Landmark study results published in 2010 showed that the drug, made by California-based Gilead Sciences, helped ward off HIV in healthy gay men who engage in risky sex behaviors by 44 to nearly 73 per cent. But critics note that the pill is costly -- up to USD 14,000 per year -- and some warn that the clinical trial did not represent real-world circumstances and could lead to a spike in unprotected sex and a new surge in AIDS cases.
The Antiviral Drugs Advisory Committee is expected to issue a decision this evening. The Food and Drug Administration does not have to follow its advice, though it often does. Truvada is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs and was FDA approved in 2004. Drug maker Gilead Sciences Inc of California has filed a supplemental new drug application to market it for prevention purposes. If approved, "it needs to be understood that it is really adding another element to the tool kits or the combination of preventions that can be used," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
"It should not be looked upon as substituting other preventions." Some of the data being mulled comes from the iPrEx HIV Prevention Study, carried out from July 2007 to December 2009 in six countries -- Brazil, Ecuador, Peru, South Africa, Thailand and the United States. The study was conducted among 2,499 men, including 29 transgendered women, between the ages of 18 and 67 who were sexually active with other men but were not infected with the virus that causes AIDS.
Participants were selected at random to take a daily dose of Truvada -- a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate -- or a placebo. Those in the study who took the drug regularly had almost 73 per cent fewer infections. Across the entire study, including those who had not been as faithful in taking Truvada, there were 44 per cent fewer infections than those who took a placebo.