News (Updated March 26, 2006)
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Thu Mar 23, 1:54 PM ET
Behavioral problems and lower than average scores on tests measuring development and intellectual capacity are common in HIV-infected children, according to a report in the journal Pediatrics.
HIV-infected children are at high risk for developing neurological and neurodevelopmental impairments, the authors explain, but the effect of HIV infection on specific behavioral issues is poorly understood.
Dr. Molly L. Nozyce from the Bronx Lebanon Hospital Center, New York and colleagues characterized the behavioral and intellectual profiles of 274 children with stable HIV infection previously treated with antiretroviral drugs.
The children scored significantly lower than the average score of 100 in the general population on intellectual evaluations, the authors report.
The results from the Conners' Parent Rating Scale (CPRS) indicated that 16 percent of the children had a conduct problem, 25 percent had a learning problem, 28 percent were psychosomatic, 19 percent were impulsive-hyperactive, 8 percent had an anxiety problem, and 20 percent had attention deficit with hyperactive disorder (ADHD).
The authors note that the prevalence of ADHD in the general population, according to the American Psychiatric Association, is 3 percent to 5 percent.
Anxiety problems were more likely among children over 9 years of age, the results indicate, but children who lived with their biological parents were less likely to have conduct problems, learning problems or hyperactivity.
Children with CD4 counts below 660 cells per microliter, white blood cells used to follow the loss of immune function, were more likely to have conduct problems than were children with higher CD4 counts, the researchers note. Children with higher IQ scores were less likely to have learning problems or behaviors associated with ADHD.
There were no gender differences for any of the behavioral parameters evaluated, the investigators observe, and there were no significant correlations between behavioral problems and neuroimaging results.
The source of behavioral abnormalities in HIV-positive children "is likely to be multifactorial, including factors such as prenatal drug exposure, difficult family environment, level of maternal education, changes in caregivers, exposure to lead, nutrition and poverty," the researchers suggest.
"As therapies improve and children live longer, studies such as ours will help raise awareness and promote the development of therapeutic interventions designed to improve learning and behavior in this population of children," the authors conclude.
SOURCE: Pediatrics, March 2006.
Tue Mar 21, 2006 04:52 PM ET
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As reported in the journal PLoS Medicine, Dr. Rebecca F. Baggaley, and colleagues from Imperial College London, constructed a mathematical model of HIV spread in developing countries that incorporated ART use and stratified infection by stages. In addition, the impact of ART was assessed in the context of various scenarios, such as the provision of laboratories to measure CD4+ cell counts and viral load, two tests that gauge the progression of HIV infection.
The researchers assumed that ART consisted of a standard three-drug regimen, with no "salvage" therapy available for those who experienced treatment failure. They also assumed that all sexual intercourse was heterosexual and that risk-taking behavior changed among some HIV-infected patients upon initiating ART.
Based on these and other parameters, the analysis showed that regardless of availability, the use of ART for AIDS patients had little impact on averting infections.
By contrast, the widespread coverage of ART for HIV-infected patients who have not progressed to AIDS did seem to avert HIV infections, but the absolute magnitude of this effect was small, the report indicates.
For all HIV-infected patients, increasing ART availability was associated with increases in drug resistance, the authors report.
"Our analysis found that ART cannot be seen as a direct transmission prevention measure, regardless of the degree of coverage," the researchers write. "Counseling of patients to promote safe sexual practices is essential and must aim to effect long-term change."
SOURCE: PLoS Medicine, April 2006.
Thu Mar 23, 2006 10:30 AM ET
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The group, which is the world's largest producer of AIDS treatments, said on Thursday that radio frequency identification (RFID) tags would be placed on all bottles of Trizivir shipped in the United States.
The tagged bottles of Trizivir -- a three-in-one combination pill -- will begin appearing on pharmacists' shelves in mid-April.
The move is being treated as a pilot project but it could lead to broader adoption of the technology in the next few years.
"There is potential for it to move to other parts of the world but I think we are going to see how it goes the U.S. first," a company spokeswoman said.
Drug firms have been researching RFID technology for several years in a bid to tackle a growing wave of counterfeiting, which the World Health Organisation last month estimated accounted for 10 percent of the global medicines market.
Its adoption has proved slower than some experts initially predicted, however, partly because of costs.
