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June 14, 2009)
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10 Jun 2009
Source: IRIN
JOHANNESBURG,
10 June 2009 - Findings from a clinical trial in Haiti bring the first
conclusive evidence that HIV-positive people in developing countries have a
significantly better chance of survival if they start antiretroviral (ARV)
treatment earlier.
Last week, an independent
data and safety monitoring board recommended immediately ending a trial being
carried out by the Haitian Group for the Study of Kaposi's Sarcoma and Immune
Deficiency Disorders (GHESKIO) Centers, because the evidence in favour of
earlier treatment was so overwhelming.
The tests were being run
in the capital,
Recent studies in the
developed world have found that starting HIV-infected patients on treatment when
their CD4 cell count (a measure of immune system strength) drops below 350
greatly reduces AIDS-related mortality. Waiting until it fell below 200 was
previously thought to be optimal.
However, some experts
argued that these findings could not be extrapolated to resource-limited
settings because they were based on patient records rather than a large,
randomised test in a poor country.
The trial in
By the time the trial was
stopped, six participants in the group that began treatment earlier had died,
compared to 23 in the group that started treatment later.
The number of patients who
contracted tuberculosis (TB), a common and often deadly opportunistic infection
in people living with HIV, was 18 in the early-treatment group, compared to 36
in the other group.
The monitoring board
recommended that all the trial participants now be offered ARV treatment and
followed for 12 months to ensure that they adhered to the timetable for taking
their medication.
"The public health
community now has evidence from a randomized, controlled clinical trial - the
gold standard - that starting ART [antiretroviral treatment] at CD4 cell counts
between 200 and 350 in resource-limited settings yields better health outcomes
than deferring treatment until CD4 cell counts drop below 200," said NIAID
Director Anthony S. Fauci in a statement.
Although some countries
changed their ARV treatment protocols after evidence from earlier studies, many
in the developing world still wait until patients have a CD4 count of 200 or
less to begin treatment. The study investigators were confident that many more
countries would revise their treatment guidelines.
Carl Dieffenbach, director
of the NIAID Division of AIDS, noted that raising the threshold for starting ARV
treatment would greatly increase the number of people needing medication, and
the need for the global community to provide more support to buy ARVs.
GlaxoSmithKline said
Thursday after the World Health Organization declared a global flu epidemic that
it would be ready within weeks to begin large-scale vaccine production.
Sanofi-Aventis also said it had started working on its own version. On Friday,
Swiss pharma giant Novartis announced it had created an experimental vaccine
that has not been tested in people. Novartis' vaccine was made via a cell-based
technology that may prove faster than the traditional way of making vaccines,
which relies on chicken eggs.
Many rich countries like
The likely scramble for
vaccines will leave many people in poorer countries empty-handed.
So far, swine flu has been
mostly detected in developed countries like the
"We do not know how
this virus will behave under conditions typically found in the developing
world," WHO chief Dr. Margaret Chan said Thursday. She said the agency
expects to see a "bleaker" picture as the virus makes its way to
Africa and
WHO spokesman Gregory
Hartl said officials were concerned people in poorer countries and those
fighting other health problems like malaria, tuberculosis, malnutrition and
pneumonia might be more susceptible to swine flu.
On Friday, WHO said that
74 countries had reported nearly 30,000 cases including 145 deaths. But so far,
the virus appears to be mild. Most people don't need medical treatment to get
better.
But the virus might have a
more devastating effect in people with underlying health problems. About half of
the people who have died from swine flu have had complications like asthma,
diabetes, and obesity.
"Any population that
has health challenges is potentially going to be at higher risk with H1N1 (swine
flu)," Hartl said.
In May, officials led by
Chan and U.N. Secretary General Ban Ki-moon asked vaccine makers to save a
portion of their production for poor countries. Chan was aiming to get 10
percent of the global pandemic vaccine supply reserved for poor nations.
Some companies have agreed
to help. GlaxoSmithKline PLC offered to donate 50 million doses of pandemic
vaccine to WHO for distribution to developing countries.
During the bird flu
crisis, Sanofi-Aventis promised WHO about 60 million doses based on the H5N1
strain. WHO is now talking with Sanofi to switch some or all of those vaccines
over to swine flu doses.
Because more than 95
percent of flu vaccines are still made in eggs, the Novartis announcement is
unlikely to significantly boost the world's pandemic vaccine supply.
But the news pushed up
Novartis shares by 4 percent to 44.82 Swiss francs ($41.56) on the
WHO and nongovernment
organizations like Oxfam are continuing to ask drugmakers to make some of their
pandemic vaccines available for poorer countries at a cheaper price, as well as
asking donor countries and organizations to pay for the doses.
But in a pandemic
situation, WHO's attempts to secure vaccine for the poor and even the contracts
countries have signed with drugmakers may make little difference to who actually
gets the vaccine, some experts say.
In previous pandemics,
vaccines have never left the country where they are made before all of that
country's own needs have been met.
"WHO can say whatever
it wishes, but pharmaceutical companies will take their marching orders from the
politicians," said David Fedson, a vaccines expert and former professor of
medicine at the
"Do you think any
doses of vaccine made in France,
Ultimately, Fedson said
health officials and politicians will have to deal with a limited amount of
vaccine for the billions worldwide who want it. "There's a lot of dirtiness
in vaccine politics," he said. "We may try our best, but we won't
succeed in doing what's necessary."
On Sunday June 7, 2009
Beacon Biotechnology is
seeking funding to broaden tests of the device, a disposable computer chip about
the size of a pencil erase. The company says the chip can use a single drop of
body fluid to detect up to 112 diseases or genetic conditions in as little as 15
minutes.
Biotechnology entrepreneur
Fred Mitchell says he wants to raise about $8 million to expand tests of the
chip so that he can seek federal approval for marketing.
If successful, Beacon will
join the competitive ranks of biotech companies with products that allow doctors
to speed diagnoses.
"The ability to
diagnose something quickly and treat it, or reassure patients that they don't
have something, is a big benefit," said Michelle Barron, an assistant
professor in the infectious-disease division at the
"As a society, we
want an answer now, not two days from now," Barron told The Denver Post.
"Medicine doesn't always work that way, but it's a good goal."
Mitchell said that in a
recent test, Beacon's "BrightSpot" device accurately detected an
HIV-positive blood sample in 13 minutes, compared to a commercially available
unit that took three hours.
Beacon, launched in late
2006, has raised just under $1 million from investors. Like most biotech
companies, Beacon's funding has slowed considerably in the past year in concert
with the weakening economy.
Still, Mitchell is seeking
about $8 million in venture capital and licensing fees -- an amount that would
enable the firm to bring a highly sensitive quick-test unit to market by 2011
that could detect swine flu and other strains.