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May 16, 2010)
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May 16, 2010
Biomedical engineers at
Timing is crucial for the
newborn.
In order to be effective,
the drug, known as Nevirapine, must be given to the newborn within days of
birth. The challenge to date has been reaching distant mothers who give birth at
home. Since most mothers are not up to traveling that soon after delivery to get
medication, the biomedical engineers developed a way of providing the medication
in a simple manner and with a long shelf-life --- pouches made of foil and
plastic that can hold a single dose of Nevirapine.
“In
Gamache presented the
results of the Duke research in
While healthcare workers
in
Also, as Gamache
explained, drug manufacturers have not shown much interest in devising
single-dose systems because of development costs and limited marketing potential
outside the
“In our system, the
pharmacist can fill an individual pouch for women early in their pregnancy, and
they can take it home with them,” Gamache said. “When the baby is born, the
mother can then easily rip off the corner of the pouch and empty the drug into
the newborn’s mouth. Further treatments can be given to the baby at the clinic
or hospital later when travel becomes easier for the mother.”
The WHO estimates that
just 32 percent of infants born to HIV-positive mothers received prophylactic
antiretroviral drugs like Nevirapine, compared to 45 percent of their pregnant
mothers.
“If borne out in
upcoming clinical trials, it would be expected that the current gap in
anti-retroviral prophylaxis between mothers and their children could be reduced
with the pouch,” Malkin said. “This could be accomplished at little
additional cost and could be a significant step in creating a generation of
children free of HIV.”
The team has conducted
field testing the past year on the use of the pouches with nurses and
pharmacists in
Although the latest
studies were conducted with Nevirapine, the Duke researchers also plan to test
the system with other anti-HIV medications and combinations of medications.
The research was supported
by Duke’s Research in Practice Program and the Provost’s Common Fund. Pratt
undergraduates Michael Spohn, Shannon Skinner and Peter Horgan were also part of
the team.
May 10, 2010
Health
Researchers say the
findings raise the possibility that vaccination against the virus, known as the
human papillomavirus (HPV), could help curb the world's HIV pandemic.
The investigators found
that among 2,168 Kenyan men between the ages of 18 and 24, half tested positive
for HPV at the start of the study. Over the next 3.5 years, nearly 6 percent of
those men became infected with HIV, versus just under 4 percent of those who had
tested HPV-negative at the outset.
When the researchers
controlled for a number of HIV risk factors, men with HPV were still 80 percent
more likely than their HPV-negative counterparts to become infected with HIV,
suggesting the genital wart virus itself may boost a person's susceptibility to
HIV.
The findings are published
in the Journal of Infectious Diseases.
There are more than 100
strains of HPV, some of which cause genital and anal warts. In most people, the
immune system clears the infection fairly rapidly. However, persistent infection
with certain HPV strains can eventually lead to cancer in some cases.
Persistent HPV infection
is the primary cause of cervical cancer, and it can also lead to cancers of anus
and penis.
The current findings come
from a larger clinical trial that, along with two other trials in
In this latest study, HPV
infection itself was linked to a higher risk of acquiring HIV even when the
researchers factored in circumcision, as well as the men's reported sexual
history and whether they had the genital herpes virus -- which has already been
linked to an increased risk of HIV infection.
All of this suggests that
HPV vaccination, along with circumcision, could help stem the HIV pandemic,
according to lead researcher Dr. Jennifer S. Smith, of the
"Finding a vaccine to
prevent HIV is the greatest hope for curbing the world's AIDS pandemic, but so
far there is no such vaccine," Smith said in a written statement from the
university. "However, there is a vaccine to prevent specific types of HPV
infection, and vaccinating young men before they become sexually active could
potentially help prevent the spread of HIV."
There are two vaccines
that can prevent infection with certain cancer-related strains of HPV: Gardasil
(from Merck) and Ceravix (from GlaxoSmithKline). In the
The current findings,
according to Smith's team, warrant clinic trials to test whether HPV vaccination
can lower the risk of HIV infection.
If vaccination does prove
effective, cost could stand as a major obstacle to bringing it to developing
nations where HIV transmission rates are high. The required three doses of the
HPV vaccines cost roughly $400 in the
It's not clear why HPV
infection might increase the odds of HIV infection, but it is biologically
plausible, according to Smith's team. Skin lesions caused by HPV, for example,
might act as "portals of HIV entry," the researchers note. In
addition, HPV may induce the production of certain inflammatory proteins in the
genital area, which may in turn boost susceptibility to HIV infection.
