Truvada for AIDS Prevention Gets Green Light from Food and Drug Administration (FDA)

Truvada received approval from the U.S. FDA for HIV/AIDS prevention today, becoming the first drug to receive approval as a preventive measure for uninfected individuals at high risk to reduce their chances of becoming infected. Truvada, manufactured by Gilead Sciences, Inc., previously was approved for use in combination with other antiretroviral drugs as a treatment for HIV-infected adults and children 12 years or older.

In December 2010, publication of results from the pioneering Pre-exposure Prophylaxis Initiative study, led by UCSF researcher Robert Grant, MD, MPH, from the Gladstone Institute of Virology and Immunology, first clearly established that prophylactic treatment can reduce the incidence of infection among men who have sex with men, and greatly expanded the discussion about using HIV treatment to prevent infection.

Major studies reviewed by the FDA before approving Truvada included the UCSF-led study, as well as the Partners PrEP trial. Results of the TDF2 study of young heterosexual men and women in Botswana also indicated that preexposure prophylaxis with Truvada treatment was effective in preventing transmission to uninfected partners.

UCSF researchers and physicians remain very active in evaluating preexposure prophylaxis approaches.

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