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May 2014 VA Hep C Treatment Guidelines
UPDATE: Feb 26, 2016-
Funding and Prioritization Status Update

UPDATE: March 2016
VA Hep C Treatment Guidelines
VA to treat all vets in system
 

By Judith Graham
VA Extends New Hepatitis C Drugs to All Veterans in Its Health System

 
Orange Count Registry
Vietnam vets blame 'jet guns' for their hepatitis C
By Lily Leung Feb. 14, 2016 
 
CBS News Investigates
Congress outraged over hepatitis C treatment VA can't afford
Dr. Raymond Schinazi played a leading role developing a drug that cures hepatitis C while working seven-eighths of his time for the VA
 
ibtimes.com| By amynordrum
 


Hepatitis C drug costing VA, DoD millions
By Patricia Kime, Staff writer
We're looking at a company who is milking a cash cow for everything it's worth," Sanders said. 
 


VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Arizona Republic 12:27 a.m. EDT June 21, 2015
 


VA to outsource care for 180,000 vets with hepatitis C
, The Republic | azcentral.com 11:51 a.m. MST June 19, 2015
Dr. David Ross, the VA's director public-health pathogens programs, resigned from the working group. "I cannot in good conscience continue to work on a plan for rationing care to veterans," he wrote.
 


VA Region Stops Referring Patients To Outside Hospitals Thanks To Budget Shortfall
Michael Volpe Contributor ...According to a memo — the entire region has been forced to stop all “non-VA care” referrals due to a budget shortfall.
 

DisabledVeterans.org
OIG INVESTIGATES VA CHOICE PROGRAM PROBLEMS
Sen. Mark Kirk admitted the VA Choice Program is a failed joke in a letter to Secretary Bob McDonald despite attempts to fix it.
 

 
Denied Hep C VA dental care?
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Dried Hepatitis C Blood Exposure 11/23/2013 Weeks later inconspicuous blood transmits virus and more likely to cause accidental exposures to Hep C
 

Lack of Standards for
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1970 Jetgun Nursing Instructions
 

2014 AASLD Study Hepatitis C not an STD

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Special to ABCNEWS.com  

 A simple blood test might have prevented hundreds of thousands of cases of  hepatitis C, a blood-borne viral infection that often leads to chronic and fatal liver damage.  

In the unfolding story of the hepatitis C epidemic now affecting some  4 million Americans, the failure to use this test is a badly neglected  chapter. And you won’t find much, if any, medical or media reference these  days to this saga—namely how the test, available since the late 1950s, could have been used early on to screen the blood supply and reject many donors infected with hepatitis C. 

      The public focus on hepatitis C also includes little mention of the questionable way this disease was tracked and managed by doctors, blood bankers and government health officials. Research Bedrock The blood test at issue, known as ALT, measures the liver enzyme alanine aminotransferase. 

A study back in 1959 showed that blood donors with raised ALT levels were three to five times more likely to transmit hepatitis than those with normal levels. In those days, only hepatitis A and B had been identified. By the mid-1970s, researchers had developed specific blood tests to detect each type. Meanwhile, hepatitis continued to crop up in about 10 to 15 percent of blood transfusion recipients.

This form of hepatitis first became known as non-A and non-B, then was later dubbed hepatitis C.  Once this new type was identified, it begged the question of whether blood banks should routinely use ALT to test for it, especially since there was no specific blood test for hepatitis C like there was for A and B. 

Preliminary research evidence back then supported the idea that ALT could be of value. By 1981, studies published in the New England Journal of Medicine and the Journal of the American Medical Association had confirmed that the higher a blood donor’s ALT score, the greater the risk that a blood transfusion recipient would become infected with hepatitis C. 

Some researchers suggested that screening blood donors with the ALT test could prevent as many as 40 percent of post-transfusion hepatitis C infections; the net loss in units of donated blood would have been about 3 percent. Between 1981 and 1983, an intense debate raged in medical journals. 

Those opposed to ALT testing, including blood bankers and government officials, called for more studies and planning. They expressed concern about the nonspecific nature of the test, the added costs to the blood banking system and the loss of donors who might be falsely detected as positive for hepatitis C. Some critics of the test didn’t think hepatitis C was a serious disease. 

 Ahead of the Pack
 Despite the controversy, several blood banks began routine ALT testing in 1982. The New York Blood Center, for one, figured testing would add about $2.40 to the cost of a unit of blood and considered it worth the expense, given that up to 10,000 New Yorkers would likely be protected against hepatitis C each year. Also that year, and then again in 1984, published cost- benefit analyses of ALT testing showed significant benefit from such a program. By 1986, ALT testing of donated blood finally became routine, and another indirect blood test was also used routinely. 
A specific test for hepatitis C has since been developed and all blood banks now use it. One estimate is that one in 10,000 to 100,000 pints of donated blood may still be contaminated by the virus, compared to around one in 100 pints in the late 1960s. 

