US green light for Gilead’s HIV combo
By David Rowlands, Feb 8 2018 12:48PM
Gilead’s new combination therapy Biktarvy has been approved by the US Food and Drug Administration for the treatment of HIV.
The once-daily single tablet regimen combines the novel investigational integrase strand transfer inhibitor bictegravir with emtricitabine/tenofovir alafenamide (FTC/TAF; marketed as Descovy).
The therapy has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.
The application centered on data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.