Showing posts with label HCV tests. Show all posts
Showing posts with label HCV tests. Show all posts

Wednesday, January 31, 2018

Evaluation of dried blood spot samples for screening of hepatitis C and human immunodeficiency virus in a real-world setting

Scientific Reports
volume 8, Article number: 1858 (2018)
doi:10.1038/s41598-018-20312-5

Evaluation of dried blood spot samples for screening of hepatitis C and human immunodeficiency virus in a real-world setting
Sonia Vázquez-Morón, Pablo Ryan, Beatriz Ardizone-Jiménez, Dolores Martín, Jesus Troya, Guillermo Cuevas, Jorge Valencia, María A. Jimenez-Sousa, Ana Avellón & Salvador Resino

Full Text
https://www.nature.com/articles/s41598-018-20312-5

Abstract
Both hepatitis C virus (HCV) infection and human immunodeficiency virus (HIV) infection are underdiagnosed, particularly in low-income countries and in difficult-to-access populations. Our aim was to develop and evaluate a methodology for the detection of HCV and HIV infection based on capillary dry blood spot (DBS) samples taken under real-world conditions. We carried out a cross-sectional study of 139 individuals (31 healthy controls, 68 HCV-monoinfected patients, and 40 HCV/HIV-coinfected patients). ELISA was used for anti-HCV and anti-HIV antibody detection; and SYBR Green RT-PCR was used for HCV-RNA detection. The HIV serological analysis revealed 100% sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The HCV serological analysis revealed a sensitivity of 92.6%, specificity of 100%, PPV of 100%, and NPV of 79.5%. Finally, the HCV-RNA detection test revealed a detection limit of 5 copies/µl with an efficiency of 100% and sensitivity of 99.1%, specificity of 100%, PPV of 100%, and NPV of 96.9%. In conclusion, our methodology was able to detect both HCV infection and HIV infection from the same DBS sample with good diagnostic performance. Screening for HCV and HIV using DBS might be a key strategy in the implementation of national programs for the control of both infections.

Monday, May 15, 2017

Listen - Testing, Care, and Cure of Hepatitis C Can Be Done in Primary Care

Testing, Care, and Cure of Hepatitis C Can Be Done in Primary Care

Medscape
News & Perspective > CDC Expert Commentary

COMMENTARY
Alexander Millman, MD

Despite many challenges, an increasing number of HCV-infected patients are being treated and cured, and many can be managed in primary care.

As we consider opportunities for improving testing, care, and cure of HCV in the United States, it can be useful to visualize a person progressing along a care cascade from HCV diagnosis to cure. In essence, it starts with a person being tested for HCV with an HCV antibody test. If the test is positive, then the diagnosis must be confirmed with an HCV RNA test.

Persons who test positive for HCV RNA should have their genotype checked and an assessment of the severity of liver disease. Their healthcare provider can then implement an HCV treatment plan appropriate to the person's specific needs. Sustained virologic response or cure is determined by testing for the presence of HCV RNA 12 weeks after the completion of treatment.

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Wednesday, February 8, 2017

Initial HCV test results are false positive in almost half of general population

Initial HCV test results are false positive in almost half of general population

Nearly half of patients in the general population who test positive for hepatitis C virus (HCV) do not have the disease, according to Dr. Anne Moorman and her associates.

From a sample of 22,359 National Health and Nutrition Examination Study participants, 479 people received positive HCV antibody test results from 2007 to 2012. Of this group, 477 participants underwent further follow-up testing using a recombinant immunoblot assay. RIBA testing confirmed positive test results for 323 participants, while 105 patients received negative test results and 49 received indeterminate test results.

Continue reading....

Wednesday, October 26, 2016

Review - Laboratory tests relevant for the treatment of HCV infection in the era of DAA therapy

Clinical Laboratory Testing in the Era of Directly Acting Antiviral Therapies for Hepatitis C

Full Text Article
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Citation Wilson EM, Rosenthal ES, Kattakuzhy S, Tang L, Kottilil S. 2017. Clinical laboratory testing in the era of directly acting antiviral therapies for hepatitis C. Clin Microbiol Rev 30:23–42. https://doi.org/10.1128/CMR.00037-16.

SUMMARY
Directly acting antiviral (DAA) combination therapies for chronic hepatitis C virus (HCV) infection are highly effective, but treatment decisions remain complex. Laboratory testing is important to evaluate a range of viral, host, and pharmacological factors when considering HCV treatment, and patients must be monitored during and after therapy for safety and to assess the viral response. In this review, we discuss the laboratory tests relevant for the treatment of HCV infection in the era of DAA therapy, grouped according to viral and host factors.


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Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. A link to the above mentioned article (PDF) was tweeted by Mr. Chang this morning.

Monday, March 21, 2016

FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis

FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis

INDIANAPOLIS, March 21, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its hepatitis C virus (HCV) quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to providing an accurate measurement of how much virus is in a patient's blood, to help a physician determine the best course of treatment. This expanded use for the test saves a physician time in making a treatment decision and helps improve patient care.

"Hepatitis C can be a silent killer, but with several highly effective new antiviral drugs on the market, there is a very high cure rate," said Alan Wright, MD, MPH, chief medical officer at Roche Diagnostics. "That's why the CDC recommends HCV testing for persons at risk for infection and for everyone born between 1945 and 1965. But a positive HCV antibody test alone does not indicate an active infection. So it's critical for physicians to diagnose an active infection by detecting the presence of hepatitis C virus RNA."
The Roche test is the first quantitative HCV RNA test to be approved for use as an aid in diagnosis for active HCV infection. This expanded indication is in addition to its approved use as a viral load test to help physicians assess a patient's response to antiviral therapy. Roche HCV viral load tests have also been used to establish the treatment efficacy of direct-acting antiviral treatment regimens recently approved by the FDA. The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 is part of Roche's expanding portfolio of diagnostic tests to diagnose, confirm and manage hepatitis C infection.
 
About the test
The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 represents the latest innovation in Roche's virology test portfolio. The dual-probe PCR assay is intended for use in the management of patients with chronic HCV, in conjunction with clinical and laboratory markers of infection, and as an aid in diagnosis for individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The test is an in vitro nucleic acid amplification test for the detection and quantitation of hepatitis C virus RNA genotypes 1 to 6 in human EDTA plasma or serum. It can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy and to assess viral response to antiviral treatment (response-guided therapy), as measured by changes of HCV RNA levels.
The real-time polymerase chain reaction (PCR)-based HCV test is designed for use on Roche's fully automated COBAS AmpliPrep/COBAS TaqMan System, an established platform for viral load monitoring of multiple infectious diseases that improves workflow in testing laboratories. The system can be combined with the cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.

Saturday, November 14, 2015

One-step test for hepatitis C virus infection developed by UC Irvine Health researchers

One-step test for hepatitis C virus infection developed by UC Irvine Health researchers

Related research shows blood or urine sample can be used

Orange, Calif. -- UC Irvine Health researchers have developed a cost-effective one-step test that screens, detects and confirms hepatitis C virus (HCV) infections. Dr. Ke-Qin Hu, director of hepatology services, will present findings at the Annual Meeting of American Association for the Study of Liver Disease (AASLD) in San Francisco, Nov. 14-16. Current blood-based HCV testing requires two steps and can be expensive, inconvenient and is not widely available or affordable globally.

"Our novel HCV antigen test system has significantly improved sensitivity and specificity over current tests. Importantly, for the first time, we can use urine specimens for one-step screening and diagnosing of HCV infection," said Hu, professor of gastroenterology and hepatology at UC Irvine School of Medicine. "Finding a more convenient, easy-to-use and cost-effective screening alternative is imperative, because HCV is significantly under-screened and under-diagnosed."

Although the current HCV screening test is specific and sensitive, it cannot distinguish active infection from a previous infection. A blood sample is required, and two steps are required. First, virus-specific antibodies must be detected in the blood. Then, the sensitive HCV RNA PCR test must be administered to confirm whether or not the infection is active. Hu said many developing countries are not equipped to administer the two-step test, especially the HCV RNA PCR test. In the U.S., its cost is above $200. The novel HCV antigen test system developed by Hu's UC Irvine lab could significantly reduce the cost, human resources and time required for the test results.

"The ability to detect infection using urine rather than blood avoids needle stick and blood sample collection, greatly reduces the cost and necessary clinical infrastructure for screening and diagnosis, helping to promote widespread adoption of the test on a global scale," Hu said.

According to the Centers for Disease Control and Prevention, approximately 150 million people worldwide and 3.2 million people in the U.S. are infected with HCV. Effective screening and fast diagnosis are critical for treatment and controlling transmission.

"Those who are HCV infected can now be cured, before a further liver injury and complications develop, but only if they are diagnosed" Hu said.

People with an HCV infection do not usually experience symptoms until more serious liver injury develops, such as fibrosis, cirrhosis, or liver cancer. The CDC recommends screening tests for high-risk patients, including intravenous drug users, and individuals who had blood transfusions before 1992, as well as those born between 1945 and 1965.

