June 22, 2010

FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies


For Immediate Release: June 21, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Test advances ability to detect HIV infection earlier

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.


Liver at Risk in Diabetes

By Crystal Phend, Senior Staff Writer, MedPage Today
Published: June 21, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Although the liver is often overlooked in diabetes, even newly-diagnosed cases carry a substantial risk of serious hepatic damage, researchers found.

In a population-based study, newly-diagnosed diabetes was associated with a near doubling in the rate of liver cirrhosis, liver failure, or liver transplant compared with people in the general population who did not have diabetes, according to Gillian Booth, MD, MSc, of St. Michael's Hospital in Toronto, and colleagues.

After adjusting for important contributors to liver disease, the association remained significant with a 77% increased risk for newly-diagnosed diabetes patients (95% confidence interval 68% to 86%), they reported online in CMAJ.Action Points


Note that the retrospective study could not determine whether diabetes caused the liver disease seen during follow-up.

Note that diabetes guidelines do not recommend screening for liver disease.


"The negative impact of diabetes on the retinal, renal, nervous, and cardiovascular systems is well recognized, yet little is known about its effect on the liver," they wrote.

Although much still remains to be discovered about the mechanisms and cause of the link between diabetes and liver disease, nonalcoholic steatohepatitis (NASH) is almost certainly involved, according to Kenneth Cusi, MD, who has been studying this condition at the University of Texas Health Science Center in San Antonio.

Steatosis is known to arise in relationship to insulin resistance in obesity, and most people with the condition do have some degree of glucose abnormality, he explained in an interview.

The two seem to "feed on each other," Cusi said.

Unlike with eye disease, cardiovascular disease, and kidney disease, guidelines for diabetes care don't recommend screening for liver disease.

"However, when the liver fails," Booth's group cautioned in the paper, "there is no equivalent form of management, such as hemodialysis or retinal photocoagulation."

They suggested that liver disease "may be appropriate for addition to the list of target-organ conditions related to diabetes," with annual screening by means of a blood test, such as for the liver enzyme alanine aminotransferase.

But the sensitivity of blood tests and even ultrasound aren't great for identifying fatty liver disease that is the precursor to more serious liver problems and liver biopsy is not a feasible screening method, Cusi noted.

Also, it would first have to be shown that preventive measures such as weight loss and glycemic and lipid control are effective in diabetes, as they are in isolated fatty liver without diabetes, the researchers said.

To expand evidence for the link, the researchers retrospectively examined the administrative databases of the universal healthcare system in the province of Ontario from 1994 through 2006.

They compared 438,069 adults with newly diagnosed diabetes and an age-, sex-, and regionally-matched control group of 2,059,708 individuals without known diabetes. Preexisting liver or alcohol-related disease were cause for exclusion.

During a median of 6.4 years of follow-up, serious liver disease -- liver cirrhosis, liver failure, or liver transplant -- developed in 2,463 newly-diagnosed diabetes cases and 5,902 controls.

Thus, unadjusted liver disease incidence was 92% higher with diabetes (8.19 per 10,000 person-years with diabetes and 4.17 without it).

This difference remained significant across mutually-adjusted patient subgroups by age, gender, urban versus rural residence, and income level.

Diabetes appeared to have the most pronounced link with liver cirrhosis (adjusted hazard ratio 2.55, 95% CI 2.35 to 2.76) and the least with liver transplantation (adjusted HR 1.31, 95% CI 1.05 to 1.64).

Hypertension and obesity didn't appear to entirely account for the relationship with diabetes. The risk of serious liver disease in nondiabetic individuals with preexisting hypertension or obesity was elevated but less so than among those with diabetes.

But the researchers cautioned that it is difficult to separate out the effects of these related conditions.

"Although our findings and those of the U.S. study [which found elevated chronic NASH risk in veterans with diabetes] edge forward the idea that diabetes may be harmful to the liver, the question remains of whether this effect extends beyond the metabolic syndrome," they wrote.

Another question that remains to be answered is causality.

Booth's group pointed out that hepatic fat content rises in parallel with insulin resistance and glucose dysregulation and that diabetes as a complication of cirrhosis typically doesn't arise until cirrhosis reaches an advanced stage.

However, they noted, they couldn't rule out the pre-existence of subclinical liver disease before study entry.

The study was funded by the Banting and Best Diabetes Centre at the University of Toronto and by the Institute for Clinical Evaluative Sciences, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care

The researchers reported no conflicts of interest.

Cusi reported support from the American Diabetes Association and the Boris Welcome Fund and an award from the VA. Takeda provided the study drug for research he is doing in NASH but no personal renumeration to Cusi.

