New Advancements in HIV Prevention

May 17, 2012
Two new items are under consideration by the Food and Drug Administration (FDA) that could reduce the number of HIV infections:
  1. Last week, a panel of experts recommended that the FDA approve a pill known as Truvada that could be taken preemptively by healthy but at-risk individuals to prevent the contraction of HIV. The pill is already approved for the treatment of HIV, and the FDA’s final decision about whether to approve it for prevention is expected next month.
  2. The other advancement awaiting formal approval by the FDA is an over-the-counter HIV test kit, which allows consumers to perform oral HIV tests in the privacy of their homes. The test, which detects antibodies to the virus in saliva, returns results in about 20 minutes. On Tuesday, a 17-member advisory panel unanimously recommended that the FDA approve this kit for over-the-counter-use. While the agency declined to comment on when it will release its final decision, executives for the manufacturer expect a decision sometime this summer.
According to the Center for Disease Control, there are approximately 1.2 million people living with HIV in the United States. One in five of those individuals is unaware of the infection, and about 50,000 new people are infected each year. Should the FDA choose to approve the drug and at-home test, the above numbers could be reduced. In fact, the FDA associate director for research in the office of biostatistics and epidemiology stated that the test could identify up to 45,000 cases annually of infected individuals and avoid more than 4,000 new transmissions each year in the United States. Although the FDA tends to heed the recommendations of its advisory panels, the path forward for each of these advancements is not entirely clear. In particular, the panel’s decision to recommend the use of Truvada to prevent HIV infections was far from unanimous: The 22-member panel took three votes, one for each of the three at-risk populations it considered for the drug (men who have sex with men, HIV-negative partners of people with the virus, and a generic category described as “other individuals at risk for acquiring HIV through sexual activity”). Each vote contained a few dissents and abstentions, with the third vote garnering 10 dissents and abstentions. Dissenting voters expressed a wide variety of concerns, including that HIV-negative individuals who take the drug might develop a drug-resistant strain of the virus or abandon other safe-sex practices under the impression that the drug protects them from all risks of sex. One downfall of the over-the-counter test kit is that the test is not quite as accurate when performed at home as it is when performed professionally; the at-home version showed to be 93% accurate in detecting HIV versus 99% accurate when used by trained professionals. Additionally, the over-the-counter version showed 93% accuracy in detecting the presence of HIV, but 99% accuracy in detecting the absence of the virus. These concerns are certainly valid, and it is now up to the FDA to weigh them against the demonstrated benefits of each advancement and the recommendations of the respective panels. Yet the challenge of our Jewish tradition in responding to this epidemic is clear. Where pain and suffering exist, we must bring comfort and solace. Where prejudice and ignorance prevail, we must provide acceptance and knowledge. Caring for the sick, saving lives and performing deeds of loving kindness have been our values and our commitments since Sinai. They remain our guiding principles in dealing with this harrowing epidemic. Photo courtesy of

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