Two
major organisations for access to AIDS medication on Monday announced new
deals with generic medicine manufacturers to reduce the price of second-line
anti-retroviral drugs.
Six new and more affordable child-friendly
formulations would also be made available under the new agreements, said the
two organisations, UNITAID and the Clinton Foundation HIV/AIDs Initiative.
Compared to prices they announced in May last year,
the reduction would be as much as 19 percent for the most frequently used
second-line treatment such as tenofovir, lamivudine and lopinavir/ritonavir.
The latest prices for a second-line regimen involving
all three drugs are 16 percent lower than the average price in low-income
countries and 46 percent lower than in middle-income countries.
Second-line treatments are necessary for patients who
have developed a resistance to first-line treatments.
They currently cost 5-10 times more than a first-line
therapy in a low-income country, thereby limiting access for many patients
in these countries.
Almost 500,000 patients will need such medication by
2010, according to the two organisations.
UNITAID, a UN-backed drugs funding initiative, also
announced the extension of its pediatric project, with six new formulations
which are more child-friendly.
"Today's announcement is an important step in
helping to save the millions of children and adults infected with HIV in the
developing world who still lack access to life-saving drugs," said
former United States President Bill Clinton, who launched the foundation.
UNITAID's Executive Board chairman Philippe
Douste-Blazy added: "This achievement represents a major step in our
partnership to provide more treatments to hundreds of thousands of children
through 2010 and to continue to lower the price of second-line
treatment."
GENEVA (AP) -- A U.N.-backed fund says it is on target to
provide treatment to 250,000 children with HIV/AIDS by the end of the year.
Geneva-based UNITAID says this is an increase of about
100,000 compared to 2007. The organization supplies low-cost drugs to the
developing world.
The fund said in a statement Monday that the increase is
the result of pharmaceutical companies agreeing to lower prices and provide
new drug combinations to treat more difficult forms of AIDS.
UNITAID receives money from a tax imposed by some
countries on airline tickets. It also cooperates with a charitable foundation
set up by former U.S. President Bill Clinton.
The World Health Organization estimates that 2.1 million
people die from AIDS-related illnesses each year.
NEW YORK (Reuters Health) - Among patients infected with
HIV, the virus that causes AIDS, initiating antiretroviral therapy, there are
significant differences in specific adverse events according to sex and race,
but not in the overall rate of adverse events, death from any cause, or
treatment withdrawal rates because of drug toxicity, new research indicates.
Published data on the rate and types of adverse events by
sex and race are limited, note researchers in the Journal of Acquired Immune
Deficiency Syndromes.
Dr. Ellen M. Tedaldi from Temple University School of
Medicine, Philadelphia, and colleagues compared the frequency and types of side
effects by sex and race in 1,301 patients in an antiretroviral therapy (ART)
initiation trial, including 701 blacks, 225 Latinos and 273 women.
During an average follow-up of 5 years, there were 409
grade 4 adverse events -- a rate of 8.9 per person per 100 years. Rated on a
scale of 1 to 4, an adverse event of grade 4 is the most severe.
There were 176 deaths -- a rate of 3.0 per person per 100
years; and 523 ART discontinuations for any toxicity -- a rate of 13 per person
per 100 years.
Compared with white patients or patients of any other
race, cardiovascular and kidney adverse events were 2.64- and 3.83-times more
frequent, respectively, in black patients. This finding is consistent with the
greater rates of heart disease, diabetes, and kidney disease found in the
general black population, the investigators point out.
Rates of serious psychiatric events were 2.45-times higher
in black men than in men of other races. "It is likely that grade 4
psychiatric adverse events represent a constellation of factors that include
psychosocial and biologic associations," Tedaldi and colleagues suggest.
For example, this may reflect undiagnosed mental illness or the central nervous
system effects of HIV infection.
They also found that women had a 2.34-fold greater risk of
grade 4 anemia compared with men, which was "not unexpected" given
that the women were predominantly premenopausal and African American.
"Use of these results could inform HIV treating
clinicians about particular issues to consider in the selection of
antiretroviral regimens for diverse populations," the clinicians conclude.
SOURCE: Journal of Acquired Immune Deficiency Syndromes,
April 1, 2008.
CHICAGO, April 30 (Reuters) - A new process to extract
and copy the essential elements of cells that make human antibodies has
provided a shortcut to making targeted, infection-fighting proteins known as
monoclonal antibodies, U.S. researchers said on Wednesday.
The process allowed them to make influenza-specific
antibodies in as little as a month, and they said the discovery could lead new
treatments for other infectious diseases such as hepatitis C, pneumococcal
pneumonia or anthrax.
It could even be used in an influenza pandemic to
protect health workers until a vaccine could be made, they said.
