University of California Irvine study: One-step test for hepatitis C virus infection developed

16 Nov

The National Medical Association which an association of doctors of African descent reports the following hepatitis C facts:

Hepatitis C Statistics

General Statistics
• Hepatitis C virus commonly spread through sharing of needles, or other equipment to inject drugs. 1
• Risk of transmission occurs more if the person has a pre-existing virus such as HIV. 1
• 3.2 million persons in the United States have chronic Hepatitis C virus infection. 1
• Approximately 75%-85% of people infected with Hepatitis C virus develop chronic infection. 1
• After exposure, average time of symptoms is 6-7 weeks; however, most do not have any symptoms. 1
• Approximately 70-80% of people with acute Hepatitis C do not have symptoms. 1
• Of every 100 people infected with Hepatitis C about: 1
• 75-85 people will develop chronic Hepatitis C Virus infection; of those
o 60-70 people will go on to develop chronic liver disease
o 5-20 people will go on to develop cirrhosis over a period of 20-30 years
o 1-5 people will die from cirrhosis or liver failure.

African American Hepatitis C Statistics
• African American represents 13% of the U.S population, but make up about 22% of the chronic hepatitis C cases.1
• African Americans have significantly higher rates of chronic hepatitis C infections than do Caucasians and other ethnic groups. 1
• 4 of every 100 infant born to mothers with Hepatitis C become infected with the virus. 1
• Chronic liver disease, often Hepatitis C-related is the leading cause of death among people ages 45-64 among African Americans. 1
• Lack of testing for Hepatitis C among African Americans. 1
• There is no vaccine for Hepatitis C. 1
• 26 Americans die each day from Hepatitis C complications. 2
• Each year approximately 170,000 new cases of HCV occur in the United States of America. 2
Source: Centers for Disease Control and Prevention – http://www.cdc.gov/hepatitis/AfricanAmerica-HepC.htm

Hepatitis C Now Trumps HIV as Cause of Death in U.S.

More U.S. residents are now dying of hepatitis C complications than HIV-related illnesses, according to data summarized in the February 21 issue of Annals of Internal Medicine.
• The discovery that HCV infection is now responsible for more deaths than HIV infection is due, in large part, to the continued decline of AIDS-related deaths over the decade. Whereas HIV contributed to six per 100,000 deaths in 1999, the rate dropped to less than four per 100,000 deaths in 2007.
• Hepatitis C–related deaths have increased sharply.
• With respect to crude numbers, roughly 12,700 HIV-related deaths were reported to the National Center for Health Statistics in 2007. More than 15,000 HCV-related deaths were reported to the center that year.
• Co-infection with HIV nearly doubled the risk of death from HBV-related complications and quadrupled the risk of death from HCV-associated liver disease.
Source: Hep Smart + Strong – http://www.hepmag.com/articles/hiv_hcv_deaths_2501_21929.shtmlhttp://www.nmanet.org/index.php?option=com_content&view=article&id=291&Itemid=420

The World Health Organization (WHO) has a concise description of hepatitis C.

According to WHO:

Key facts

• Hepatitis C is a liver disease caused by the hepatitis C virus: the virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness.
• The hepatitis C virus is a bloodborne virus and the most common modes of infection are through unsafe injection practices; inadequate sterilization of medical equipment; and the transfusion of unscreened blood and blood products.
• 130–150 million people globally have chronic hepatitis C infection.
• A significant number of those who are chronically infected will develop liver cirrhosis or liver cancer.
• Approximately 500 000 people die each year from hepatitis C-related liver diseases1.
• Antiviral medicines can cure approximately 90% of persons with hepatitis C infection, thereby reducing the risk of death from liver cancer and cirrhosis, but access to diagnosis and treatment is low.
• There is currently no vaccine for hepatitis C; however research in this area is ongoing.
________________________________________
Hepatitis C virus (HCV) causes both acute and chronic infection. Acute HCV infection is usually asymptomatic, and is only very rarely associated with life-threatening disease. About 15–45% of infected persons spontaneously clear the virus within 6 months of infection without any treatment.
The remaining 55–85% of persons will develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis of the liver is 15–30% within 20 years.

