Indication extension and inclusion of a new presentation in a new indication
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Clinical Benefit
Substantial
The Committee deems that the clinical benefit of TRIUMEQ (dolutegravir/abacavir/lamivudine) 50 mg/600 mg/300 mg film-coated tablets is substantial only in the treatment of paediatric patients weighing at least 25 kg to less than 40 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 reverse transcriptase inhibitors (NRTIs).
The Committee deems that the clinical benefit of TRIUMEQ (dolutegravir/abacavir/lamivudine) 5 mg/60 mg/30 mg dispersible tablets is substantial only in the treatment of paediatric patients weighing at least 14 kg to less than 25 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 reverse transcriptase inhibitors (NRTIs).
Clinical Added Value
no clinical added value
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 25 kg to less than 40 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, as in adults and adolescents, TRIUMEQ (dolutegravir/ abacavir/lamivudine) 50 mg/600 mg/300 mg film-coated tablets provides no clinical added value (CAV V) compared to separate doses of the different components of the fixed-dose combination in paediatric patients weighing at least 25 kg to less than 40 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 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 14 kg to less than 25 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 paediatric patients weighing at least 14 kg to less than 25 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 reverse transcriptase inhibitors (NRTIs).
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