- Written by senior healthcare analyst for infectious diseases, Dr. Ramya Kartikeyan, and healthcare analyst for infectious diseases, Dr. Brad Tebbets.
The FDA’s approval of Truvada (emtricitabine and tenofovir disoproxil fumarate) for use by healthy individuals at a higher risk of contracting an HIV infection is likely to change the face of the HIV-retroviral debate for the foreseeable future. Gilead Sciences Inc. first obtained approval for Truvada in 2004, for use in HIV-infected patients, 12 years and older, in combination with other marketed antiretroviral drugs. With the new FDA approval issued on July 16, 2012, Truvada will be the first pill to be used as a pre-exposure prophylactic (PrEP) by at-risk individuals as a part of a Risk Evaluation and Mitigation Strategy (REMS), involving a training and education program for the medical practitioners who are involved in distribution of this drug.
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