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Thursday, 19 July 2012

HIV/AIDS PREVENTION DRUG NOW OUT FOR SALE



The first-ever daily pill to help prevent against HIV was approved Monday by US regulators for use in uninfected adults who are at risk for getting the virus that causes AIDS. Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV in otherwise healthy people, in combination with safe sex and regular testing.

“Truvada alone should not be used to prevent HIV infection,” said Debra Birnkrant, director of the division of antiviral products at the FDA. Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.

The drugmaker must also include a warning that Truvada for PrEP “must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least
every three months during use.”

The goal of the approval is to eventually cut back on the rate of new infections in the United States, which have stayed steady in recent years at about 50,000 annually, she said. A key goal of the US strategy against HIV/AIDS, set forth in 2010, is to decrease the number of new infections by 25 percent by 2015.

“The hope is that over time it will decrease the rate of new infections or incidence in the United States.”

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