥ 14 kg to < 12 years | 86 | 100% additional benefit not proven | |
| Dolutegravir / Abacavir / Lamivudin (1) | Triumeq® | ViiV Healthcare GmbH | HIV infection, ≥ 12 years | 54,398 | 9% Indication of considerable additional benefit |
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