FDA Approves Dolutegravir to Treat HIV-1 Infection
The U.S. Food and Drug Administration (FDA) today approved dolutegravir (Tivicay), a new drug to treat HIV-1 infection. Dolutegravir is an oral integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. The drug is taken in combination with other antiretroviral drugs.
Dolutegravir is approved for use in a broad population of HIV-infected patients. It can be used to treat both treatment-naive and treatment-experienced HIV-infected adults, including those who have been treated with other integrase strand transfer inhibitors. Dolutegravir is also approved for children aged 12 years and older weighing at least 40 kg who are treatment-naive 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, MD, MPH, Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs like [dolutegravir] that add to the existing options remains a priority for the FDA.”
Clinical Trial Details
Dolutegravir’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 dolutegravir or raltegravir (Isentress), each in combination with other antiretroviral drugs, or a fixed-dose combination of efavirenz, emtricitabine, and tenofovir (Atripla). Results showed dolutegravir-containing regimens were effective in reducing viral loads.
A fifth trial established the pharmacokinetics, safety, and activity of dolutegravir as part of treatment regimens for HIV-infected children aged 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 insomnia and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants coinfected with hepatitis B and/or C.
Dolutegravir is marketed by ViiV Healthcare and manufactured by GlaxoSmithKline.
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