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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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Help with VA Claims
 


 
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
# 1 Conclusion of Law 
# 2 Conclusion of Law 
 
More Claims
Jetgun Decisions
Hep C Decisions
 
Search Board of Appeals Website
BVA Jetgun Decisions
BVA Hepatitis C Decisions

Great Advice!  
After the jetgun win
What to do next

 

 

Prevalence of Hepatitis C (HCV) Among Military Retirees and Veterans

In Military history there are major problems with the hepatitis B virus documented in troop population in Korea through the 1960s. Attack rates in the range of 8 to 10 per thousand (among 50,000 troops). This resulted in a policy of immune globulin use for all deployed soldiers. By 1970, rates were one-half to one-third of the earlier rates. 1960s Army Immunization Program PDF Version

In 1999 it was determined by scientists, the process to make immune globulin was inefficient at preventing the transmission of blood borne pathogens especially Hepatitis C.

Hepatitis B immune globulin is listed as a Red Cross Risk Factor for transmission of Hepatitis C.

Please wait for the pictures to load.
 

Of the 26 million retired military and veterans, almost 9 million served during Vietnam War, more than 3.2 million had active duty in Asia between 1964 and 1973. It is conservatively estimated that 10% (2.6 million) are now infected with Hepatitis C (HCV.)

As early as the 1940's, Stokes and Neefe (1945) reported that epidemic icteric hepatitis could be either prevented or attenuated by the parenteral administration of human serum gamma globulin. In 1964, a program designed to protect all military personnel stationed in Asia against hepatitis was instituted. A 16-percent solution of human serum gamma globulin in a dose of 0.05 ml/lb was used. The gamma globulin was prepared from blood donated in the United States. A significant decrease in the prevalence of hepatitis during that year as compared to the previous year was seen in preliminary observations in both Korea and Vietnam. ..the incidence of icteric hepatitis in American troops hospitalized in Southeast Asia was significantly affected by the administration of gamma globulin from the United States (Conrad 1972).
 

1942
  • Yellow Fever Vaccine-Associated Hepatitis Epidemic During World War II: Follow-up More Than 40 Years Later-... it appears that about 330,000 men who received these vaccines developed HBV infection, the ratio of icteric:anicteric hepatitis being 1:7. This epidemic thus is the largest point-source hepatitis B outbreak ever recorded
     
  • Sawyer WA Meyer KF Eaton MD Bauer JH Putnam P Schwentker FF : Jaundice in Army personnel in the western region of the United States and its relation to vaccination against yellow fever Am J Hyg 1944 ; 39 : 337-430
     
  • Idem Jaundice in Army personnel in the western region of the United States and its relation to vaccination against yellow fever Am J Hyg 1944 ; 40 : 35-107
     
  • Walker DW : Some epidemiological aspects of infectious hepatitis in the U.S. Army Am J Trop Med 1945 ; 25 : 75-82
     
  • Norman JE, Mortality follow up of the 1942 epidemic of hepatitis B in the U.S. Army, Hepatology 18:790, 1993
The Blood, Plasma, and Related Programs in the Korean War A plasma program was also developed which later had to be discontinued because of the risk of serum hepatitis associated with plasma infusions (p. 776). The production of human serum albumin was substituted for the production of plasma and was supplemented by the production of plasma expanders (the so-called blood substitutes of World War II).
1965 With the increasing involvement in Vietnam after 1965, national stockpiles of gamma globulin were significantly depleted and a reassessment of the prophylactic program was necessary. The dose of gamma globulin administered to soldiers was reduced to 5 ml of a 16-percent solution after arrival overseas, with a second injection 5 months later (DA Circ). It was decided, in 1966, that only persons under high risk of exposure to infectious hepatitis would receive the inoculations of gamma globulin. A continuing incidence greater than five cases per 1,000 per year in particular units was suggested as a guideline for this high risk group. ... the case rates for viral hepatitis ranged between 4 and 10 per 1,000 troops per annum (HOA).
1966 As the number of troops, and consequently the number of cases of hepatitis, increased and the necessity for air evacuation of these patients from Vietnam became apparent, the prolonged period of treatment and hospitalization not only caused a loss of duty time but also produced a logistical problem of evacuation and replacement. The opening of the 6th Convalescent Center at Cam Ranh Bay, Vietnam, on 16 May 1966, provided a way station to which hepatitis patients could be evacuated for convalescence. However, the prolonged recovery phase was still a major factor contributing to the number of man-days lost to combat units.

