Wednesday, July 06, 2011

Physicians urge FDA not to approve Truvada
Alaric Dearment

LOS ANGELES — A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

Fifty-five physicians signed a letter spearheaded by the AIDS Healthcare Foundation citing concerns about the use of Gilead’s Truvada (tenofovir disoproxil fumarate and emtricitabine) for “pre-exposure prophylaxis,” or PrEP. Concerns included the risk of a decrease in condom use and a lack of information showing proper use in “real world” situations.

“As medical care providers, we strongly support continued research on the prevention of HIV, but oppose approval of a pre-exposure prophylaxis that runs the risk of contributing to the spread of HIV and drug-resistant viruses,” the physicians wrote. “Our first obligation is to do no harm to individuals and to the public health.”

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