The FDA eliminates REMS for Truvada and its four approved generics

July 5, 2019

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, said the Food and Drug Administration in a news release.  

FDA says 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. In June the U.S. Preventive Services Task Force (USPSTF) released a final grade A recommendation statement on preexposure prophylaxis (PrEP) for the prevention of HIV infection. The Task Force found that clinicians should offer PrEP to persons at high risk for HIV.

The FDA encourages at-risk individuals to have an ongoing dialogue with their healthcare 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 Centers for Disease Control and Prevention as well as local health departments.

For older populations already living with HIV, Gilead Sciences, Inc., the maker of Truvada, launched the Gilead HIV Age Positively initiative, granting $17.6 million to 30 U.S. organizations that will use the funds to improve the lives of people who are aging with HIV. By some estimates, the company noted more than 80 percent of people living with HIV will face at least one age-related medical condition by 2030 which has risen significantly from 29 percent in 2010.