In addition to Hu, researcher Wei Cui is also listed as an author of the AASLD abstract entitled A Highly Specific and Sensitive Hepatitis C Virus Angtigens Enzyme Immunoassay (HCV-Ags EIA) for One-step Diagnosis of Viremic HCV Infection.

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UC Irvine Health comprises the clinical, medical education and research enterprises of the University of California, Irvine. Patients can access UC Irvine Health at physician offices throughout Orange County and at its main campus, UC Irvine Medical Center in Orange, Calif., a 411-bed acute care hospital that provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation. U.S. News & World Report has listed it among America's Best Hospitals for 15 consecutive years. UC Irvine Medical Center features Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program, Level I trauma center and Level II pediatric trauma center, and is the primary teaching hospital for UC Irvine School of Medicine. UC Irvine Health serves a region of more than 3 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook and Twitter.

About the University of California, Irvine: Currently celebrating its 50th anniversary, UCI is the youngest member of the prestigious Association of American Universities. The campus has produced three Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 30,000 students and offers 192 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $4.8 billion annually to the local economy. For more on UCI, visit http://www.uci.edu.

Wednesday, May 21, 2014

Paper-based diagnostics could curb hepatitis C pandemic

Paper-based diagnostics, made with a scrapbooking tool, could curb hepatitis C pandemic

To the relief of patients diagnosed with hepatitis C, the U.S. Food and Drug Administration approved two new treatments late last year, and a few more are on the way. Now scientists are solving another side of the disease's problem: identifying the millions more who have the virus but don't know it — and unwittingly pass it on. A report in the ACS journal Analytical Chemistry describes a novel, scrapbook-inspired test that does just that.

Xuan Mu, Zhi Zheng and colleagues point out that the hepatitis C virus (HCV), a blood-borne pathogen that can cause liver cirrhosis, cancer and even death, kills more people in the U.S. than HIV. It also infects an estimated 150 million people around the world. Although diagnostic tests exist, they require an initial screening and then a costly second test for confirmation. The extra office visits, money and time required for a definitive diagnosis means a lot of people simply can't or won't follow up. To make diagnosis more accessible, the researchers took advantage of the recent development of new, inexpensive paper-based medical technologies and applied it to HCV screening.

Taking a page from the popular scrapbooking pastime, the scientists used a flower-shaped metal paper cutter to punch out shapes from special paper for their diagnostic test. The method solves the problem of patterning the paper, made of nitrocellulose — a highly flammable substance — without using heat. They add antigens, antibodies and other chemicals to the paper to test patient samples. With one flower-shaped paper, they can conduct both HCV tests on a sample simultaneously in just minutes, instead of hours.

###

The authors acknowledge support from the National Scientific and Technological Major Project of China and the National Natural Science Foundation of China.

The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. With more than 161,000 members, ACS is the world's largest scientific society and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.

To automatically receive news releases from the American Chemical Society, contact newsroom@acs.org.

Thursday, May 15, 2014

Rapid Hepatitis C Testing Among Persons at Increased Risk for Infection


Rapid Hepatitis C Testing Among Persons at Increased Risk for Infection —
Lauren J. Stockman, MPH, Sheila M. Guilfoyle, Andrea L. Benoit, James M. Vergeront, MD, Jeffrey P. Davis, MD
Morbidity and Mortality Weekly Report. 2014;63(14):309-311.

Discussion Only
Introduction

As a tool for enhanced surveillance in Wisconsin, use of the rapid HCV test facilitated screening at four agencies where predominantly young persons at increased risk for HCV infection receive outreach testing, syringe exchange, and other harm reduction services. Most persons who inject drugs acquire HCV infection during their first years of injecting, and sharing of injection equipment has been found to be the most important behavior associated with infection.[3,9] The prevalence of HCV infection among program participants was 20%. Results of previous studies have demonstrated higher prevalence of HCV infection among persons who inject drugs in the United States (range = 35%–65%).[9] However, participants in this program were tested within agencies offering harm reduction services and, therefore, might exhibit safer injection practices or more preventive behaviors compared with other persons who inject drugs.

A majority (70%) of the HCV infections detected during this program were active, viremic infections. This finding, coupled with self-reported behaviors of recent and continued sharing of injection equipment despite participation in a syringe exchange service, is concerning. These data suggest that prevention messages that emphasize the risk for HCV transmission during the sharing of any injection equipment (not only syringes) are highly important. All-oral therapeutic regimens with shorter duration and fewer adverse effects are now available to cure HCV infection and reduce the risk for transmission. Efforts to link persons with viremia to medical care are critical to limit the spread and impact of hepatitis C in Wisconsin.

Although use of the rapid HCV test provides a result at the point-of-visit, additional tests are needed to differentiate past infections from current infections. Therefore, HCV antibody surveillance strategies also should include the collection of blood specimens for RNA diagnostic testing. In the current program, venous blood specimens were obtained from 78% of participants with positive results from rapid HCV tests. The number of specimens collected to confirm current HCV infection might be increased, where practical, with additional training in venipuncture at each agency and enhancement of messages informing clients of the importance of HCV testing and knowledge of the test results.

The findings in this report are subject to at least three limitations. First, although rapid HCV tests were readily available, they were not accepted by all clients at the four agency sites, and data regarding rates of refusal of the rapid tests were not collected systematically. Second, efforts were made by each agency to refer clients with positive HCV test results to medical services; however, data regarding linkage to treatment of acute HCV infection were not collected systematically. Such data are essential to help determine where efforts to improve access to treatment might be needed. Finally, populations served by the four agencies might not be representative of the general Wisconsin population, which might account for all or part of the demographic differences between the HCV-positive population in Wisconsin and the persons with positive HCV test results in this pilot program.

During this pilot program, a rapid HCV test was used to increase HCV awareness and diagnose HCV infections within the context of supportive and accessible community public health programs. This partnership of state public health and community organizations can play an important role in efforts to decrease HCV infections among young persons who inject drugs. Recent evidence suggests that availability of HCV detection services in integrated care settings that combine substance abuse treatment and injection safety is most effective at reducing HCV infection among persons who inject drugs.[10] The use of rapid HCV tests could be a powerful tool for screening, conveying prevention information, and initiating treatment in this population with a high prevalence of HCV infection.

Read full article at Medscape.......

Tuesday, October 8, 2013

Hepatitis C Virus can affect your liver and your health

HEPATITIS C (HCV) by Dr. Robert Gish

In this mini lecture, Dr. Gish examines the Hepatitis C and how the Hepatitis C Virus can affect your liver and your health. 

Dr. Gish explains the importance of talking to your healthcare provider about starting treatment now or waiting, he urges patients to keep up with new therapies and data.  



Uploaded Oct 6 by Bob Gish

Wednesday, September 25, 2013

Hepatitis C Survey on Stigma, Lack of Awareness and Not Being Tested




The Centers for Disease Control and Prevention (CDC) and US Preventive Services Task Force recommend that all people born from 1945 through 1965 to be tested for hepatitis C. A serious liver disease which causes cirrhosis, liver cancer and is the leading cause of liver transplants in the United States, killing more than 15,000 Americans each year. More than 75 percent of the estimated 3 million US citizens with HCV are baby boomers. Officials reported the screening strategy will identify over 800,000 people infected with the virus, prevent 100,000 cases of cirrhosis - over 50,000 cases of liver cancer, and save more than 120,000 lives.

A recent survey by Wakefield Research and funded by Roche/Genentech reported on the lack of HCV awareness, stigma, testing and misconceptions about the disease in Miami, Washington DC and Philadelphia. The survey is available online this week at NATAP.

As an example one of the fourteen online questions asked in the survey.


Continue reading @ NATAP

In the spring Jules Levin reported on an interesting study which was presented at the Digestive Disease Week (DDW) this May in Orlando, Florida; Key Drivers and Barriers to Treatment Initiation and Adherence in Individuals with Hepatitis C, also available at NATAP 

As seen below in figure 1, the objective of this study was to understand factors that motivate or provide barriers to individuals initiating and adhering to IFN-based HCV treatment.



View full results of the study provided by NATAP

Related
August 2013
Hey Grandma, Let's Get You Checked for Hep C

July 2013
Reflex RNA testing should follow a positive HCV antibody test

Tuesday, July 16, 2013

T-Cells May Show HCV Exposure in Healthcare Workers With Negative Antibodies


T-Cells May Show HCV Exposure in Healthcare Workers With Negative Antibodies

By Robert Goodier

NEW YORK (Reuters Health) Jul 15 - Measuring T-cell responses reveals exposure to hepatitis C in healthcare workers who test negative for antibodies against the virus, a new study has found.

T-cell proliferation assays may be a more sensitive test, the results suggest. But the low-level exposures that the assays can detect are highly unlikely to be a health risk for the patient or for others, according to experts who spoke to Reuters Health.

Rather, the results suggest that T-cell assays should be included in surveillance studies that monitor exposure to hepatitis C, said Dr. Barbara Rehermann, Chief of the Immunology Section of the Liver Diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland, in email to Reuters Health.

