FDA Approves New HIV-1 Drug

The FDA has approved ViiV Healthcare’s Tivicay (dolutegravir), an integrase strand transfer inhibitor, for the treatment of HIV-1 infection in combination with other antiretroviral drugs.

Tivicay is specifically indicated in treatment-naïve and in treatment-experienced adults, including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved in children >12 years weighing >40kg who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

The safety and efficacy of Tivicay was evaluated in 2,539 patients across four clinical trials. Patients were randomized to Tivicay or Isentress (raltegravir; Merck), each in combination with antiretroviral drugs, or Atripla (efavirenz, emtricitabine, and tenofovir; Bristol-Myers Squibb and Gilead).

Study results showed that Tivicay-containing regimens were effective in viral load reduction. A fifth trial established the pharmacokinetics, safety, and activity of Tivicay as part of treatment regimens in children >12 years old weighing >40kg who have not previously taken integrase strand transfer inhibitors.

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