Calling For Increased Research In Flu Transmission To Prepare For Pandemic Flu Outbreak

Researchers at Rhode Island Hospital have completed a study to better understand the impact of infection control measures during a possible flu pandemic. Their study focused on the likelihood of the transmission of flu from individuals showing no symptoms (asymptomatic) or from individuals who are infected but have not yet exhibited symptoms. The researchers call on the scientific community to better understand the transmission of influenza in order to provide guidelines for effective pandemic flu planning. Their findings are published in the March-April 2009 edition of Public Health Reports.

The study, from Rhode Island Hospital’s department of epidemiology and infection control and the division of infectious diseases, notes that public health measures for controlling outbreaks involve isolation of symptomatic individuals and the quarantine of individuals with whom they have had contact. This intervention is dependent upon early identification of symptoms, and the success of the intervention can be limited by transmission that occurs prior to symptom onset and transmission from asymptomatic infection.

Senior author Leonard Mermel, DO, ScM, medical director of the department of epidemiology and infection control at Rhode Island Hospital, along with Eleni Patrozou, MD, performed a systematic review of literature on viral shedding and disease transmission. The review included animal studies, human studies, inoculation experiments, vaccine and antiviral drug efficacy studies, and observations during outbreaks.

Mermel says, „Our findings indicate that pre-symptomatic transmission of influenza has been inferred based on the presence of the virus in the upper respiratory tract rather than from the appropriate transmission experiments. This is troubling because our review of the literature does not support significant influenza transmission based on positive nasopharyngeal cultures in the absence of symptoms.“

Their findings also indicate that small-particle aerosols expelled from infected individuals may play a greater role in influenza transmission than previously recognized. The problem, however, is that it remains unclear as to how many of these droplets are generated by asymptomatic or pre-symptomatic individuals.

Mermel adds, „Asymptomatic individuals may shed influenza virus, but studies have not conclusively determined if these individuals effectively transmit influenza to others. Our review of the literature suggests that the role of asymptomatic or pre-symptomatic influenza-infected individuals in disease transmission may have been overestimated in recent articles that have served as the basis for national and international pandemic planning.“

He concludes, „Based on the historical record over the last century, we must be prepared for another pandemic. Our research tells us that a better understanding of transmission dynamics is essential if we are to develop effective influenza pandemic plans.“

###

Founded in 1863, Rhode Island Hospital (rhodeislandhospital) in Providence, RI, is a private, not-for-profit hospital and is the largest teaching hospital of The Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, emergency medicine and trauma, neuroscience, orthopedics, pediatrics, radiation oncology and surgery. Rhode Island Hospital ranks among the country’s leading independent hospitals that receive funding from the National Institutes of Health (NIH), with NIH research awards of nearly $27 million annually and nearly $46 million in total. It is home to Hasbro Children’s Hospital, the state’s only facility dedicated to pediatric care. Rhode Island Hospital is a founding member of the Lifespan health system.

Source: Nancy Cawley

Lifespan

CDC Recommendations For Routine HIV Testing Largely Ignored

Despite national guidelines issued by the US Centers for Disease Control and Prevention recommending that all Americans aged 13 to 64 be
routinely tested in all healthcare settings, private, federal and state organizations have largely failed to do so.

This was the main theme of a national summit held this week in Arlington, Virginia, called the Forum for Collaborative HIV Research where 300
leading HIV researchers, policymakers and healthcare providers met to discuss new advances and barriers to routine HIV testing.

Many working in the field believe routine HIV testing is the key to slowing down the epidemic in the US where there are more than 1.1 million
Americans living with HIV.

Last year nearly 60,000 people were infected with HIV in the US, where 50 to 70 per cent of new sexually transmitted infections are spread by
Americans who don’t realize they are infected, said a statement issued by the Forum for Collaborative HIV Research.

Director of the Forum, Dr Veronica Miller said:

„Two years after the CDC recommended routine testing, initial successes show its potentially powerful impact, but major barriers keep it from being
the national norm.“

„With HIV, ignorance is not bliss“ said Miller, explaining that people who don’t realize they are infected are three times more likely to pass on
HIV.