"With just a few tablespoons of blood, we can now
rapidly generate human antibodies that can be used for immunization, diagnosis
and treatment of newly emerging strains of influenza," said Patrick
Wilson, an immunology researcher at the Oklahoma Medical Research Foundation,
whose study appears in the journal Nature.
"In the face of a disease outbreak, the ability to
quickly produce infection-fighting human monoclonal antibodies would be
invaluable," Wilson said in a statement.
Antibodies are immune system proteins that recognize and
help orchestrate an immune attack on bacteria, viruses and parasites.
Monoclonal antibodies are specially engineered to attack a certain protein.
But making them is laborious, involving sifting through
white blood cells known as B cells to find the needed antibody or vaccinating
mice and altering their antibodies to look like human antibodies. It can take
years.
"A better approach would be to have a way to very
quickly generate monoclonal antibodies at a very high efficiency," Wilson
said in a telephone interview.
He said they had succeeded in doing so.
"We can go from vaccine to antibody in just a
month. That is the surprise," Wilson said.
'BURST OF CELLS'
To make the antibodies, the researchers vaccinated
volunteers against seasonal flu. Then they examined a type of immune system
cell known as antibody-secreting plasma cells, which produce a surge of
antibodies as part of an initial response to infection.
Wilson and colleagues were able to capture and purify
these cells, and they found as many as 80 percent of these purified antibodies
were flu-specific.
He said the finding could lead to emergency treatments
for a pandemic influenza, or to treat people with seasonal flu.
"We now can take these cells and quickly go to
antibodies," said Wilson, who worked on the project with scientists at
Emory University in Atlanta.
While it has not yet been tested against potential
pandemic strains of influenza, such as the H5N1 strain that causes bird flu,
those studies are underway, Wilson said.
The process also could be used to make antibodies for
hepatitis C or antibiotic-resistant infections or even for human
immunodeficiency virus or HIV, the virus that causes AIDS.
And the method could be used to generate fully human
monoclonal antibodies for cancer and immune disease treatments such as
Genentech Inc's <DNA.N> breast cancer drug Herceptin and Johnson &
Johnson's <JNJ.N> Remicade for rheumatoid arthritis and other immune
diseases.
There are more than 20 monoclonal antibody-based
therapies approved in the United States, and hundreds more are in development.
Most are made from mouse antibodies, which can cause an allergic reaction in
some people.
"It allows the world to have a new opportunity to
generate many antibodies to many different things," Wilson said. (Editing
by Maggie Fox and Xavier Briand)
WASHINGTON (Reuters) - A new type of treatment that trains
immune system cells to better recognize the AIDS virus may help control the
deadly and incurable infection, Australian researchers reported on Friday.
Tests on monkeys infected with a similar virus shows the
treatment controlled the infection, although it does not cure it, and tests are
already planned in people.
The treatment is called OPAL, for Overlapping
Peptide-pulsed Autologous Cells, and would be categorized as an immunotherapy
technique, or a so-called therapeutic vaccine, Stephen Kent of the University of
Melbourne and colleagues said.
Writing in the Public Library of Science journal PLoS
Pathogens, they said the treatment involves mixing a patient's own blood cells
with tiny bits of protein from the virus.
These cells are then re-infused into the patient.
"Levels of virus in vaccinated monkeys were 10-fold
lower than in controls, and this was durable for over one year after the initial
vaccinations," they wrote.
"The immunotherapy resulted in fewer deaths from
AIDS. We conclude this is a promising immunotherapy technique. Trials in
HIV-infected humans of OPAL therapy are planned."
The AIDS virus infects more than 33 million people
globally and has killed 25 million since it was identified in the 1980s.
While there is no cure and no vaccine, cocktails of drugs
can control the virus. But they have side-effects, are expensive and eventually
often stop working.
Kent's team took small bits of the virus called peptides
and placed them in lab dishes with both whole blood and isolated immune system
cells.
This helped train the cells to recognize the virus and
attack it more effectively, they wrote in the paper, freely available here
The macaque monkeys were infected with a related virus
called SIV or simian immunodeficiency virus.
HIV is tricky to treat because it attacks the immune
system. It specifically goes after immune cells called CD4 T cells, the very
cells that are supposed to attack and kill viruses.
"Virus-specific CD4 T cells are typically very weak
in HIV-infected humans or SIV-infected macaques; dramatic enhancement of these
cells were induced by OPAL immunotherapy and this may underlie its
efficacy," they wrote.
The treatment appears to work best if started right after
someone becomes infected.
"Although it may be challenging to identify humans
within three weeks of infection, this is when HIV-1 subjects typically present
(show up at a doctors office) with acute infection," they wrote.
Two
major organisations for access to AIDS medication on Monday announced new
deals with generic medicine manufacturers to reduce the price of second-line
anti-retroviral drugs.