Dr. Rehermann and her team published their research online June 28 in the Journal of Infectious Diseases.

They performed T-cell assays on samples from 72 healthcare workers who had been in contact with a source of the virus, most of them through an accidental stick by a contaminated needle. During six months of follow-up, none of the workers tested positive for a chronic hepatitis C infection, but nearly half had evidence of an immune response to the virus, denoted by white blood cells, not by antibodies.

"Part of the interest of this study is we're learning more about how our bodies control viruses and how quickly we're able to respond to them," said Dr. Henry Bodenheimer at Beth Israel Medical Center in New York City, who was not involved in the research.

"It seems that very low level infection can be controlled by our immune systems. That's new information. Much of the time people have relied on antibodies. Studying T-cells is a more difficult, but a novel approach," Dr. Bodenheimer told Reuters Health.

The findings may lead to new approaches to vaccine development or treatments that stimulate the immune response to fight hepatitis infection, Dr. Bodenheimer said.

But, he added, this study does not suggest that testing methods should be changed. Antibody tests can detect chronic infection, but there is no evidence that the infection detected by T-cell assays was transmissible or linked to long-term consequences in the healthcare workers, Dr. Bodenheimer pointed out.

Past studies have offered a range of estimates of the risk of transmission of the virus to exposed healthcare workers, from 0 to 10.3%, with an average of 0.5%, according to a 2005 report in Clinical Infectious Diseases (see http://bit.ly/15g4une). The reason for that variation is not clear, however.

In this new study, assays of peripheral blood mononuclear cells in proliferation found hepatitis C-specific T-cell responses in 30 out of 63 participants tested, or 48%.

Interferon-gamma enzyme assays found at least two hepatitis-specific responses in 26 out of 62 participants tested, or 42%.

Fifty-three subjects underwent both tests. Thirteen (24%) responded to both, 21 (40%) did not respond to either, and 19 (36%) responded to one but not the other.

Those who were exposed to the virus after high-risk, rather than low-risk, needle sticks had higher proliferative T-cell responses.

"Whether these T-cell responses reflect protective immunity or whether they are downstream events of protective innate immune responses or abortive replication of defective viral genomes requires further studies in suitable models," Dr. Rehermann and her team write.

In the general population, the Centers for Disease Control and Prevention now recommends that all Baby Boomers, those born from 1945 to 1965, be tested for hepatitis C.

SOURCE: http://bit.ly/15g7cZW

J Infect Dis 2013.

Wednesday, July 10, 2013

Reflex RNA testing should follow a positive HCV antibody test

Reflex RNA testing should follow a positive HCV antibody test

Last Updated: 2013-07-09 18:15:20 -0400 (Reuters Health)

By Will Boggs, MD

NEW YORK (Reuters Health) - Between a third and half of patients with positive hepatitis C results do not undergo reflex HCV RNA testing to confirm their diagnosis, according to a report from the New York City Department of Health and Mental Hygiene.

"When screening for hepatitis C, order a reflex test rather than a simple antibody test," Katherine Bornschlegel, MPH, from the New York City Department of Health and Mental Hygiene (DOHMH), Long Island City, New York told Reuters Health by email. "If the antibody test is positive, the lab will immediately do the RNA test using the same specimen, and you will learn the patient's infection status without needing an additional visit or blood draw."

"Even if your patient is not currently a candidate for antiviral treatment, knowing the hepatitis C infection status can help you manage your patient's care (e.g., counsel to avoid alcohol, screen for HCC)," Bornschlegel said.

About 3.2 million people in the US (and an estimated 129,000 in New York City) have chronic HCV infection. National guidelines recommend that all patients with a positive HCV antibody test undergo HCV RNA testing to determine their infection status.

As part of their routine public health surveillance, Bornschlegel and colleagues assessed whether clinicians actually order HCV RNA tests for their antibody-positive patients.

As reported June 19 online in The American Journal of Medicine, they obtained information from clinicians for a sample of 245 patients newly reported with a positive HCV antibody test.

After the initial investigation (in which the DOHMH asked clinicians to order RNA tests for patients who had not had them), HCV RNA testing had not been ordered for 90 patients. Nine months after the DOHMH asked the clinician to order the HCV RNA test, 81 (33.1% of all patients) still did not have an HCV RNA test done.

About half of the 245 patients (119, 48.6%) had a positive RNA test. Of these, 22 had the HCV RNA test only after the DOHMH requested that the clinician order the test. Forty-five patients (18.4%) tested HCV RNA negative (12 of these after DOHMH requested that the clinician order the test).

Clinicians said 28 (34.6%) of the 81 patients who did not have HCV RNA testing completed had not returned for follow-up, 18 (22.2%) were seen in facilities that did not do HCV RNA testing or that referred the patient elsewhere for RNA testing, 12 (14.8%) were tested in jail, five (6.2%) had died, and two (2.5%) did not have insurance coverage.

Initial testing for these 81 patients had taken place in medical facilities (38 patients, 46.9%), drug or alcohol rehabilitation facilities (24, 29.6%), and jails (12, 14.8%).

"If we assume that 33% did not have RNA testing, then we estimate that 3332 of the 10,065 patients newly reported with a positive HCV test in New York City in 2010 were not tested for HCV RNA," the authors say. "Alternatively, if we used the percentage of patients who never had RNA testing plus those patients who got RNA testing only after our request (47%), then we estimate that 4721 patients would not have received RNA testing."

"We believe it is time for reflex HCV RNA testing for all positive antibody tests to become routine, just as reflex Western blot testing became routine for human immunodeficiency virus," the researchers say.

"Educating clinical staff as well as social workers and counselors in drug rehabilitation facilities and jails on the importance of HCV RNA testing will help ensure that more patients get RNA testing," they explain. "In response to our findings, in December 2010, the NYC DOHMH developed a bulletin for primary care providers about diagnosis and management of HCV."

"We are still assessing this," Bornschlegel said. "It will be difficult to ascribe any improvement to the bulletin, however, because there are other initiatives underway as well and many publications on improved antiviral treatments."

"Knowing which patients have HCV infection after a single visit would greatly streamline the process of ensuring that patients who screen HCV antibody positive get the additional testing necessary," the investigators say. "Patients with positive RNA can then be counseled about measures for protecting their liver and improving their health, and evaluated for antiviral treatment."

SOURCE: http://bit.ly/18LqpYv

Am J Med 2013.

Monday, June 10, 2013

Testing for HCV Infection

 
Testing for HCV Infection
 
Jane P. Getchell, DrPH, Kelly E. Wroblewski, MPH, Alfred DeMaria Jr, MD, Christine L. Bean, PhD, Monica M. Parker, PhD, Mark Pandori, PhD, D. Robert Dufour, MD, Michael P. Busch, MD, PhD, Mark E. Brecher, MD, William A. Meyer, PhD, Rick L. Pesano, MD, PhD, Chong-Gee Teo, MD, PhD, Geoffrey A. Beckett, MPH, Aufra C. Araujo, PhD, Bernard M. Branson, MD, Jan Drobeniuc, MD, PhD, Rikita Hatia, MPH, Scott D. Holmberg, MD, MPH, Saleem Kamili, PhD, John W. Ward, MD

Morbidity & Mortality Weekly Report. 2013;62(18):362-365. 

Introduction
In the United States, an estimated 4.1 million persons have been infected with hepatitis C virus (HCV), of whom an estimated 3.2 (95% confidence interval [CI] = 2.7–3.9) million are living with the infection.[1] New infections continue to be reported particularly among persons who inject drugs and persons exposed to HCV-contaminated blood in health-care settings with inadequate infection control.[2]
                       
Since 1998, CDC has recommended HCV testing for persons with risks for HCV infection.[3] In 2003, CDC published guidelines for the laboratory testing and result reporting of antibody to HCV.[4] In 2012, CDC amended testing recommendations to include one-time HCV testing for all persons born during 1945–1965 regardless of other risk factors.[1

CDC is issuing this update in guidance because of 1) changes in the availability of certain commercial HCV antibody tests, 2) evidence that many persons who are identified as reactive by an HCV antibody test might not subsequently be evaluated to determine if they have current HCV,[5] and 3) significant advances in the development of antiviral agents with improved efficacy against HCV.[6] Although previous guidance has focused on strategies to detect and confirm HCV antibody,[3,4] reactive results from HCV antibody testing cannot distinguish between persons whose past HCV infection has resolved and those who are currently HCV infected. Persons with current infection who are not identified as currently infected will not receive appropriate preventive services, clinical evaluation, and medical treatment. Testing strategies must ensure the identification of those persons with current HCV infection.

This guidance was written by a workgroup convened by CDC and the Association of Public Health Laboratories (APHL), comprising experts from CDC, APHL, state and local public health departments, and academic and independent diagnostic testing laboratories, in consultation with experts from the Veterans Health Administration and the Food and Drug Administration (FDA). The workgroup reviewed laboratory capacities and practices relating to HCV testing, data presented at the CDC 2011 symposium on identification, screening and surveillance of HCV infection,[7] and data from published scientific literature on HCV testing. Unpublished data from the American Red Cross on validation of HCV antibody testing also were reviewed.

