FDA Clears First Test for Recent Infection With Toxoplasmosis Parasite

/PRNewswire/ -- On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months.

Toxoplasmosis is caused by the parasite Toxoplasma gondii. The infection can cause serious health problems in people with compromised immune systems. Women who become infected just before or during pregnancy may pass the parasite on to their unborn child, resulting in miscarriage, stillbirth, or an abnormally small or large head. Infection can also lead to vision loss, mental disability, seizures or other health problems later in life for the child.

Cats are most often associated with the parasite, but many other species of animals and birds also serve as hosts. The parasite also is found in people worldwide. Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms.

Toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness, according to the Centers for Disease Control and Prevention. More than 60 million people in the United States may be infected with Toxoplasma gondii. The parasite may be transmitted to people when they eat raw, undercooked or contaminated meat or come in contact with infected cat feces or litter.

The VIDAS TOXO IgG Avidity assay can be used to rule out recent Toxoplasma gondii infection. The test works by detecting how strongly IgG avidity antibodies bind to the Toxoplasma gondii antigens in the assay. IgG avidity antibodies from infections older than four months bind tightly with the antigens, while IgG avidity antibodies from infections acquired in the past four months form weaker bonds.

"Toxoplasmosis can have serious and lasting health consequences for infants that acquire the infection in the womb," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. "This test gives doctors an additional tool to determine if women with confirmed cases of toxoplasmosis acquired the infection before or during pregnancy."

The VIDAS TOXO IgG Avidity Assay test is for use in people who have been confirmed with the Toxoplasma gondii infection by using the VIDAS TOXO IgG II test and who are pregnant or have swollen lymph glands. The VIDAS TOXO IgG Avidity Assay test alone should not be used as a basis for clinical decisions.

The performance of the VIDAS TOXO IgG Avidity Assay has not been established for prenatal screening, for immunocompromised patients, or for cases of toxoplasmosis reinfection or relapse, and the FDA has not cleared or approved the VIDAS TOXO IgG Avidity Assay for blood or plasma donor screening.

The VIDAS TOXO IgG Avidity assay is manufactured by bioMerieux Inc. of Hazelwood, Mo.

-----

Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

Streptococci and E. coli Continue to Put Newborns at Risk for Sepsis

Bloodstream infections in newborns can lead to serious complications with substantial morbidity and mortality. What’s more, the pathogens responsible for neonatal infections have changed over time. In recent years, however, antibiotic prophylaxis given to at-risk mothers has reduced the incidence of early-onset group B streptococcal infections among their babies.

A new nationwide, multi-site study aimed at determining current early-onset sepsis rates among newborns, the pathogens involved, and associated morbidity and mortality demonstrates that the most frequent pathogens associated with sepsis are group B streptococci (GBS) in full-term infants and Escherichia coli in preterm infants.

The study, which included nearly 400,000 newborns, also found that infection rates in newborns increased with decreasing gestational age and birth weight. The overall rate of infection was 0.98 per 1,000 live births; 0.41 per 1,000 live births involving GBS and 0.28 per 1,000 live births involving E. coli.

The study appears online April 25 and in the May 2011 issue of Pediatrics.

GBS emerged as the leading cause of early-onset sepsis and meningitis in newborns in the 1970s. In 2002, the Centers for Disease Control and Prevention recommended universal screening of women at 35 to 37 weeks of pregnancy followed by chemoprophylaxis for women with GBS colonization.

Sepsis occurs when pathogenic bacteria enter the blood stream, causing systemic infection. In infants less than 72 hours old, sepsis is considered of early onset.

“Infections occur in almost one case per thousand live births,” says Barbara Stoll, MD, lead investigator for the study. Stoll is the George W. Brumley, Jr., Professor and Chair, Department of Pediatrics in Emory University School of Medicine. “With approximately 4 million births a year in the United States, this equates to a substantial burden of disease. We estimate that approximately 3,000 infants a year develop early-onset sepsis. With current mortality rates, approximately 300 to 350 deaths per year are associated with neonatal sepsis. So, it’s not inconsequential.”

The study also shows that opportunities for prevention of neonatal GBS infections continue to be missed. “Missed opportunities for prevention of GBS include failure to screen all women who deliver at term, failure to provide antibiotics to all colonized women or to those who delivered preterm with unknown colonization status and false negative GBS screens among women who deliver with GBS infection,” says Stoll.

“Our findings suggest that accurate point-of-care diagnostic tests at the time a woman comes in for delivery would enhance our ability to identify at-risk women.”

In addition, the gap in linking electronic medical records between a woman’s obstetrician and the hospital where she delivers can also impede prevention. “A community health record that links the medical record in a physician’s office with the hospital where the woman gets care could enhance identification and therapy for at-risk women,” says Stoll. “If a woman has been screened for GBS and is known to be colonized, that information should be available to the health care team taking care of her at the time she is in labor.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Centers for Disease Control and Prevention.

By Robin Tricoles

-----

Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

Patients Who Survive Sepsis Infections Are More Than Three Times as Likely to Develop Cognitive Problems

/PRNewswire/ -- Older adults who survive severe sepsis are at higher risk for long-term cognitive impairment and physical limitations than those hospitalized for other reasons, according to researchers from the University of Michigan Health System.

Research to be published Oct. 27 today in the Journal of the American Medical Association showed that 60 percent of hospitalizations for severe sepsis were associated with worsened cognitive and physical function among surviving older adults. The odds of acquiring moderate to severe cognitive impairment were 3.3 times higher following an episode of sepsis than for other hospitalizations.

Severe sepsis also was associated with greater risk for the development of new functional limitations following hospitalization, says lead author, Theodore (Jack) Iwashyna, M.D., Ph.D., assistant professor of internal medicine at U-M.

