Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3) – Genvoya®

HIV infection, 2 to < 6 years

Characteristics

Start date 01.11.2022 – Marketing authorisation: 03.10.2022
Resolution 20.04.2023
INN Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid
Brand name Genvoya®
Pharm. company Gilead Sciences GmbH
G-BA Procedure ID D-884
ATC code J05AR18 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
Specialty ACT change

Therapeutic indication of the resolution

Genvoya is used to treat HIV-1 infections in children aged 2 to <6 years and weighing at least 14 kg. There must be no mutations in the HIV virus known to be associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Subpopulation Indication Comparator
a) Treatment-naïve children with HIV-1 infection aged 2 to < 6 years who are not known to be resistant to the class of integrase inhibitors, emtricitabine, or tenofovir mutations have been detected 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) Pre-treated children with HIV-1 infection aged 2 to < 6 years who are known to have no mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. Substances, taking into account the previous therapy(ies) and the reason for the change in therapy, in particular therapy failure due to virological resistance 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
ACT change 24.05.2022 – vor Dossiereinreichung, neuer wissenschaftliche Erkenntnisse

a) treatment-naïve children with HIV-1 infection aged 2 to < 6 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir-associated mutations has been detected

  • For treatment-naïve and treatment-experienced children with HIV-1 infection aged 2 to < 6 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir; additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any direct comparative data for either treatment-naïve or treatment-experienced children with HIV-1 infection aged 2 to < 6 years for elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in the present therapeutic indication against the specified appropriate comparator therapy.
  • As the study is single-arm and lacks a comparison with the appropriate comparator therapy, it is not suitable for assessing additional benefit.
  • Overall, based on the GS-US-292-0106 study, no added benefit over the appropriate comparator therapy can be inferred for either treatment-naïve or treatment-experienced children aged 2 to < 6 years with HIV-1 infection, in whom no resistance to the class of integrase inhibitors, Mutations associated with emtricitabine or tenofovir do not provide an additional benefit compared to the appropriate comparator therapy.
  • Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
  • An additional benefit is therefore not proven.

b) treatment-experienced children with HIV-1 infection aged 2 to < 6 years, in whom no mutations associated with resistance to the class of integrase inhibitors, emtricitabine or tenofovir have been detected

  • For treatment-naïve and treatment-experienced children with HIV-1 infection aged 2 to < 6 years, in whom no resistance to the class of integrase inhibitors, emtricitabine or tenofovir; an additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any direct comparative data for either treatment-naïve or treatment-experienced children with HIV-1 infection aged 2 to < 6 years for elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in the present therapeutic indication against the specified appropriate comparator therapy.
  • As the study is single-arm and lacks a comparison with the appropriate comparator therapy, it is not suitable for assessing additional benefit.
  • Overall, based on the GS-US-292-0106 study, no added benefit over the appropriate comparator therapy can be inferred for either treatment-naïve or treatment-experienced children aged 2 to < 6 years with HIV-1 infection, in whom no resistance to the class of integrase inhibitors, Mutations associated with emtricitabine or tenofovir have not been shown to provide an additional benefit compared to the appropriate comparator therapy.
  • Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.
  • The additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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