Changes in HCV Testing Technologies
Since the 2003 guidance was published,[4] there have been two developments with important implications for HCV testing:

  1. Availability of a rapid test for HCV antibody. The OraQuick HCV Rapid Antibody Test (OraSure Technologies) is a rapid assay for the presumptive detection of HCV antibody in fingerstick capillary blood and venipuncture whole blood. Its sensitivity and specificity are similar to those of FDA–approved, laboratory-conducted HCV antibody assays.[8] In 2011, a Clinical Laboratory Improvements Amendments waiver was granted to the test by FDA. The waiver provides wider testing access to persons at risk for HCV infection, permitting use of the assay in nontraditional settings such as physician offices, hospital emergency departments, health department clinics, and other freestanding counseling and testing sites.
  2. Discontinuation of RIBA HCV. The Chiron RIBA HCV 3.0 Strip Immunoblot Assay (Novartis Vaccines and Diagnostics) that was recommended[4] for supplemental testing of blood samples after initial HCV antibody testing is no longer available. As a result, the only other FDA-approved supplemental tests for HCV infection are those that detect HCV viremia.
Identifying Current HCV Infections
In 2011, FDA approved boceprevir (Victrelis, Merck & Co.) and telaprevir (Incivek, Vertex Pharmaceuticals) for treatment of chronic hepatitis C genotype 1 infection, in combination with pegylated interferon and ribavirin, in adult patients with compensated liver disease. Boceprevir and telaprevir interfere directly with HCV replication. Persons who complete treatment using either of these drugs combined with pegylated interferon and ribavirin are more likely to clear virus (i.e., have virologic cure), compared to those given standard therapy based on pegylated interferon and ribavirin.[9] Viral clearance, when sustained, stops further spread of HCV and is associated with reduced risk for hepatocellular carcinoma[10] and all-cause mortality.[11] Other compounds under study in clinical trials hold promise for even more effective therapies.[6]
                        
Because antiviral treatment is intended for persons with current HCV infection, these persons need to be distinguished from persons whose infection has resolved. HCV RNA in blood, by nucleic acid testing (NAT), is a marker for HCV viremia and is detected only in persons who are currently infected. Persons with reactive results after HCV antibody testing should be evaluated for the presence of HCV RNA in their blood.

Benefits of Testing for Current HCV Infection
Accurate testing to identify current infection is important to 1) help clinicians and other providers correctly identify persons infected with HCV, so that preventive services, care and treatment can be offered; 2) notify tested persons of their infection status, enabling them to make informed decisions about medical care and options for HCV treatment, take measures to limit HCV-associated disease progression (e.g., avoidance or reduction of alcohol intake, and vaccination against hepatitis A and B), and minimize risk for transmitting HCV to others; and 3) inform persons who are not currently infected of their status and the fact that they are not infectious.

Recommended Testing Sequence
The testing sequence in this guidance is intended for use by primary care and public health providers seeking to implement CDC recommendations for HCV testing.[1,3,4] In most cases, persons identified with HCV viremia have chronic HCV infection. This testing sequence is not intended for diagnosis of acute hepatitis C or clinical evaluation of persons receiving specialist medical care, for which specific guidance is available.[12]
                       
Testing for HCV infection begins with either a rapid or a laboratory-conducted assay for HCV antibody in blood (Figure). A nonreactive HCV antibody result indicates no HCV antibody detected. A reactive result indicates one of the following: 1) current HCV infection, 2) past HCV infection that has resolved, or 3) false positivity. A reactive result should be followed by NAT for HCV RNA. If HCV RNA is detected, that indicates current HCV infection. If HCV RNA is not detected, that indicates either past, resolved HCV infection, or false HCV antibody positivity.



Figure.
Recommended testing sequence for identifying current hepatitis C virus (HCV) infection

* For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.

To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be considered. Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.
 
Initial Testing for HCV Antibody
An FDA-approved test for HCV antibody should be used. If the OraQuick HCV Rapid Antibody Test is used, the outcome is reported as reactive or nonreactive. If a laboratory-based assay is used, the outcome is reported as reactive or nonreactive without necessarily specifying signal-to-cutoff ratios.
 
Testing for HCV RNA
An FDA-approved NAT assay intended for detection of HCV RNA in serum or plasma from blood of at-risk patients who test reactive for HCV antibody should be used. There are several possible operational steps toward NAT after initial testing for HCV antibody:
  1. Blood from a subsequent venipuncture is submitted for HCV NAT if the blood sample collected is reactive for HCV antibody during initial testing.
  2. From a single venipuncture, two specimens are collected in separate tubes: one tube for initial HCV antibody testing; and a second tube for HCV NAT if the HCV antibody test is reactive.
  3. The same sample of venipuncture blood used for initial HCV antibody testing, if reactive, is reflexed to HCV NAT without another blood draw for NAT.[13]
  4. A separate venipuncture blood sample is submitted for HCV NAT if the OraQuick HCV Rapid Antibody Test for initial testing of HCV antibody has used fingerstick blood.

Supplemental Testing for HCV Antibody
If testing is desired to distinguish between true positivity and biologic false positivity for HCV antibody, then, testing may be done with a second HCV antibody assay approved by FDA for diagnosis of HCV infection that is different from the assay used for initial antibody testing. HCV antibody assays vary according to their antigens, test platforms, and performance characteristics, so biologic false positivity is unlikely to be exhibited by more than one test when multiple tests are used on a single specimen.[14]

Test Interpretation and Further Action

Table.  Interpretation of results of tests for hepatitis C virus (HCV) infection and further actions
 
Test outcomeInterpretationFurther action
HCV antibody nonreactiveNo HCV antibody detectedSample can be reported as nonreactive for HCV antibody. No further action required.

If recent HCV exposure in person tested is suspected, test for HCV RNA.*
HCV antibody reactivePresumptive HCV infectionA repeatedly reactive result is consistent with current HCV infection, or past HCV infection that has resolved, or biologic false positivity for HCV antibody. Test for HCV RNA to identify current infection.
HCV antibody reactive,

HCV RNA detected
Current HCV infectionProvide person tested with appropriate counseling and link person tested to medical care and treatment.
HCV antibody reactive,

HCV RNA not detected
No current HCV infectionNo further action required in most cases.

If distinction between true positivity and biologic false positivity for HCV antibody is desired, and if sample is repeatedly reactive in the initial test, test with another HCV antibody assay.

In certain situations§ follow up with HCV RNA testing and appropriate counseling.
* If HCV RNA testing is not feasible and person tested is not immunocompromised, do follow-up testing for HCV antibody to demonstrate seroconversion. If the person tested is immunocompromised, consider testing for HCV RNA.

It is recommended before initiating antiviral therapy to retest for HCV RNA in a subsequent blood sample to confirm HCV RNA positivity.

§If the person tested is suspected of having HCV exposure within the past 6 months, or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.

Laboratory Reporting
"Acute hepatitis C" and "hepatitis C (past or present)" are nationally notifiable conditions, and are subject to mandated reporting to health departments by clinicians and laboratorians, as determined by local, state or territorial law and regulation. Surveillance case definitions are developed by the Council of State and Territorial Epidemiologists in collaboration with CDC.[15] In all but a few jurisdictions, positive results from HCV antibody and HCV RNA testing that are indicative of acute, or past or present HCV infection, are reportable. Specific policies for laboratory reporting are found at health department websites.[16]

Future Studies
Research, development, validation, and cost-effectiveness studies are ongoing to inform the best practices for detecting HCV viremia and for distinguishing between resolved HCV infection and biologic false positivity for HCV antibody in persons in whom HCV RNA is not detected. Outcomes of these studies will provide comprehensive guidance on testing, reporting, and clinical management, and will improve case definitions for disease notification and surveillance.

http://www.medscape.com/viewarticle/804472_1

Thursday, October 18, 2012

Hepatitis C Point-of-Care Tests Are Highly Accurate

Medscape Medical News

Hepatitis C Point-of-Care Tests Are Highly Accurate

Jennifer Garcia

Oct 15, 2012

October 15, 2012 — A new meta-analysis demonstrates that point-of-care tests (POCTs) for the diagnosis of hepatitis C (HCV) have a high level of accuracy and may help increase screening rates for this disease. These findings are published in the October 15 issue of the Annals of Internal Medicine.
The study, led by Sushmita Shivkumar, MSc, from McGill University and McGill University Health Centre, Montreal, Quebec, Canada, reviewed 19 studies that evaluated the diagnostic accuracy of POCTs and rapid diagnostic tests (RDTs) that screen for HCV in oral fluid, whole blood, serum, or plasma. The researchers found that POCTs had the highest sensitivity (whole blood, 98.9% [95% confidence interval (CI), 94.5% - 99.8%] and serum or plasma, 98.9% [95% CI, 96.8% - 99.6%]). RDTs of serum or plasma had the next-highest sensitivity (98.4%; 95% CI, 88.9% - 99.8%), followed by POCTs of oral fluid (97.1%; 95% CI, 94.7% - 98.4%).

