BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) - HIV

The Committee deems that the clinical benefit of BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) 50 mg/200 mg/25 mg film-coated tablet is substantial only for the treatment of human immunodeficiency virus-1 (HIV-1) infection in paediatric patients weighing at least 25 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

The Committee deems that the clinical benefit of BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) 30 mg/120 mg/15mg film-coated tablet is substantial only for the treatment of human immunodeficiency virus-1 (HIV-1) infection in paediatric patients at least 2 years of age and weighing at least 14 kg to less than 25 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Considering:

• very limited efficacy and safety data in children based almost exclusively on extrapolation of the results observed in adults and adolescents,
• the available data (non-comparative study, with a small sample size) in children weighing at least 25 kg with HIV infection, suggesting an efficacy and safety profile comparable to that described in adults,
• its good safety, good palatability and ease of administration (dosing without requirements in terms of food),

the Committee deems that, as in adults, BIKTARVY (bictegravir/emtricitabine/tenofovir
alafenamide) 50 mg/200 mg/25 mg film-coated tablet provides no clinical added value (CAV V) in the current care pathway for paediatric patients weighing at least 25 kg with HIV-1 infection without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Considering:

• very limited efficacy and safety data in children based almost exclusively on extrapolation of the results observed in adults and adolescents,
• the available data (non-comparative study, with a small sample size) in children weighing at least 14 kg to less than 25 kg with HIV infection, suggesting an efficacy and safety profile comparable to that described in adults,
• its good safety, good palatability and ease of administration (dosing without requirements in terms of food),

the Committee deems that BIKTARVY bictegravir/emtricitabine/tenofovir alafenamide)
30 mg/120 mg/15 mg film-coated tablet (provides no clinical added value (CAV V) in the current care pathway for paediatric patients at least 2 years of age and weighing at least 14 kg to less than 25 kg  without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.