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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?
Please click here

 
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
Mass Vaccinations
1970 Jetgun Nursing Instructions
 

2014 AASLD Study Hepatitis C not an STD

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Info: Plan Backfires-
VBA Fast Letter Boost Claims
 
Legal- Fed Regs state:
Judge decision may be relied upon
Cotant v. Principi, 17 Vet.App. 116, 134 (2003),
 
Service Connected Claims
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Hepatitis C Transmission Associated with Immunoglobulin

Quote: "Since the 1940s, immune globulin products licensed in the United States have been safely administered; these products previously have not been known to be associated with the transmission of bloodborne agents, including HIV. Cases of non-A, non-B hepatitis (of which HCV is the primary etiologic agent) have been previously associated
with an unlicensed IGIV product used in a clinical trial in the United States and with IGIV products manufactured and distributed abroad; however, reasons for these episodes of transmission ( 2 ) and the episodes described in this report have not been determined. Since mid-May 1994, the approved manufacturing process for both Gammagard ® and Polygam® includes a solvent-detergent treatment designed to inactivate contaminating viruses. Products manufactured with this treatment should not pose a risk for HCV transmission to recipients."

Outbreak of Hepatitis C Associated with Intravenous Immunoglobulin Administration
United States, October 1993–June 1994
MMWR 43(28);505-509
Publication date: 07/22/1994

On February 21, 1994, the Food and Drug Administration (FDA) was notified of 14 possible cases from three different countries of acute hepatitis C among persons who had received Gammagard®*, an intravenous immunoglobulin (IGIV) product manufactured by Baxter Healthcare Corporation (Glendale, California). The company removed Gammagard® from the worldwide market on February 23, 1994. The American Red Cross removed Polygam® (IGIV manufactured by Baxter Healthcare from American Red Cross plasma) from the market on the same date. This report presents preliminary findings of an evaluation of transmission of hepatitis C virus (HCV) infection from these products and guidelines for monitoring patients who may have received them.†

As of July 19, 1994, CDC had received 112 reports from 24 states and Puerto Rico of possible cases of acute HCV infection in recipients of IGIV; 111 were in persons who received Gammagard®, and one was in a person who received Polygam®. Medical and epidemiologic information and serum samples for HCV serologic testing are being collected from each person. The dates of onset (defined by occurrence of symptoms or first abnormal alanine aminotransferase [ALT] value) for suspected cases were from October 1993 through June 1994 (Figure 1). Of 74 reported persons with possible HCV infection for whom risk factor data (e.g., blood transfusion or injecting-drug use) were available, 68 (92%) had receipt of IGIV as the only risk factor for infection.

The median age of persons with reported cases was 37 years (range: 2–84 years); 52% were female, and 63% received IGIV for treatment of a primary immuno-deficiency disorder (e.g., hypogammaglobulinemia). Of 62 persons tested at CDC for serologic markers of viral hepatitis, 42 (68%) were positive for antibody to HCV (anti-HCV), and none were positive for serologic markers of acute hepatitis A or hepatitis B virus infection. Anti-HCV was detected in 20 (53%) of 38 patients with a diagnosis of primary immunodeficiency and in 21 (95%) of 22 patients with other diagnoses. In blinded testing of serum specimens from 36 persons with suspected cases, none were positive for antibody to human immunodeficiency virus (HIV)-1 or HIV-2.

To assess the risk for HCV infection among persons who received IGIV and to identify risk factors for infection, a cohort study among persons exposed to different IGIV  products at one hospital and a case-control study of persons from throughout the United States have been initiated. Lot-specific denominator data needed to complete these analyses are not yet available from the manufacturer. Preliminary analysis of the cohort study found 16 (7%) cases of HCV infection among 245 recipients of Gammagard  ® (three persons with HCV infection had also received other IGIV products within 6 months of onset). However, no cases of HCV infection were found among 55 recipients who had received only other IGIV products (p<0.05, two-tailed Fisher exact test).

Additional laboratory testing for HCV will be performed on serum samples from infected persons and on samples of implicated and nonimplicated lots of IGIV. Other cohort studies will examine any association between HCV infection and receipt of other IGIV products or intramuscular immune globulin (IGIM). In one of these studies involving persons who received IGIM in 1993, no anti-HCV seroconversions were found among 513 persons tested at least 6 months after IGIM administration (95% confidence interval=0–0.7%).
*Of 112 reported possible cases, the date of illness onset or date of first abnormal alanine aminotransferase level was available for 81 cases.

FIGURE 1. Possible cases* of hepatitis C virus infection reported among persons receiving GammagardÒ or PolygamÒ — United States, October 1993–June 1994 506 MMWR July 22, 1994


Reported by: L Schneider, R Geha, Harvard Medical School, Boston. Walter Reed Army Institute of Research, Washington, DC. Div of Transfusion Transmitted Diseases and Div of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration. Div of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases; Dept of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Heart, Lung, and Blood Institute, National Institutes of Health. Hepatitis Br and Epidemiology Activity, Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases, CDC.