Among patients who had no limitations before sepsis, more than 40% developed trouble with walking. Nearly 1 in 5 developed new problems with shopping or preparing a meal. Patients often developed new problems with such basic things as bathing and toileting themselves.

"We used to think of sepsis as just a medical emergency, an infection that you get sick with and then recover," said Iwashyna, "But we discovered a significant number of people face years of problems afterwards.

"Those problems are bigger and more common than we expected. Most older Americans suffer real brain and body problems. We need new treatments, not just for the sepsis infection, but to prevent these new disabilities afterwards."

Sepsis is an overwhelming infection that can result in failure of multiple organ systems. The initial infections are often common problems, such as pneumonia or a urinary tract infection. About 40 percent of those with severe sepsis die from the infection.

Anyone can get sepsis, but older people and those with weakened immune systems are most vulnerable. Sepsis is probably the most common cause of critical illness in the United States.

The best data available are from the 1990s, when it was estimated that 750,000 people each year were diagnosed with sepsis. Researchers believe that number has doubled each decade.

"These new data show a majority of older patients suffer with real life-changing burdens after beating sepsis. This is an underrecognized public health problem with major implications for patients, families and the health care system," Iwashyna says.

"We need to make sure families have the resources they need to care for survivors of sepsis when they go home. It's not enough just to get them through the acute episode. We need to start preparing them for the years of problems they may have afterwards."

"This research underscores the need for physicians who care for older adults to focus early on preventing infections that can lead to sepsis," says study co-author Kenneth M. Langa, M.D., Ph.D., a core investigator for the Ann Arbor Veterans Administration Health Services Research and Development Service's Center of Excellence and professor of internal medicine at U-M.

Older patients need to get their flu and pneumonia vaccines in order to decrease their risk for infections, and physicians need to be aware of the long-term risk for cognitive and physical disabilities that many patients may face, Langa said.

"In contrast to Alzheimer's disease and other forms of dementia, the cognitive impairment associated with sepsis is likely at least partially preventable through better acute care of the sepsis episode and better rehabilitation efforts afterwards," Langa says.

"We need to start working early – from the beginning of the hospitalization – to make sure patients do not develop new disability. There are innovative new ways to care for people that might help prevent this disability," Iwashyna says.

The research was supported primarily by the National Institute on Aging and the National Heart, Lung and Blood Institute.

The researchers used data from the NIA-supported Health and Retirement Study , a long-term study that collects information on the health, economic, and social factors influencing the health and well-being of a nationally representative sample Americans over age 50.

"This research makes clearer how acute medical problems in older adults may have an important lasting impact and contribute to a downward trajectory in both cognitive and physical function," says Richard Suzman, Ph.D., director of the NIA's Division of Behavioral and Social Research, which supports the HRS.

"The unique nature of the rich HRS dataset that links both survey data and Medicare administrative data made this innovative study possible and will also facilitate future studies of the long-term impact of critical illness on older adults and the family members that care for them."

The HRS, now in its 18th year, follows more than 22,000 people over the age of 50, collecting data every two years, from pre-retirement to advanced age.

The NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. For more information on research and aging, go to www.nia.nih.gov.

Additional authors: E. Wesley Ely, M.D., M.P.H. of the Tennessee Valley Veteran's Affairs (VA) Healthcare System and Vanderbilt University; Dylan M. Smith, Ph.D., of Stony Brook University Medical Center.

Journal reference: Journal of the American Medical Association, 2010; 304(16): 1787-1794.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

Old Drug Holds Promise Against Opportunistic Lung Bug

/PRNewswire/ -- A drug to treat inflammation plays a surprising role reducing the level of infection caused by an opportunistic bug that is deadly for AIDS and cancer patients and others with weakened immune systems.

The drug, sulfasalazine, spurs the body to get rid of the fungal evaders by enhancing the body's ability to chew them up instead of leaving the debris to litter the lungs, where it would continue to provoke an onslaught of harmful inflammation.

Besides opening a new avenue for research on Pneumocystis pneumonia or PCP, caused by the fungus Pneumocystis jirovecii, the work with mice also offers the possibility of manipulating immune cells called macrophages to improve treatment of infections.

The findings by scientists at the University of Rochester Medical Center were published August 19 in the journal PLoS Pathogens.

During a bout with Pneumocystis, the lungs become a battlefield, where the body pits an array of impressive forces against marauding microbes. But even when the body gets the upper hand, the damage is tremendous. Immune cells like neutrophils and macrophages can flood the lungs, literally suffocating the patient. And when the debris from dead microbes fills the lungs, more and more immune cells are called in to clean up the area, making matters worse. It becomes harder and harder to breathe.

"Many people assume that once the microbe is dead, patients usually start to feel better immediately. But with Pneumocystis, patients do not always undergo a rapid clinical improvement following antibiotic treatment. Even though the bug has been killed, the debris that is left in the lungs continues to promote inflammation," said corresponding author Terry Wright, Ph.D., an infectious disease specialist and associate professor of Microbiology and Immunology and of Pediatrics.

Pneumocystis is a common bug that infects nearly everyone at some point; the authors say that more than 80 percent of children have been infected by the age of 2. Most people shake off the infection without consequence, but for people with cancer, AIDS, or other diseases that compromise their immune system, the infection can be deadly. Usually there are few signs that the patient is sick until the infection is well established and the fungus is widespread in the lungs. Among cancer patients, mortality rates as high as 40 percent have been reported.

Since the body's immune response is central to how Pneumocystis kills patients, doctors use two different types of drugs in tandem to treat patients - an antibiotic to kill the bug, and steroids or another type of drug to reduce the consequent inflammation.

Central to the study were mice in which the disease progresses in a manner very similar to AIDS patients. The remarkable strides in AIDS therapy in recent years have come with a down side for many patients, thanks to Pneumocystis: When anti-retroviral therapy kicks in, a patient's immune system often becomes stronger very quickly - and if the fungus is present, the immune system attacks it vigorously, causing a potentially deadly form of pneumonia.

