July 1, 2019
"Since 2012 when the FDA first approved Truvada for a pre-exposure prophylaxis (PrEP) indication, there has been a safe and effective HIV prevention method that, when used along with safer sex practices, can help lower the chances of getting sexually-transmitted HIV,” said Debra Birnkrant, M.D., director of FDA’s Division of Antiviral Products. “We have also reinforced to health care professionals and at-risk individuals that before starting PrEP with Truvada, or emtricitabine/tenofovir disoproxil fumarate, and during its use, health care professionals should routinely screen patients for HIV, at least once every three months. This screening diminishes the risk of individuals with undiagnosed HIV infection developing a resistant strain of HIV while using PrEP. When used according to these guidelines, PrEP can be a powerful HIV prevention tool. When it was first introduced, we took steps to ensure that health care professionals and at-risk individuals understood not only the risks associated with the medication, but also the additional HIV prevention methods they should follow. Now, after seven years, we have evidence showing that the vast majority of health care professionals and at-risk individuals are aware of these risks and prevention methods, and educational materials and treatment guidelines are readily available from the U.S. Centers for Disease Control and Prevention. Therefore, as of today, we are eliminating the risk evaluation and mitigation strategy (REMS) for Truvada and its generics. As a result, the FDA is no longer requiring the drug manufacturers to provide educational materials. We will continue to monitor for risks of these products, as we do for all medicines, and inform the community as appropriate if new risks are identified."
The U.S. Food and Drug Administration 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 labeling 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 (REMS), 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.
Today, the FDA announced the elimination of the REMS for Truvada and its four approved generics. With the removal of the REMS for emtricitabine/tenofovir disoproxil fumarate for PrEP, drug manufacturers are no longer required to provide educational materials; however, the approved labeling and Medication Guide explaining the risks and benefits of the product will continue to convey the important safety information and be widely available. Prescribers should continue to follow the labeled directions for the initiation and proper use of Truvada for the PrEP indication to minimize the risk of developing resistant HIV-1 variants when HIV-1 infection is present. The FDA continues to encourage at-risk individuals to have an ongoing dialogue with their health care professional about the benefits and risks of PrEP and other HIV prevention strategies when taking PrEP. Additionally, health care providers and at-risk individuals should access educational materials and treatment guidelines readily available from sources like the U.S. Centers for Disease Control and Prevention as well as local health departments.
In Feb. 2019, a new initiative, Ending the HIV Epidemic: A Plan for America, was announced by the U.S. Department of Health and Human Services, a once-in-a-generation opportunity to eliminate new HIV infections in our nation. This initiative will provide the hardest hit communities with the additional expertise, technology and resources required to address the HIV epidemic in their communities, focusing on certain geographic hotspots. The aim is to reduce new infections by 75 percent in the next five years and by 90 percent in the next ten years, averting more than 250,000 HIV infections in that span.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.