     Exactly how much harm has been caused by the delay in testing the blood system for hepatitis C may never be known. There’s still a lot to be learned about how the virus does its damage and how many among the infected will actually develop significant diseases such as cirrhosis, liver cancer or liver failure. It’s usually estimated that about 10,000 Americans die each year from the complications of hepatitis C infection. 

Many don’t even know they’re living with the virus, however, because it can be “silent” for decades before symptoms become obvious. So far, drug treatments are effective for only a small number of patients, and a vaccine is far off.

Federal Heads in the Sand 
The federal government recently launched a campaign to notify hundreds of thousands of blood transfusion recipients who may have been infected. Should we be cynical about such an effort? Is this a typical example of what governments do after they miss an opportunity to prevent the spread of an illness, and is the government liable in this case? 

Americans trusted a public health system that ultimately failed them. Rather than err on the side of safety, health officials chose for years to resist reasonable scientific evidence in favor of using the ALT test. They instead involved themselves in controversies surrounding the imperfect nature of the test and its additional cost when it was clearly the only weapon available to fight hepatitis C. 

Perhaps Congress should investigate why ALT testing was not implemented until 1986. A congressional committee could probe the medical literature on the subject and read the well-researched volumes of the recent Canadian commission on tainted blood. Committee members might want to inquire why the Food and Drug Administration never issued a formal regulation requiring ALT testing of donated blood, and how blood industry representatives who sat on government health committees may have influenced decisions about testing.  Better late than never.             

end

Nicholas Regush produces medical features for ABCNEWS. In the weeks ahead, he’ll take an inside look at other trouble spots in medicine, herald some innovative achievements and analyze medical trends that will likely have great impacts on our lives.

Ann Intern Med 1977 Jul;87(1):14-20 Transmission of non-A, non-B hepatitis. (Jul 1977) Hoofnagle JH, Gerety RJ, Tabor E, Feinstone SM, Barker LF, Purcell RH
 In studies conducted in the early 1950s, sera from six asymptomatic blood donors, implicated in the transmission of viral hepatitis, were inoculated into 10 to 20 volunteers each. Five of these "implicated" donor sera transmitted clinically apparent hepatitis to the recipients. The stored serum samples from these studies have been reanalyzed using serologic markers for hepatitis B virus and hepatitis A virus infection. Two of  the donor sera were hepatitis B surface antigen (HBsAg)-positive, and both transmitted hepatitis B virus infection to all susceptible recipients, half of whom showing clinical symptoms. The remaining three infectious donors were HBs-Ag-negative, yet were icterogenic to 10% to 47% of recipients. Testing of serum samples from these recipients with hepatitis showed no evidence of hepatitis B virus or hepatitis A virus infection. This study and other recent evidence suggest that there is a third type of human viral hepatitis--non-A, non-B hepatitis--which is due to a transmissible agent and may well be associated with a chronic carrier state.
PMID: 195505, UI: 77220027
------------------
Serum alanine aminotransferase of donors in relation to the risk of non-A,non-B hepatitis in recipients: the transfusion-transmitted viruses study.
(Apr 1981) AUTHORS: Aach RD; Szmuness W; Mosley JW; Hollinger FB; Kahn RA; Stevens CE; Edwards VM; Werch J SOURCE: N Engl J Med 1981 Apr 23;304(17):989-94
 
ABSTRACT: To evaluate the incidence of post-transfusion hepatitis and factors influencing its occurrence, the Transfusion-Transmitted Viruses Study  prospectively followed 1513 transfusion recipients from 1974 through 1979. The attack rate for non-A,non-B hepatitis was 10 per cent. The incidence of hepatitis was directly related to the alanine aminotransferase (ALT) level in blood donors. In recipients of multiple transfusions of blood that had no donor-ALT level above 29 IU per liter the attack rate was 6 per cent or less; at higher donor-ALT levels the attack rate increased progressively, reaching 45 per cent in recipients of units with an ALT of 60 IU or greater. A similar relation was observed among recipients of single units of blood. Moreover, hepatitis developed in 10 of 11 recipients of two units with an ALT level of 45 IU or greater. These data indicate that screening blood for ALT levels would reduce the incidence of non-A,non-B post-transfusion hepatitis. 
CITATION IDS: PMID: 6782484 UI: 81148757
------------------------
Should donor blood be screened for elevated alanine aminotransferase levels? A cost-effectiveness analysis. (Nov 1984) 