Wright's team looked at the effects in mice of sulfasalazine, an anti-inflammatory drug that has proven useful in treating conditions like Crohn's disease and rheumatoid arthritis. The team found that Pneumocystis-infected mice treated with sulfasalazine developed much less severe disease than untreated mice. The sulfasalazine-treated mice had better lung function, less weight loss, and were generally healthier than untreated animals.

While some of the benefit was due to the drug's anti-inflammatory properties and was expected, the result included a big surprise: The drug also spurs the body to remove the bug more aggressively by boosting the activity of immune cells called macrophages.

"This was unexpected," said first author Jing Wang, Ph.D., research assistant professor in Pediatrics. "Since we reduced the response of the immune system, you would think the mice would get sicker. But instead, the mice treated with sulfasalazine were healthier. At first we thought it was due solely to the anti-inflammatory activity of the compound, but it turns out that sulfasalazine actually results in a reduced fungal burden. The drug helps the body clear the infection.

"We initially thought we had done something wrong, and so we repeated the experiment again and again. Then, when new technology was developed, we were able to document that the body cleared the infection more readily with sulfasalazine," added Wang.

Scientists have long known that the body's immune T cells are central to the body's response to fight off the infection. The Rochester team showed that the body's T cells spur macrophages to attack the fungus - to engulf its particles and chew them up in a process known as phagocytosis.

While scientists have long suspected that role for macrophages, the Rochester team relied on a new technology to gather the first direct evidence of macrophages engulfing fungal particles. The scientists worked closely with Timothy Bushnell, Ph.D., and others at Rochester's Flow Cytometry Resources Core, investigating new ways to use lasers to capture images of molecular events. Bushnell's team ultimately connected the team with scientists at Amnis. Together the group developed a new way to capture macrophage phagocytosis in single cells from mice infected with Pneumocystis. The technology enabled the team to capture more than 40,000 such events, compared to just a handful when using conventional microscopy.

The team showed that as macrophage activity increased, the animals' health improved and levels of fungus decreased. For example, 17 days after infection, mice treated with sulfasalazine had nine times as many macrophages that had engulfed fungal particles compared to mice that had not been treated with the compound.

"This marks a new direction in which to look for new therapies to treat Pneumocystis as well as other inflammatory diseases. Identifying modulators that can increase or decrease the action of our immune system in a precise manner is a growing area of research," said Wright. Recently researchers have come to realize that there are different kinds of macrophages, and Wright noted that the type whose activity is trigged by sulfasalazine does not contribute to inflammation.

In addition to Wang and Wright, other authors include Francis Gigliotti, M.D., professor of Pediatrics and of Microbiology and Immunology, and also chief of Infectious Disease at Golisano Children's Hospital; Samir Bhagwat, Ph.D., research assistant professor of Pediatrics; and Thaddeus George from the Amnis Corp. in Seattle. The work was funded by the National Heart Lung and Blood Institute and the Strong Children's Research Center.

-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Approves First Diagnostic Assay to Detect Both HIV Antigen and Antibodies

/USNewswire/ -- The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings.

HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person's body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.

"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."

The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical.

The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously.

The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

ARCA Launches First Therapeutic Trial with GeoVax Vaccine

PRNewswire-- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the first study using the same products for treatment of persons who already have HIV infection. ARCA is the only site for this trial.

"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson, Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."

To be eligible for the study, persons should have had a negative HIV test followed by a positive test up to 6 months later, and they should have started drugs to fight HIV within 6 months of being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for safety and for the ability of the vaccine to elicit protective immune responses in vaccinated participants. Patients will be compensated for their participation in the study. Only 10 to 12 persons will be selected to participate. Persons who believe they may qualify for the study should contact ARCA at vaccine@arcatlanta.org or 404-876-2317. ARCA is also interested in identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV drugs.

ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The trial is based on the achievement of excellent post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

About the AIDS Research Consortium of Atlanta

ARCA is a registered 501(c)(3) not-for-profit clinical research, testing, outreach and educational organization founded in 1988. ARCA works through a network of more than 50 physicians and 5 public health clinics to conduct clinical drug and vaccine trials and prevention research studies. 2 ARCA also provides patient and care-provider educational programs, free STD testing for men, and free, anonymous HIV testing when funds are available. More than 6000 Atlantans have learned their HIV status through ARCA's HIV testing program. ARCA has become one of the most respected and successful HIV/AIDS research facilities in the country over the past two decades by enrolling more than 2,000 metro Atlanta residents in more than 300 clinical drug trials that provide the latest investigational HIV/AIDS medications at no cost to them. ARCA has contributed key scientific information leading to the FDA approval of more than 27 individual and combination drugs now available for people with HIV/AIDS worldwide. ARCA was one of only three centers in the US that participated in a Centers for Disease Control and Prevention (CDC) study to test the safety of tenofovir, an existing HIV medicine, as a possible tool to prevent HIV infections. Over a 14 year period, ARCA enrolled more than 10.000 Atlantans with HIV infection in a CDC study to better understand HIV and AIDS. In all, more than 20,000 Atlantans have participated in ARCA studies and services. For more information, visit www.arcatlanta.org.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization

The U.S. Food and Drug Administration  announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

Until this clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA), which allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.

On April 26, 2009, the U.S. Department of Health and Human Services declared a public health emergency due to the 2009 H1N1 Influenza Virus. EUAs for devices will cease to be effective when the public health emergency declaration expires.

“With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The United States experienced its first wave of 2009 H1N1 Influenza Virus in the spring of 2009, followed by a second wave in the fall. The U.S. Centers for Disease Control and Prevention estimates that between 43 million and 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.

