FDA approves Truvada for HIV prevention
"Today’s approval marks an important milestone in our fight against HIV," said Margaret Hamburg, M.D., the FDA commissioner. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) from Truvada's manufacturers, Gilead Sciences, which is in the process of approval. A REMS ensures that the benefits of a new drug outweigh its risks. In the case of this medication, the REMS focuses on educating individuals who take Truvada as a way to prevent HIV, as well as their healthcare providers.
Researchers conducted trials with Truvada involving approximately 4,700 straight couples, in which one partner was infected with HIV. The new drug decreased the likelihood of the uninfected individual contracting the virus by 75 percent, as compared to the people who received the placebo. In addition, scientists observed no significant side effects.
When tested on men who have sex with men, as well as transgender women who are sexually active with males, Truvada reduced the rate of HIV by 42 percent.