ViiV Healthcare, HIV company established by GlaxoSmithKline and Pfizer, has announced the FDA approval of an integrase inhibitor, Tivicay (dolutegravir) 50mg tablets, for the treatment of HIV-1.
Tivicay is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40kg.
ViiV Healthcare chief executive officer Dr Dominique Limet said, "Today's approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV/AIDS global response."
The approval was based on data from four pivotal Phase III trials, which included 2,557 adults with HIV treated with at least one dose of study medication in addition to children aged 12 years and older.
Used without a pharmacokinetic boosting agent, Tivicay can be taken with or without food and at any time of the day.
ViiV chief medical officer Dr John Pottage said, "In many regimens, the differentiating component is the third agent. Tivicay provides a new opportunity for healthcare professionals to choose the right regimen for their patients, providing a focal point around which to individualise therapy."
The Phase III program included two trials in treatment-naive patients, one where a once-daily Tivicay-based regimen was compared to twice-daily raltegravir and another where the regimen of once-daily Tivicay and abacavir/lamivudine was compared to once-daily Atripla.
Treatment-experienced patients who had not previously been treated with an integrase inhibitor, were also included in the program where a once-daily, Tivicay-based regimen was compared to twice-daily raltegravir.
In the fourth trial, the effectiveness of twice-daily Tivicay on viral load was assessed in treatment-experienced patients with resistance to multiple classes of HIV medicines.