Specificity of POCTs of whole blood and serum or plasma was also high, at 99.5% (95% CI, 97.5% - 99.9%) and 99.7% (95% CI, 99.3% - 99.9%), respectively. The specificity of RDTs of serum or plasma followed, at 98.6% (95% CI, 94.9% - 99.6%), and then the specificity of POCTs of oral fluid, at 98.2% (95% CI, 92.2% - 99.6%).

"Although both diagnostic test types are rapid, RDTs require special equipment, such as centrifuges and refrigerators, whereas POCTs eliminate the need for electricity and are more robust at high temperatures, thus offering additional opportunities to expand screening," the study authors note.
The researchers evaluated studies conducted between 1992 and 2012 that screened for HCV in adults (≥18 years of age), regardless of risk profile and across all study designs. Studies on prevalence, those missing relevant information, manufacturer reports, and studies of the accuracy of laboratory-based tests were excluded.

The authors acknowledge possible study limitations, such as detection and sampling bias of the original studies as well as the influence of variable reference standards used in different studies. These differences may have had an effect on sensitivity and specificity estimates. In addition, coinfection status may alter the rate of false-positive results because of differences in the immune response and should be considered when interpreting test results. The study authors postulate that standardized reference standards and stratification by coinfection should be considered for future diagnostic accuracy studies.

Because the tests evaluated in this meta-analysis detected antibodies to HCV, the study authors note that these POCTs could not differentiate between acute and chronic infections and could not detect infection within 3 months of exposure. Cases with possible false-negative or false-positive results would require further screening, which may depend on available resources.

"Given the convenience of POCTs and their rapid turnaround time, these results show great potential for expanded first-line screening for hepatitis C infection and demonstrate the utility of blood-based singleton POCTs and of multiplex POCTs designed to provide integrated HIV and HCV screening of at-risk populations," the study authors conclude.

Funding for this study was provided by the Canadian Institutes of Health Research. One coauthor has received additional support from Grand Challenges Canada and the Bill and Melinda Gates Foundation. The remaining authors have disclosed no relevant financial relationships.
Ann Intern Med. 2012;157:558-566. Abstract

Thursday, September 13, 2012

Confidential Hepatitis C test for Baby Boomers is now offered by ANY LAB TEST NOW®

Anonymous testing allows those included in this age group to get tested for this contagious disease without the social stigma.

Alpharetta, GA (PRWEB) September 12, 2012
ANY LAB TEST NOW® offers a confidential blood test that can detect Hepatitis C, with results back in 24-48 hours. Baby boomers are particularly at-risk because they came of age prior to the medical and lifestyle precautions that surfaced during the HIV outbreak in the 1980s. They weren't aware of the dangers of sharing needles, for example, and hospitals didn't take the same precautions during blood transfusions.Reliable tests to screen the blood supply for hepatitis C were not available until the early 1990s. Since it can go undetected for such a long period of time, it is imperative that anyone in this age range be tested and treated before symptoms arise. Consumers can take the test anonymously and avoid any perceived social stigma. If the disease is detected they should consult with their physician quickly for appropriate care.

According to the CDC, nearly two-million baby boomers are infected with Hepatitis C. If you were born between 1945 and 1965, the Center for Disease Control and Prevention recommends you get tested. People who have the disease may not show symptoms for 30 years and at times not until they have suffered significant liver damage.

“It is especially important for us to provide this type of testing to consumers for diseases like Hepatitis C that cannot be cured but, can be treated if detected early,” said Clarissa Bradstock, COO. “We are committed to providing the most technologically advanced lab tests encouraging consumers to take control of their health.”

Today hepatitis C is commonly transmitted through sharing needles to inject drugs. Some experts suggest that in some cases hepatitis C could have spread through routes including shared razors and toothbrushes, manicures or sniffed cocaine.

Americans can get tested for Hepatits C at any of ANY LAB TEST NOW® ’s more than 150 locations nationwide. A doctor’s order is provided and no appointment is necessary. Visit http://www.anylabtestnow.com for a location near you.


Read more: http://www.beaumontenterprise.com/business/press-releases/article/Confidential-Hepatitis-C-test-for-Baby-Boomers-is-3861329.php#ixzz26OOn6ZaM

Monday, January 30, 2012

Hepatitis C News Ticker: The ELF test-Blood Test Instead of Liver Biopsy?


New On The Blog  


 In The News
Researchers at MIT and their colleagues said they have devised a way to produce liver-like cells from stem cells, a key step in studying why people respond differently to Hepatitis C.      
     
An infectious disease that can cause inflammation and organ failure, Hepatitis C has different effects on different people, but no one is sure why, the researchers said in a press release from MIT. Some people are very susceptible to the infection, while others are resistant.

The researchers said that by studying liver cells from different people in the lab, they may determine how genetic differences produce these varying responses. However, liver cells are hard to get and very difficult to grow in a lab dish because they tend to lose their normal structure and function when removed from the body.

The researchers, from MIT, Rockefeller University and the Medical College of Wisconsin, have come up with a way to produce liver-like cells from induced pluripotent stem cells (iPSCs), which are made from body tissues rather than embryos. Those liver-like cells can then be infected with Hepatitis C and help scientists study the varying responses to the infection.

The scientists claim this is the first time an infection has been made in cells derived from iPSCs. Their new technique is described in the Jan. 30 issue of the Proceedings of the National Academy of Sciences. The development, they said, may also eventually enable personalized medicine, in which doctors could test the effect of different drugs on tissues derived from the patient being treated and then customize therapy for that patient.

The new study is a collaboration between Sangeeta Bhatia, professor of health sciences and technology and electrical engineering and computer science at MIT; Charles Rice, professor of virology at Rockefeller; and Stephen Duncan, professor of human and molecular genetics at the Medical College of Wisconsin.

The iPSCs are derived from normal body cells, often skin cells. By turning on certain genes in those cells, the scientists can revert them to an immature state that is identical to embryonic stem cells, which can turn into any cell type. Once the cells become pluripotent, they can be directed to become liver-like cells by turning on genes that control liver development.

The researchers’ goal is to take cells from patients who have unusual reactions to hepatitis C infection, transform them into liver cells and study their genetics to see why people respond as they do. “Hepatitis C virus causes an unusually robust infection in some people, while others are very good at clearing it. It’s not yet known why those differences exist,” Bhatia said in a statement.


Blood Test Instead of Biopsy Identifies Liver Damage 
Siemens is marketing the first rapid, automated biomarker test for diagnosing and assessing liver fibrosis. The ELF test (Enhanced Liver Fibrosis test) takes approximately one hour to complete and requires only a blood sample

The ELF test (Enhanced Liver Fibrosis test) takes approximately one hour to complete and requires only a blood sample. The process is therefore less invasive but just as reliable as the previously required biopsy, and it usually takes about a week to deliver a biopsy result.

The new test was developed by Siemens Healthcare in collaboration with University College London and can be used as a routine test on the Siemens ADVIA Centaur Immunoassay System.
Liver fibrosis is the result of chronic liver damage caused by vi-ral hepatitis, alcoholic cirrhosis, or fatty liver disease. It is characterized by scarring of the liver tissue, which can lead to cirrhosis or cancer of the liver over the long term — a frequent cause of death worldwide.


At present, the “gold standard” for assessing the severity of a liver fibrosis is a liver biopsy, which involves the removal of a small amount of liver tissue. This biopsy has drawbacks, however: It is painful; it entails some risk for the patient; and it tests only a small sample of the liver.

With the automated ADVIA Centaur ELF Test, a fast and mini-mally invasive technique is now available for determining both the severity of a liver fibrosis and the risk that it will worsen. The test examines three direct blood serum biomarkers: hyaluronic acid (HA), procollagen III N-terminal propeptide (PIIINP), and the tissue inhibitor of metalloproteinase 1 (TIMP-1). These direct biomarkers are molecules that are involved in the formation of fibrosis. In the test, special reagents react with the biomarkers and generate light in the process. The greater the intensity of this chemiluminescence, the greater the presence of the biomarker.

A special algorithm is used to convert the results of the three biomarkers into the ELF score, which indicates the degree of fibrosis. The combination of three biomarkers increases the accuracy of the test. As an international clinical trial has shown, the ELF test can precisely differentiate between slight, moderate, and serious cases of fibrosis. In the event of slight or moderate fibrosis, patients normally have no symptoms. Doctors can thus intervene before significant damage to the liver and monitor the progress of therapy.

To complement the ELF test, Siemens is also offering imaging and laboratory diagnostic technologies like hepatitis blood tests and ultrasound systems that help physicians identify liver fibrosis at an early stage and monitor its development.

Dr. Norbert Aschenbrenner | Source: Siemens Innovation News
Further information: www.siemens.com/innovationnews

A molecule in liver cell membranes that plays a role in cholesterol uptake also enables hepatitis C virus (HCV) to enter cells, according to research reported in the January 8, 2012, advance online edition of Nature Medicine.

