The FINANCIAL — The U.S. Food and Drug Administration (FDA) has approved Tivicay (dolutegravir) 50-mg tablets, according to ViiV Healthcare. Tivicay is an integrase inhibitor 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 40 kg (approx. 88 lbs).
“Today is a very important milestone for patients and the scientists and teams who developed Tivicay and brought it to this point of FDA approval. I am very proud that we are serving people living with HIV with a much-needed new treatment option. 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,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.
The submission included data from four pivotal Phase III clinical trials that treated 2,557 adults (who received at least one dose of study medication) with HIV across the treatment spectrum; it also included data in children aged 12 years and older. Tivicay was used without a pharmacokinetic boosting agent. Tivicay can be taken with or without food and at any time of the day, according to GlaxoSmithKline plc.
“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,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “HIV treatment should not be a ‘one-size fits all’ paradigm,” he added.
This wide-ranging Phase III programme included two trials in treatment-naïve 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. It also included treatment-experienced patients who had not previously been treated with an integrase inhibitor, where a once-daily, Tivicay-based regimen was compared to twice-daily raltegravir. The fourth trial studied 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.
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