Conference co-chair and Director of the Brown University AIDS Program, Dr Ken Mayer said:

„The healthcare system is routinely missing critical opportunities to identify and treat HIV-infected individuals — in emergency rooms, doctors‘
offices, veteran’s hospitals and prisons.“

The result is that many people aren’t tested until the later stages of the disease, even when the symptoms are quite evident, he said.

Dr Richard Rothman of the Johns Hopkins University Department of Emergency Medicine told the Forum that since the CDC issued its
recommendations in 2006 routine testing for HIV in Emergency Rooms (ERs) has improved minimally with only 50 to 100 of the 5,000 ERs
nationwide routinely testing for HIV.

This is a missed opportunity said Rothman because there is evidence that of the 2.8 million ER tests performed over the last 12 years, 6 per cent were
HIV positive, much higher than the national prevalence of AIDS in the US population.

And according to a number of studies it is not just ER patients, who are largely uninsured, but also people with full private coverage who are going
untested. One study that reviewed insurance claims from plans covering nearly 8 million members found that in 2006 under 5 per cent of insured
people with illnesses potentially linked to AIDs were tested for HIV.

Another study found that only 36 per cent of insured people treated for sexually transmitted diseases were tested and yet they represent a high risk
group for HIV. And despite the fact prison inmates are 2.5 times more likely to be infected than the average American, most correctional facilities at
state and federal level don’t routinely test for HIV, they only test inmates thought to be at higher risk.

Another high risk group is veterans. In the year up to the end of September 2006, fewer than 10 per cent of inpatient and 5 per cent of outpatient
veterans were tested. Here the situation appears to be held back by the fact that under VA regulations HIV testing can only be carried out with written
informed consent and documented counselling before and and after testing.

However, the Department of Veteran Affairs hopes this barrier will be removed when new legislation that President Bush signed last month kicks in
that waives the need for written consent.

Miller said the point of routine testing is to stop transmission and getting people treated earlier.

„But new data show that late entry to care is a more serious problem than previously known and is costing years of healthy life,“ she said.

The healthcare system is stuck in the past about HIV testing, said Summit co-chair Dr John G Bartlett, of The Johns Hopkins University.

„HIV testing started in 1985 when there was no treatment, a morbid death, an unrealistic fear of contagion and terrible stigma,“ said Bartlett.

„Now HIV is treatable, we have a test that takes minutes and costs ten dollars. Individuals benefit enormously from treatment, as does society,“ he
added.

Another barrier is the attitude of ER staff who appear to be unaware of the new guidelines and the evidence supporting them. Surveys of ER staff
often show that most of them oppose testing. Other barriers that showed up in a survey include lack of funding and the increased burden on ER staff.

The Summit also heard about the many successes including:

A voluntary HIV testing scheme taken up by up to 25,000 New York City inmates between 2004 and 2006 showed that 30 per cent of the men
and 23 per cent of the women who tested positive did not know they had HIV and of these 90 per cent were neither men who have sex with men nor
intravenous drug users showing the shortcomings of testing only in high risk groups.
A Chicago ER employed two health educators offering rapid HIV testing and over 15 months nearly 2,000 patients took up the option. 15 of
them (0.8 per cent) were found to be HIV positive and were linked to care, although one patient, who was tested in a late stage of the infection, died in
hospital.
Some cities have brought in innovative and proactive schemes. In New Orleans, for example, mobile testing vans are reaching Latino immigrant
groups, and men who have sex with men are taking up offers of HIV testing in bars and bath houses. Cities like Oakland, California, Washington, DC,
and New York City, and states like Florida and North Carolina, have also brought in widespread schemes that reach out to high risk groups.
Chris Barnhill, a 21 year old man, found out he was HIV positive at 16 when Metro TeenAIDS came to his college in Washington DC. He had
been infected at birth. He said if he hadn’t had the test he would just have got „sicker and sicker“. „I wouldn’t have known what was going on,“ he
said, „I would have found out on my deathbed that I had AIDS, when it would be too late“.
State by state, policies are slowly changing. Since 2006 at least 16 states have passed legislation that brings practices more in line with the CDC
guidelines, although 10 states are still incompatible with them.