The Simplexa Influenza A H1N1 (2009) test is manufactured by Focus Diagnostics Inc. in Cypress, Calif.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

CDC Study Finds U.S. Herpes Rates Remain High

/PRNewswire/ -- About 1 in 6 Americans (16.2 percent) between the ages of 14 and 49 is infected with herpes simplex virus type 2 (HSV-2), according to a national health survey released today by the Centers for Disease Control and Prevention. HSV-2 is a lifelong and incurable infection that can cause recurrent and painful genital sores.

The findings, presented at the 2010 National STD Prevention Conference, indicate that herpes remains one of the most common sexually transmitted diseases (STDs) in the United States.

The new estimate, for 2005-2008, comes from CDC's National Health and Nutrition Examination Survey (NHANES), a nationally representative survey of the U.S. household population that assesses a broad range of health issues.

The findings suggest relatively stable HSV-2 prevalence since CDC's last national estimate (17 percent for 1999-2004), because the slight decline in prevalence between the two time periods is not statistically significant.

The study finds that women and blacks were most likely to be infected. HSV-2 prevalence was nearly twice as high among women (20.9 percent) than men (11.5 percent), and was more than three times higher among blacks (39.2 percent) than whites (12.3 percent). The most affected group was black women, with a prevalence rate of 48 percent.

As with other STDs, biological factors may make women more susceptible to HSV-2 infection. Additionally, racial disparities in HSV-2 infection are likely perpetuated because of the higher prevalence of infection within African-American communities, placing African-Americans at greater risk of being exposed to herpes with any given sexual encounter.

"This study serves as a stark reminder that herpes remains a common and serious health threat in the United States. Everyone should be aware of the symptoms, risk factors, and steps that can be taken to prevent the spread of this lifelong and incurable infection," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community."

Research shows that people with herpes are two to three times more likely to acquire HIV, and that herpes can also make HIV-infected individuals more likely to transmit HIV to others. CDC estimates that over 80 percent of those with HSV-2 are unaware of their infection. Symptoms may be absent, mild, or mistaken for another condition. And people with HSV-2 can transmit the virus even when they have no visible sores or other symptoms.

"Many individuals are transmitting herpes to others without even knowing it," said John M. Douglas, Jr., M.D., director of CDC's Division of STD Prevention. "We can't afford to be complacent about this disease. It is important that persons with symptoms suggestive of herpes -- especially recurrent sores in the genital area -- seek clinical care to determine if these symptoms may be due to herpes and might benefit from treatment."

Combination of Prevention Approaches Needed to Reduce National Herpes Rates

Although HSV-2 infection is not curable, there are effective medications available to treat symptoms and prevent outbreaks. Those with known herpes infection should avoid sex when herpes symptoms or sores are present and understand that HSV-2 can still be transmitted when sores are not present. Effective strategies to reduce the risk of HSV-2 infection include abstaining from sexual contact, using condoms consistently and correctly, and limiting the number of sex partners.

CDC does not recommend HSV-2 screening for the general population. However, such testing may be useful for individuals who are unsure of their status and at high risk for the disease, including those with multiple sex partners, those who are HIV-positive, and gay and bisexual men.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage

Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine

Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine and Presented at the AIDS Vaccine 2009 Conference Provide Insight for Future Research

/PRNewswire/ -- Detailed results from the Prime-Boost HIV Vaccine Clinical Trial involving more than 16,000 adult volunteers in Thailand show that an investigational HIV vaccine regimen was safe and modestly effective at reducing the rate of HIV infection compared to placebo. These results were presented today by the trial collaborators to researchers gathered at the AIDS Vaccine 2009 Conference in Paris, France and published online by The New England Journal of Medicine.

"This is the first evidence that a prime-boost HIV vaccine regimen may prevent infection and represents a significant step forward for vaccine research," said Colonel Nelson Michael, Director, Division of Retrovirology, Walter Reed Army Institute of Research and Director, U.S. Military HIV Research Program (MHRP). "While it will not likely have any immediate public health benefit, we are hopeful that the findings will guide additional studies and accelerate research efforts toward a more effective vaccine."

According to the collaborating partners, the prime-boost combination of ALVAC HIV and AIDSVAX B/E appeared to lower the rate of HIV infection by 31.2 percent compared to placebo based on the modified intent-to-treat (mITT) population (n=51 vs. n=74, respectively; p=0.04). There was no effect on the amount of virus in the blood of the study volunteers who received either vaccine or placebo and subsequently became infected with HIV.

"Experts are interpreting the results and planning additional studies to maximize the knowledge gained from this study. Our first step is to see if we are able to determine correlates of protection," said Colonel Jerome Kim, Deputy Director (Science), MHRP and the HIV vaccines product manager for the U.S. Army. "Observations will inform future basic research, non-human primate and clinical studies to build on the RV144 result."

"All of this together emphasizes the opportunities these trial results afford - a new vantage point to examine what we understand about vaccine design, immunogenicity testing and animal models," added Colonel Kim. "Further research is required to determine if immunological mechanisms mediating protection against HIV may be different from those that control viral replication."

The trial results, first announced by trial collaborators on September 24, 2009, are based on the mITT population, which is the most clinically relevant analysis for this proof-of-concept study. Data from the mITT population, which was monitored by the independent Data and Safety Monitoring Board during its periodic review of the study, include all volunteers who entered the study less seven individuals who were already HIV infected on the first day of vaccination. "Given that you cannot protect someone from an infection that they already have acquired, the modified intent-to-treat analysis excluded these individuals," said Michael.

The detailed study data, which were embargoed for release before the AIDS Vaccine 2009 Conference and The New England Journal of Medicine publication, provide analyses of multiple data subgroups including ITT and per protocol (PP), their definitions and results. Data from the PP population show similar trends (26.2 percent reduction in HIV infection compared to placebo; n=36 vs. n= 50 respectively; p=0.16), though the results did not reach statistical significance due to the exclusion of nearly one-third of volunteers from the analysis and the associated loss of statistical power. For the ITT population, the vaccine regimen reduced infection rates by 26.4 percent compared to placebo (n=56 vs. n=76 respectively; p=0.08).

