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January 24, 2010)
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ScienceDaily (Jan. 21,
2010) — Circumcising newborn boys as a way to prevent HIV infection in later
life is more cost-effective than circumcising adult males, finds a new Rwandan
study in PLoS Medicine.
It has already been
conclusively shown, from three randomized clinical trials in
But performing the
operation in adolescents and adults is linked with a higher risk of
complications than circumcising newborns. And the operation is quicker and
simpler to perform in newborns. The new study, by Agnes Binagwaho (Rwanda
Ministry of Health) and colleagues, therefore set out to compare three different
strategies as applied to
The researchers used a
technique called "cost-effective analysis," which looks at the balance
between the costs of a medical intervention and its benefits. They estimated
that each neonatal MC would cost just US$15 whereas each adolescent or adult MC
would cost US$59. They found that neonatal MC would in fact save more money than
it costs, because the operation is cheap to perform and would prevent HIV
infections that are expensive to treat.
The study findings, say
the authors, "suggest that
In an expert commentary on
the new study, Seth Kalichman (
Story Source:
Adapted from materials
provided by Public Library of Science, via EurekAlert!, a service of AAAS.
Journal References:
Binagwaho A, Pegurri E,
Muita J, Bertozzi S. Male Circumcision at Different Ages in Rwanda: A
Cost-Effectiveness Study. PLoS Medicine, 2010; 7 (1): e1000211 DOI:
10.1371/journal.pmed.1000211
Kalichman SC. Neonatal
Circumcision for HIV Prevention: Cost, Culture, and Behavioral Considerations.
PLoS Medicine, 2010; 7 (1): e1000219 DOI: 10.1371/journal.pmed.1000219
ANI, 22 January 2010
HIV infection and its
treatments are leading to premature aging of human brains, say researchers.
The study led by researchers from Washington University School of Medicine in
"The graying of the AIDS patient community makes this infection's effects
on the brain a significant source of concern," said first author Dr Beau
Ances, assistant professor of neurology at
"Patients are surviving into their senior years, and a number of them are
coming forward to express concerns about problems they're having with memory and
other cognitive functions.
"We believe the virus crosses into the brain using infected immune
cells.”Once in the brain, HIV doesn't directly infect neurons but instead
affects supporting cells that can release immune factors that harm
neurons," Ances added.
During the study, researchers used magnetic resonance imaging scanners and a new
technique known as arterial spin labeling that allows precise, non-invasive
blood flow measurement.
They recruited 26 subjects with HIV and 25 uninfected controls. When individuals
were resting in the scanner, brain blood flow values were significantly reduced
in subjects with HIV compared to uninfected controls.
These reductions decreased brain blood flow to levels roughly equivalent to
readings seen for uninfected individuals 15 to 20 years older.
When scientists asked participants to perform a visual task, which normally
triggers an increase in blood flow to particular regions of the brain involved
in the task, participants with HIV had greater blood flow increases, suggesting
the brain and its support systems had to work harder to get the task done.
"Brain blood flow levels decline naturally as we age, but HIV, the
medications we use to control it or some combination of the two appear to be
accelerating this process independent of aging," Ances added.
The study appears online in The Journal of Infectious Diseases .
Subtle changes in the
immune system soon after infection with HIV have an impact on long-term
prognosis, investigators from the
“Immunologic disturbances…are established early in HIV infection and are
observed even among subjects with relatively preserved CD4 cell counts”, write
the investigators, who also note that “the magnitude of these disturbances
correlate with progression.”
HIV is traditionally viewed as a slow and progressive illness. However, the rate
of disease progression can vary between individuals.
CD4 cell count and viral load are the main measurements used to decide when a
patient should start HIV treatment. Most guidelines recommend that treatment
should be started when a patient has a CD4 cell count of around 350 cells/mm3.
However, there is still uncertainty about the best time to initiate
antiretroviral therapy, and identifying patients most likely to benefit from
earlier initiation of treatment could help reduce levels of HIV-related illness
and death.
