Giving us all a nice start to the week, the FDA has just given the green light to Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals.
Taken daily, the drug is being touted as part of a pre-exposure prophylaxis (PrEP) strategy, in combination with safer sex practices, to reduce the risk of HIV infection in high-risk adults, including those with HIV-infected partners. The FDA previously allowed Gilead Sciences to manufacture Truvada (emtricitabine/tenofovir disoproxil fumarate) for use in conjunction with other antiretroviral agents for HIV-positive people.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret A. Hamburg. “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 medication shouldn’t be perceived as a cure or vaccine: Truvada for PrEP is only prescribed fpr individuals who are confirmed to be HIV-negative prior to using the drug. In double-blind studies of 2,499 HIV-negative men and women in high-risk categories, Truveda was effective in reducing the risk of HIV infection by 42% compared with the placebo. There are also potential side-effects including changes in fat distribution in the body and blood, kidney and liver dysfunction and weakening of the bones.
Today’s approval is heartening sign, definitely, but not a magic bullet.