In what could be considered a watershed moment in the world's 30-year fight against HIV, U.S. government advisors recommended the Food and Drug Administration (FDA) give the go-ahead to a drug that has been shown to be effective in preventing the virus from replicating.
The drug, Truvada, if approved fully by the FDA on June 15, would become the first pill to prevent HIV infection.
Truvada was recently given a thumbs by the FDA advisory committee following votes of yeas and nays that highlighted concerns ranging from side-effects of persistent diarrhea to concerns about "a false security" possibly resulting in some at-risk men using the drug as an excuse to opt out of using condoms all together.
"We want to thank the advisory committee for recommending approval of Truvada for a pre-exposure prophylaxis," said Stephen Bailous, executive vice president, National Association of People With AIDS (NAPWA). "We urge the FDA to move with caution toward final approval or disapproval, carefully weighing possibilities of side effects and increased risk behavior, but also weighing carefully the risks of letting an informal market grow without FDA regulation and clinical guidelines."
Another concern involved the clinical trials which were largely conducted in Africa. Although African-American women account for the largest share of new HIV infections among U.S. women (57 percent in 2009), African-American women, according to reports, were not part of the clinical trials.
"We have to do better for full inclusion of African-American women in clinical trials overall," said A. Toni Young, executive director of the Washington, D.C.-based Community Education Group. "HIV is one of the areas, but if you look at any clinical trials, African-American women are typically on the other end. This is not abnormal."
According to the District of Columbia Department of Health (DOH), more than 3 percent of the District's population, aged 13 and older, are living with HIV/AIDS. The rate is higher than many developing nations and is at a level that the World Health Organization classifies as an epidemic.
Truvada is not new to the pharmaceutical marketplace. In fact, it has been marketed by California-based Gilead Sciences since 2004 as a treatment for those infected with the virus. Doctors usually prescribe it as part of a "drug cocktail" to repress the virus.