The Food and Drug Administration (FDA) has eliminated the Risk Evaluation and Mitigation Strategy (REMS) for Truvada (emtricitabine/tenofovir disoproxil fumarate; Gilead) and its 4 approved generics for HIV-1 pre-exposure prophylaxis (PrEP).
Removal of the REMS means that drug manufacturers are no longer required to provide training materials to healthcare providers and educational information to consumers; safety information will continue to be available via the approved drug labeling and Medication Guide. In 2012, the FDA established the REMS due to the risk of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV-1 infection.
“After 7 years, we have evidence showing that the vast majority of healthcare professionals and at-risk individuals are aware of these risks and prevention methods, and educational materials and treatment guidelines are readily available from the US Centers for Disease Control and Prevention,” the Agency explained in a press statement.
Truvada, a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, both HIV-1 nucleoside analog reverse transcriptase inhibitors, is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35kg. Individuals must have a negative HIV-1 test immediately prior to initiating Truvada for HIV-1 PrEP.
Truvada is also approved for use with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17kg.
In May 2019, Gilead announced a partnership with the CDC that would provide uninsured Americans at risk for HIV with free PrEP.
For more information visit fda.gov.