Gilead Sciences Canada, a subsidiary of Gilead Sciences Incorporated, has revealed that the Ontario Drug Benefit Program is offering eligible patients access to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) tablets, a once-daily single tablet and complete regimen intended for the treatment of HIV-1 infection in adults, it was reported yesterday.
Health Canada provided a Notice of Compliance for the product in July 2018.
The product is the company's fourth tenofovir alafenamide-based therapy. The tenofovir alafenamide-based therapies include Genvoya (elvitegravir 150mg/cobicistat 15 mg/ emtricitabine 200mg/tenofovir alafenamide 10mg), Descovy (emtricitabine 200mg/tenofovir alafenamide 10mg and 25mg) tablets and Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) tablets.
The approval of BIKTARVY was supported by data from four Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically-suppressed adults.
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