Pfizer became the first drug maker to use RFID on a large scale, when it started tagging shipments of Viagra -- one of the world's most counterfeited medicines -- in January.
Radio tags have also been used on a smaller scale for shipments of opioid drugs, which are often targeted by criminals for diversion into the illegal market.
RFID uses a tiny silicon chip and antenna about the size of a postage stamp that is attached to each bottle of medicine, transmitting a unique code.
The code can be read by wholesalers and pharmacists with special scanners, allowing tight monitoring of drugs as they move through the supply chain.
Thu Mar 23, 2006 03:12 PM ET
By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - Years ahead of having a new product, a foundation set up to develop a tuberculosis vaccine opened its first factory on Thursday.
The Aeras Global TB Vaccine Foundation cut the tape on a research and production facility in Rockville, Maryland, that Chief Executive Officer Dr. Jerald Sadoff predicts will be able to produce 150 million doses of vaccine a year -- perhaps eventually 300 million a year.
Sadoff is not disturbed that there actually is no modern tuberculosis vaccine yet.
"We are going to be using it for making replacement BCG for the world," said Sadoff, a former Merck and Co. vaccine executive, describing the Bacille Calmette-Guerin vaccine which has "been around for 80 years."
"It sort of works but it doesn't really work very well," Sadoff said in an interview.
"One of the things we think we can do is replace this very old vaccine with a modern vaccine using some modern technology."
The World Health Organization estimates that 2 billion people, one-third of everybody alive, are infected with tuberculosis. Of these, about 8 million become ill every year and 1.75 million die.
TB is the biggest killer of people with HIV, causing about 13 percent of AIDS deaths. The HIV pandemic has caused a resurgence in TB, which thrives in people with weak immune systems.
BEST HOPE FOR CONTROL
Intensive use of antibiotic cocktails for weeks on end can cure TB, but experts say a vaccine has better hope of controlling the bacterial-caused disease.
"Vaccination with BCG still remains the standard for TB prevention in most countries because of its efficacy in preventing life-threatening forms of TB in infants and young children, and also because it is the only vaccine available, is inexpensive, and requires only one encounter with the baby," WHO says in a statement on its Web site, http://www.who.int.
While a new TB vaccine is still 7 to 10 years away, the nonprofit Aeras wants to hit the ground running with an $80 million grant from the Bill and Melinda Gates Foundation.
It also has projects going with Dutch biotechnology company Crucell NV, Denmark's Statens Serum Institut, the University of Cape Town in South Africa, GlaxoSmithKline and others.
"In private industry you really have to start building your factory early so there is no gap between time regulatory agencies allow you to sell it and the time you go to market," Sadoff said.
"You need to be able to do your clinical trials with a final product. So we can have all that ready."
Aeras has been running human, clinical trials since 2004 with rBCG30, a jazzed-up version of the original BCG vaccine.
The BCG vaccine used a weakened version of M. bovis, the cattle version of Mycobacterium tuberculosis, which causes most cases of human TB.
For its interim vaccine, Aeras genetically engineered the BCG bacteria to secrete large amounts of a protein of M. tuberculosis.
QUICKEST DELIVERY
"With more than 4,700 people dying every day from TB, the world needs an effective TB vaccine as soon as possible," Sadoff said. "This new facility can deliver a TB vaccine to the world as soon as one is available."
Aeras is working on newer technology using Shigella, a bacteria that causes diarrhea. The new vaccine weakens Shigella so it does not cause illness, but instead delivers a tiny nanoparticle containing genetic material from M. tuberculosis. Like BCG, it would be an oral vaccine, Sadoff said.
A vaccine plant on U.S. soil, like the Aeras facility, is a rare thing. Corporate vaccine makers have been fleeing the U.S. market, citing difficult regulations, fear of lawsuits and low profits. Nearly all U.S. vaccines are made in factories in other countries.
Sadoff said the plant could be adapted to make other types of vaccines if needed.
"We are confident this technology can be applied to just about any important vaccine -- such as malaria, HIV and flu and biodefense ones," he said.
He is not afraid of competition.
"For TB there just is not a market, let's face it," Sadoff said.
"Even though it is the world's most widely used vaccine, the market is small compared to a new HPV virus (a vaccine against cervical cancer) or rotavirus (a vaccine against a common cause of fatal childhood diarrhea) or pneumococcal conjugate vaccine."
Such vaccines can earn tens of millions of dollars for their makers.