Soon after infection, HIV causes massive destruction of CD4 and CD8 memory
cells. Investigators wished to see if there was a relationship between levels of
such cells soon after infection with HIV and progression to AIDS or death. They
also assessed the role of immune activation, levels of naive CD4 and CD8 cells,
and levels of cell-associated viral load on outcome.
The study population comprised 466
The patients had a median age of 26 (range, 18 to 53), most were men (94%), and
were racially diverse (50% white; 39% African American; 6% Hispanic; 5% other).
At this time, median CD4 cell count was 552 cells/mm3, with median viral load
being 4.2 log10. The median duration of follow-up was four years, during which
time 135 individuals developed an AIDS-defining illness or died.
The investigators found that there was no relationship between disease
progression and either the number or proportion of CD4 and CD8 memory cells.
However, they found a number of other measures were strongly associated with
disease progression.
Patients who had higher levels of naive CD8 cells were significantly less likely
to progress to AIDS or die, even after taking into account CD4 cell count (p =
0.03). “These data are in agreement with findings in chronic infection and
suggest that individuals capable of maintaining naive cells after the earliest
stages of infection have a lower risk of AIDS”, comment the investigators.
Survival of CD8 memory cells, which was assessed by monitoring a marker called
CD127, was also shown to be associated with a better prognosis (p < 0.003).
The influence of immune activation on disease progression was also assessed.
This was done by monitoring the Ki-67 marker in CD4 and CD8 cells. Individuals
with the highest levels of this marker in both CD4 (p = 0.009) and CD8 cells (p
= 0.037) had a significantly increased risk of developing AIDS or dying.
“Early levels of immune activation may set the stage for future disease”,
comment the authors.
Most of the cells infected by HIV during the early stage of infection with the
virus die. However, a small number of cells survive and these carry HIV’s DNA.
The investigators carried out tests to see if levels of cell-associated HIV had
an impact on prognosis. Patients with higher levels of cells that carried
HIV’s DNA in the period shortly after seroconversion had significantly faster
disease progression. This remained the case even after adjusting for other
factors associated with prognosis, such as CD4 cell count, viral load and age (p
= 0.027).
“We performed a detailed evaluation of T cells and cell-associated viral load
in a large, well-characterized cohort with long-term follow-up. The strength of
this study is the comprehensive evaluation of T cells at early time points after
seroconversion, with a large number of end points”, write the investigators.
The investigators recommend that markers of HIV proliferation and immune
activation should be assessed “to identify subjects most at risk of
progression and likely to benefit from early therapeutic intervention.”
HIV treatment can have a positive impact on the immunologic and virologic
parameters assessed in the study. The investigators therefore conclude, “our
data indirectly support early initiation of therapy.”
Reference
Ganesan A et al. Immunologic and virologic events in early infection predict
subsequent rate of progression. J Infect Dis 201 (online edition), 2009.
Scientists have observed a
rise in the number of HIV/AIDS cases among adults 50 and older over the course
of the epidemic.
Diane Zablotsky, UNC Charlotte Associate Professor of Sociology, pointed out
that "historically when you looked at AIDS diagnoses people 50 and older
accounted for 10 percent of all diagnoses", and the number was up to 12.5
by 2007 in
Zablotsky laid the blame behind the upsurge on the lack of talk about HIV/AIDS
prevention and transmission.
Zablotsky, in an analysis of National Health Interview data, discovered that
almost half of women over age 50 were totally uninformed about HIV, compared
with only 14 percent of younger adults.
While working at the National Institutes of Aging, Zablotsky published one of
the first papers on the issue.
She said: "When I first started my work, when we were trying to explore the
situation with HIV generally, our first approach was to alert people that this
[HIV/AIDS] was something that people across the life course need to know about.
She added: "What we need to talk about is how you make choices to stay
well."
Source-ANI
• Shift in expectations
over health in developing world
• Critics say GSK hopes for profits in future years
No other big
pharmaceutical companies have moved to join GSK's patent pool for neglected
tropical diseases, such as malaria. Photograph: PA
Few who hear him doubt
Andrew Witty's desire to improve health in the developing world is sincere. But
critics of GlaxoSmithKline's chief executive point out that his moves to reduce
the price of medicine in poor countries have cost Britain's biggest drug company
little, and that there may be benefits in future years from business in emerging
markets.
