The U.S. Food and Drug Administration announced a major first today, approving Truvada, a drug intended to prevent HIV infections for people at high-risk of contracting it. It’s the first pill approved to reduce the likelihood of getting HIV for people having sex with infected individuals.
Taken daily, Truvada reduced the risk of HIV infection by 42% compared to a placebo in clinical trials where HIV-negative people had unprotected sex with multiple partners, including some HIV carriers, says the FDA. Another trial was conducted with heterosexual couples where one person had HIV and the two had sex using condoms, Truvada reduced the risk 75% of the time. In May, the pill was said to be close to FDA approval.
According to a professor of global health and medicine who led the trial:
“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure. 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.”
The medication is already approved to be used in combination with other antiretroviral drugs for the treatment of HIV, but this is the first drug to be approved for prevention purposes. The FDA says it should be taken and used along with other methods, including safe sex practices, risk reduction counseling, and regular HIV testing.
“Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Dr. Margaret Hamburg 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.”
The FDA is requiring that the makers of the drug study those who acquire HIV while on the medication, to find out if a person could develop a resistance to it.
FDA approves Truvada, first pill to prevent HIV infections [Boston Globe]