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The US Food and Drug Administration (FDA) today approved a new drug called dolutegravir (Tivicay, GlaxoSmithKline) as an adjunct to other antiretroviral drugs that treat individuals infected with HIV-1, the agency announced.

Dolutegravir, an integrase strand transfer inhibitor, interferes with an enzyme needed for HIV to multiply. It is a once-a-day pill.

The new drug is indicated for HIV-infected adults who have never taken HIV antiretroviral therapy as well as HIV-infected adults who have previously received this therapy, including other integrase strand transfer inhibitors. Clinicians also can order dolutegravir together with other antiretrovirals for children aged 12 years or older, weighing at least 40 kg, who are treatment-naïve or treatment-experienced but have not previously received other integrase strand transfer inhibitors, a restriction not found with adults.

"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 Tivicay that add to the existing options remains a priority for the FDA."

In February, the agency granted priority review status to dolutegravir. Its approval comes 4 days after the FDA okayed the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen.

The FDA determined that dolutegravir is safe and effective on the basis of 4 clinical trials involving 2539 participants with HIV. Drug regimens for treating HIV that included dolutegravir proved effective in reducing viral loads, according to the agency. The pharmacokinetics, safety, and activity of the drug with regard to children defined in the pediatric indication were established in a fifth clinical trial.

Insomnia and headache were common adverse events observed in the clinical trials. Among the more serious adverse events were hypersensitivity reactions and abnormal liver functions among patients who also were infected with hepatitis B or C, or both. The drug's label contains instructions on how to monitor patients for such serious adverse events.

More information on today's FDA decision is available on the agency Web site.

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