The study was funded by
the U.S. National Institutes of Health and the Canadian Institutes of Health
Research.
SOURCE: Journal of
Infectious Diseases, June 1, 2010.
Over half of those
surveyed have patients who have tested positive for the disease
FRIDAY, May 14 (HealthDay
News) -- A new U.S. survey, touted as the first of its kind, reveals that
primary care doctors are taking over a larger share of care for people with HIV,
the virus that causes AIDS.
Fifty-four percent of
primary care doctors surveyed said they treat HIV-positive patients, and 43
percent said the number of HIV cases they treat had increased over the past
year.
Among primary care
physicians who treat HIV-positive patients, more than one-third said they see
more than 200 cases a year.
"The state of HIV
primary care is evolving rapidly, with serious implications for the health-care
system," Brian Hujdich, executive director of HealthHIV, the organization
that commissioned the report, said in a news release.
Hujdich called on more
medical education for primary care doctors so they can provide better care.
HealthHIV, located in
The report, based on a
national survey of 1,165 respondents, will be presented in July at the
International AIDS Conference in
16 May 2010
MitoSciences announces that it has just been awarded $590,000 by the National
Institutes of Health to support the development of companion diagnostic tests
for antiviral drugs. The award was made after competitive scientific review and
was issued under The American Recovery and Reinvestment Act of 2009.
The tests, developed in collaboration with the
The problem of mitochondrial toxicity is now sufficiently well-recognized that
the FDA recently released recommendations that all new antiviral drug candidates
should be screened for toxicity to mitochondria. MitoSciences' tests have been
used by multiple antiviral drug developers in their FDA submissions.
"Drug-induced mitochondrial toxicity is a problem that is receiving growing
recognition," said Jean-Paul Audette, CEO of MitoSciences. "A number
of drugs that were removed from the market are now known to inhibit
mitochondrial function, and we are working with groups at most of the world's
largest drug companies to help them include mitochondrial toxicity screening
earlier in their safety assessment programs."
MitoSciences has developed the MitoTox™ line of assays, which is the most
complete set of solutions for identifying adverse mitochondrial effects caused
by a wide range of therapeutic compounds. The MitoTox™ line of assays is
offered both as kits and also as a service through MitoSciences' CRO division.
MitoSciences is also working to validate several of the MitoTox™ assays for
use in clinical applications, such as companion diagnostics, and in this effort
is collaborating with leading clinical researchers in multiple countries.
Source
MitoSciences
16 May 2010
In the 27 years since HIV was discovered, scientists have learned a great deal
about the virus and how it causes AIDS. Making a vaccine to stop it, however,
has proved a greater challenge than anyone could have imagined. Plain good news
in this field has been a rarity. So it is with special pleasure that we note on
this World AIDS Vaccine Day, May 18, that there has been a sizeable dose of it
in the past year.
Last September, a candidate vaccine regimen tested in a large clinical trial in
Weeks prior to the release of those results, researchers at and affiliated with
the International AIDS Vaccine Initiative (IAVI) served up another advance: the
discovery of two powerful new antibodies capable of neutralizing a wide variety
of HIV variants and the identification of the site on the virus to which they
attach. This site provides researchers with a promising new model to use to
design a vaccine against AIDS. Subsequently, researchers affiliated with IAVI
and the U.S. National Institutes of Health have discovered still more broadly
neutralizing antibodies to HIV.
Of course, making a vaccine against HIV remains one of the toughest problems of
modern science.
The considerable work that lies ahead will include, first, the continued
clinical assessment of candidate AIDS vaccines. That the protective effect seen
in the Thai trial was a surprise to most researchers was instructive,
underscoring the vital importance of human testing. It is especially important
that researchers devise and test candidate HIV vaccines that are of relevance to
the developing world, particularly sub-Saharan
Second, we believe, HIV researchers must harness the latest scientific insights
and technological tools to generate potentially more promising HIV vaccine
candidates for human trials. These would include candidates designed to induce
immunity in the lining of the gut, where HIV replicates early in the course of
infection. It would include candidates that, though safe, behave more like
naturally occurring viruses and are meant to elicit more vigorous immune
responses. Perhaps most important, it would include candidates that prompt the
immune system to deploy powerful antibodies like the ones recently discovered,
which neutralize the majority of HIV variants circulating in the world.