Mayer said that many „model“ programs are showing what’s possible and now all that remains is for the country to move from „isolated successes to a
national movement“.

„The barriers must be removed,“ he added.

Sources: Forum for Collaborative HIV Research.

: Catharine Paddock, PhD

$1.5 Million Grant Aids The Investigation Into Evolving Malaria Resistance

Funded by a $1.5 million grant from the National Institutes of Health, scientists at Binghamton University, State University of New York, hope to understand how the malaria parasite Plasmodium falciparum evolved resistance to the once-effective medication chloroquine.

„Malaria is responsible for 1-3 million deaths a year, most of whom are children under 5 in sub-Saharan Africa,“ said J. Koji Lum, associate professor of anthropology and biological sciences, principal investigator for the grant. „This is equivalent to the death toll from the attacks of 9/11 every eight to 24 hours.“

Lum and Ralph Garruto, professor of biomedical anthropology and a co-investigator on the grant, together have about 11,000 archived human blood samples from malarious regions of the Pacific collected from the 1950s to the present. The samples will be analyzed and researchers will document the accumulation of genetic changes that resulted in chloroquine’s treatment failure in the Pacific.

Malaria is relatively easy to eliminate in places that have a good health-care infrastructure. In the developing world, particularly in the tropics, the disease is treated primarily through chemotherapy, Lum said.

The problem is that parasites develop resistance to the drugs over time. This study will help scientists understand how malaria parasites evolved resistance to chloroquine. They also hope to learn lessons that may be relevant to current treatments and their interactions with the disease. Ultimately, a better understanding of past episodes of drug resistance evolution will help doctors get the maximum possible impact from newer drugs.

Other studies have had to rely on theoretical modeling of resistant parasites to infer how they evolved. Lum and Garruto expect to be able to directly observe the accumulation of the nine mutations in the transporter gene that confer resistance to chloroquine. They’ll study parasites collected during the past 50 years and stored in the freezers of the NIH-BU Biomedical Anthropology archive.

„This funding will allow us to do a little bit of time traveling,“ Lum said.

Lum considers malaria the most important infectious disease in human history. It continues to exact a devastating toll, in part because the resulting loss of education, work and young lives creates a cycle that makes it nearly impossible for nations to rise from poverty.

To eliminate malaria, countries must treat their entire populations, even asymptomatic adults. But there’s rarely enough money and medicine for developing nations to do that, Lum explained. Doctors focus their energies on the young, people who are clearly ill. Adults who have developed some level of immunity to malaria end up as reservoirs for parasites, continuing to spread the illness without ever feeling sick.

###

Source: Gail Glover

Binghamton University

Risk Of Death Increases In IBD Patients With Hospital-Acquired Infections

Death and length of stay are increased among hospitalized inflammatory bowel disease (IBD) patients who develop hospital-acquired infections, according to a study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute. Also, health-care-associated and hospital-acquired infections are most frequent in patients with severe liver disease, according to an additional study published in the journal.

„Our data demonstrate that inflammatory bowel disease patients with hospital-acquired infections are at increased risk of inpatient mortality and experience a significantly longer length of stay in the hospital,“ said Raffi Karagozian, MD, of Brigham and Women’s Hospital and lead author of this study. „Though hospital-acquired infections are low-frequency events, increased vigilance to avoid these infections among patients could improve outcomes.“

Among the 2,324 patients with IBD examined in this study, there were 20 deaths and 22 reported cases of hospital-acquired infections (these types of infections occur in approximately 1 percent of hospitalized cases with IBD). The mortality from these infections among IBD patients was 13.6 percent, compared with 0.9 percent among controls.

The median length of stay for patients with IBD and hospital-acquired infections was 22 days, versus six days for controls. Of these 22 cases, 15 were urinary tract infections, five were blood stream infections and two were from multiple sources.

Hospital-acquired infections affect approximately two million patients each year in the U.S., resulting in 90,000 deaths with an estimated $4.5 to $5.7 billion per year towards patient care costs. Between 5 percent and 10 percent of patients admitted to acute care hospitals acquire one or more infections, and the risks have steadily increased during recent decades.

