Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) has received approval from the US Food and Drug Administration (FDA).
Truvada is the first agent to get approval for HIV prevention in uninfected adults, a strategy known as pre-exposure prophylaxis (PrEP).
As part of prevention strategy, Gilead has worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of Truvada for PrEP.
Gilead Sciences Research and Development executive vice president and chief scientific officer Norbert Bischofberger said the decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort.
"This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide," Norbert added.
The approval was based on two placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP.
The iPrEx trial lead investigator Robert Grant said, "The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world."
