A panel of US health experts has for the first time backed a drug to
prevent HIV infection in healthy people.
The panel recommended US regulators approve the daily pill, Truvada,
for use by people considered at high risk of contracting the Aids
virus.
The US Food and Drug Administration (FDA) is not required to follow
the panel's advice, but it usually does.
Some health workers and groups active in the HIV community have
opposed the approval of the drug.
However, correspondents say the move could prove to be a new milestone
in the fight against HIV/Aids.
Truvada is already approved by the FDA for people who are
HIV-positive, and is taken along with existing anti-retroviral drugs.
Studies from 2010 showed that Truvada, made by California-based Gilead
Sciences, reduced the risk of HIV in healthy gay men -and among
HIV-negative heterosexual partners of people who are HIV-positive - by
between 44% and 73%.
June decision
The Antiviral Drugs Advisory Committee, whichadvises the FDA, voted
19-3 in favour of prescribing the drug to the highest risk group -
non-infected men who have sex with multiple male partners.
They also approved it, by majority votes, for uninfected people with
HIV-positive partners and for other groups considered at risk of
acquiring HIV through sexual activity.
Truvada has been used as atreatment for people infected with HIV in
the US since 2004
The votes followed an 11-hour meeting of the panel in Silver Spring,
Maryland, and a lengthy public comments session.
Opposition to the prospect of approving the drug is based on concerns
that users could gain a false sense of security, and fears of a
drug-resistant strain ofHIV.
There is also concern that the high cost of Truvada could divert
limited funding from more cost-effective options.
"We need to slow down. I care too much about my community not to speak
my concerns," said Joey Terrill, of the Aids Healthcare Foundation,
which campaigned against the drug's approval.
Nurse Karen Haughey told the panel: "Truvada needs to be taken every
day, 100% of the time, and my experience as a registered nurse tells
me that won't happen.
"In my eight years, not onepatient that I've cared for has been 100% adherent."
But others welcomed the panel's recommendation.
"This brings us closer to a watershed for global HIV prevention
efforts," said Mitchell Warren, executive director of the Aids Vaccine
Advocacy Coalition, after the vote.
The FDA is expected to make its decision by 15 June.
In the UK, Sir Nick Partridge, chief executive of Terrence Higgins
Trust, said: "There is no single method of prevention that can on its
own stop the transmission of HIV.
"Adding Truvada to our existing range of prevention programmes,
including safer sex campaigns, using condoms and regular testing for
HIV is an exciting prospect.
"But we need to know if people at highest risk of infection are
prepared to take a pill every day and whether there would be
anincrease in risk-taking behaviour which could outweigh the
prevention effectiveness of Truvada."
He said a clinical trial to invesitgate these issues would begin in
the UK in the autumn./
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Sunday, May 13, 2012
HADEES:->-HIV prevention pill Truvada backed by US experts:
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