Posts
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 HIV
infection.
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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
