New York Times (05.11.12) - Friday, May 11, 2012
On Thursday, advisors to the Food and Drug Administration
recommended the agency approve the use of Truvada in healthy
people who are at high risk for HIV infection.
FDA's advisory panel, composed of 22 outside medical experts,
evaluated studies of once-a-day Truvada and heard scientific
presentations. Several speakers told the panel better
prevention methods besides condoms and counseling are needed
to make a dent in the estimated 50,000 new infections that
occur in the United States each year. Truvada is not meant to
replace these safe-sex measures but to be used with them to
enhance protection. The drug is already approved for treating
Many newly infected Americans are men whose sexual partners
are unaware of their infection; young black men who have sex
with men are at highest risk. Truvada would be prescribed for
high-risk groups like MSM with multiple sex partners, people
in serodiscordant relationships, and sex workers.
One panelist characterized the expanded use of the HIV drug,
which costs around $14,000 a year, as "an amazing opportunity
to turn the tide on this epidemic."
However, the advisors struggled with how to ensure healthy
people taking Truvada do so safely and effectively. While the
medicine would come with specific instructions, including the
need for HIV screening before starting the regimen and other
lab tests, FDA officials said Thursday there is no practical
way to enforce a testing requirement. Further, such a
requirement could pose a barrier to use. Some panelists voted
"no" or abstained due to a lack of data for Truvada's efficacy
in women and African-Americans.
FDA typically follows the guidance of its advisory panels.
Agency approval may make it more likely that health insurers
would cover the cost of the drug's preventive use.