In examining the problem of treating hundreds of patients with infectious hepatitis at the 6th Convalescent Center, Repsher and Freebern (1969) were impressed by the benignity of the clinical course in most of the patients, the occurrence of relapses despite adherence to a bed rest regimen...

1969 New York Times Washington, July 28 -- The 59-year old doctor, whose companies have been blamed for the repeated use of dangerous methods and inadequate equipment, is estimated to have produced the plasma for about a fourth of an important byproduct that is widely used to protect people exposed to infectious diseases.... An executive of Cutter Laboratories once acknowledged, for instance, that gross contamination was apparent in the areas where the largest blood plasma operations were conducted. The rooms were "sloppy," he observed...When a Government doctor asked why Cutter continued to reward such an enterprise with hundreds of thousands of dollars' worth of business, the executive explained that the Stough group enjoyed crucial "contacts" with well placed officials. ......

With neither Government nor industry intruding, with most of their records held in secret, with officials passing the problem on to someone else, Dr. Stough prospered at his work throughout the nineteen-sixties. .......

 

 
1969~1974 - VA - Anicteric hepatitis [HCV] has developed four times [400%]more frequently than icteric [HBV] hepatitis, the total incidence for all 6 years being 11.3%. There is indirect evidence to suggest that an undefined agent is responsible for the majority of instances of post-transfusion hepatitis occurring presently. PMID: 1235478
 
1972 A large body of data is available from the Korean era (Conrad 1969). Conrad (1972) did a study of all soldiers arriving in Korea through a single airport. Between May 1967 and August 1969, 107,803 troops were given, upon arrival, either a 10-ml injection containing 2 ml, 5 ml, or 10 ml of a 16-percent human serum gamma globulin or a 10-ml albumin-sucrose-potassium glutamate solution.

A second injection of the same material was given to 65 percent of these soldiers 5 to 7 months later.

Soldiers having symptoms or physical findings of hepatitis were hospitalized and examined. A liver biopsy specimen was obtained from 82 percent of the patients. Results showed 467 documented cases of icteric viral hepatitis in the subjects studied. The calculated incidence was 5.67 cases per 1,000 among the control subjects, who received the albumin, while among soldiers given various amounts of gamma globulin it was 4.04 (2 ml group), 3.39 (10 ml group), and 2.90 (5 ml group) cases per 1,000.

1977 72(1):111-21 Jan Veterans Administration cooperative study A randomized, double blind controlled trial of the efficacy of immune serum globulin for the prevention of post-transfusion hepatitis. A Seeff LB, Gastroenterology ...controlled trial has been conducted in 11 Veterans Administration hospitals during a 49-month period The data suggest, however, that a similar reduction in type non-A, non-B hepatitis would have occurred had commercial blood been excluded from use. Furthermore, the efficacy of the ISG, manufactured in 1944, against apparent type non-A, non-B hepatitis suggests that this overlooked disease has existed from at least that time. Publication Types: Clinical trial Randomized controlled trial More info
1982
J Infect Dis Sporadic non-A, non-B hepatitis: frequency and epidemiology in an urban U.S. population.
Alter MJ, et al. Baltimore, Maryland between February 1979-August 1980. Of the 295 patients with serologically diagnosed hepatitis, 42% had non-A, non-B hepatitis;
 
1983
In 1983 members of NEPMU6 conducted a large shipboard hepatitis study. The results documented that sailors and Marines did acquire hepatitis, particularly hepatitis B during WESTPAC deployments (Sailors 4.9%, Marines 6.8%). The data helped provide scientific justification of our immunization programs as carried out today with the newer hepatitis vaccines.
  • Navy Environmental and Preventive Medicine Unit 6 (NEPMU6) Turns Fifty
    By Captain H. James Beecham III, MC, USN

  • Devereux J, Haeberli P, Smithies O. A comprehensive set of sequence analysis programs for the vax. Nucleic Acids Res 1983;12:387–95.

 

1986

THE ARMED FORCES EPIDEMIOLOGICAL BOARD
Its First Fifty Years by Theodore E. Woodward, M.D.

...During these discussions, the Board leaned heavily on Dr. Saul Krugman for advice and guidance. His broad and authoritative experience in the fields of hepatitis and its control by hepatitis vaccines has made him an important resource, not only for the Board, but also for the nation....During a Board meeting in June 1986, Captain Michael Stek, Jr., MC, USN, presented data and press clippings that suggested that a contaminated jet injector gun, which had been used at a private clinic in California in 1985, was responsible for causing hepatitis in sixty-four patients. The possibility was also raised that HIV infection might be transmitted by the jet gun when biological products, such as gamma globulin, were administered. After numerous meetings, the Board recommended, in March 1988,

  • that the jet injector gun be used only with authorized
  • military technical parts and that it be sterilized
  • according to standard procedures.


