FDA approves new drug for HIV treatment
Tivicay, which is also known as dolutegravir, is an integrase strand transfer inhibitor that interferes with an enzyme HIV requires for multiplication. Safety and efficacy studies involving 2,539 participants found that regimens of Tivicay with other antiretroviral drugs effectively reduced viral loads.
"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," Edward Cox, the director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."
Tivicay was approved for use in a broad population of HIV-infected patients, including HIV-infected adults who never took HIV therapy, HIV-infected adults who previously took HIV therapy and children ages 12 years and up weighing at least 88.2 pounds who are treatment-naive or treatment-experienced but have never previously taken other integrase strand transfer inhibitors.
Common side effects observed during clinical trials included insomnia and headache. Serious side effects included hypersensitivity reactions and abnormal liver function in patients co-infected with hepatitis C or hepatitis B.
Tivicay is marketed by ViiV Healthcare and manufactured by GlaxoSmithKline.
According to the U.S. Centers for Disease Control and Prevention, approximately 50,000 Americans are infected with HIV annually with about 15,500 Americans dying from the disease in 2010.