Gilead's HIV-Stopping Pill Finally Approved By FDA

GileadGilead’s HIV-blocking Truvada approved for use by high-risk, uninfected people.

Photo: Gilead

The first ever pill that prevents transmission of HIV to high risk, uninfected individuals was approved today by the FDA. The drug, called Truvada, is produced by San Francisco-area biotech company Gilead Sciences, and is taken daily.”Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Margaret A. Hamburg, M.D. said in a statement. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”

The drug works by preventing HIV from making copies of itself inside our cells. If the virus can’t make copies of itself, it can’t infect more cells.

Before being approved the drug underwent multiple rounds of testing in high-risk human populations, including those who have unprotected sex with HIV, of possibly HIV-infected partners.

The drug is already on the market as a medicine for people already living with HIV, but wasn’t approved for use by those who aren’t already infected. Those who would be taking the drug as a preventative measure would need to be diligent about taking it every day.

Doctors can now start prescibing the drug to uninfected people. It should be used in combination with a safe-sex education program and counseling to decrease risky behaviours.

In May, the FDA announced that they found the drug “save and effective” for HIV prevention. The FDA’s report on the drug said it would likely save people from “infection with a serious and life-threatening illness that requires lifelong treatment.”

The drug currently costs $900 per month, which works out to $11,000 per year.

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