ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads of less than 500,000 copies/mL. ViiV plans to submit regulatory applications for the two-drug regimen this year.

The double-blind, international, duplicate GEMINI 1 and 2 trials in a total of about 1,400 patients showed that once-daily oral dolutegravir/lamivudine was non-inferior to Tivicay dolutegravir plus Truvada emtricitabine/tenofovir in the proportion of patients who achieved HIV-1 RNA levels of less than 50 copies/mL at week 48. The company will present full data from the trials at a scientific meeting...