Veterans Administration cooperative study on hepatitis and dentistry. Am Dent Assoc Sep;113(3):390-6 Schiff ER, Oral and maxillofacial surgeons composed the highest
prevalence occupation (24.0%),
 

1987

VA also funded the CDC Vietnam Experience Study published in 1987 and 1988

Vietnam Experience Study (VES) (excerpts from report)

February 13, 1987 / 36(5);61-4
Current Trends Postservice Mortality Among Vietnam Veterans

The CDC has recently completed the first phase of the Vietnam Experience Study (VES), a comprehensive study of the health of Vietnam veterans. The VES is a historical cohort study in which the health of 9,324 Vietnam veterans is compared with that of 8,989 non-Vietnam veterans who served in Korea, Germany, or the United States during the Vietnam era. Eligibility for the study was limited to male U.S. Army veterans who first entered military service between 1965 and 1971, who served a single term of enlistment, and who were discharged alive in the enlisted pay grades E-1 through E-5. Participants were randomly selected from computerized lists of accession numbers taken from the military personnel files of Army veterans who were discharged during the relevant time period.

...this group of veterans has not yet reached the age at which chronic diseases have an important impact on mortality...

Jun 7 1987 Possible infectious causes in 651 patients with acute viral hepatitis during a 10-year period (1976-1985). Liver - Six hundred and fifty-one patients with acute viral hepatitis were identified serologically between January 1976 and December 1985. Of these, 109 (17%) had hepatitis A, 135 (21%) had hepatitis B, and 407 (62%) had hepatitis non-A, non-B. click here
 

1988

Health status of Vietnam veterans. II. Physical health. The Centers for Disease Control Vietnam Experience Study. JAMA 1988;259(18):2708-2714. A study from the Centers for Disease Control and Prevention on the health status of Vietnam veterans found 3% had used “hard drugs,” including amphetamines, barbiturates, cocaine, heroin, psychedelics, phencyclidine and methaqualone. (See FY 1987)
 

Out of all Vietnam Vets that used drugs (3% or 270,000), 90 to 95 percent of all GI users sniffed ("snorted") the drug or inserted a little in a cigarette and smoked it. Only 13,500 are assumed to have injected illicit drugs

  • The Consumers Union Report on Licit and Illicit Drugs by Edward M. Brecher and the Editors of Consumer Reports Magazine, 1972 some 90 to 95 percent of all GI users sniffed ("snorted") the drug or inserted a little in a cigarette and smoked it.
     

  • Recreational Drug Information Website relatively few were either dysfunctional or addicted users after their return to the United States (58)
     

  • Hepatitis C in Vietnam Era Veterans Bradford Waters, M.D. Staff Hepatologist, Memphis VA Medical Center, Associate Professor of Medicine, University of Tennessee, Memphis 90-95% of addicts smoked heroin and only 5-10% of that group injected
     

  • Failure of gloves and other protective devices to prevent transmission of hepatitis B virus to oral surgeons. JAMA;259(17):2558-60 Reingold AL, Kane Department of Biomedical and Environmental Health Sciences, School of Public Health, University of California, Berkeley. A survey of 434 oral surgeons was conducted to examine risk factors for hepatitis B virus (HBV) infection. Overall, 112 (26%) of the participants demonstrated serologic evidence of past or current infection with HBV. click here
     

  • Centers for Disease Control. 1988. Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus and Other Bloodborne Pathogens in Healthcare Settings. MMWR, 37:377-382, 387, 388.

 

1989
Non-A Non-B hepatitis is identified as Hepatitis C Virus by the CDC and Chrion Pharmaceutical who would later possess over 100 exclusive rights involving the Hepatitis C virus.
1990
  • Alter MJ, et al. Risk factors for acute non-A, non-B hepatitis in the United States and association with hepatitis C virus antibody. JAMA 1990; 264:2231-5. The incidence of non-A, non-B hepatitis remained relatively stable (average, 7.1 cases per 100,000, but there were significant changes in disease transmission patterns.
     
  • The Pentagon revealed that the Office of the Surgeon General of the Army established a "hepatitis C registry" during the early 1990s.

