GSK ’s ViiV Healthcare has reported positive headline data from the Phase III GEMINI clinical programme of its two-drug regimen of dolutegravir and lamivudine for treatment-naïve adults with HIV-1 infection.
Dolutegravir is an integrase strand transfer inhibitor (INSTI), while lamivudine is a nucleoside analogue.
The Phase III programme included randomised, double-blind, multi-centre, parallel group GEMINI-1 and GEMINI-2 trials, both of which have met the primary endpoint of non-inferiority at week 48.
It was further observed that the safety profile of the two-drug regimen was consistent with the product labelling for the drugs.
This regimen of dolutegravir and lamivudine was compared with a three-drug product that comprised dolutegravir and tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), which are nucleoside reverse transcriptase inhibitors.
ViiV Healthcare chief scientific and medical officer John Pottage said: “The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination.
“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.”
Together, the GEMINI 1 and GEMINI 2 studies involved about 1,400 HIV-1 patients who were antiretroviral therapy (ART) naïve and had less than 500,000 copies per millilitre of viral load at baseline.
Performed across sites in Europe, North America, Asia Pacific, Central and South America, and South Africa, the studies aimed to validate non-inferior efficacy, safety and tolerability of once-daily dolutegravir and lamivudine regimen at 48 weeks.
ViiV Healthcare intends to submit applications for regulatory approval of the two-drug regimen later this year.