RESEARCH TRIANGLE PARK – ViiV Healthcare, which has researchers based in RTP, is reporting what it calls “landmark” late-stage clinical trial results for its two-drug combo that it says is “demonstrating the ability to control HIV.”
ViiV, which is majority owned by GlaxoSmithKline, disclosed phase 3 trial results of the combo treatment on Thursday and “will now plan for regulatory submissions for the two-drug regimen of dolutegravir and lamivudine later this year.”
The study results met its primary endpoint, ViiV said, “demonstrating similar efficacy of two-drug regimen compared to standard three-drug regimen.”
More than 70 million people have been infected with the HIV virus and some 35 million people have died of HIV, according to the World Health Organization.Trhough 2016, nearly 37 million people have died.
AIDS is the most severe phase of HIV infection, according to the Centers for Disease Control.
“The safety results for the 2DR of dolutegravir and lamivudine were consistent with the product labelling for the medicines,” HiiV said in a statement. “No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance.”
The study included some 1,400 men and women with HIV at testing sites across Europe, North and South America, South Africa and in the Asia Pacific.
“People with HIV are living longer and more productive lives. However, under current standard of care, many patients still take three or more medicines every day. The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination,” said John Pottage, chief scientific and medical officer of ViiV Healthcare. They affirm our two-drug regimen strategy, and reinforce our belief that many patients can control their disease with two drugs instead of three or more. Importantly, the studies show that this two-drug regimen could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world.”
