Phase III GEMINI-1 and GEMINI-2 studies of Tivicay + Epivir meet primary endpoint in HIV-1.- ViiV Healthcare.

ViiV Healthcare announced positive headline results from its phase III GEMINI-1 and GEMINI-2 studues evaluating the safety and efficacy of a two-drug regimen (2DR) of Tivicay + Epivir (dolutegravir + lamivudine) compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment naïve HIV-1 infected adults with baseline viral loads less than 500,000 copies per ml.

The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA less than 50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48. The safety results for the 2DR of dolutegravir and lamivudine were consistent with the product labelling for the medicines. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance. Full results from the studies will be presented at an upcoming scientific meeting. ViiV Healthcare now plans for regulatory submissions for the two-drug regimen of dolutegravir and lamivudine later this year.

Comment: Comment: The GEMINI trials are the third development programme undertaken by ViiV Healthcare to investigate a two-drug regimen for the treatment of HIV.