The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health. Trial collaborators include the U.S. Army, the Thai Ministry of Public Health, Mahidol University, the Armed Forces Research Institute of Medical Sciences - U.S. and Thai components, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, Global Solutions for Infectious Diseases and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

RV144 Trial Background

RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or "prime" vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.

The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.

More than 16,000 HIV-negative men and women between the ages of 18 to 30 years participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-year period. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

HIV Vaccine Study First to Show Some Effectiveness in Preventing HIV

/PRNewswire/ -- A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC(R) HIV and AIDSVAX(R) B/E lowered the rate of HIV infection by 31.2% compared with placebo.

"This is the first HIV vaccine candidate to successfully reduce the risk of HIV infection in humans. We are very excited and pleased with the outcome of this trial and congratulate all those who participated in it," said Lieutenant General Eric Schoomaker, Surgeon General, U.S. Army. "In addition, this study is an outstanding example of international and interagency collaboration involving many partners from the Thai and U.S. governments, private companies, non-profit organizations and volunteers."

In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is statistically significant. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study. More detailed results of this study will be presented next month at the AIDS Vaccine Conference, October 19 through 22 in Paris, France.

This finding has important implications for the design of future HIV vaccines and how they are tested, however additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection. Given the significant threat of HIV infection worldwide, an efficacious vaccine is urgently needed, as part of a broader prevention effort to help control the epidemic.

Collaborating partners on this study, referred to as RV144, include the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, and Global Solutions for Infectious Diseases (GSID). The collaborators are already working with external experts to determine the need for additional studies on this vaccine regimen and consider the impact of this study's findings on other HIV vaccine candidates.

"These results show that development of a safe and effective preventive HIV vaccine is possible, " said Colonel Nelson Michael, Director, Division of Retrovirology, Walter Reed Army Institute of Research and Director, U.S. Military HIV Research Program (MHRP). "While these results are very encouraging, we recognize that further study is required to build upon these findings."

Colonel Jerome Kim, Deputy Director, Science, MHRP and the HIV vaccines product manager for the U.S. Army added that, "knowledge gained through this study will be used to accelerate future study design and testing as researchers continue the search for a safe, globally-effective HIV vaccine."

The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health and all collaborators for their hard work in achieving this important milestone.

RV144 Phase III Trial Background

RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or "prime" vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.

The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.

More than 16,000 HIV-negative men and women between the ages of 18 to 30 participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-years. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used in this study and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.

For additional information, please visit www.hivresearch.org

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Researchers Find Common Respiratory Virus Hijacks Lung Cells to Stay Alive

/PRNewswire/ -- Approximately one-half of all infants are infected with the respiratory syncytial virus (RSV) during the first year of life, and almost all children have been infected at least once by the time they reach their second birthday. Researchers at West Virginia University have discovered what makes RSV such a severe and persistent illness.

Senior author Giovanni Piedimonte, M.D., and his team have discovered that RSV prompts the release of a molecule that keeps the invaded cells alive despite the infection. The mechanism allows infected cells to survive for a longer period of time while they continue to produce viral particles, thus contributing to the severity and persistence of the infection.

Research results are published in the current issue of the journal PLoS ONE.

Inflammation of the airways caused by RSV often results in wheezing, cough and respiratory distress, creating the most common respiratory infection in infancy or childhood. Each year, an estimated 125,000 infants in the United States are hospitalized with RSV, the leading cause of infant hospitalization.

"There is still no effective therapy or medical treatment for RSV infection. While often mild, it still is responsible for the deaths of hundreds of infants in the United States each year," said Dr. Piedimonte, chair of the WVU Department of Pediatrics and physician-in-chief of WVU Children's Hospital. "The virus also strikes in nursing homes and causes deaths in the elderly population, so understanding how it works is critical."

Piedimonte said up to 500 infants may die of the infection each year. RSV may also predispose children to long-term health problems such as asthma. Other groups at high risk for severe RSV disease include the elderly, adults with underlying respiratory or cardiac disease, and those with a compromised immune system.

"Viruses must find a way to survive inside the host, and in this case RSV has found a way of keeping alive the cells that they infect," Piedimonte explained. "The virus invades the cell, which then produces a small molecule called NGF, or nerve growth factor. NGF allows the cell to survive while the virus reproduces itself. Finally, the cell explodes releasing new viral particles ready to infect the neighboring cells."

In determining how the virus instructs the infected cell to prolong its life, the researchers may have established a blueprint for development of new anti-viral drugs aimed at interfering with the action of NGF, Piedimonte said. He added that RSV may prefer the lower respiratory tract specifically because the smaller airways there allow for more efficient production of NGF.

"The interesting part of the RSV infection is that the viruses induce NGF production within an hour of coming into contact with the human cells - that is, even before they start multiplying," said the paper's lead author, Sreekumar Othumpangat, Ph.D., a researcher in the WVU Pediatric Research Institute.

Children born prematurely as well as those with chronic lung or heart disease are at higher risk for severe RSV infections.

The laboratory studies were done using human cells. Now that Piedimonte's team has discovered how RSV prolongs the life of its host cell, they are proceeding with other studies to see if they can pinpoint the same mechanism in common cold and influenza viruses.

The paper's other authors are Laura F. Gibson, deputy director of the Mary Babb Randolph Cancer Center at WVU, and Lennie Samsell, a research assistant in the Pediatric Research Institute.

The article, "NGF Is an Essential Survival Factor for Bronchial Epithelial Cells during Respiratory Syncytial Virus Infection," is available online at http://dx.plos.org/10.1371/journal.pone.0006444.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Avian Influenza Strain Primes Brain for Parkinson's Disease

/PRNewswire/ -- At least one strain of the H5N1 avian influenza virus leaves survivors at significantly increased risk for Parkinson's disease and possibly other neurological problems later in life, according to new research from St. Jude Children's Research Hospital.

