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FDA Approves Tivicay (Dolutegravir) for Treatment of HIV-1
The FDA has approved Tivicay (dolutegravir, ViiV Healthcare/GlaxoSmithKline), a new drug to treat human immunodeficiency virus-1 (HIV-1) infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is taken daily in combination with other antiretroviral agents.
Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat both treatment-naïve and treatment-experienced HIV-infected adults, including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children aged 12 years and older weighing at least 40 kg (approximately 88 lbs) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.
The safety and efficacy of Tivicay 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, Merck), each in combination with other antiretroviral drugs, or Atripla (Gilead), a fixed-dose combination of efavirenz, emtricitabine, and tenofovir. The results showed that 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 aged 12 years or older weighing at least 40 kg who had not taken integrase strand transfer inhibitors.
Common side effects observed during clinical studies included insomnia and headache. Serious side effects included 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 serious side effects.
Source: FDA; August 12, 2013.