JAMA 1984 Nov 23-30;252(20):2839-45 Silverstein MD, Mulley AG, Dienstag JL 
We examined the cost-effectiveness of alanine aminotransferase (ALT) screening of donor blood to prevent non-A, non-B posttransfusion hepatitis. Based on estimated costs of ALT screening, blood replacement, and medical evaluation of donors with high ALT levels, we concluded that screening at an ALT level of 45 IU would cost $3.82 per unit. In a population requiring an average of 3.7 units per transfusion, one case of hepatitis would be prevented for every 115 units screened, resulting in a cost of $439 per case prevented. With an estimated direct medical cost of $1,181 per case of non-A, non-B hepatitis, expected net savings for each case prevented would be $742. Screening at other ALT thresholds would be less cost-saving. Sensitivity analyses indicate that screening would be cost-saving for a wide range of cost estimates and number of units per transfusion. Alanine aminotransferase screening is warranted until more sensitive and specific screening tests for transmissibility of non-A, non-B hepatitis become available.


LabCorp's National Genetics Institute Receives FDA Approval for Nucleic Acid Tests for HCV and HIV-1
BURLINGTON, N.C
., Sept. 21 /PRNewswire/ -- Laboratory Corporation of America(R) Holdings (NYSE: LH) (LabCorp(R)) today announced that its National Genetics Institute Inc. (NGI) had its Biologics License Applications for the UltraQual(TM) HCV RT-PCR and UltraQual(TM) HIV-1 RT-PCR assays approved by the U. S. Food and Drug Administration (FDA). NGI's UltraQual(TM) assays for HCV and HIV-1 are the first nucleic acid amplification tests (NAT) to be approved by the FDA for donor screening and will result in earlier detection of HCV or HIV-1 infection in plasma donors as well as increase the overall safety of plasma derived products. The FDA has also approved the use of the NGI UltraQual(TM) HIV-1 RT-PCR assay in combination with approved pooling algorithms as an alternative to currently licensed HIV-1 p24 antigen tests for the screening of Source Plasma.

When used in combination with FDA approved pooling and resolution algorithms, NGI's UltraQual(TM) HCV RT-PCR and UltraQual(TM) HIV-1 RT-PCR assays are indicated for the qualitative detection of Hepatitis C Virus (HCV) and Human Immunodeficiency Virus, type 1 (HIV-1) nucleic acids in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples respectively.

"Our NGI laboratory team has once again demonstrated outstanding scientific leadership by becoming the first clinical laboratory to have these important assays approved by the FDA," said Myla P. Lai-Goldman, M.D., executive vice president, chief scientific officer and medical director. "These tests represent a totally new and innovative approach to screening plasma donations. In addition to enhanced product safety, these extremely sensitive assays allow us to test large numbers of donations in a very efficient manner when used in combination with complex pooling algorithms. We look forward to employing these assays with Alpha Therapeutic Corporation, which has simultaneously
received approval by the FDA to combine its pooling and resolution algorithms
with LabCorp/NGI's newly approved assays."

The first national clinical laboratory to fully embrace genomic testing, Laboratory Corporation of America(R) Holdings (LabCorp(R)) has been a pioneer in commercializing new diagnostic technologies. As a national laboratory with annual revenues of $1.9 billion in 2000 and over 18,000 employees, the company offers more than 4,000 clinical tests ranging from simple blood analyses to sophisticated molecular diagnostics. Serving over 200,000 clients nationwide, LabCorp leverages its expertise in innovative
clinical testing technology with its Centers of Excellence. The Center for Molecular Biology and Pathology, in Research Triangle Park, North Carolina, offers state-of-the-art molecular gene-based testing in infectious disease, oncology and genetics. Its National Genetics Institute in Los Angeles is an industry leader in developing novel, highly sensitive polymerase chain reaction (PCR) methods for testing hepatitis C and other blood borne infectious agents. LabCorp's Minneapolis-based Viro- Med offers molecular microbial testing using real time PCR platforms, while its Center for Esoteric Testing in Burlington, North Carolina, performs the largest volume of specialty testing in the network. LabCorp's clients include physicians, state and federal government, managed care organizations, hospitals, clinics, pharmaceutical and Fortune 1000 companies, and other clinical laboratories.

Each of the above forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace and adverse actions of governmental and other third-party payors. Further information on potential factors that could affect LabCorp's financial results is included in the Company's Form 10-K for the year ended December 31, 2000 and subsequent SEC filings.
SOURCE Laboratory Corporation of America Holdings