FDA Approves New HIV Drug, Tivicay

    August 13, 2013

The U.S. Food and Drug Administration (FDA) this week approved a new drug for the treatment of HIV.

Called Tivicay, the drug is an integrase strand transfer inhibitor. In other words, it inhibits HIV by blocking an enzyme necessary for its growth. When taken daily with other antiretroviral drugs, it can reduce viral loads in patients with HIV.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”

Tivicay is approved for adults and children age 12 and older. Both HIV patients who have had HIV therapy and those that haven’t have been approved to use the new drug.

The FDA approved Tivicay following a safety and efficacy trials involving over 2,500 patients. It was found to be effective, with side effects ranging from insomnia and headaches to hypersensitivity. Patients with hepatitis B or C were also at risk for “abnormal” liver function. Another trial found that Tivicay is safe for children 12 and over with HIV.