Tags : HIV-1

ViiV Healthcare Reports Submission of MAA to EMA for the

Shots: The MAA is based on P-III ATLAS and FLAIR studies results assessing cabotegravir + rilpivirine (monthly injectable) in 1,100+ patients with HIV-1 infection with suppressed viral load who are not resistant to cabotegravir or rilpivirine demonstrated similar efficacy to 3-drug oral regimen The EMA’s MAA follows NDA submission of dual regimen to the US […]Read More

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives European Commission Marketing Authorization for

Shots: The marketing authorization is based on GEMINI 1 & 2 studies result assessing Dovato vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine in 1400+ patients with HIV-1 infection for 48wks. The GEMINI 1 & 2 studies result demonstrated that two drug regimen showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies/ml compared three-drug regimen in […]Read More

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to

Shots: The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir + Edurant (rilpivirine) (injected monthly) vs SOC (three-drug regimen) in 1,100+ patients infected with HIV + viral suppression across 16 countries for 48wks. The P-III ATLAS & FLAIR studies resulted in maintaining […]Read More

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

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