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Published On: Mon, Aug 12th, 2013

FDA approves Tivicay, a new drug to treat HIV-1 infection

PRESS RELEASE

The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

This thin section transmission electron micrograph (TEM) depicts numerous virions revealed in a preparation of HIV (human immunodeficiency virus). Image/CDC

This thin section transmission electron micrograph (TEM) depicts numerous virions revealed in a preparation of HIV (human immunodeficiency virus). Image/CDC

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. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “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.

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.

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 kg 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 manufactured by GlaxoSmithKline, based in Research Triangle Park, N.C. Isentress is marketed by Whitehouse Station, N.J.-based Merck, and Atripla is marketed by San Francisco, Calif.-based Gilead.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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  1. FDA approves new drug to treat HIV infection | Ghana Health Nest says:

    […] FDA approves Tivicay, a new drug to treat HIV-1 infection […]

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    […] “HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. “The … Read more on The Global Dispatch […]

  3. News & Tips | TheInvestmentMan says:

    […] FDA approves Tivicay, a new drug to treat HIV-1 infection (theglobaldispatch.com) […]

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