16 July 2018 - - Mississauga, Ontario-based research biopharmaceutical company Gilead Canada, a subsidiary of global Gilead Sciences, Inc. (NASDAQ: GILD), was granted a notice of compliance by Health Canada for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection, the company said.
Biktarvy combines the integrase strand transfer inhibitor (INSTI) bictegravir, with the Descovy (FTC/TAF) dual nucleoside reverse transcriptase inhibitor backbone, and is the smallest INSTI-based triple-therapy STR available. It is indicated as a complete regimen for the treatment of HIV-1 infection in adults.
The approval of Biktarvy is supported by data from four ongoing phase 3 studies, studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and studies 1844 and 1878 in virologically suppressed adults.
Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies.
Through 48 weeks, no participants in any of the four studies failed Biktarvy with treatment-emergent virologic resistance, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome.
Gilead Sciences discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.
The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 40 countries worldwide.