This month, the FDA has ushered in several steps toward supporting HIV prevention. On Monday, the federal agency approved the drug, Truvada, which prevents HIV. When taken in combination, the drugs work to stop HIV from establishing itself and multiplying in the body.
Two weeks ago on July 3, the FDA approved an over-the-counter HIV Test, OraQuick In-Home HIV Test, which had a 99.98% accuracy rate in clinical trials. It is the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
The test requires users to swab the inside of their mouths and receive results within 20 to 40 minutes of taking the test. A positive outcome doesn’t necessarily indicate HIV infection but that the tester needs to go to a medical setting for additional testing to confirm the results.
There are currently 1.2 million people in the United States living in the United States and 50,000 new cases diagnosed each year. African Americans are most affected by HIV. In 2009, African Americans made up a mere 14% of the United States population, yet accounted for 44% of all new HIV infections, according to the Centers for Disease Control and Prevention.
Statistics further state:
— In 2009, black men accounted for 70% of the estimated new HIV infections among all blacks. The estimated rate of new HIV infection for black men was more than six and a half times as high as that of white men, and two and a half times as high as that of Latino men or black women.
— In 2009, black women accounted for 30% of the estimated new HIV infections among all blacks. Most (85%) black women with HIV acquired HIV through heterosexual sex. The estimated rate of new HIV infections for black women was more than 15 times as high as the rate for white women, and more than three times as high as that of Latina women.
These two newest initiatives should work towards impacting infection rates. The availability of the over-the-counter HIV test should encourage more people to take control of knowing their own status without being detracted by the stigma associated with getting a test done at a clinic or doctor’s office. After unprotected sex, consumers could easily go down to the local drug store, when the drug hits the shelves, and can test to confirm that they were not infected.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”
Meanwhile, those who are sexually active and want to take extra precautions to not contract the infection could begin a daily Truvada treatment. It could also be beneficial for those who are living with partners and spouses that have HIV. The technology and affect of antiviral medicines have been in use for decades and perhaps paved the way for this recently announced breakthrough with Truvada.
Truvada was initially approved in 2004 for use in the treatment of HIV, but this new approval for the prevention of HIV is based on three studies recently published in the New England Journal of Medicine which together found that when taken daily, Truvada, reduces the risk of acquiring HIV infection.