June 30, 2012
AIDS Drug Could Get Approved This Summer
redOrbit Staff & Wire Reports - Your Universe Online
The fight against AIDS could get some help this summer, as the Food and Drug Administration (FDA) is expected to approve a drug used to prevent the transmission of HIV, the AIDS virus. Made by Gilead Sciences of Foster City, California, Truvada is already widely used in combination with other drugs to treat patients with HIV. To help the approval process, 2 studies have been published in The Lancet which show just how effective Truvada is at preventing the spread of HIV.If Truvada is approved for the prevention of HIV, as an FDA advisory panel is suggesting, it could be prescribed to healthy patients at a high risk of contracting AIDS, such as partners of those who already carry the AIDS virus.
Known as “Quad,” Truvada is a combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, and can be taken just once a day to prevent the contraction of HIV. Quad could also bring relief to those adults currently undergoing antiretroviral treatment, which includes a hefty regimen of 4 different drugs several times a day.
Harvard Medical School researchers conducted one of the studies, randomly assigning 700 North American patients 2 different single-pill treatments: Quad or a standard treatment pill known as Atripla. Nearly one year later, 88% of the Quad patients experienced a suppression of HIV while 84% of Atripla patients experienced a similar suppression. The study also found both pills to be safe, as only 3.7% of the Quad patients reported stopping the treatment due to side effects.
"Response to the Quad was favorable across a wide range of patients, including those with high HIV viral loads who are sometimes difficult to treat," said Dr. Paul Sax of the Harvard Medical School, according to ABCNews.com.
"The side effect profile differed, in that Quad caused fewer rashes and central nervous system side effects than Atripla, but more nausea," Sax said. "Overall, both treatments were very well tolerated. These results suggest that Quad will be an important new option for HIV treatment if it is approved."
If the pill is approved for the prevention of the spread of HIV, Dr. Sax says it will be important for these patients to be diligent in their treatment.
"Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication."
While Dr. Sax´s study found promising results, other doctors, such as Dr. Mark Kline–a pediatric AIDS expert at Baylor College of Medicine in Houston, Texas–thinks the study merely scratches the surface.
"The real unmet need in HIV/AIDS is for simple treatment regimens safe and effective for HIV-infected patients who have failed other therapies because of viral resistance," Kline told ABC News.
If approved, Howard Jaffe, president of Gilead Foundation–a non-profit arm of Gilead Sciences–says those at high risk will still have to take extra precautions, such as condoms, counseling, and testing.
"We're lucky we have airbags in cars, but they don't make seat belts obsolete,” he told USA Today.
An FDA advisory committee met last month to review data on Quad. While they voted in favor to approve the drug, a final decision is expected later this summer.