In the battle against HIV/AIDS
, it’s impossible to have too many weapons. Now, within the same month, the FDA has loaded up on two promising additions to our country’s arsenal.
A new drug and the recently approved at-home HIV test could be a large part of the future of HIV resistance . . . although not everyone is happy.FDA Approves At-Home Testing
In the first major move, the U.S. Food and Drug Administration approved OraQuick
, an in-home HIV test. The first over-the-counter and home-use test kit of its kind, OraQuick detects the presence of antibodies to human immunodeficiency virus type 1 and type 2; the same virus that causes AIDS
According to the FDA press release, the “test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes.” While a positive result does not necessarily mean that a man or woman is conclusively infected with HIV, it does mean that additional testing should be done as soon as possible.
The kit is a big win in the eyes of most medical professionals, as government officials estimate that about 240,000 of the 1.2 million HIV carriers in the U.S. are not aware they are infected. And despite the fact that new infections have held steady at about 50,000 per year for the last two decades, we’re always in the business of improving those numbers. The FDA hopes that OraQuick will be an option for those who might not otherwise get tested.
Perhaps even more importantly, the manufacturing company, Orasure, expects to develop a toll-free call center to provide counseling and medical referrals to test users. According to the Associated Press, the call center operators will be bilingual in English and Spanish, and will have undergone 160 hours of training on HIV counseling and testing.FDA Follows up Quickly with a Drug for HIV-Resistance
Less than two weeks after the good news about OraQuick was released by the FDA, they came out with another victory for the HIV/AIDS community
. The Food and Drug Administration announced the approval of Truvada
, the first drug of its kind to reduce the risk of HIV infection in uninfected individuals.
Truvada, which is taken daily, would be used in combination with safer sex practices to reduce the risk of HIV in adults and children 12 years or older. It is marketed towards the high-risk population, and works optimally along with risk-reducing counseling and other prevention methods. And the numbers are promising.
The drug was tested in two large, randomized and double-blind clinical trials that included placebo controls. In the first, looking at almost 2,500 men and transgender women with a high number of sex partners with unknown HIV status, Truvada reduced the risk of HIV infection by 42 percent compared with the placebo. In the second, 4,658 heterosexual couples with one partner who was HIV-infected were researched. In that evaluation, the reduced risk of becoming infected stood at 75 percent compared with the placebo.
While these numbers are staggeringly positive, there are some groups who are voicing their opposition.The Other Side of the Debate
The good news seems to be that adding Truvada as a prevention strategy will provide wholly useful. It is, however, going to cost about $14,000 per year, a number that isn’t easily attainable for everyone. To be fair, however, that cost seems minimal compared to the price of HIV-related health care.
But more importantly, some groups, including the AIDS Healthcare Foundation, asked the FDA to reject the new medication. The concern was that it could give patients a false sense of security and reduce the use of condoms, which is far and away the most reliable preventative measure against HIV. The FDA, however, is taking the stance that having a working drug on the market will only help the cause, without taking away from all of the amazing work that pro-protection advocacies have done.
So it looks like progress marches on, and the fight against HIV picks up a few new allies. Maybe soon it will be a fair fight.Cited Sources
Chappelle, Rita. "OraQuick Press Release." FDA.gov
. N.p., 3 July 2012. Web. 31 July 2012. <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310542.htm>.
Jefferson, Erica. "Truvada Press Release." FDA.gov
. N.p., 16 July 2012. Web. 31 July 2012. <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm>.