In a second study, researchers found that the large majority of total bacterial infections (54) in hospitalized cirrhotic patients were health-care associated (22) or hospital acquired (20). Bacterial resistance was also more frequent among patients with either of these infections. These infectious episodes worsened liver function in 62 percent of patients. In addition to the severity of the liver disease, protein malnutrition was an important risk factor for the development of infections in liver cirrhosis.

Cirrhosis occurs when the liver is permanently scarred or injured by chronic conditions and diseases. The scar tissue that forms in cirrhosis harms the structure of the liver, blocking the flow of blood through the organ.

„It is worth noting that in-hospital death was higher in cirrhotic patients with health-care-associated infections compared with those not infected. In addition, infected cirrhotic patients showed worse long-term survival (compared to those without infections) even if they were discharged from the hospital,“ said Manuela Merli, MD, of Sapienza University of Rome and lead author of this study. „Bacterial infections are in fact a frequent and serious burden among patients with cirrhosis because they can further deteriorate liver function.“

Cases of infection are reported in 40 percent of hospitalized cirrhotic patients. As infections worsen, liver function deteriorates and mortality increases. Therefore, cirrhotic patients should be closely monitored for infections.

Source:
Alissa J. Cruz
American Gastroenterological Association

The Metabolic Activity Of Microbial Communities

Microbial communities are performing important functions all around us – from the earth in our flowerpots to the human gut. Now researchers have developed a method for studying the metabolic functions of microbial communities in detail. It is now possible for the first time, thanks to a new algorithm developed at the UFZ, to use the incorporation of stable carbon isotopes into proteins to investigate natural remineralisation processes in much greater detail, to identify relevant key species and to study the way they interact in complex decomposition processes.

The new Protein-SIP technique makes it possible to measure carbon flux in microbial communities very accurately, say researchers from the Helmholtz Centre for Environmental Research (UFZ), the Max Planck Institute for Infection Biology and the Universities of Oslo and Greifswald writing in Molecular and Cellular Proteomics.

Although in the past it was possible to identify species with metabolic activity using DNA or RNA analyses, the new method can also identify carbon flux and therefore food chains within a microbial community. This means that it is now possible to analyse the interaction between individual groups of micro-organisms within a community.

News headlines like „Uncovering the genetic secrets of intestinal bacteria“ and „Hand bacteria used to catch criminals“ show that microbiologists all over the world are currently working hard to explore the world of bacteria living on and in the human body. The scope of potential applications is huge and could range from forensic medicine and simpler medical diagnosis to entirely new treatments. However, simply identifying the genes is not enough, because bacteria do not live on their own, but in large communities. „It’s like a city with lots of people. Imagine a fire breaks out. Normally, fire-fighters would deal with it, but if there are no fire-fighters around, other people have to step in to prevent disaster,“ explains Dr Ingo Fetzer of the UFZ. „But who is responsible for what within these microbial communities? This is an important question that scientists are only just starting to investigate.“ And it is not just human gut flora that are at issue. Microbes are tiny organisms that, unseen by the human eye, control all the major biological processes on earth – from the global carbon cycle to the remineralisation of organic material and the breakdown of harmful substances.