Big Pharma

Vertex Falls as Analyst Cuts Sales Estimates on Hepatitis C Pill

Vertex Pharmaceuticals Inc. (VRTX) fell the most in two months after an analyst with Leerink Swann & Co. cut sales predictions for the company’s hepatitis C pill that was approved by U.S. regulators last year.

Vertex’s Incivek, among the first new hepatitis C drugs to reach the market in nearly a decade, could be eclipsed by new pill-only treatments with fewer side effects and shorter courses of treatment. Incivek is given with interferon, an injected medicine. Merck & Co.’s similar pill, Victrelis, was also approved last year.

Shares of Cambridge, Massachusetts-based Vertex fell 4.2 percent to $34.48 at 10:18 a.m., after declining 5.2 percent in the biggest intraday drop since Nov. 14.
Howard Liang, an analyst with Leerink Swann in Boston, cut his sales forecast for Incivek by 35 percent from $2.3 billion this year to $1.5 billion. Liang also cut his target price for Vertex shares from $66 to $48.

“In light of recent development of interferon-free regimens and likely more aggressive development as a result of recent transactions in the space, we are further curtailing the Incivek tail,” Liang said in a note to clients today.

Vertex had $420 million in revenue from Incivek in the third quarter of 2011. Revenue from the drug accounts for 64 percent of the company’s sales.
To contact the reporter on this story: Drew Armstrong in Washington at darmstrong17@bloomberg.net;


Liver Cancer

by George Ochoa
Two Mayo Clinic studies have clarified the importance of chronic hepatitis C virus (HCV) in the rising trend of liver cancer, or hepatocellular carcinoma (HCC). 
One study (Yang et al. Mayo Clin Proc. 2012;87:9-16) analyzed longitudinal trends in the incidence, etiology, treatment of HCC and survival in community residents in Olmsted County, Minn. The researchers found that in earlier periods (1976-1990, 1991-2000), alcohol use was the most common risk factor, but, in 2001 to 2008, HCV filled that role. At the same time, HCC incidence rose dramatically, from 3.5 per 100,000 person-years for the 1976 to 1990 time period, to 3.8 for the period from 1991 to 2000, to 6.9 for the 2001 to 2008 period.

Study author W. Ray Kim, MD, associate professor of medicine, Mayo Clinic College of Medicine, Rochester, Minn., wrote in an email: “The biggest and unique risk factor of HCC is underlying liver disease. Our data showed that previously alcohol, more recently HCV has become the underlying cause.”

The second study (Shire et al. Mayo Clin Proc. 2012;87:17-24) investigated a sample of Somali immigrants seen at Mayo Clinic from July 1, 1996, to Oct. 31, 2009. Non-Somali Olmsted County residents served as controls. The frequencies of chronic hepatitis B virus (HBV) and HCV, and their associations with HCC, were studied. Both HBV and HCV occurred frequently in the sample of Somalis, but HCV was the major risk factor for HCC. There were significant differences in the HCV genotype distributions between Somalis and non-Somalis.
The high prevalence of HCV in the Somali sample came as a surprise to the researchers. “We didn’t expect it,” Abdirashid M. Shire, PhD, assistant professor of medicine, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, said in an interview. The study, Dr. Shire added, “supports the value of early detection” of HCV. “It’s very important to screen for HCV.” Dr. Kim reported that his study also “indirectly” supports the value of early detection and treatment to improve outcomes.
—Drs. Kim and Shire had no relevant financial disclosures

28 January 2012
Researchers at CIC Biogune, the Cooperative Centre for Research into Biosciences and led by Dr. Maria Luz Martinez Chantar, have found a strong relationship between high levels of Hu antigen R (HuR) protein and the...

 By Denise Mann
HealthDay Reporter
THURSDAY, Jan. 26 (HealthDay News) -- Popular cholesterol-lowering statins may also lower risk for liver cancer among people with hepatitis B, a new study shows. Hepatitis B, an inflammation of the liver due to the hepatitis B virus, is one of the main causes of liver cancer.
This is not the first time that statins have shown promise in reducing risk for cancer. Other studies have hinted that these drugs may play a role in preventing certain types of cancer, including breast cancer. 

In the new study of more than 33,000 individuals with hepatitis B followed from 1997 to 2008, those who took a statin were less likely to develop liver cancer, when compared to participants who were not prescribed statins. What's more, the longer a person took statins, the greater the liver-cancer risk reduction. Study participants were prescribed the statins to treat high cholesterol levels. Overall, 1,021 people developed liver cancer during the study period.
More research is needed to see how statins may lower liver cancer risk among people with hepatitis B, the researchers said. 

"Statins have potential protective effects against cancers [and] carriers of hepatitis B virus infection have a substantial risk of [liver] carcinoma," said Dr. Pau-Chung Chen, a professor of environmental medicine and epidemiology at National Taiwan University, in Taipei. "Statin use is not only a benefit to preventing cardiovascular diseases, but also an additional, convenient and acceptable strategy for preventing hepatocellular carcinoma," or liver cancer, Chen said.

However, statins can cause a potentially dangerous rise in liver enzymes and liver damage. Regular liver function tests are required for all people who take statins.
The study appeared online Jan. 23 in the Journal of Clinical Oncology.

"This is exciting and unequivocally solid research," said Dr. Eugene Schiff, a professor of medicine and director of the Center for Liver Diseases at the University of Miami Miller School of Medicine.
"One of the issues is that statins are relatively contraindicated in people with liver disease," Schiff said. But "the take-home message for people with hepatitis B or anybody with liver disease is that statins are safe. This re-emphasizes the point that if someone has chronic hepatitis B and there is an indication for statins, they should get them and they may be beneficial far beyond lowering cholesterol: They may also reduce their risk for liver cancer." 

Dr. David Bernstein, chief of hepatology at North Shore University Hospital and Long Island Jewish Medical Center in Manhasset, N.Y., is more cautious. "In almost all other liver conditions, cirrhosis must be present before [liver cancer] develops," he said. During cirrhosis, scar tissue replaces healthy liver tissue. "Statins must be used with caution in patients with cirrhosis, which can limit their use in patients with liver disease at risk of developing liver cancer," he said. "Further studies are needed in this patient population to confirm these findings."

More information
For information on hepatitis B, visit the U.S. National Digestive Diseases Information Clearinghouse.
Copyright © 2012 HealthDay. All rights reserved.

 Transplant

27 January 2012
According to Johns Hopkins researchers, individuals who donate a portion of their liver for live transplantation usually recover safely from the procedure and can expect to live long, healthy lives...

A study in February's issue of Gastroenterology estimates early death, acute liver failure, and long-term mortality among live liver donors.

Dr Abimereki Muzaale and colleagues from Maryland, USA estimated the risk of perioperative mortality or acute liver failure for live liver donors in the United States, and avoid selection or ascertainment biases and sample size limitations.

The research team followed up 4111 live liver donors in the United States between 1994 and 2011 for a mean of 8 years.

Deaths were determined from the Social Security Death Master File. Survival data were compared with those from live kidney donors and healthy participants of the National Health and Nutrition Examination Survey (NHANES) III.

The team observed that 7 donors had early deaths.
Risk of early death among live liver donors is almost 2 per 1000 donors
Gastroenterology

The research team found that risk of death did not vary with age of the liver recipient or portion of liver donated.

There were 11 catastrophic events.

The team found that risk did not vary with recipient age, or portion of liver donated.

The researchers noted that long-term mortality of live liver donors was comparable to that of live kidney donors and NHANES participants.

Dr Muzaale's team concluded, "The risk of early death among live liver donors in the United States is almost 2 per 1000 donors."

"Mortality of live liver donors does not differ from that of healthy, matched individuals over a mean of 8 years."
30 January 2012

How common is transmission of hepatitis C through organ donation, and what types of preventive practices can be put into place to prevent this from happening?

Even after a liver transplant, patients can often experience a recurrence of hepatitis C. How should it be treated in this setting?

HCV Brain Function 

Chronic HCV infection causes progressive liver disease and can also be associated with various CNS abnormalities. To date, however, few studies have investigated the mechanisms by which these abnormalities arise, that is, whether they are a result of impaired hepatic function or virus replication in the CNS. Thus, the researchers quantified HCV RNA levels in the brain and liver of 10 individuals infected with HCV. They also investigated the expression of HCV entry receptors in the brain, and conducted in vitro studies to ascertain whether two brain-derived endothelial cell lines could support HCV infection.

The issue of whether the hepatitis C virus (HCV) affects brain function continues to arouse interest, investigation, and debate. Symptoms such as fatigue, poor memory, and concentration ("brain fog") are commonplace and an effect of this infection on mental health related quality of life, which is independent of liver fibrosis, is well established this study provides a substantial link between HCV and cerebral dysfunction by demonstrating a reduction in spectroscopic markers of cerebral inflammation and an improvement in cognition, following HCV eradication

Research

This article takes an in-depth look at hepatitis C treatment options in a specialized community of people on methadone maintenance.

