FDA Approves Truvada : First Step Towards AIDS – HIV Prevention Vaccine Medication

In a recent announcement, the FDA said that is has approved the use of a drug called Truvada as a way to “reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected.” The announcement is seen my many as another step towards a vaccine for the prevention of HIV virus and AIDS.

HIV-1 is the most common form of HIV and according to the FDA, for the first time, adults who do not have HIV but are at risk of becoming infected can take a medication to reduce the risk of sexual transmission of the virus. The FDA announcement indicated that the medication is to be taken once daily in combination with safer sex practices to lower the risk of acquiring HIV.

The decision was based on data from two large clinical trials of Truvada. From the data is appears that daily use of Truvada significantly reduced the risk of HIV infection by 42 percent. The study, sponsored by the National Institutes of Health (NIH), showed the diminished infection rates in about 2,500 HIV-negative gay and bisexual men and transgender women. A reduction of 75 percent was shown in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.

According to Debra Birnkrant, M.D., director of the Division of Antiviral Products at FDA, Truvada works to prevent HIV from establishing itself and multiplying in the body. While the drug itself is not new, approved in 2004 for HIV treatment, what is new is the use of the drug in prevention instead of treatment.

“In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” Birnkrant says. “But it is still better to prevent HIV than to treat a life-long infection of HIV.”

Currently, Truvada is not a vaccine for HIV. In the FDA announcement, Birnkrant stressed that Truvada is part of a comprehensive HIV prevention plan which includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections.