TRIUMEQ (dolutegravir/abacavir/lamivudine) - HIV

The clinical benefit of TRIUMEQ (dolutegravir/abacavir/lamivudine) 5 mg/60 mg/30 mg dispersible tablets is substantial only in the treatment of children at least 3 months of age weighing from 6 kg to less than 14 kg with HIV-1 infection not carrying the HLAB*5701 allele and in whom the virus has no mutations leading to resistance to integrase inhibitors (INIs) and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).

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 (phase 1/2 study) in children weighing at least 6 kg to less than 14 kg with HIV infection, suggesting an efficacy and safety profile comparable to that described in adults and adolescents,
• its good safety, good palatability and ease of administration (dosing without requirements in terms of food),

the Committee deems that TRIUMEQ (dolutegravir/abacavir/lamivudine) 5 mg/60 mg/30 mg dispersible tablets provides no clinical added value (CAV V) compared to separate doses of the different components of the fixed-dose combination in children at least 3 months of age weighing from 6 kg to less than 14 kg with HIV-1 infection not carrying the HLAB*5701 allele and in whom the virus has no mutations leading to resistance to integrase inhibitors (INIs) and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).