FDA 

The FDA recently granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to OraSure Technologies for its OraQuick HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens. With this waiver, the OraQuick HCV test now can be used by more than 180,000 sites in the United States to test individuals who are at risk for hepatitis C virus (HCV) infection.
The CLIA, passed by Congress in 1988, establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results, regardless of where a test is performed. As defined by the CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The FDA determines the criteria for tests being simple with a low risk for error, and approves manufacturers’ applications for waivers.


The CLIA waiver granted for OraSure’s OraQuick HCV Rapid Antibody Test, extends the use of the assay to more than 180,000 facilities, such as outreach clinics, community-based organizations and physician offices, according to a press release from OraSure.
“A CLIA waiver for our OraQuick HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at-risk individuals in the United States,” said Douglas A. Michels, president and CEO of OraSure Technologies. “The CLIA waiver will enable health care providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and treated.”

The OraQuick HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to HCV. The test is approved for fingerstick whole blood specimens and venipuncture whole blood specimens in individuals aged 15 years or older, and provides results in 20 minutes. The assay has not been approved for use in patient populations without signs or symptoms of HCV, and its use has not been established for testing patients younger than 15 years of age or for pregnant women.
—Based on a press release from OraSure Technologies


 Healthy You

A study recently published in the Journal of Pain Research shows that practicing yoga boosts levels of the stress hormone cortisol and could help ease some symptoms of fibromyalgia such as pain, fatigue, muscle stiffness and depression.


Under stressful conditions yeast genomes become unstable, readily acquiring or losing whole chromosomes to enable rapid adaption. The musical spectrum was derived from the copy number data of the aneuploid yeast genomes selected under different stress conditions, where the gain and loss of chromosomes are represented as red and green bars, respectively.

Released: 1/25/2012 12:00 PM EST
Embargo expired: 1/29/2012 1:00 PM EST
Source: Stowers Institute for Medical Research
 
Newswise — KANSAS CITY, MO— Cells trying to keep pace with constantly changing environmental conditions need to strike a fine balance between maintaining their genomic integrity and allowing enough genetic flexibility to adapt to inhospitable conditions. In their latest study, researchers at the Stowers Institute for Medical Research were able to show that under stressful conditions yeast genomes become unstable, readily acquiring or losing whole chromosomes to enable rapid adaption.

The research, published in the January 29, 2012, advance online issue of Nature, demonstrates that stress itself can increase the pace of evolution by increasing the rate of chromosomal instability or aneuploidy. The observation of stress-induced chromosome instability casts the molecular mechanisms driving cellular evolution into a new perspective and may help explain how cancer cells elude the body’s natural defense mechanisms or the toxic effects of chemotherapy drugs.
“Cells employ intricate control mechanisms to maintain genomic stability and prevent abnormal chromosome numbers,” says the study’s leader, Stowers investigator Rong Li, Ph.D. “We found that under stress cellular mechanisms ensuring chromosome transmission fidelity are relaxed to allow the emergence of progeny cells with diverse aneuploid chromosome numbers, producing a population with large genetic variation.”

Known as adaptive genetic change, the concept of stress-induced genetic variation first emerged in bacteria and departs from a long-held basic tenet of evolutionary theory, which holds that genetic diversity—evolution’s raw material from which natural selection picks the best choice under any given circumstance—arises independently of hostile environmental conditions.
“From an evolutionary standpoint it is a very interesting finding,” says graduate student and first author Guangbo Chen. “It shows how stress itself can help cells adapt to stress by inducing chromosomal instability.”

Aneuploidy is most often associated with cancer and developmental defects and has recently been shown to reduce cellular fitness. Yet, an abnormal number of chromosomes is not necessarily a bad thing. Many wild yeast strains and their commercial cousins used to make bread or brew beer have adapted to their living environs by rejiggering the number of chromosomes they carry. “Euploid cells are optimized to thrive under ‘normal’ conditions,” says Li. “In stressful environments aneuploid cells can quickly gain the upper hand when it comes to finding creative solutions to roadblocks they encounter in their environment.”

After Li and her team had shown in an earlier Nature study that aneuploidy can confer a growth advantage on cells when they are exposed to many different types of stress conditions, the Stowers researchers wondered whether stress itself could increase the chromosome segregation error rate.
To find out, Chen exposed yeast cells to different chemicals that induce various types of general stress and assessed the loss of an artificial chromosome. This initial screen revealed that many stress conditions, including oxidative stress, increased the rate of chromosome loss ten to 20-fold, a rate typically observed when cells are treated with benomyl, a microtubule inhibitor that directly affects chromosome segregation.

The real surprise was radicicol, a drug that induces proteotoxic stress by inhibiting a chaperone protein, recalls Chen. “Even at a concentration that barely slows down growth, radicicol induced extremely high levels of chromosome instability within a very short period of time,” he says.
Continued growth of yeast cells in the presence of radicicol led to the emergence of drug-resistant colonies that had acquired an additional copy of chromosome XV. Yeast cells pretreated briefly with radicicol to induce genomic instability also adapted more efficiently to the presence of other drugs including fluconazole, tunicamycin, or benomyl, when compared to euploid cells.
Interestingly, certain chromosome combinations dominated in colonies that were resistant to a specific drug. Fluconazole-resistant colonies typically gained an extra copy of chromosome VIII, tunicamycin-resistant colonies tended to lose chromosome XVI, while a majority of benomyl-resistant colonies got rid of chromosome XII. “This suggested to us that specific karyotypes are associated with resistance to certain drugs,” says Chen.

Digging deeper, Chen grew tunicamycin-resistant yeast cells, which had adapted to the presence of the antibiotic by losing one copy of chromosome XVI, under drug-free conditions. Before long, colonies of two distinct sizes emerged. He quickly discovered that the faster growing colonies had regained the missing chromosome. By returning to a normal chromosome XVI number, these newly arisen euploid cells had acquired a distinctive growth advantage over their aneuploid neighbors. But most importantly, the fast growing yeast cells were no longer resistant to tunicamycin and thus clearly linking tunicamycin resistance to the loss of chromosome XVI.
Researchers who also contributed to the work include William D. Bradford and Chris W. Seidel both at the Stowers Institute for Medical Research.
The study was funded in part by the National Institute of General Medical Sciences.

About the Stowers Institute for Medical Research
The Stowers Institute for Medical Research is a non-profit, basic biomedical research organization dedicated to improving human health by studying the fundamental processes of life. Jim Stowers, founder of American Century Investments, and his wife Virginia opened the Institute in 2000. Since then, the Institute has spent over 800 million dollars in pursuit of its mission.
Currently the Institute is home to over 500 researchers and support personnel; over 20 independent research programs; and more than a dozen technology development and core facilities. Learn more about the Institute at www.stowers.org.

New research finds milk drinkers scored better on memory and brain function tests

Pouring at least one glass of milk each day could not only boost your intake of much-needed key nutrients, but it could also positively impact your brain and mental performance, according to a recent study in the International Dairy Journal.1 Researchers found that adults with higher intakes of milk and milk products scored significantly higher on memory and other brain function tests than those who drank little to no milk. Milk drinkers were five times less likely to "fail" the test, compared to non milk drinkers.

Researchers at the University of Maine put more than 900 men and women ages 23 to 98 through a series of brain tests – including visual-spatial, verbal and working memory tests – and tracked the milk consumption habits of the participants. In the series of eight different measures of mental performance, regardless of age and through all tests, those who drank at least one glass of milk each day had an advantage. The highest scores for all eight outcomes were observed for those with the highest intakes of milk and milk products compared to those with low and infrequent milk intakes. The benefits persisted even after controlling for other factors that can affect brain health, including cardiovascular health and other lifestyle and diet factors. In fact, milk drinkers tended to have healthier diets overall, but there was something about milk intake specifically that offered the brain health advantage, according to the researchers.

In addition to the many established health benefits of milk from bone health to cardiovascular health, the potential to stave off mental decline may represent a novel benefit with great potential to impact the aging population. While more research is needed, the scientists suggest some of milk's nutrients may have a direct effect on brain function and that "easily implemented lifestyle changes that individuals can make present an opportunity to slow or prevent neuropsychological dysfunction."
New and emerging brain health benefits are just one more reason to start each day with lowfat or fat free milk. Whether in a latte, in a smoothie, on your favorite cereal, or straight from the glass, milk at breakfast can be a key part of a healthy breakfast that help sets you up for a successful day. The 2010 Dietary Guidelines for Americans recommend three glasses of lowfat or fat free milk daily for adults and each 8-ounce glass contains nine essential nutrients Americans need, including calcium and vitamin D.

About the National Milk Mustache "got milk?"® Campaign
The Milk Processor Education Program (MilkPEP), Washington, D.C., is funded by the nation's milk processors, who are committed to increasing fluid milk consumption. The National Fluid Milk Processor Promotion Board, through MilkPEP, runs the National Milk Mustache "got milk?"® Campaign, a multi-faceted campaign designed to educate consumers about the health benefits of milk. For more information, go to www.whymilk.com. Deutsch, A Lowe and Partners Company, is the creative agency for the National Milk Mustache "got milk?"® Campaign.
1Crichton GE, Elias MF, Dore GA, Robbins MA. Relation between dairy food intake and cognitive function: The Maine-Syracuse Longitudinal Study. International Dairy Journal. 2012; 22:15-23.


