May 16, 2012
The Food and Drug Administration's Blood Panel Advisory Committee has approved both Truvada PrEP and the OraSure Rapid HIV test for home use. The panel voted yesterday after deliberation and testimonies in support and against both products. Truvada, a pill with a combination of tenofovir and emtricitabine, has been recommended for use as a pre-exposure prophylaxis (PrEP) for HIV-negative partners in serodiscordant relationships. The OraSure Rapid HIV test is an oral-swab based test that can give results in about 20 minutes. The FDA does not have to accept the recommendations from the committee but it usually does.
Truvada has been proven to be generally safe and effective in preventing new HIV infections in clinical trials. It has a 75 percent success rate of reducing infections when used as directed. The concerns from the trials were that it wasn't proven to be as effective in women, a patient can develop a resistance to the drug over time, side effects that could harm an otherwise healthy person, and that if a person doesn't adhere to the strict regimen their chances for infection will rise again. And while a prescription is a great start there has to be a balanced approach to ending the epidemic.
The OraSure in-home HIV test was unanimously voted 17-0 in favor of approval. The over-the-counter test is predicted to identify as many as 45,000 people living with HIV in the US who didn't know they were infected. The test will allow users to collect their own oral sample, place it in a vial of developer solution, and interpret their own results in as little as 20 minutes after sample collection. Concerns about this test were that the test would not be sensitive enough to pick up on HIV anti-bodies in the sample and could produce false-negatives.
Local AIDS Service Organizations are already showing support for the in-home test. Stephen Bailous Executive Vice President of NAPWA and Chair of the EMA Ryan White Planning Council stated, "We welcome in-home testing. We know there are risks in allowing people to test themselves for HIV without counseling, but we also know we are still seeing more than 50,000 new HIV infections every year, and a large majority of them come from sexual contact with people who do not know they have the virus. In-home testing is one of many new testing and treatment options that promise to bring the end of AIDS in America."
The agency is expected to announce its decision on or before June 15th.
Recommended reading: HIV Testing Comes Closer to Home