The number of species of higher organisms on the planet is estimated to be between five and 100 million. There are only vague conjectures about the number of species of micro-organisms. This means that researchers have to concentrate on just a few species. So how is it possible to identify the key organisms within the microbial communities? In order to answer this question more easily, researchers at the Helmholtz Centre for Environmental Research combined the use of stable isotopes with protein measurements using mass spectrometry and bioinformatics. In the new method, microbial communities are fed a carbon source containing the heavy, non-radioactive isotope 13C as well as normal carbon, 12C. The two isotope masses differ by 1.0035 atomic mass units. Because they are stable isotopes, the method is also known as Stable Isotope Probing (SIP). Once the bacteria have consumed the isotope-marked substrate, the 13C atoms are incorporated into the bacterial proteins. The bacteria that make use of the substrate itself incorporate the 13C first. Other species of bacteria only make use of metabolites from the first group and incorporate less 13C into their proteins and do so later. For the analysis, the proteins of all the bacterial species from a sample are extracted and cut into specific fragments using the enzyme trypsin. The fragments are analysed using a mass spectrometer to determine the amino acid sequence of the peptides. When compared with a genome database, this reveals a peptide’s origin, i.e. the bacterium it comes from. Peptides are protein fragments – organic compounds containing a number of amino acids. These consist primarily of carbon and nitrogen, which are two of the basic building blocks of all molecules within organisms and are therefore passed on even in mixed microbial cultures. In a second step, the researchers calculate the level of 13C incorporation. The 13C level then provides an elegant, direct and accurate measure of the metabolic activity of the species in question. „We first tested this key technology in 2008 in a joint project conducted by two UFZ departments to analyse the metabolic activity of one specific species of bacteria within a mixed culture. We have been studying the structure and function of the microbial communities involved in the breakdown harmful substances for years. But it is only with the advent of the new mass spectrometers and their more accurate measurements that we have been able to achieve a breakthrough in developing the method,“ says project coordinator Dr Martin von Bergen from the Department of Proteomics.

Now it is possible to calculate the level of 13C incorporation into the peptides using the decimal places of the peptide masses. The researchers make use of the 0.0035 deviance in atomic mass units over and above the theoretically precise figure of 1.000 atomic mass units between 12C and 13C. Since there are more than 20 carbon atoms in a peptide, the decimal places are shifted over around 0.07 atomic mass units. Prof. Hauke Harms from the Department of Environmental Microbiology is very pleased with the new method: „Our new algorithm will make research work much easier in future. The method offers great potential for studying communities, which are at the heart of microbial ecology.“

With support from the German Research Foundation (DFG) and the EU, researchers will now identify the key organisms in the breakdown of environmental pollutants such as benzene and polycyclic hydrocarbons in the absence of oxygen. „In conjunction with other techniques, Protein-SIP is a very good tool for investigating the food web involved in the breakdown of benzene, for example. Protein-SIP is already being used in projects with national and international partners to identify the metabolic activities of methane bacteria from oil deposits and the methane cycle in marine sediments,“ Dr Hans Richnow (Department of Isotope Biogeochemistry) adds. These projects are of relevance for securing energy supplies and conserving the quality of the environment.

The Protein-SIP method makes it possible to trace the carbon flux within mixed bacterial cultures. Other potential applications include the treatment of biofilms, such as those used in sewage works, and the optimisation of biogas generation processes and the analysis of the human intestine.. The next step for the Leipzig-based researchers is to examine the relationship between the intestinal bacteria of termites and earthworms and their host organisms.

The United Nations have declared 2010 as the ‚International Year of Biodiversity‘. The goal of this is to bring the issue of biodiversity with its many facets to the collective conscience of the public. With its expertise the UFZ contributes to investigating the consequences and causes of the loss of biodiversity as well as developing mitigation options.

Publications:

Nico Jehmlich, Ingo Fetzer, Jana Seifert, Jens Mattow, Carsten Vogt, Hauke Harms, Bernd Thiede, Hans Hermann Richnow, Martin von Bergen, and Frank Schmidt (2010): Decimal place slope: a fast and precise method for quantifying 13C incorporation levels for detecting the metabolic activity of microbial species Mol Cell Proteomics. dx.doi/10.1074/mcp.M900407-MCP200

Jehmlich N, Schmidt F, Hartwich M, von Bergen M, Richnow HH, Vogt C. Incorporation of carbon and nitrogen atoms into proteins measured by protein-based stable isotope probing (Protein-SIP). Rapid Commun Mass Spectrom. 2008 Sep;22(18):2889-97.

Jehmlich N, Schmidt F, Taubert M, Seifert J, von Bergen M, Richnow HH, Vogt C. Comparison of methods for simultaneous identification of bacterial species and determination of metabolic activity by protein-based stable isotope probing (Protein-SIP) experiments. Rapid Commun Mass Spectrom. 2009 Jun;23(12):1871-8.

