Bictegravir / Emtricitabin / Tenofoviralafenamid (2) – Biktarvy®

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.