ViiV Healthcare has applied to the Food and Drug Administration (FDA) for approval of the two-antiretroviral single-tablet regimen of Tivicay (dolutegravir) plus Epivir (lamivudine) for the treatment of HIV.
The application is based on the results of the GEMINI 1 and 2 studies, which included more than 1,400 people with HIV who had viral loads up to 500,000 before starting treatment. Forty-eight-week results from the studies were presented at the International AIDS Conference in Amsterdam (AIDS 2018). By that decisive point in the studies, the two-drug combo was as effective as a three-drug regimen of Tivicay plus Truvada (tenofovir disoproxil fumarate/emtricitabine).