In the August 10 online early edition of the Proceedings of the National Academy of Sciences, researchers reported that mice which survived infection with an H5N1 flu strain were more likely than uninfected mice to develop brain changes associated with neurological disorders like Parkinson's and Alzheimer's diseases. Parkinson's and Alzheimer's involve loss of brain cells crucial to a variety of tasks, including movement, memory and intellectual functioning. The study revealed the H5N1 flu strain caused a 17 percent loss of the same neurons lost in Parkinson's as well as accumulation in certain brain cells of a protein implicated in both diseases.

"This avian flu strain does not directly cause Parkinson's disease, but it does make you more susceptible," said Richard Smeyne, Ph.D., associate member in St. Jude Developmental Neurobiology. Smeyne is the paper's senior author.

"Around age 40, people start to get a decline in brain cells. Most people die before they lose enough neurons to get Parkinson's. But we believe this H5N1 infection changes the curve. It makes the brain more sensitive to another hit, possibly involving other environmental toxins," Smeyne explained.

Smeyne noted the work involved a single strain of the H5N1 flu virus, the A/Vietnam/1203/04 strain. The threat posed by other viruses, including the current H1N1 pandemic flu virus, is still being studied.

Early indications are that the H1N1 pandemic strain carries a low neurologic risk, said Richard Webby, Ph.D., director of the World Health Organization Collaborating Center for Studies on the Ecology of Influenza in Animals and Birds, which is based at St. Jude. Webby, who is also an associate member of the St. Jude Department of Infectious Diseases, was not involved in the H5N1 study led by Smeyne.

This study also supports the theory that a hit-and-run mechanism is at work in Parkinson's disease. The investigators believe the H5N1 infection sparks an immune response that persists long after the initial threat is gone, setting patients up for further devastating losses from a second hit, possibly from another infection, drug or environmental toxin. In this case, researchers believe the flu virus is the first hit that sets up development of Parkinson's at a later time.

An estimated 4.1 million Americans, including 1 to 2 percent age 55 and older, have Parkinson's. Many suspect both genetic and environmental factors play a role in its development. The disease is linked to the death of dopamine-secreting cells in an area of the midbrain known as the substantia nigra pars compacta (SNpc). Dopamine is a neurotransmitter responsible for stimulating the motor neurons that control movement. Parkinson's is usually diagnosed after individuals lose 70 to 80 percent of the dopamine-producing cells. Treatment is available, but there is no cure.

Flu is primarily a respiratory disease, but indirect evidence dating back to 1385 links it to neurological problems, including the brain inflammation known as encephalitis. The association between flu and brain disorders like Parkinson's was strengthened by an outbreak of encephalitic lethargic, also known as von Economo's encephalopathy, following the 1918 Spanish flu pandemic. Some of those patients developed Parkinson's symptoms.

St. Jude researchers launched this study nearly three years ago in response to the threat posed by avian flu. Smeyne said there was concern about possible long-term neurological risks facing H5N1 survivors.

Previous studies had isolated H5N1 in the nervous system. But this is the first to show the path the virus takes to enter the brain as well as the aftermath of the infection. Smeyne said the virus' path from the stomach through the nervous system and into the brain is reminiscent of how Parkinson's unfolds.

In this study, mice were infected with an H5N1 flu strain isolated in 2004 from a patient in Vietnam. Robert Webster, Ph.D., said the strain remains the most virulent of the avian flu viruses. Webster, a co-author of the study, holds the Rose Marie Thomas Chair in Infectious Diseases at St. Jude.

About two-thirds of the mice developed flu symptoms, primarily weight loss. After three weeks there was no evidence of H5N1 in the nervous systems of the mice that survived.

But the inflammation the infection triggered within the brain continued for months. It was similar to inflammation associated with inherited forms of Parkinson's. Although the tremor and movement problems disappeared as flu symptoms eased, investigators reported that 60 days later mice had lost roughly 17 percent of dopamine-producing cells in SNpc, a structure found in the midbrain.

Researchers also found evidence that the avian flu infection led to over-production of a protein found in the brain cells of individuals with both Alzheimer's and Parkinson's diseases. The protein, alpha-synuclein, collected in H5N1-infected cells throughout the brain, including the midbrain where key dopamine-producing cells are located. There was little protein accumulation in the brain cells of uninfected mice.

The study marks the first time scientists were able to naturally trigger the protein build-up in an experimental Parkinson's system. "The virus activates this protein," Smeyne explained.

Other authors in this paper include Haeman Jang, David Boltz and Yun Jiao (St. Jude); and Katharine Sturm-Ramirez and Kennie Shephard (formerly of St. Jude).

This work was supported in part by the National Institute of Allergy and Infectious Diseases, National Parkinson's Foundation, Michael J. Fox Foundation, National Institutes of Health and ALSAC.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients

/PRNewswire / -- The Centers for Disease Control and Prevention (CDC) Foundation, CDC and Amgen today announced the launch of a three-year campaign to reduce infections among cancer patients. The campaign will provide resources and educational tools to help patients, families and healthcare providers better prevent and manage treatment-related infections.

"Cancer patients undergoing chemotherapy are at a higher risk for infections, which can impact their treatment success, lead to hospitalization and cause life-threatening complications," says Charles Stokes, president and CEO of the CDC Foundation. "This partnership between the CDC Foundation, CDC and Amgen brings together experts and resources from government and the private sector to address a critical health issue for cancer patients."

Each year, according to a 2005 study published in Cancer, 60,000 cancer patients in the United States are hospitalized for chemotherapy-related neutropenia - or low white blood cell count - which is a risk for serious infection, and a patient dies every two hours from this complication.