"With 7,400 people newly infected with HIV every day, the best hope we have
of ending this human catastrophe is to develop and widely distribute effective
vaccines against the virus," said Seth Berkley, the CEO and founder of IAVI.
Success in that endeavor will depend on the continued support of policymakers,
advocates, community representatives, researchers, nongovernmental
organizations, commercial enterprises, donors and, not least, the volunteers who
participate in vaccine and related studies, seeking nothing in return for their
trouble but the satisfaction of doing their bit to rid the world of AIDS. On
this thirteenth World AIDS Vaccine Day, we at IAVI extend our heartfelt thanks
to all of these parties for their dauntless determination and tireless efforts
to make AIDS vaccines a reality.
Source
International AIDS Vaccine Initiative (IAVI)
Study of sufferers finds
mortality could double in Lothians
15 May 2010
By ADAM MORRIS
HEALTH chiefs have been
warned to prepare for a huge rise in liver deaths linked to a hepatitis C
epidemic 30 years ago.
A report studying the
health of sufferers over 15 years has found that the number dying from liver
disease could double across the Lothians.
It has caused a shock not only for the estimated 6,000 living with the illness
in the Lothians, but also for NHS bosses who may have to cope with the hike.
The paper – released by the Eurosurveillance journal and the first of its type
– also warned that
People who caught the disease in the 1970s and 1980s are now entering their
third and fourth decade living with the illness, and it has prompted calls for
more testing of the disease.
It is estimated that half the people who have been infected don't know it. Given
that it is curable in around 50 per cent of cases, it is those living in
ignorance who are in most danger.
The report warned: "Over the past 15 years we have observed an increasing
contribution from hepatitis C infection to mortality due to liver-related causes
in
"Deaths increased steadily among the 35-54 years age group, and the largest
percentage of deaths linked to the hepatitis C diagnosis database were of people
born from 1950 to 1959.
"This is consistent with infection of young people in the 1970s and 1980s
– before hepatitis C was identified – and the natural history of chronic
hepatitis C."
The illness has caught up with thousands of
The problem has become so noticeable that the Hepatitis C Trust –
traditionally an English-based charity – opened an office in
"It's actually just as cost effective for the NHS to treat someone now than
to wait until they need treated for liver disease. People at risk only need to
have injected once, or even just have had a dodgy tattoo."
Scottish agencies Health Protection Scotland and ISD Scotland were also involved
in producing the publication.
The report continued: "Hepatitis C infection constitutes a significant,
growing, public health burden in
"A better understanding of the risk factors associated with developing
hepatitis C-related liver disease will improve treatment and survival."
'Stupid mistake' that cost Petra
PETRA Wright "dabbled" briefly in drugs as a teenager, but decades
later it caught up with her.
The 56-year-old was diagnosed with hepatitis C 25 years after the
"stupid" mistake, and had long since turned her life around. Now
having battled the disease for years, she is set to embark on a course of
treatment this summer to finally rid herself of the condition.
When diagnosed she had to change her diet and give up alcohol, and even went to
work for the Hepatitis C Trust, where she is now the charity's Scottish officer.
She said: "Treatment is changing all the time and they're getting really
quite smart at it.
"There is no reason for people not to get tested if they suspect they might
have it.
"The symptoms are such that it's not always obvious, but new tests coming
in can give you the result in 20 minutes.
"There's no need for it to be a death sentence.
"I think some people maybe assume it's something you have to manage –
like HIV – rather than can simply cure."
14 May 2010
Genetic Immunity, a multi-national biopharmaceutical company developing
nanomedicine vaccines announces publication of the Company's innovative work to
develop a stable liquid formulation to deliver a novel nanomedicine. Appearing
in the International Journal of Pharmaceutics, the paper addresses how Genetic
Immunity was able to overcome significant hurdles facing the field to
successfully formulate the first topically administered nanomedicine therapeutic
vaccine for the treatment of HIV/AIDS, DermaVir.
