HIV Treatment Tivicay Receives FDA Approval

The US Food and Drug Administration (FDA) has approved a new tablet to treat a broad population of HIV-infected adults and children in combination with other antiretroviral (ARV) agents.

Marketed by ViiV Healthcare and manufactured by GlaxoSmithKline, once-daily, 50-milligram Tivicay (dolutegravir) is the second HIV integrase strand transfer inhibitor (HIV-1 INSTI) to receive FDA approval, as it follows the October 2007 approval of Merck’s twice-daily, 400-milligram Isentress (raltegravir) for the treatment of HIV-1 infection.

The FDA approved Tivicay for use in both treatment-naive and treatment-experienced HIV-1 patients, including those who have been treated with Isentress before. The HIV-1 INSTI is also approved for use in treatment-naïve or treatment-experienced children ages 12 and older who weigh at least 40 kilograms and have not previously taken Isentress, which is indicated for children ages 2 and up who weight at least 10 kilograms.

Results from four pivotal phase III studies — SPRING-2, SINGLE, SAILING, and VIKING-3 — ultimately formed the basis for Tivicay’s FDA approval. In those clinical trials, which enrolled a total of 2,557 HIV-infected patients, the drug was shown to reduce viral loads just as effectively as or better than single-tablet Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) and Isentress in combination with other ARV therapies.

Though roughly 50,000 Americans become infected with HIV annually, ViiV Chief Medical Officer John Pottage, MD, noted in a statement that “HIV treatment should not be a ‘one-size fits all’ paradigm.”

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, added in a press release. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”