Jehmlich, N., Schmidt, F., von Bergen, M., Richnow, H.-H., Vogt, C. (2008): Protein-based stable isotope probing (Protein-SIP) reveals active species within anoxic mixed cultures. The ISME Journal 2, 1122-1133

Source:
Tilo Arnhold
Helmholtz Association of German Research Centres

Bush Administration Acknowledges Proposed Medicaid Rule Would Reduce Funding For Rural Hospitals, Nursing Homes

CMS on Friday made public a proposed rule under which state Medicaid reimbursements to health care providers operated by local governments could not exceed actual costs, the AP/San Francisco Chronicle reports. Under the rule, health care providers, rather than state and local governments, would have to receive all Medicaid reimbursements to which they are entitled. Dennis Smith, director of the Center for Medicaid and State Operations at CMS, said that the rule would help eliminate financing agreements under which health care providers receive state Medicaid reimbursements that exceed the actual cost of services and states receive extra matching funds from the federal government as a result. The rule would save the federal government an estimated $3.9 million over five years, CMS said. The rule states, „We expect this rule to have a significant economic impact on a substantial number of small entities, specifically health care providers that are operated by units of government.“ According to CMS, local governments or hospital districts nationwide operate 1,153 hospitals, 822 nursing homes and 113 intermediate care centers for the mentally retarded. In most cases, health care providers „not affected by the proposal tend to be more in urban, more affluent areas,“ the AP/Chronicle reports. CMS will issue a final rule after a 60-day public comment period. Rachel Klein, deputy director of health policy at Families USA, added that the rule would affect the ability of states to fund their Medicaid programs and make „it harder for people to get the critical health care services they rely on“ (Freking, AP/San Francisco Chronicle, 1/14).

„Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

UNAIDS Welcomes United Kingdom’s new ВЈ1.5 billion AIDS strategy

UNAIDS welcomes the new initiative announced by the United Kingdom’s Prime Minister, Tony Blair. This commitment, to spending at least ВЈ1.5 billion over the next three years on HIV-related programmes, represents a tremendous step forward in the global effort to combat AIDS. UNAIDS also applauds the strategy’s strong focus on women, young people and orphans; often the most vulnerable groups. The UK is once again showing the importance of directed and informed leadership.

„UNAIDS welcomes the UK’s new strategy on AIDS. This is a qualitative step forward, and demonstrates the scale of leadership needed if we are to turn this crisis around,“ said Dr Peter Piot, Executive Director of UNAIDS. „With its significantly increased financial contribution, the strategy reinforces the United Kingdom’s position as a pre-eminent global AIDS funder.“

The unveiling of the ВЈ1.5 billion initiative will add significantly to the growing pool of international funding aimed at challenging HIV.

A critically important component of the new UK Strategy is the recognition of the need for greater harmonisation of AIDS funding by donors.

The UK co-hosted a meeting with UNAIDS and the USA in April this year to reach a groundbreaking agreement among the world’s leading donors on the basic principles that underpin AIDS funding. UNAIDS looks forward to working with the UK to turn this approach – known as the „three ones“ into reality at country level.

For more information, please contact Mahesh Mahalingam, UNAIDS, Geneva, (+ 41) 22 791

4918. For more information please visit our website, unaids

HHS Secretary Leavitt Visits Indian Facilities That Provide HIV/AIDS Care, Treatment

HHS Secretary Mike Leavitt on Monday visited a hospital and HIV/AIDS education and prevention facility in Chennai, India, Bloomberg reports. Leavitt visited the hospital as part of a trip to India that focuses on import safety, as well as scientific and research collaboration, according to HHS spokesperson Holly Babin. HHS last year through agencies such as NIH, CDC and FDA committed $30 million to U.S.-India collaboration for various programs, including HIV surveillance and treatment, Bloomberg reports (Seshadri/Blum, Bloomberg, 1/7).

According to the United News of India, the Government Hospital of Thoracic Medicine provides treatment to more than 30,000 people living with HIV/AIDS from Tamil Nadu, Andhra Pradesh and other Indian states annually (United News of India, 1/5). Leavitt on Monday said that GHTM is an „extraordinarily fine testing center and clinical delivery system,“ adding that HHS, CDC and NIH are proud to be part of its development (Economic Times, 1/7). Under the third phase of India’s National AIDS Control Programme, 10 additional hospitals will be identified over the next five years and developed into centers using the GHTM model (United News of India, 1/5).

