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Canadian Drug Review Reimbursement Decision


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  Celsentri
Generic Maraviroc
Company ViiV Healthcare ULC
Indication HIV
Condition Infectious and parasitic diseases
Submission Type
Patient Population Maraviroc, when used in combination with other antiretroviral agents, has a Health Canada indication for the treatment of adults infected with chemokine receptor 5 (CCR5)-tropic HIV-1. Maraviroc is a CCR5 antagonist. It is available as 150 mg and 300 mg oral tablets. The Health Canada-approved dose is 300 mg twice daily, but adjustments are recommended (from 150 mg to 600 mg twice daily) based on the patient’s concomitant medications.
Status Complete
Date of Recommendation 2011-07-18
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that maraviroc not be listed for patients with human immunodeficiency virus type 1 (HIV-1) who are treatment naive.
Reason for Recommendation The one double-blind randomized controlled trial (RCT) in HIV-1 patients who were treatment naive failed to meet one of its co-primary end points based on the preplanned analysis. That is, non-inferiority of maraviroc compared with efavirenz was not demonstrated based on the proportion of patients achieving a viral load of < 50 copies/mL at 48 weeks. In addition, non-response due to virologic failure or viral rebound occurred statistically significantly more frequently in the maraviroc treatment group compared with efavirenz at 96 weeks.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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