Geographical distribution
Hepatitis C is found worldwide. The most affected regions are Africa and Central and East Asia. Depending on the country, hepatitis C infection can be concentrated in certain populations (for example, among people who inject drugs); and/or in general populations. There are multiple strains (or genotypes) of the HCV virus and their distribution varies by region.

Transmission
The hepatitis C virus is a bloodborne virus. It is most commonly transmitted through:
• injecting drug use through the sharing of injection equipment;
• in health care settings due to the reuse or inadequate sterilization of medical equipment, especially syringes and needles;
• the transfusion of unscreened blood and blood products;
• HCV can also be transmitted sexually and can be passed from an infected mother to her baby; however these modes of transmission are much less common.
Hepatitis C is not spread through breast milk, food or water or by casual contact such as hugging, kissing and sharing food or drinks with an infected person.

Symptoms
The incubation period for hepatitis C is 2 weeks to 6 months. Following initial infection, approximately 80% of people do not exhibit any symptoms. Those who are acutely symptomatic may exhibit fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, grey-coloured faeces, joint pain and jaundice (yellowing of skin and the whites of the eyes)…. http://www.who.int/mediacentre/factsheets/fs164/en/

A 2007 study, The costs and impacts of testing for hepatitis C virus antibody in public STD clinics estimated the test costs:

Abstract

OBJECTIVES:
To estimate the cost and cost-effectiveness of testing sexually transmitted disease (STD) clinic subgroups for antibodies to hepatitis C virus (HCV).

METHODS:
HCV counseling, testing, and referral (CTR) costs were estimated using data from two STD clinics and the literature, and are reported in 2006 dollars. Effectiveness of HCV CTR was defined as the estimated percentage of clinic clients in subgroups targeted for HCV antibody (anti-HCV) testing who had a true positive test and returned for their test results. We estimated the cost per true positive injection drug user (IDU) who returned for anti-HCV test results and the cost-effectiveness of expanding HCV CTR to non-IDU subgroups.

RESULTS:
The estimated cost per true positive IDU who returned for test results was $54. The cost-effectiveness of expanding HCV CTR to non-IDU subgroups ranged from $179 to $2,986. Our estimates were most sensitive to variations in HCV prevalence, the cost of testing, and the rate of client return.

CONCLUSIONS:
Based on national data, testing IDUs in the STD clinic setting is highly cost-effective. Some clinics may find that it is cost-effective to expand testing to non-IDU men older than 40 who report more than 100 lifetime sex partners. STD clinics can use study estimates to assess the feasibility and desirability of expanding HCV CTR beyond IDUs. http://www.ncbi.nlm.nih.gov/pubmed/17542455

University of California Irvine researchers may have developed a cheaper test.

Science Daily reported in One-step test for hepatitis C virus infection developed:
Related research shows blood or urine sample can be used:

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…. http://www.sciencedaily.com/releases/2015/11/151114185041.htm

Citation:

One-step test for hepatitis C virus infection developed
Related research shows blood or urine sample can be used
Date: November 14, 2015

Source: University of California – Irvine

Summary:
A cost-effective one-step test that screens, detects and confirms hepatitis C virus (HCV) infections has been developed by researchers. Current blood-based HCV testing requires two steps and can be expensive, inconvenient and is not widely available or affordable globally.

Medical Press reported the following information from the University of California Irvine:

One-step test for hepatitis C virus infection developed
November 14, 2015

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.
Explore further: Only half newly reported HCV cases receiving follow-up test

Provided by: University of California, Irvine
http://medicalxpress.com/news/2015-11-one-step-hepatitis-virus-infection.html

A cheaper and simpler hepatitis C test could save lives as more of those at risk can be tested.

Resources:

Viral Hepatitis – Statistics & Surveillance

http://www.cdc.gov/hepatitis/Statistics/index.htm

Frequently Asked Questions About Hepatitis C

http://www.cpmc.org/learning/documents/hepatitisc-ws.html

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