Editorial Note: The temporal association of acute hepatitis C with Gammagard® administration and the absence of other risk factors among these patients indicate that HCV was most likely transmitted by administration of Gammagard®. The report of one possible case in a person who received only Polygam® and had no other risk factors
suggests that Polygam® also may be associated with transmission of HCV. Preliminary analysis of data from epidemiologic studies suggests that HCV transmission is not related to the administration of other IGIV products or IGIM, and there is no need for change in the use of these products.

Since the 1940s, immune globulin products licensed in the United States have been safely administered; these products previously have not been known to be associated with the transmission of bloodborne agents, including HIV. Cases of non-A, non-B hepatitis (of which HCV is the primary etiologic agent) have been previously associated
with an unlicensed IGIV product used in a clinical trial in the United States and with IGIV products manufactured and distributed abroad; however, reasons for these episodes of transmission ( 2 ) and the episodes described in this report have not been determined. Since mid-May 1994, the approved manufacturing process for both Gammagard
® and Polygam® includes a solvent-detergent treatment designed to inactivate contaminating viruses. Products manufactured with this treatment should not pose a risk for HCV transmission to recipients.

Chronic hepatitis develops in more than 60% of persons infected with HCV ( 3 ). All patients who received Gammagard® or Polygam® since April 1, 1993 (6 months before the first reported case), should be screened for evidence of HCV infection and the results interpreted according to the algorithm established by the Public Health Service (PHS) (Table 1). Initial screening of these patients should include a test for ALT activity and an FDA-licensed enzyme immunoassay (EIA) for anti-HCV. All specimens repeatedly (two or more times) reactive for anti-HCV should be tested using an FDA-licensed supplemental anti-HCV assay to reduce the likelihood of false-positive EIA results.

Because some patients will have a prolonged interval between exposure and seroconversion to anti-HCV, patients who are anti-HCV–negative but have abnormal ALT levels should be retested for anti-HCV 3–6 months later. In most patients with normal immune status, seroconversion occurs within 6 months after infection ( 3,4 ). However, approximately 10% of HCV-infected patients with normal immune status will be persistently negative for anti-HCV, even after prolonged follow-up ( 3 ). Persons with immunodeficiency disorders may be less likely to seroconvert or may have longer intervals between infection and seroconversion than persons with normal immune function.

For anti-HCV–negative persons with elevated ALT levels, the diagnosis of hepatitis C is possible with the use of polymerase chain reaction (PCR) for the detection of HCV RNA. However, PCR assays, which are difficult and expensive to perform, should be done only by experienced laboratories using specimens that have been properly collected, stored, and handled. These assays are not licensed by FDA. Patients aged ³18 years with chronic hepatitis C (abnormal ALT levels for more than 6 months) should be evaluated for possible therapy with alpha interferon by a physician experienced in its use ( 5 ). Patients should be informed that the proportion of adults with chronic hepatitis C who sustain a long-term response to alpha interferon is low (approximately 20%). Although FDA has not licensed alpha interferon for patients aged <18 years, they can be considered for therapy if entered into an approved study protocol.

All patients with hepatitis C should be considered potentially infectious. However, because of limited data on the risk of household, sexual, and perinatal transmission and because testing cannot determine infectivity, PHS does not recommend substantial changes in behavior based on knowledge of infection status
( 1 ). PHS recommends that household articles such as toothbrushes and razors that could become contaminated with blood should not be shared, and cuts or skin lesions should be covered to prevent the spread of infectious secretions or blood

( 2 ). HCV transmission by sexual contact appears to occur, but this route of transmission is much less efficient than that for other bloodborne sexually transmitted diseases

( 3 ). Although anti-HCV–positive persons should be informed of the potential for sexual transmission,-there are insufficient data to recommend changes in current sex practices for persons with one steady sex partner. To prevent many sexually transmitted diseases, including hepatitis and HIV infection, persons with multiple partners should follow safer sexual practices, including reducing the number of sex partners and using barriers (e.g., latex condoms) to prevent contact with body fluids. No evidence supports advising against pregnancy based on anti-HCV status or using any special treatments or precautions for pregnant women or their offspring.


References
1. CDC. Public Health Service inter-agency guidelines for screening donors of blood, plasma, organs, tissues, and semen for evidence of hepatitis B and hepatitis C. MMWR 1991;40(no.RR-4):6–17.
2. Lever AML, Webster ADB, Brown D, Thomas HC. Non-A, non-B hepatitis occurring in agammaglobulinaemic patients after intravenous immunoglobulin. Lancet 1984;2:1062–4.
3. Alter MJ. The detection, transmission, and outcome of hepatitis C virus infection. Infectious Agents and Disease 1993;2:155–66.
4. Vallari DS, Jett BW, Alter HJ, Mimms LT, Holzman R, Shih JW. Serological markers of posttransfusion hepatitis C viral infection. J Clin Microbiol 1992;30:552–6.
5. Hoofnagle JH. Therapy of acute and chronic viral hepatitis. Adv Intern Med 1994;39:241–75.
Vol. 43 / No. 28 MMWR 509

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