Posted by Michael Wonder on 02 Jul 2019
FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV
1 July 2019 - The U.S. FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate) in 2004 for the treatment of HIV-1 infection in combination with other antiretroviral drugs.
In 2012, the FDA approved the use of Truvada for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), in combination with safe sex practices, to reduce the risk of sexually-acquired HIV-1 infection in at-risk adults, and later in 2018 for adolescents weighing at least 35 kilograms (77 pounds). The labelling also includes instructions for HIV-1 screening in patients taking the drug for PrEP.
As part of the 2012 approval, the FDA established a Risk Evaluation and Mitigation Strategy, which among other things, required manufacturers to make available training materials for health care professionals and educational information for consumers, due to the risk of developing a resistant strain of HIV (HIV-1 variants) when starting PrEP or continuing its use in a patient who has undiagnosed HIV-1 infection. This could make the resistant HIV-1 more difficult to treat.