For Your Reading Pleasure

Chuck Garcia is launching the January 2012 collection of daily blog entries for the “31 Days of Wellness”, our annual celebration of the New Year, and the opportunity to start anew as we ring in the New Year. Enjoy, visit us daily, and send us your feedback.
Dr. Joe Galati



 


OH My Aches And Pains
As I am getting ready to start Hepatitis C (HCV) treatment, I've been running across some pretty interesting pieces of information that I think will make my treatment experience more successful.


 Behind The Headlines

Behind the Headlines provides an unbiased and evidence-based analysis of health stories that make the news.

How our system works
  • Each day the NHS Choices team selects health stories that are making headlines.
  • These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information.
  • Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.


The idea that regularly eating fried foods causes heart attacks is a ‘myth’, The Daily Telegraph has today reported.

The newspaper has panned conventional wisdom based on a large Spanish study investigating how people’s fried food consumption was linked to their risk of events such as heart attacks and episodes of heart pain. To study the relationship researchers surveyed over 40,000 people on how much fried food they ate during the previous year, looking at any episodes related to coronary heart disease over an average period of 11 years.

In this particular setting the researchers found no link between consuming food fried in olive or sunflower oils and the risk of heart disease (the UK’s biggest killer) or death from any cause. However, while such a phenomenon could exist in the context of this specific group of people eating a specific type of diet, the research does not support the idea that fried food is generally harmless, or that it represents diets among the UK population. For example, most participants reported eating a relatively small amount of fried food each day, much less than might be typically found in a fry-up or a fast food meal. In short, it is not clear whether the same study conducted in the UK would have the same results.

Many news sources have reported the results in an accurate, measured way. However, The Daily Telegraph’s account has been somewhat overcooked, as the study did not look at the impact of factors such as frying with other types of fats, reusing oils several times (as is the case in most fast food outlets), or consuming fried snacks high in salt, sugar or calories.

Where did the story come from?
The study was carried out by a collaboration of researchers from Spanish universities and other health organisations based in Spain. It was funded by Spain’s FIS Fund for Health Research and published in the peer-reviewed British Medical Journal.

Media reports were generally balanced, with many making the point that the study was primarily concerned with a Mediterranean diet containing olive oil, which is typically very different from the dietary patterns in the UK. This limits how relevant this study is to the UK population. Many news sources also rightly warn against assuming that the study results suggested that consuming large amounts of fried foods is not harmful. The Telegraph included a picture of a full English breakfast, which is not a recognised part of a Mediterranean dietary pattern.

What kind of research was this?
This prospective cohort study investigated the association between people’s consumption of fried foods and their risk of experiencing coronary heart disease events such as heart attacks and heart pain (angina) which require surgery. It was conducted in a Spanish population.
Previous research has shown fried foods have been associated with high blood pressure, obesity and low levels of ‘good’ cholesterol (high-density lipoproteins or HDL cholesterol). However, existing studies into the association of fried food and coronary heart disease provided mixed results, the authors report.

When food is fried the nutritional content changes; water is lost and fat is absorbed, increasing the calorie content of the food. During frying, the oils also deteriorate and change into other forms, especially when reused, as is often the case in fried fast food outlets. This process leads to a loss of unsaturated fats and an increase in harmful trans fats.
A prospective cohort study is a good way of investigating whether fried foods are linked to heart disease because you can be sure the consumption of the food occurred before the development of the disease. However, the limitation is that you cannot be certain that fried foods caused a disease because its development may be influenced by numerous other factors, some measured in the research and some not.

The best type of study to definitively assess this link would be a large randomised controlled trial, providing it could be performed ethically. However, given the cost and complexity of such a task, this approach may ultimately be impractical.

What did the research involve?
The participants were Spaniards enrolled in a research project called the European Prospective Investigation into Cancer and Nutrition (the EPIC-Spain cohort). The analysed cohort consisted of 40,757 adults aged between 29 and 69 who were recruited between 1992 and 1996. They were followed up for an average of 11 years to see what diseases they developed and what they died of.
When enrolled, participants were asked by trained interviewers to complete a questionnaire about the food they consumed over a typical week during the previous 12 months. Only foods consumed at least twice a month were recorded. 

The study’s authors report that this method had previously been shown to be accurate (validated) at assessing the diet of Spanish people. The type of oil used for frying (olive oil versus sunflower oil or other vegetable oils) was recorded and then checked again after two years. No further information on diet was collected at a later date.

At enrolment, the researchers also recorded non-dietary variables. These included demographic variables such as age and sex as well as educational level, body mass index (BMI), smoking and physical activity levels. Participants were also asked if they had coronary heart disease, diabetes, high blood pressure, cancer or angina or had experienced a heart attack or stroke in the past.
For the analysis, people were divided into four groups depending on their level of fried food consumption. The researchers specifically analysed how consuming fried food was linked to the chance of having a coronary heart disease event and dying from any cause (known as all-cause mortality) and how these varied for the four groups.

The analysis was adjusted for a large number of factors, including energy intake, educational level, smoking and physical activity. This statistical technique aims to minimise the effect these external factors have on the association of interest, in this case between fried food and heart disease.

What were the basic results?
An average of 138g of fried food was consumed daily, including 14g of oil used for frying. About 7% of the total amount of food consumed was fried. Of the total amount of fried food consumed, 24% (34g/day) was fish, 22% (31g/day) meat, 21% (30g/day) potatoes, and 11% (15g/day) eggs. Almost two thirds (62%) of participants used olive oil for frying, the rest used sunflower oil or other vegetable oils.
During the 11-year follow up, 606 definite cases of heart disease were recorded (466 heart attacks and 140 episodes of angina requiring surgery) and 1,135 deaths from all causes.
Fried food consumption was not associated with the risk of coronary heart disease after adjusting for possible confounders. There was also no association between fried fat consumption and death from all causes. These findings were no different in those who fried using olive oil compared to sunflower oil or other vegetable oils.

In the study, coronary heart disease events were defined as definite, probable and possible depending how they were assessed. The researchers first analysed their data using only the definite cases of coronary heart disease and found no association between fried food and these cases. The same result was found when they combined the definite coronary heart disease cases with those that were less certain (probable and possible groups).

How did the researchers interpret the results?
The researchers concluded that within the EPIC-Spanish cohort they found ‘no association between consumption of fried food and risk of coronary heart disease or all-cause mortality’.
They point out that their results are ‘directly applicable only to Mediterranean countries with frying methods similar to those in Spain’ and state that oil (mainly olive and sunflower) rather than solid fat is used for frying in Spain. They also point out that the majority of fried food eaten in Spain is not necessarily fast food.
They also make the important point that ‘frying with other types of fats, reusing oils several times, or consuming fried snacks high in salt may still be harmful’.

Conclusion
This study found no association between how often people ate fried food and their risk of coronary heart disease or death from any cause in a large Spanish cohort.
This study has strengths, including using a valid method of assessing diet, a large sample size and long follow-up time, but also has significant limitations. The following limitations should be considered when interpreting the findings of this study:
  • The study looked at frying using olive oil or sunflower oil in the context of a Mediterranean diet. The authors make the important point that frying with other types of fats or reusing oils several times may still be harmful. Reusing oils is common in fast food preparation in the UK, and so this study does not show that consuming this type of food is not linked to heart disease.
  • Diet was measured only when the participants were first enrolled. Any changes in diet after this will be missed and could lead to an association being masked because of error in the classification of fried food consumption.
  • Fried food consumption was self-reported using a computerised questionnaire and so there may have been under-reporting given that many people perceive it to be unhealthy and may want to partially conceal the amount they eat. This could potentially hide an association.
  • The study did not assess the extent to which the oils were reused, assuming that this was not common in foods consumed in the home. Hence, the effects of foods fried in reused oils are still unknown and may warrant further research as reusing oils is known to make them more harmful, the authors report.
  • This study cannot separate the effect of the food from the cooking method. For example, the beneficial effect of omega 3 fatty acids from fish compared with the effect of frying this fish in oil that may be harmful. Therefore, the food itself blurs the link between the cooking method and disease. It is not clear whether the same results would be found if the study was conducted on the UK diet, which is generally considered less healthy than the Mediterranean diet.
  • This study cannot say that consuming fried foods at a higher level than their highest consumption group (249.6g/day) does not increase risk of heart disease.
Bearing in mind the limitations, this study showed that there may not be a link between consuming foods fried in olive oil or vegetable oil and coronary heart disease in Spanish adults consuming a typical Mediterranean diet. The relevance of this to the UK is limited due to differences in diet and the type of fried foods consumed in the two countries.
It is important to note that frying foods with other types of fats, particularly saturated fats such as lard or butter, reusing oils several times, or consuming fried snacks high in salt may still be harmful.

Links to the headlines
Fried food heart risk 'a myth'. The Daily Telegraph, January 25 2012
You'll be oil right. The Sun, January 25 2012