Contentious support
May 14, 2012
THE US Food and Drug Advisory’s
decision to back Truvada to prevent
the transmission of HIV, has caused
a stir amongst the healthcare
community, with some saying its
preventative usage may see at-risk
patients stop using other
preventative methods like condoms.
The backing means that the FDA
is likely to approve the indication
for prophylactic Truvada in three
populations: HIV-uninfected men
who have sex with men, in HIVuninfected
partners in relationships
with infected partners, and for
individuals at risk of acquiring HIV
through sexual activity.
Opponents to the approval also
cited non-adherence concerns
given that Truvada’s efficacy
depends on consistent daily
administration, as well as concerns
that treating HIV-naïve patients
with the drug will result in the
evolution of a drug-resistant HIV
strain.
The Advisory committee however
has stood by its decision saying that
it based its decision on a study
which found that men who have
sex with men and who took PrEP
Truvada had 43.8% fewer infections
than men taking a placebo.
The committee also considered
data showing that the drug
decreased infection rates by 63% in
men and women at high risk of
infection in Botswana, and data
that showed that the drug decreased
transmitted infections by 62% in
serodiscordant Kenyan couples, and
that combination treatment with
the Tenofovir resulted in a 73%
reduction in infections.
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