What GSK has done is shift
pharma's agenda. Even if other companies will not join in with its patent pool,
declining to allow scientists to explore their patented compounds to see if any
could become treatments for neglected diseases, the entire industry has to deal
with changing expectations. Witty talks of duties and responsibilities for drug
companies who have been lambasted for an uncaring pursuit of profits and tarred
with their attempt to use the courts to block access to cheap medicines for Aids
in
Witty's original proposals
dropped out of the blue last February. They involved price cuts for drugs in the
poorest countries and a promise to reinvest in the local economy 20% of any
profits GSK made there. He made no secret of the small amounts of money involved
– GSK's total profits are not more than about £5m in the least developed
countries (LDCs) where few can afford their drugs. The amount ploughed back into
local projects will be about £1.5m for the last year. Only small change for GSK,
but, says Witty: "Small change in
The move which was the
most significant was the announcement that GSK would form a patent pool for
neglected tropical diseases, such as malaria, sleeping sickness and river
blindness. The company duly listed all its patented compounds that might
possibly be useful in the search for new treatments and invited researchers to
investigate them.
Witty said he hoped other
companies would join in. One biotech did, but none of the big pharmaceutical
companies have shown any interest. Nor did scientists queue up to investigate
the compounds in the pool.
Dr Bernard Pécoul,
executive director of the Drugs for Neglected Diseases Initiative, said he was
not surprised. "They consulted us. We said the patent pool isn't enough.
You also need to share the knowledge you have [of these compounds]," he
said. GSK took note. The patent pool has become a "knowledge pool".
And a fund of $8m has been set up to support scientists with ideas from around
the world who would like to go to GSK's tropical disease research labs in Tres
Cantos,
If GSK thought its patent
pool for neglected diseases would get it off the hook when it comes to its
patents on HIV drugs, it was wrong. Oxfam was just one of the organisations that
took the opportunity today to return to the HIV argument.
"GSK today took
welcome steps to improve research and development for diseases neglected by
large pharmaceutical firms," said Dr Mohga Kamal-Yanni, senior health
policy adviser.
"But the company is
still dragging its feet on a more pressing problem – the lack of affordable
and effective medicines for people with drug-resistant HIV. Lives are at risk
because of a lack of reasonably-priced second-generation anti-retrovirals and
lack of children's medicines. GSK is standing in the way of a solution by
failing to join Unitaid's patent pool which is designed to improve access to
effective affordable medicines."
The nub of the problem –
and the reason why Witty's innovations launched a year ago have not borne more
fruit – is that pharma companies don't talk to each other, let alone
collaborate. They compete. Witty may invite other companies to join a patent
pool for neglected diseases – where none of them stand to make any money
because only poor people get them – but he is reluctant to join a patent pool
for HIV drugs which are highly lucrative in the wealthy world.
Nonetheless, his attitude
seems more placatory than it was. GSK is now talking seriously with Unitaid, the
organisation formed by donor governments including the
GSK, says Pécoul, is more
innovative than others. "They are trying to propose something a little bit
different." But other big companies are moving too.
"I feel like we've
made progress. We have forever moved GSK forward and into a different place in
the way we think about the developing world and the LDCs," said Witty.
By Ransdell Pierson
Ransdell Pierson Wed Jan 20, 12:05 am ET
"(Its) sales in
dollars will be a very small number," Glaxo Chief Executive Officer Andrew
Witty said of the product during an interview with journalists in
Glaxo will likely derive a
"small 5 percent return" on the product -- enough to help encourage
other drugmakers to continue their own research against diseases in least
developed countries that remain big killers, he said.
"We must ... ensure
that we do not do anything which would discourage other companies from entering
into this field," Witty said. "If we set a precedent of not-for-profit
(pricing), we could discourage others from doing research into malaria or other
neglected tropical diseases."
Witty said the vaccine,
called Mosquirix, is expected in 2011 to complete late-stage trials involving
16,000 people. If proven safe and effective, and approved by regulators, it
would be the first vaccine to protect against infection with mosquito-borne
parasites that cause malaria in
Glaxo last year said it
would grant researchers in developing countries access to 800 related patents
and patent applications -- known as a 'patent pool' -- related to tropical
diseases.
