Bictegravir / Emtricitabin / Tenofoviralafenamid (2) – Biktarvy®
HIV-Infection, 2 until < 18 years
Characteristics
| Start date | 01.01.2023 – Marketing authorisation: 21.11.2022 |
|---|---|
| Resolution | 15.06.2023 |
| INN | Bictegravir/Emtricitabin/Tenofoviralafenamid |
| Brand name | Biktarvy® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-893 |
| ATC code | J05AR20 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 |
| DDD | 1 O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Biktarvy is used for the treatment of human immunodeficiency virus 1 (HIV-1) infection in paediatric patients aged 2 to < 18 years and weighing at least 14 kg. The HIV virus must not be currently or previously resistant to the class of integrase inhibitors, emtricitabine or tenofovir. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Treatment-naïve children with HIV-1 infection aged 2 to < 6 years who have no current or past evidence of resistance to the integrase inhibitor class, emtricitabine or tenofovir. | Abacavir + lamivudine or abacavir + emtricitabine, in each case in combination with – dolutegravir or – lopinavir/ritonavir or – raltegravir or – nevirapine or – atazanavir + ritonavir or – darunavir + ritonavir |
| b) | Therapienaive Kinder mit HIV-1 Infektion im Alter von 6 bis < 12 Jahren, bei denen weder aktuell noch in der Vergangenheit Resistenzen gegen die Klasse der Integrase- Inhibitoren, Emtricitabin oder Tenofovir nachgewiesen worden sind | Abacavir + lamivudine or abacavir + emtricitabine, in each case in combination with – dolutegravir or – atazanavir + ritonavir or – darunavir + ritonavir |
| c) | Treatment-naïve adolescents with HIV-1 infection aged 12 to < 18 years, in whom neither current nor past resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected. | Tenofoviralafenamide + emtricitabine or abacavir + lamivudine or abacavir + emtricitabine. emtricitabine in each case in combination with – dolutegravir or – atazanavir + ritonavir or – darunavir + ritonavir or – elvitegravir/cobicistat |
| d) | Therapy-experienced children and adolescents with HIV-1 infection aged 2 to < 18 years. years of age, in whom neither current nor past resistance to the class of class of integrase inhibitors, emtricitabine or tenofovir have been detected. | Patient-specific antiretroviral therapy using the approved active substances; taking into account the previous therapy(ies) and the reason for the change in therapy, in particular 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 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Age |
a) treatment-naïve children with HIV-1 infection aged between 2 and < 6 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected, either currently or in the past
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of bictegravir/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
- An additional benefit is therefore not proven.
b) treatment-naive children with HIV-1 infection aged 6 to < 12 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected either currently or in the past
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of bictegravir/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
- An additional benefit is therefore not proven.
c) treatment-naïve adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected either currently or in the past
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of bictegravir/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
- An additional benefit is therefore not proven.
d) treatment-experienced children and adolescents with HIV-1 infection aged 2 to < 18 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected either currently or in the past
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of bictegravir/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
- An additional benefit is therefore not proven.
- For children and adolescents with HIV-1 aged 2 to < 18 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir has been detected either currently or in the past, additional benefit is not proven.
- The pharmaceutical manufacturer has not provided any direct comparative data for bictegravir/emtricitabine/tenofovir alafenamide in the indicated therapeutic indication against the specified appropriate comparator therapy.
- As it lacks a comparison with the appropriate comparator therapy, the single-arm study is not suitable for assessing additional benefit.
- Overall, based on the GS1474 study, no added benefit over the appropriate comparator therapy can be inferred for either treatment-naïve or treatment-experienced children and adolescents with HIV-1 infection aged 2 to < 18 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir, no additional benefit can be inferred compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Bictegravir / Emtricitabin / Tenofoviralafenamid (2) | Biktarvy® | Gilead Sciences GmbH | HIV-Infection, 2 until < 18 years | 184 | 100% additional benefit not proven | |
| Bictegravir / Emtricitabin / Tenofoviralafenamid (1) | Biktarvy® | Gilead Sciecnes GmbH | HIV infection | 66,800 | 100% additional benefit not proven |
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