Healthcare professionals are highly concerned about the impact that infections have on treatment outcomes. According to a new Harris Interactive, Inc. survey of oncologists, infectious disease (ID) specialists and patients, 92 percent of oncologists say it is extremely to very important to prevent infections to achieve successful outcomes in chemotherapy patients.

Physicians are also concerned about emerging antibiotic resistance in this population, with 96 percent of ID specialists and 79 percent of oncologists reporting an increase in antibiotic-resistant infections in cancer patients over the past five years.

"We know that patients who acquire drug-resistant infections have more severe illness and higher risk of death," says Arjun Srinivasan, M.D., a medical epidemiologist in the Division of Healthcare Quality Promotion at CDC. "Programs to improve infection control in cancer patients, whose immune systems may be compromised by chemotherapy, will aid in saving the lives of these high-risk patients."

The comprehensive education campaign will include curricula for healthcare professionals on infection control for cancer patients and appropriate antibiotic management to prevent resistance. It will also include an online education program for patients and caregivers.

"We believe joining forces with the CDC Foundation and CDC on this important public health initiative helps us achieve our mission to serve patients by bringing together experts in infectious disease and cancer to improve infection control and promote appropriate antibiotic stewardship for these high-risk patients," says Sean Harper, M.D., chief medical officer and head of Global Development at Amgen.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

Mayo Clinic Study Finds Increased Risk of Pneumococcal Disease in Asthma Patients

/PRNewswire-USNewswire/ -- Mayo Clinic research shows adults with asthma are at increased risk of serious pneumococcal disease caused by Streptococcus pneumoniae, the most common bacteria causing middle ear infections and community acquired pneumonia. It also causes blood stream infections and brain infections. According to the Centers for Disease Control, pneumococcal infection is one of the leading causes of death from a vaccine-preventable disease. The researchers recommend including asthma as an indication for pneumococcal vaccination in adults. The results of the study were recently published in the October edition of the Journal of Allergy and Clinical Immunology.

"We found that adults with invasive pneumococcal disease, a serious, potentially fatal disease, are seven times more likely to be asthmatics. Our study also showed that 17 percent of the burden of invasive pneumococcal disease can be attributable to asthma at a population level. This is quite a significant impact on the burden of invasive pneumococcal disease," says Young Juhn, M.D., a pediatric and adolescent medicine physician-scientist at Mayo Clinic and lead author of the study. "Invasive pneumococcal disease is a vaccine-preventable disease. The implication is that we have the ability to significantly reduce instances of this potentially fatal disease by expanding the indication for the pneumococcal vaccine to include adults with asthma."

Researchers used a population-based, retrospective case-control study of 3,941 records from the Rochester, Minn. population to see if there was a higher incidence of pneumococcal disease among people with asthma. Adults diagnosed with asthma were almost seven times more likely to develop invasive pneumococcal diseases than adults who were not diagnosed with asthma. In children the sample size for was not large enough to draw a definitive conclusion.

"The Advisory Committee on Immunization Practices (ACIP), which is the governing body for immunization practices in the United States, voted unanimously to include asthma as a pneumococcal vaccine condition at the recent ACIP meeting in October, 2008. Adults with asthma should receive the pneumococcal vaccine," says Dr. Juhn.

Further research implications include finding out why a connection exists between instances of pneumococcal disease and asthma, determining whether the connection between asthma and this particular bacterial infection also exists with other bacterial infections, such as pertussis (whooping cough), and the connection between asthma and other non-infectious diseases, such as inflammatory bowel disease, juvenile diabetes, and rheumatoid arthritis. Dr. Juhn does not believe all asthmatic patients react the same way. He is looking for a subset of asthmatic patients who have an increased susceptibility to microbial infection.

Study authors, in addition to Dr. Juhn, include Hirohito Kita, M.D., Department of Allergic Diseases Research, Mayo Clinic; Barbara Yawn, M.D., Department of Epidemiology, Mayo Clinic; Thomas Boyce, M.D., Department of Pediatric Infectious Diseases, Mayo Clinic; Kwang Yoo, M.D., Ph.D., Department of Internal Medicine, Kunkook University, Republic of Korea; Michaela McGree, Department of Biostatistics, Mayo Clinic; Amy Weaver, Department of Biostatistics, Mayo Clinic; Peter Wollan, Ph.D., Department of Epidemiology, Mayo Clinic; and Robert Jacobson, M.D., Department of Pediatric and Adolescent Medicine, Mayo Clinic.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

CDC Expands Testing Recommendations For Chronic Hepatitis B Virus Infection

The U.S. Centers for Disease Control and Prevention (CDC) today (September 18, 2008) published new recommendations for health care providers that are designed to increase routine testing in the United States for chronic hepatitis B, a major cause of liver disease and liver cancer. CDC recommends testing all individuals born in Asia and Africa, as well as testing additional at-risk populations, including men who have sex with men (MSM) and injection-drug users (IDUs). The recommendations, published today in CDC′s Morbidity and Mortality Weekly Report (MMWR) Recommendations & Reports, also for the first time give health professionals guidance for effective management of chronically infected hepatitis B patients.

“Chronic hepatitis B affects the lives of more than one million Americans, many of whom do not even know they are infected. These new recommendations are critical to identifying people who are living with the disease without the benefits of medical attention,” said John W. Ward, M.D., director of CDC′s Division of Viral Hepatitis. “Testing is the first step to identify infected persons so that they can receive lifesaving care and treatment, which can break the cycle of transmission, slow disease progression, and prevent deaths from liver cancer.”

In the United States, chronic hepatitis B is the underlying cause of an estimated 2,000 – 4,000 deaths each year from cirrhosis and liver cancer. The CDC recommendations are key to increasing the early diagnosis of chronic hepatitis B virus (HBV) infection, since many of the estimated 800,000 – 1.4 million Americans with chronic HBV infection have no symptoms and are unaware of their disease.