During his visit, Leavitt also plans to meet with senior government officials, university faculty and students, and business leaders. According to an e-mailed statement, Leavitt will visit facilities that produce food, medicine and other products exported to the U.S. Leavitt — as well as FDA Commissioner Andrew von Eschenbach and David Hopper, U.S. consul general to South India — on Tuesday are scheduled to visit a generic drug plant operated by India’s largest pharmaceutical manufacturer, Dr. Reddy’s Laboratories.

„Our commitment to India“ and to the Indian Ministry of Health and Family Welfare is a „strong and ongoing one,“ Leavitt said, adding that in his reauthorization request for the President’s Emergency Plan for AIDS Relief, President Bush is „seeking to double the money we can spend to help our friends around the world, including India“ (Bloomberg, 1/7). Leavitt also said that HIV/TB co-infection is „ravaging“ the country (Economic Times, 1/7).

Indian Health Minister Anbumani Ramadoss, who visited Loyola College with Leavitt on Monday, said that HIV/AIDS awareness efforts should focus more on rural populations because of the high HIV prevalence recorded in such groups. Leavitt and Ramadoss attended the launch of a life skills curriculum designed for Loyola’s Red Ribbon Club (The Hindu, 1/8). Ramadoss also called for increased sex education in the country. „As much as 86% of HIV transmission is through unsafe sex,“ he said, adding, „Thus, over 600 million youth in our country are at risk due to lack of awareness. All this while, we were doing sex and not talking about it. It is time we talked about it“ (New Indian Express, 1/8).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Blacks Hit Hardest By HIV Infection Among Nation’s Young Adults

HIV infection is significantly more common among non-Hispanic blacks than it is among any other young adult racial or ethnic group in the United States, according to the first study drawn from the nation’s general youth population.

The infection rate for young non-Hispanic blacks ages 19 to 24 is 4.9 per 1,000 people compared to a rate of 0.22 per 1,000 for all other races. The overall HIV infection rate for young adults was 1 per 1,000, a figure that is lower than other estimates of HIV prevalence that relied on different reporting methods. It also was much lower than reported rates of other sexually transmitted diseases. The HIV infection rate among young adult men was slightly higher than that for young women.

The new study appears in the current issue the American Journal of Public Health and draws on the National Longitudinal Survey of Adolescent Health and uses data from more than 13,000 young adults who agreed to be screened for HIV infection.

„The infection rate for non-Hispanic blacks is 20 times greater than the remainder of the population and this disparity begins early in life,“ said Martina Morris, lead author of the paper and a sociologist who directs the University of Washington’s Center for the Studies in Demography and Ecology.

The study differed from previous ones in that it had a large representative sample of young adults and did not rely on data of HIV cases reported to the Centers for Disease Control (CDC). The new study sample included some people who were injection drug-users, in jail and men who have sex with men – groups that are known to have higher HIV rates. However, the study was not designed to estimate HIV prevalence in these specific groups.

Morris noted that earlier studies have estimated that half of all HIV infections in the early 1990s were acquired before age 25. However, data from the new study suggest that by 2000 the fraction of infection acquired before age 25 had dipped to between 15 percent and 30 percent.

Overall, of the nearly 13,200 individuals who were screened, 15 tested positive for HIV, eight were indeterminate and the remainder were negative. Twelve of the 15 positive tests were among non-Hispanic blacks.

Although whites, Hispanics, Asians and American Indians were represented in the sample, federal and university human subjects guidelines protecting confidentiality prevented HIV infection rates from being calculated for these groups. Because of the small number of cases – three – it might have been possible to uncover the identity of those who tested positive.

Morris said the results of the study parallel the racial disparities for other sexually transmitted diseases seen in CDC data. For example, rates of gonorrhea are about 17 times greater among black youth, and rates of syphilis are 12 times greater and rates of chlamydia are about five times greater.

„We need to understand the mechanism that controls the spread of these pathogens. The persistent differentials across a wide range of disease suggests a common mechanism,“ she said.

