Single tablet Tivicay + Epivir for HIV filed with EMA.- ViiV Healthcare.

ViiV Healthcare announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of Tivicay + Epivir (dolutegravir (DTG) and lamivudine (3TC)) for the treatment of HIV-1 infection. The submission is based on the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL. The results of these studies were presented at the 2018 International AIDS Society meeting in July.

A new drug application (NDA) to the US FDA is planned for this single tablet regimen for October, using a priority review voucher. Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen for HIV-1 therapy are anticipated in the coming months.

Comment: Results from the GEMINI 1 and 2 studies showed GSK's combination to be as effective in controlling levels of the HIV virus as the three-drug regimen containing Gilead Sciences' competing therapy Truvada � data that GSK hopes will convince physicians to more widely consider two-drug combinations.