    According to the response, the Pentagon concluded "that hepatitis C did not constitute a significant drain on either personnel or medical resources. The Department of Defense admitted that "the registry was neither complete nor a truly random sample."...The response, written by Anne Johnson-Winegar, stated that the original intent of the registry was to:

    * Maintain a list
    * Track the natural progression
    * Attempt to assess the impact
    * Establish a database of infected persons who could be followed over time.

    Data was collected from May 1990 through October 1993," said Johnson-Winegar. "Data was collected from medical treatment facility blood banks and clinical laboratories, from prevention medicine services, and from the references at WRAIR. The reporting of patient data by the preventative medicine services was mandated by OTSG, but compliance varied from post to post. In the absence of patient data from preventative medical resources, only hepatitis C virus antibody tests results were known for an individual."

    While the Pentagon disbanded the hepatitis C registry for military personnel in 1993, after concluding that the infection rate was only one percent, recent studies indicate that military veterans have the highest hepatitis C rate in the nation. Statistics by the American Liver Foundation show that 1.8 percent of the U.S. population is Hepatitis C positive. Twelve to 14 percent of those infected are veterans.
     
  • Hepatitis C Epidemiology in Military and Veteran Populations: Proceedings of the Second Biennial Conference, March 7, 1990 (1991) Institute of Medicine- Yellow Fever Vaccine-Associated Hepatitis Epidemic During World War II: Follow-up More Than 40 Years Later
     
  • Enomoto N, Takada A, Nakao T, et al. There are two major types of hepatitis C virus in Japan. Biochem Biophys Res Commun 1990;170:1021–5.[ISI][Medline]
First Hepatitis C test was introduced to the blood banks. It detected only 46% of the positive results. In recent years, all blood donors have been extensively screened by interview and tested for a number of infectious disease markers. Before 1985, donor units were issued for transfusion only if they were seronegative for syphilis and negative for hepatitis B surface antigen (HBsAg). All donors had to successfully complete a donor interview and were asked to voluntarily exclude themselves if they were in an AIDS risk group.

From 1985 through 1989, serologic testing for HIV and human T-lymphotropic virus (HTLV) along with a more sensitive (second-generation) test for HBsAg were added to the testing menu. The donor interview was expanded to include direct questioning about participation in activities that put donors at risk for HIV or hepatitis infection. Donors were also tested for alanine aminotransferase and hepatitis B core antibody (anti-HBc), which are surrogate markers for possible non-A, non-B hepatitis.

Since 1990, the donor interview has been expanded a number of times, and serologic testing for HCV has been implemented. By the year 2000, a third generation HBsAg test was used

Beginning in the spring of 1999, the American Red Cross and 16 member laboratories of the America’s Blood Centers began testing donor blood for the hepatitis C virus with a new research testing method known as nucleic acid amplification testing (NAT).


1991

In 1991, OSHA issued the Bloodborne Pathogens Standard (29 CFR 1910.1030) to protect workers from this risk. In 2001, in response to the Needlestick Safety and Prevention Act, OSHA revised the Bloodborne Pathogens Standard. The revised standard clarifies the need for employers to select safer needle devices and to involve employees in identifying and choosing these devices. The updated standard also requires employers to maintain a log of injuries from contaminated sharps.
 

  • van Doornum GJJ, Hooykaas C, Cuypers MT, et al. Prevalence of hepatitis C virus infections among heterosexuals with multiple partners. J Med Virol 1991;35:22–7.[ISI][Medline]
     
  • Aach RD, et al. Hepatitis C virus infection in post-transfusion hepatitis: an analysis with first- and second-generation assays. N Engl J Med 1991;325:1325-9. - test for anti-HCV antibodies in serum samples collected between 1976 and 1979 in the Transfusion-Transmitted Viruses Study (from 1247 patients who underwent transfusion and 1235 matched control subjects who did not receive transfusions). RESULTS. Of the 115 patients...the initial serum samples of 111 were anti-HCV-negative; after hepatitis developed in these 111 patients, the first-generation EIAs detected anti-HCV in 51 (46 percent), and the second-generation assay detected anti-HCV in an additional 16 (14 percent), for a total of 60 percent. Of 40 controls, 37 were anti-HCV-negative initially,

NEW YORK (Reuters Health) - The findings of a long-term study of injection drug users... These results "underscore the importance" of nucleic acid screening of blood...an "alarming" 34 percent became infected despite risk reduction counseling click here

MMWR. 1991;40:1-8) The CDC Guideline Recommendations for preventing transmission during exposure-prone invasive procedures. is here: http://www.cdc.gov/mmwr/preview/mmwrhtml/00014845.htm "The guidelines stated that infected health care workers who adhere to universal precautions and who do not perform invasive procedures pose no risk for transmitting.
 

