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 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.
ViiV markets Tivicay dolutegravir, an HIV integrase inhibitor. Gilead Sciences Inc. (NASDAQ:GILD) markets Truvada, a fixed-dose combination of the nucleoside analog reverse transcriptase inhibitor (NRTI) emtricitabine and the nucleotide reverse transcriptase inhibitor tenofovir. Lamivudine is a generic NRTI.
ViiV is a joint venture that includes GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd. (Tokyo:4507).