- 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
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