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

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.