Highlights of the recommendations

The new testing recommendations build upon and reinforce past recommendations to test all pregnant women, infants born to infected mothers, household contacts and sex partners of infected individuals, and people with HIV.

Along with continued testing of those groups, routine testing is now recommended for additional populations, including:

* Individuals born in Asia, Africa, and other geographic regions with 2 percent or higher prevalence of chronic HBV infections: Previous CDC recommendations called for testing of people born in areas with 8 percent prevalence or higher. Expanded testing is essential since the rate of liver cancer deaths and chronic HBV in the United States remains high among foreign-born U.S. populations from these areas. For example, nearly one in 12 Asian Americans and Pacific Islanders living in the United States is HBV-infected, and one-third or more are unaware.
* Men who have sex with men and injection drug users: Routine testing is needed for these persons since both have a higher prevalence of chronic HBV infection than the overall U.S. population. Up to 3 percent of MSM and up to 6 percent of IDUs are estimated to be chronically infected with HBV, compared to three tenths of one percent of the general population.
* Persons with abnormal liver function tests (not explained by other conditions) and persons who require immunosuppressive therapy (e.g., chemotherapy for malignant diseases).

The new CDC report also gives recommendations for referral of HBV-infected persons to specialists for ongoing monitoring and medical care. Such guidelines are needed now to assist providers, since most of the effective medications for chronic HBV treatment have become available only in the last five years. In addition, the recommendations advise healthcare providers to provide culturally-sensitive ongoing patient education, begin lifelong monitoring for progression of liver disease, and ensure protection of household members and other close contacts of infected persons.

Testing recommendations are a critical component of CDC’s strategy to eliminate HBV transmission. CDC continues to work with the medical community to promote comprehensive prevention and treatment efforts for HBV, which include vaccination for all infants and at-risk adults; catch-up vaccination of previously unvaccinated children; routine screening for all pregnant women; treatment of newborns of infected or untested mothers; and testing household contacts and sex partners of HBV-infected persons.

-----

www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Studies Highlight MRSA Evolution and Resilience

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections are caused primarily by a single strain — USA300 — of an evolving bacterium that has spread with "extraordinary transmissibility" throughout the United States during the past five years, according to a new study led by National Institutes of Health (NIH) scientists. CA-MRSA, an emerging public health concern, typically causes readily treatable soft-tissue infections such as boils, but also can lead to life-threatening conditions that are difficult to treat.

The study, from the National Institute of Allergy and Infectious Diseases (NIAID) of NIH, resolves debate about the molecular evolution of CA-MRSA in the United States. The findings rule out the previously held possibility that multiple strains of USA300, the most troublesome type of CA-MRSA in the United States, emerged randomly with similar characteristics. The study also offers a hypothesis for the origin of previous S. aureus outbreaks, such as those caused by penicillin-resistant strains in the 1950s and 1960s.

A second study led by the same NIAID scientists takes the issue of the evolution of MRSA a step further, revealing new information about how MRSA bacteria in general, including the USA300 group, elude the human immune system.

The first study, which appears online this week in the Proceedings of the National Academy of Sciences, found that the USA300 group of CA-MRSA strains, collectively called the epidemic strain, comprises nearly identical clones that have emerged from a single bacterial strain. It is the first time scientists have used comparative genome sequencing to reveal the origins of epidemic CA-MRSA. Frank R. DeLeo, Ph.D., at NIAID's Rocky Mountain Laboratories (RML) in Hamilton, Mont., led the research.

"Scientists are pressing ahead quickly to learn more about how some MRSA strains evade the immune system and spread rapidly," says NIAID Director Anthony S. Fauci, M.D. "The information presented in these two studies adds important new insights to that expanding knowledge base."

To understand how CA-MRSA is evolving in complexity and spreading geographically, Dr. DeLeo's group sequenced the genomes of 10 patient samples of the USA300 bacterium recovered from individuals treated at different U.S. locations between 2002 and 2005. They then compared these genomes to each other and to a baseline USA300 strain used in earlier studies. Eight of the 10 USA300 patient samples were found to have nearly indistinguishable genomes, indicating they originated from a common strain. The remaining two bacteria were related to the other eight, but more distantly.

Interestingly, of the eight nearly indistinguishable USA300 patient samples, two caused far fewer deaths in laboratory mice than the others, highlighting an emerging view that tiny genetic changes among evolving strains can profoundly affect disease severity and the potential for drug resistance to develop.

"The USA300 group of strains appears to have extraordinary transmissibility and fitness," says Dr. DeLeo. "We anticipate that new USA300 derivatives will emerge within the next several years and that these strains will have a wide range of disease-causing potential." Ultimately, Dr. DeLeo and his colleagues hope that the work will lead to the development of new diagnostic tests that can quickly identify specific strains of MRSA.

Fred C. Tenover, Ph.D., of the Centers for Disease Control and Prevention in Atlanta (CDC) contributed the 10 USA300 clinical isolates from CDC's Active Bacterial Core Surveillance system. Other study collaborators included Barry N. Kreiswirth, Ph.D., of the International Center for Public Health (ICPH) in Newark, N.J., and James M. Musser, M.D., Ph.D., of The Methodist Hospital Research Institute in Houston.

The second report, which involved scientists from RML, ICPH and Vanderbilt University Medical Center in Nashville, was recently published online in the Journal of Immunology. This study provides scientists with new details about the complex mechanisms MRSA uses to avoid destruction by neutrophils, human white blood cells that ingest and destroy microbes. When exposed to hydrogen peroxide, hypochlorous acid (the active component of household bleach) or antimicrobial proteins — all killer chemicals released by neutrophils — MRSA senses danger, escapes harm and turns the tables on the white blood cells, destroying them. Work is continuing in Dr. DeLeo's lab to understand how the bacterium senses and survives attacks by neutrophils.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.