He said the company will
likely be inclined at some point to also allow researchers access to patents
involving possible treatments for HIV - the virus that causes AIDS, which has
taken an especially heavy toll in
"We want to be part
of constructive engagement to see if we can work through the details,"
Witty said, referring to a possible HIV-drug patent pool.
In the meantime, Witty
said Glaxo has already granted eight voluntary licenses in Africa that allow
others to produce generic forms of the company's HIV treatments without paying
royalties to the London-based drugmaker.
"Last year, those
people who took those licenses from us actually manufactured and delivered into
least developed countries four times more product than we did," Witty said.
Witty spoke to reporters
ahead of a planned speech on Wednesday to the Council on Foreign Relations in
(Reporting by Ransdell
Pierson; editing by Carol Bishopric)
Wed, Jan 20 2010
* Merck says will not seek
drug approval "at this time"
* HIV drug proves
ineffective in two late-stage studies
* Trial involved patients
previously treated for HIV
* Studies continue among
previously untreated HIV patients (Adds findings from earlier mid-stage study,
share price)
By Ransdell Pierson
NEW YORK, Jan 20 (Reuters)
- Merck & Co <MRK.N> on Wednesday said its experimental HIV treatment
vicriviroc proved ineffective in two late-stage studies involving patients who
had previously been treated with other HIV medicines.
Some industry analysts had
considered the once-daily drug, which Merck acquired through its recent $41
billion purchase of Schering-Plough Corp, to be potentially the best in a new
class of HIV treatments that block receptors to CCR5-- a protein that gives HIV
an entry way into human immune system cells.
Wall Street had expected
Merck to seek approval this year for the drug. But Merck said it now has no
plans to seek marketing approval for the product "at this time."
The trial failures were
briefly mentioned in a notice on the company's Web site, headlined
"Frequently Asked Questions and Answers."
"In two Phase III
studies in this patient population, vicriviroc did not meet the primary efficacy
endpoint," the two-paragraph notice said. It said the failed trials
enrolled a high percentage of patients who continued to take three or more other
active HIV drugs, along with vicriviroc.
A previous mid-stage trial
of the drug among treatment-experienced patients suggested it was able to
suppress the virus, and was generally well tolerated, during two years of
therapy.
Merck said it will
continue mid-stage studies of the drug among a different group of patients --
those not previously treated for HIV.
Cowen and Co had expected
vicriviroc to achieve annual sales of $75 million in 2012, growing to $150
million in 2015 -- modest sales for the second-biggest
Pfizer Inc's <PFE.N>
already approved Selzentry works by the same mechanism as vicriviroc. But its
sales have been crimped by the need for patients to take a diagnostic test that
assesses whether they have mutated strains of HIV that inhibit effectiveness of
the class of drugs.
Merck, which acquired
Schering-Plough in November, bought the company largely for its pipeline of
drugs in late stages of testing.
(AFP) – 21 January, 2010
The study showed that
people who had both HIV and the virus responsible for the most common form of
herpes, HSV-2, did not cut the chance of passing it on by taking twice-daily
doses of acyclovir.
The research published in
the New England Journal of Medicine online looked at more than 3,400 African
couples -- one of each who had HIV and one of whom did not.
There were 41 infections
amongst those who took acyclovir and 43 amongst those given a placebo, which was
not a significant difference, the study said.
Five earlier studies had
demonstrated it was possible to reduce HIV levels in the blood and genital tract
through treatment for the herpes virus, but did not show if this translated into
a reduction in HIV transmission, it said.
Up to 90 percent of people
with HIV also have an HSV-2 infection, but most people who are infected with the
herpes virus are unaware because symptoms can be mild or absent, the study said.
Several studies showed
that frequent herpes recurrences increase the amount of HIV in the blood and
genital tract, said the study led by the
The herpes virus also
attracts immune cells called CD4 T-cells to the genital region, which HIV uses
to establish or pass infection, said the study.
Copyright © 2010 AFP. All
rights reserved.