Tags : Biktarvy

Clinical Trials

Gilead Presents Four-Year Data of Biktarvy for HIV-1 in Treatment-Naïve

Shots: The two OLE P-III 1489 and 1490 studies assessing Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) vs dolutegravir-containing triple for the treatment of HIV-1 in treatment naïve adults The study demonstrated the sustained efficacy & safety profile with no treatment-emergent resistance @144wks, >98% of treatment-naïve patients achieved and maintained undetectable viral load […]Read More

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

Pharma

Gilead Reports Results of Biktarvy for the Treatment of HIV-1

 Shots: The P-III 1489 study has assessed Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) in ratio (1:1) to treat HIV-1 infection in adults for 96 weeks, testing safety and efficacy P-III 1489 study results ((abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) or Biktarvy): meGFR @96wks. (-7.8 mL/min vs. -9.6 mL/min); mean percent changes from baseline in […]Read More