Tivicay, also known as dolutegravir, is applicable not just for adults who have previously received drugs to treat the virus but also for those with HIV who have never taken treatment for the illness. The medicine is an integrase strand transfer inhibitor that attacks enzymes that allow the spread of HIV, according to the statement released by the FDA.
The agency also approved the drug for use of children ages 12 and older weighing at least 40 kilograms who have not previously received other integrase strand transfer inhibitors.
Tivicay lowered the HIV virus to levels that are undetectable in more people compared with the world’s best-selling AIDS drug Atripla from Gilead Sciences Inc., based in a clinical trial released in 2012. Merck & Co.’s Isentress is the only other approved integrase strand transfer inhibitor, receiving approval in 2007 and hitting sales of $ 1.5bn last year.
Among the side effects linked to Tivicay include headaches and insomnia. Some of the serious ones are hypersensitivity reactions as well as abnormal liver function for those who have been infected with hepatitis B or C.
Every year, an estimated 50,000 Americans become infected with HIV, based on data of Centers for Disease Control and Prevention. In 2010, the disease led to 15,500 deaths.
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