Shots:

• The approval is based on P-III study GEMINI 1 (204861) and GEMINI 2 (205543) study results assessing dolutegravir and lamivudine vs DTG + TDF/FTC in 1400 patients with HIV-1 infected ART-naive adults for 48 wks.
• The study demonstrated a non-inferiority data based on plasma HIV-1 RNA <50 copies per milliliter (c/mL) and resulted in no virologic failure
• Dovato is a qd regimen of dolutegravir (DTG-50 mg) & lamivudine (3TC- 300 mg) involved in reduction of exposure to the number of ARVs and is under review by EMA and Health Canada- additional submissions planned throughout 2019. In 2009- GSK and Pfizer collaborated to build ViiV Healthcare focusing on HIV therapies

Ref: GSK | Image: Twitter