FDA has approved Viiv Healthcare’s integrase inhibitor Tivicay® (dolutegravir) 50-mg tablets, for use with other antiretroviral agents in treating HIV-1 infection. ViiV Healthcare is an HIV therapeutics company established in 2009 by GlaxoSmithKline and Pfizer.

Tivicay is indicated for infected adults, both treatment-naive and treatment-experienced, including those treated with other integrase strand transfer inhibitors; as well as for children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). The drug—which was used without a pharmacokinetic boosting agent—interferes with one of the enzymes necessary for HIV to multiply, and can be taken with or without food and at any time of day.

FDA’s approval followed submission of data from four Phase III clinical trials showing that Tivicay-containing regimens were effective in reducing viral loads in adults.

Four of the trials involved a total 2,557 adults with HIV across the treatment spectrum: one comparing a once-daily Tivicay-based regimen to Merck & Co.’s twice-daily Isentress (raltegravir) in treatment-naïve patients; another comparing once-daily Tivicay and abacavir/lamivudine to Gilead Sciences’ once-daily Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate), also in treatment-naïve patients; a third comparing a once-daily, Tivicay-based regimen to twice-daily Isentress in treatment-experienced patients; and a fourth that focused on treatment-experienced patients with resistance to multiple classes of HIV medicines, including resistance to integrase inhibitors, where the effectiveness of twice-daily Tivicay on viral load was evaluated.

Viiv also submitted data from a fifth trial that established the pharmacokinetics, safety, and activity of Tivicay as part of treatment regimens for HIV-infected children 12 and up weighing at least 40 kg who had not previously taken integrase strand transfer inhibitors.

“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 individualize therapy,” John Pottage, Jr., M.D., Viiv’s CMO, said in a statement. “HIV treatment should not be a ‘one-size fits all’ paradigm.”

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