Primary source: CMAJ
Source reference:
Porepa L, et al "Newly diagnosed diabetes mellitus as a risk factor for serious liver disease" CMAJ 2010

Thought rare, virus strikes twice in S.A.

By Don Finley - Express-News
Web Posted: 06/22/2010 12:00 CDT

Two local cases — one of them fatal — of a form of hepatitis once thought to be rare in the United States have captured the attention of state and local health officials.

Hepatitis E, a viral infection of the liver, was long considered a problem mainly in developing countries — and to a handful of Americans who traveled there — spread by contaminated food and water.

While the infection clears up on its own in most people, it causes severe illness in some and can be fatal in pregnant women.

Large outbreaks of hepatitis E have taken place in Mexico, Asia and Africa.

The Metropolitan Health District was notified late last year that three people in one San Antonio hospital had tested positive for the infection between September and November 2009. A more sophisticated test later found one of the three was not infected.

Of the two others, one was a 21-year-old woman who died while undergoing a liver transplant. An earlier home pregnancy test had been positive, but she wasn't pregnant when admitted to the hospital, health officials said. The other patient, a 44-year-old nurse's aide, had also suffered some liver damage.

“We couldn't figure out how they acquired it,” said Roger Sanchez, senior epidemiologist with Metro Health, who presented a paper on the cases at a public health meeting in Austin recently. “None of them had any (foreign) travel history. They were previously healthy. Which begs the question — how did they get it?”

But some American researchers who study hepatitis E are finding it more common in the U.S. than previously thought. In fact, the infection seems to be everywhere. What remains a mystery is why some people get sick from the virus but most don't.

“It appears to be a relatively common infection. But clinical symptoms following infection appear to be quite rare,” said Mark Kuniholm, an instructor of epidemiology and population health at the Albert Einstein College of Medicine in New York.

In a study published last July in the Journal of Infectious Diseases, Kuniholm and colleagues tested 18,695 blood samples that had been collected across the country through the National Health and Nutrition Examination Survey, which is conducted every few years by the federal government. He found one in every five people had antibodies to hepatitis E, suggesting a previous infection.

Setting aside those born in another country, the highest infection rates were in Anglo men living in the Midwest. Those who ate liver more than once a month were more likely to have antibodies.

Hepatitis E is commonly found in U.S. pigs, with one study showing 63 percent of commercially raised swine carried antibodies to the virus and 35 percent had signs of active infection. Another study found the virus in 11 percent of pig livers sold in a sample of grocery stores.

“But this virus doesn't make pigs very sick,” Kuniholm said. “And for the most part it doesn't make humans very sick. It appears that we get the virus, we develop an immune response, but the vast majority of us never get sick.”

Sanchez and Kuniholm stressed that proper cooking kills the virus.

Of the three common forms of hepatitis in the United States, A, B and C, the infection most resembles hepatitis A — which is also often spread through fecally contaminated food and water. Patients who get sick usually recover without treatment. But it's also different from hepatitis A in that person-to-person transmission isn't common with hepatitis E, and outbreaks are usually linked to water supplies contaminated by sewage. Adults are more likely to get sick from E, while children seem more susceptible to A.

And hepatitis E can be passed from animals to humans. A study found that American veterinarians who specialized in swine had higher rates of hepatitis E exposure. Antibodies also have been found in other animals, including rodents, dogs and cats.

Sanchez said there's too little information about the disease to draw any conclusions about whether more people are getting infected. It might be that the commercially available antibody test is prone to false positives. Hepatitis E isn't part of the standard panel of hepatitis tests given to liver patients. It must be specially ordered from certain labs.

Family man Leigh fought illness with a smile on his face

smile with ease

Jun 22 2010 by Alex Terrell, South Wales Echo

WHEN Leigh David Sugar passed away aged 44, it marked the departure of a beloved husband, a father and a loving son.

An entrepreneur, he established and grew the Tynant Garage in Beddau, near Pontypridd, into a respected business in the community.

It is testament to his positivity that Leigh – a beloved son to parents Margaret and Graham – held the business until recently.

Those closest to Leigh will say that he had the alchemy to make people around him laugh and smile with ease.

He would go out of his way to make a witty remark and it provided family, friends and acquaintances with a unique feeling of assurance.

His wife Barbara and daughters Kayleigh and Jodie have always been Leigh’s muse, a source of love and a reason for action, even when illness took hold. They loved to holiday, jetting off to the sunshine of the Dominican Republic, Mexico and Cuba. Leigh beamed at both his daughters’ ambition at school and university.