Morris added that recent research suggests disparities in the prevalence of sexually transmitted diseases are shaped by differences in the underlying networks that spread infection. Segregation along racial, economic and geographic lines can lead to differences in the pool of potential sex partners. In addition, when sexual partnerships overlap in time the connectivity of a sexual network increases.

„Think of it as a group of people holding hands in a circle,“ she said, „Everyone has only two partners, but the whole population is connected. This can amplify the transmission of HIV and other diseases.“

This pattern of having concurrent partners is more common among non-Hispanic blacks, so it may boost the spread of disease within this network. Segregation then keeps the disease from spreading to other groups.

„We need to better understand the way networks influence the transmission dynamics of HIV, because small difference in behavior can have large impacts on network connectivity,“ said Morris. „Behavior still matters, but people need to know what behaviors to change.“

She said one of the lessons learned from studying partnership networks and behavior in sub-Saharan Africa, which has nearly 80 percent of the world’s cases of HIV, is that prevention programs that stress having one partner at a time, as in Uganda, have been effective in reducing transmission.

Joel Schwarz
joelsu.washington.edu
University of Washington
uwnews/

FDA Approves Merck’s Antiretroviral Raltegravir

Merck on Friday announced that FDA has approved its antiretroviral drug raltegravir for use by HIV-positive people who have not responded to other treatments, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 10/12). An independent FDA panel of medical experts last month unanimously recommended accelerated approval of raltegravir, an integrase inhibitor.

Raltegravir effectively decreases HIV viral loads after 24 weeks of use among HIV-positive people who have not responded to other treatments, according to a study published in the April 14 online edition of the journal Lancet. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA. The other two enzymes necessary for viral replication, reverse transcriptase and protease, already are targeted by a variety of antiretrovirals.

According to an FDA review of raltegravir released ahead of the independent panel’s meeting, the drug is effective at treating HIV-positive people who have shown resistance to available treatments. The most common side effects were rash and increased levels of creatine in the blood, according to the review. Other potential side effects include liver injuries and cancer. In clinical trials, a higher number of cancers was found among people taking raltegravir than among those taking a placebo, but the difference could be because of a lower rate of cancer among people in the placebo group, FDA said.

Merck previously said that the drug will be used in combination with standard oral antiretrovirals by HIV-positive people who have developed resistance to their current treatments. Raltegravir will be sold under the brand name Isentress (Kaiser Daily HIV/AIDS Report, 10/11). According to Amy Rose, a Merck spokesperson, the treatment will cost about $9,850 per patient annually (Wall Street Journal, 10/12). People living with HIV who are prescribed the drug will take two 400-milligram tablets daily in combination with other antiretrovirals chosen by their physicians, the San Francisco Chronicle reports. Robert Rode, marketing vice president at Merck, said the new pills should be available in as few as two weeks.

According to Rode, Merck has been providing raltegravir at no cost to 6,000 people worldwide — including 3,400 in the U.S. — while it waited for FDA marketing approval. He added that the company has a program in place to „make this product available globally“ (Russell, San Francisco Chronicle, 10/13). Merck has promised to study the drug for at least five years to monitor any side effects that might not have appeared in initial clinical trials, Reuters reports (Dixon, Reuters, 10/12).

Reaction
„This is fantastic news,“ Warner Greene, director of the Gladstone Institute of Virology and Immunology at the University of California-San Francisco, said, adding, „This drug looks more potent than virtually anything we have ever seen.“ Martin Delaney — founder of San Francisco-based Project Inform who has participated in price negotiations with Merck on behalf of the Fair Pricing Coalition — said the company is not charging as much as he had anticipated. The price of the drug „falls in the middle of the high end for AIDS drugs,“ Delaney said, adding, „For us, that is a victory“ (San Francisco Chronicle, 10/13).

Ben Cheng, deputy director of the Forum for Collaborative HIV Research, said that as the „AIDS crisis continues, new drugs like Isentress are needed, which target the virus in unique ways.“ He added that the „HIV advocacy community is really excited and encouraged by this new treatment“ (AP/BusinessWeek, 10/12).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Isentress.