Regulatory Decision Summary for Harvoni
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.
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What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission for Harvoni was to expand the treatment indication to include adolescent patients (from ≥12 years of age) with chronic hepatitis C virus genotype 1 infection, without cirrhosis or with compensated cirrhosis.
Why was the decision issued?
Health Canada considers that the benefit/risk profile of Harvoni is favourable when used as directed in the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in patients ≥12 years of age, with or without compensated cirrhosis.
The indication is based on the results of a phase II study supporting the efficacy and safety of Harvoni in pediatric patients (≥12 years old) with HCV genotype 1 infection.
Harvoni is a fixed-dose combination treatment for oral administration. The efficacy of Harvoni was assessed by measuring the sustained virologic response rate at follow-up Week 12 (SVR12). Harvoni was found to be very effective in pediatric patients, with a high SVR12 rate (97.0% overall) observed in adolescent subjects (12 to <8 years old). These high SVR12 rates were achieved in all subgroups regardless of prior treatment status. Resistance failure was not an issue for the outcome.
The treatment was very well tolerated in these patients. The overall adverse event (AE) profiles for Harvoni treatment for 12 weeks appeared similar between adolescents and adults as reported in the phase III Harvoni studies for adults. Additionally, Harvoni has a more favorable AE profile than the treatment with Peg-interferon and Ribavirin.
The safety and efficacy of Harvoni have not been established for adolescents infected with other HCV genotypes (other than genotype 1).
Based on the data submitted, Health Canada considers that the anticipated benefits of Harvoni in patients aged 12 to 18 with genotype 1 HCV, with or without compensated cirrhosis, outweigh the potential risks under the conditions of use described in the Harvoni Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.