Regulatory Decision Summary for Triumeq
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The reason for this Supplemental New Drug Submission was the addition of a pediatric indication for adolescents aged 12 years and older and weighing at least 40 kg.
Why was the decision issued?
The purpose of this Supplemental New Drug Submission was to seek approval for the use of Triumeq (dolutegravir/abacavir/lamivudine) in adolescents aged 12 years and older and weighting at least 40 kg for the treatment of HIV-1 infection.
Health Canada considers that the benefit/risk profile of Triumeq is favourable when used as directed in the treatment of adolescent patients infected with HIV-1 and weighing at least 40 kg.
The primary efficacy and safety data supporting this indication are derived from two Phase 2/3 studies.
Abacavir and lamivudine were evaluated in a randomized, multicenter trial (ARROW) in HIV-1-infected, treatment-naïve subjects. Subjects randomized to once-daily dosing (n = 336) and who weighed at least 25 kg received abacavir 600 mg and lamivudine 300 mg, as either single drug entities or as Kivexa. At Week 96, 67% of subjects receiving abacavir and lamivudine once-daily had HIV-1 RNA less than 80 copies per mL (See Kivexa Product Monograph).
Dolutegravir was evaluated in 23 treatment-experienced, INSTI-naïve, HIV-1-infected subjects aged 12 to less than 18 years in a 48-week open-label, multicenter, dose-finding clinical trial, IMPAACT P1093. At 48 weeks, 61% of subjects treated with Tivicay once daily plus optimized background therapy achieved a viral load less than 50 copies per mL (See Tivicay Product Monograph).
Triumeq was found to be safe. One event of Grade 4 hepatitis of uncertain causality was seen in the ARROW clinical trial. No other significant serious adverse events or early discontinuations due to adverse events were noted. The adverse events profile was similar to the one reported in adults.
The safety and efficacy of Triumeq has been established and this treatment can be used in adolescent patients ≥ 12 years of age weighing at least 40 kg and infected with HIV-1.
Based on the data submitted, Health Canada considers that the anticipated benefits of Triumeq outweigh the potential risks under the conditions of use described in the Triumeq Product Monograph at this time.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.