Tags : Bictegravir

Regulatory

Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval

Shots: The approval is based on four P-III 1489 and 1490 & 1844 and 1878 studies result assessing Biktarvy vs PBO in 2,415 naive patients with HIV-1 infected & virologically suppressed adults respectively The P-III 1489 and 1490 & 1844 and 1878 studies results: @48wks. met its 1EPs; no treatment emergent virologic resistance; no discontinuation; […]Read More

Pharma

Gilead Reports Results of Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide) in

Shots: The P-III 1490 Study involves assessing of Biktarvy (BIC 50/FTC 200/TAF 25mg tablets) vs dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) in ratio (1:1) patients with HIV-1 naive to HIV therapy in adults for 96 wks. P-III Study 1490 results: HIV-1 RNA levels less than 50 copies/mL 95%; well-tolerated with low discontinuations @48 wks. […]Read More