FDA Considers Approval Of Drug That Can Prevent Aids
Washington, D.C. -
The Food and Drug Administration, FDA, will consider approving a drug that studies have shown can prevent aids, the viral infection the attacks the immune system. The approval is likely to be target to specific "high risk" people such as men who have sex with other men and men who's female partner has HIV and was shown in studies to have a 42-75% chance of preventing aids.
The drug is Truvada, made by Gilead Sciences of California, is already on the market for use with patients who already have HIV, but now could potentially be used by those who are perfectly healthy. Truvada is a combination of Emtriva and Viread, two older drugs that had marginal benefits, but when combined produced significantly increased benefits for HIV patients by preventing HIV from becoming AIDS.
FDA reviewers conclude that taking Truvada pre-emptively could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."
For women however, the results were so bad, the study was actually terminated mid way through because it had no positive effect for women.
Researchers caution that those taking it must take it every single day, and that even one missed pill can significantly reduce the drug's benefit. They also noted that the rate of reduction was also when use of condoms and counseling were included.
An estimated 1.2 million Americans have HIV according to the Centers for Disease Control and Prevention. HIV attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off foreign infections.
The approval however is not unanimous, Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York had stated that there are new drugs coming up for approval that already have a much higher rate of success and with less side affects.
Side effects with Truvada include diarrhea, dizziness, nausea and vomiting. More serious problems can include liver toxicity, kidney problems and bone thinning.