"Biological activity of DermaVir depends upon its nanomedicine formulation
that is essential for the potent expression of plasmid-DNA-encoded antigens.
During Phase I and II clinical trials, DermaVir formulation required on-site
admixture of three separate components followed by patient administration within
three hours. We report here the development of a stable single liquid
nanomedicine formulation, a significant milestone in developing DermaVir as a
commercially viable global product to treat HIV/AIDS," commented Julianna
Lisziewicz, PhD and CEO of Genetic Immunity.
Engineering novel nanomedicines presented Genetic Immunity with challenges not
faced in the development of traditional biotechnology products. "One
challenge in clinical nanomedicine development is to produce a stable
formulation with reproducible manufacturing methods," explained Genetic
Immunity's Enikö Töke, PhD. "We found several additional quality
requirements of the components that were essential both to establish the optimal
relationship between physicochemical properties and biological activity of
DermaVir and to ensure reproducible manufacturing of a stable formulation. It
became apparent that the current state-of-the-art approaches to sourcing,
testing and manufacturing were insufficient."
Genetic Immunity implemented "Quality-by-Design" in biologic product
development to manufacture a nanomedicine resulting in a new formulation of pDNA
surrounded by a chemical polymer capable of maintaining the physical stability
and biological activity of DermaVir at 4ºC.
These discoveries will support DermaVir as it enters into Phase II/III human
trials as a topically administered nanomedicine therapeutic vaccine. "Our
Phase I trial demonstrated the preliminary safety and immunogenicity of DermaVir
in HIV-positive people treated with HAART," Lisziewicz explained. "We
have now also obtained Phase II data showing safety, immunogenicity and viral
load reductions when DermaVir is used for initial treatment of HIV-infected
individuals. This is the human proof of concept of our topical nanomedicine
vaccine technology. It is our belief that DermaVir will become the first
nanomedicine vaccine developed to reconstitute HIV-specific immunity with the
potential to maintain the health of people living with HIV infection."
Source
Genetic Immunity
14 May 2010
HIV disease tends to progress at a faster rate in infected individuals who
consume two or more alcoholic drinks a day, according to an important new paper
in AIDS Research and Human Retroviruses, a peer-reviewed journal published by
Mary Ann Liebert, Inc. The article is available free online.
The article, entitled "Alcohol Use Accelerates HIV Disease
Progression," clearly demonstrates that frequent alcohol use, defined as
two or more drinks daily, is associated with declining CD4+ cell counts (which
indicate a weakened immune system) in individuals with HIV disease who either
are or are not receiving antiretroviral therapy (ART). Based on the results of a
30-month prospective study, the authors, Marianna Baum, Carlin Rafie, Sabrina
Sales, and Adriana Campa, from Florida International University (Miami),
Shenghan Lai, from Johns Hopkins University, and John Bryan Page, from
University of Miami, Florida, conclude that alcohol has a direct effect on CD4
cells and that the accelerated decline in CD4+ cell counts in frequent alcohol
users is not simply due to poorer adherence to ART in this population.
Another article by Natascha Ching, Karin Nielsen-Saines, Jaime Deville, Lian Wei,
Eileen Garratty, and Yvonne Bryson, from the David Geffen School of Medicine at
UCLA, Los Angeles, CA, demonstrated that children who were infected with HIV
while in utero via maternal-fetal transmission, were subsequently given
antiretroviral therapy, and had no detectable HIV in their blood, still produced
neutralizing antibodies against HIV, suggesting that low levels of viral
replication might still be occurring despite drug therapy. In the article "Autologous
Neutralizing Antibody to Human Immunodeficiency Virus-1 and
Replication-Competent Virus Recovered from CD4+ T-Cell Reservoirs in Pediatric
HIV-1-Infected Patients on HAART," the authors present data to support
their conclusion that the children's CD4 T-cells may contain latent HIV
reservoirs that formed early in life before antiretroviral therapy was
initiated.
"It is important that HIV infected individuals make informed decisions
relating to alcohol consumption. This article will help to achieve that
goal," says Thomas Hope, PhD, Editor-in-Chief of AIDS Research and Human
Retroviruses and Professor of Cell and Molecular Biology at the Feinberg School
of Medicine,
Source:
Vicki Cohn
Mary Ann Liebert, Inc./Genetic Engineering News