A keen horseman, Leigh rode hunts in his youth throughout the Pontypridd area.

It was here that Leigh met his sweetheart Barbara. Her father employed Leigh in their stables and they dated until their marriage in 1990.

Younger cousin David recalled how Leigh would always make him the butt of the jokes, teasing but including those around him in the fun. Leigh once repaired the car of David’s brother in a matter of hours, so nobody could tell that David had earlier driven it into a bollard – such was Leigh’s way with cars and generosity to his family.

A haemophiliac, Leigh died from liver cancer, a complication from Hepatitis C which he was given through contaminated blood products then prescribed to improve his condition. Haemophilia reduces the blood’s ability to clot and can result in internal and external bleeding without warning from a bump or bruise.

Leigh was one of 4,800 haemophiliacs in the UK to be given Hepatitis C through defective blood products, drawn from the blood of American prisoners, prostitutes and homeless patients to fuel a private enterprise.

These were injected into British patients in the 1970s and ’80s, people are still dying as a result.

Aged 26 when he discovered he had Hepatitis C, his relatives remembered how it forced him to seize what was left of his life. He refused to let it stand in the way of securing a future for his family and business. He was still fun to be around, still cracking jokes and lightening the mood, despite the uncomfortable side effects of his treatment plan.

In the pursuit for better treatments, Leigh’s family rallied, searching all over the world for advice. They even managed to get him a pioneering drug from America, and he shared his treatment experiences with other contaminated blood victims.

Barbara told relatives she recently received a letter from an elderly widow, a Tynant Garage customer, thanking Leigh for his fantastic personal service. Nothing was too much trouble for Leigh in his business, nor in his life.

Tainted Blood is a campaign for victims of contaminated blood products. The group will be conducting a protest for the campaign on June 30 in front of Parliament to urge the Government to address the issue and remember those who have passed away.

For more information visit http://www.taintedblood.info/


Transplanted organs are often far from perfect

Donors often have pre-existing conditions

Disease transmission from donated organs is extremely rare.
(AP File)

June 22, 2010

By MONIFA THOMAS Staff Reporter/mjthomas@suntimes.com

The death of a 28-year-old British woman who contracted pneumonia after receiving a lung transplant from a donor who had smoked for 30 years sparked an uproar.

But the practice of transplanting organs from donors with less-than-ideal medical histories, such as smokers and cancer survivors, isn't unusual and is, in fact, a necessity, given the shortage of donor organs, transplant specialists say.

"In a perfect world, if we were able to build organs from scratch . . . everyone would get a perfect organ," says Dr. Giuliano Testa, director of liver transplantation at the University of Chicago Medical Center. "But those perfect organs in nature are only in a minority of cases."

Organ donors who are HIV-positive or who have actively spreading cancer are automatically ruled out for transplants. But transplants involving donors who have just about any other chronic medical condition are still possible, according to the United Network for Organ Sharing.

Transplant centers make decisions on whether to use organs from donors with pre-existing medical conditions based on factors such as how ill the would-be recipient is, how likely it is another organ would be found for that person and whether there's a risk of disease transmission from the donor, says Dr. Michael Ison, a specialist in transplant infections at Northwestern Memorial Hospital who chairs the organ-sharing organization's Ad Hoc Disease Transmission Advisory Committee.

Disease transmission from donated organs is extremely rare, occurring in 0.2 percent of cases, Ison says. The United Network for Organ Sharing requires organ donors to be tested for HIV, hepatitis B and C and the Epstein-Barr virus.

The transmission of HIV and hepatitis C to four transplant recipients in Chicago from a single donor in 2007 were the first known cases in two decades.

A far greater risk for people on the transplant waiting list is dying because they didn't get a transplant. There are currently more than 100,000 people on the waiting list for an organ transplant. About 25,000 people receive transplants each year, while on average 18 people a day die waiting.

"All of transplantation is a cost-benefit ratio," says Dr. Howard Sankary, chief of intra-abdominal transplantation at Loyola University Medical Center in Maywood. "If a liver patient is going to die from their liver disease, and there's no other organ available, you would take the less-than-perfect organ because they have a chance of living."

People in need of organs are usually informed of the potential risk of disease transmission from donors when they join the transplant waiting list, Ison says. If a potential problem with a donor is identified, it's also standard policy for recipients to be notified of these issues at the time an offer is made. Ison says patients usually have one hour to decide if they'll accept the organ, though Testa says he gives his patients longer to decide.

"The majority of patients that are offered this are more than willing to accept that organ, and even in many of the disease transmission cases . . . many people still say they don't regret accepting the organ," says Ison, who is conducting a study on the subject.