The U.S. Food and Drug Administration (FDA) on Aug. 12 approved dolutegravir, a new drug to treat HIV-1 infection.
Brand-named Tivicay, the drug is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. The pill is taken daily in combination with other antiretroviral drugs.
The FDA said Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. The drug is also approved for children ages 12 years and older weighing at least 40 kilograms who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.
In a prepared statement announcing the approval, Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said, “HIV-infected individuals require treatment regimens personalized to fit their condition and their needs. The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.
The FDA said Tivicay’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads.
The agency said a fifth trial established the pharmacokinetics, safety and activity of Tivicay as part of treatment regimens for HIV-infected children ages 12 years and older weighing at least 40 kilograms who have not previously taken integrase strand transfer inhibitors.
Common side effects observed during clinical studies include difficulty sleeping (insomnia) and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The Tivicay label gives advice on how to monitor patients for the serious side effects.
Tivicay is marketed by ViiV Healthcare and manufactured by GlaxoSmithKline, both based in Research Triangle Park, N.C.
Isentress is marketed by Whitehouse Station, N.J.-based Merck, and Atripla is marketed by San Francisco-based Gilead.
Click here for more information on antiretroviral drugs used in the treatment of HIV infection.
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