SILVER SPRING, Md. (CBSDC) – The U.S. Food and Drug Administration has approved the first medication to help cut down the risk of HIV infection, a potential landmark passing in the 30-year fight against HIV.
In clinical trials, Truvada, which was approved by the FDA on Monday, is to be taken on a daily basis to help reduce the risk of HIV by 42 percent compared to a placebo. Before Monday’s decision, the drug had already been approved for usage in combination with other drugs toward HIV treatment.
“Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Margaret A. Hamburg said in a news release. “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.”
Truvada’s approval comes on the heels of two significant clinical trials administered by the FDA, overseeing about 2,500 “HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection,” according to the FDA. This trial represented the drop in the likelihood of HIV by 42 percent compared with placebo in this same sample size. Another trial involved almost 4,800 heterosexual couples where one partner was infected with HIV. In that trial, Truvada showed even more staggering results, reducing the risk of HIV by 75 percent compared with placebo.
“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” Connie Celum, a professor of global health and medicine at the University of Washington who led the trial involving heterosexual couples, told the Boston Globe. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.”
But the approval has one more hurdle. Gilead Sciences, Truvada’s California-based manufacturer, must examine those who acquire HIV while taking Truvada to see whether there is a resistance to the drug.
The most common side effects associated with Truvada include “diarrhea, nausea, abdominal pain, headache, and weight loss,” according to the FDA. A yearlong treatment of Truvada in the U.S. is expected to cost at least $13,900, according to Gilead Sciences.