1992

1993

  • Simmonds P, Holmes EC, Cha TA, et al. Classification of hepatitis C virus into six major genotypes and a series of subtypes by phylogenetic analysis of the NS-5 region. J Gen Virol 1993;74:2391–9. [Abstract/Free Full Text]


Hepatitis Surveillance

November 19, 1993 INACTIVATION OF VIRUSES IN BLOOD COMPONENT NIH GUIDE, Volume 22, Number 42, IN VITRO INACTIVATION OF VIRUSES IN BLOOD COMPONENTS- Current risks of being infected with a unit of screened blood are 1 in 3,000 for HCV, 1 in 200,000 for HBV, and 1 in 225,000 for HIV. In addition, viruses such as the human T-cell lymphotropic viruses (HTLV) types I and II, and
cytomegalovirus (CMV), also pose potential risks

Viral Hepatitis Surveillance Program 1993
Centers for Disease Control and Prevention
Issued April, 1996

...persons with hepatitis C/NANB reported injection drug use most frequently, accounting for 23% of cases during 1993 ...Overall, 58% of persons reported no known source for their infection. Dental work reported as highest incident for hepatitis non a non b


  • Polish LB, Tong MJ, Co RL, et al. Risk factors for hepatitis C virus infection among health care personnel in a community hospital. Am J Infect Control 1993;21:196–200.[ISI][Medline] CONCLUSION: Although the prevalence of antibody to hepatitis C virus in health care workers was not high, needlestick injuries were associated with an increased risk for acquiring hepatitis C virus infection.
     
  • Hyams KC, Krogwold RA, Brock S, et al. Heterosexual transmission of viral hepatitis and cytomegalovirus among U.S. military personnel stationed in the western Pacific. J Sex Transm Dis 1993;20:36–40.[ISI][Medline]
     

1994

Frequent patient-to-patient transmission of hepatitis C virus in a haematology ward.
http://www.ncbi.nlm.nih.gov/pubmed/7545963?dopt=Abstract


1 Dec 94-1 Aug 95 WALTER REED ARMY MEDICAL CENTER WASHINGTON DC Clinical Impact of Hepatitis C Infection in Military Active Duty Women- HCV-infection (2.7%) is seen in excess than the rate observed among healthy American blood donors (0.5%) .


It is estimated that 5-8% of the Vietnamese population is infected with HCV.

  • Song P, Duc DD, Hien B, et al. Markers of hepatitis C and B virus infections among blood donors in Ho Chi Minh City and Hanoi, Vietman. Clin Diag Lab Immunol. 1994:1(4):413-418.


  • Pham DQ, Walse D, Montgomery J, et al. Seroepidemiology of hepatitis C and B in an urban VA medical center. (Abstract). Hepatology 1994;326A
     

  • Wolfe L, Tamatsukuri S, Sayada C, et al. Detection of HCV RNA in serum using a single-tube, single enzyme PCR in combination with a colorimeteric microwell assay. In: Group Francais d'Estudes Moleculaires des Hepatites, GEMHEP, ed. Hepatitis C virus: new diagnostic tools. London, United Kingdom: John Libbey, 1994:83–94.
     

  • Outbreak of hepatitis C associated with intravenous immunoglobulin administration—United States, October 1993–June 1994. MMWR Morb Mortal Wkly Rep 1994;43:505–9.[Medline]

1995
The prevalence of anti-HCV among a cohort of active-duty US marines stationed in Okinawa, Japan was 0.2%...

Compliance with universal precautions among health care workers at three regional hospitals. American Journal of Infection Control. 1995;23:225–236. doi: 10.1016/0196-6553(95)90067-5. [PubMed]

National Institute of Cholera and Enteric Diseases, (e-mail:kamal412496@yahoo.com) "this continuous increase in HCV infection among IDUs, despite the needle and syringe exchange programme, is a cause for concern. The cause of this striking increase in HCV infection is unclear."
 

1996
  • Nainan OV, Cromeans TL, Margolis HS. Sequence-specific, single primer amplification and detection of PCR products for identification of hepatitis viruses. J Virol Methods 1996;61:127–34.[ISI][Medline]
     
  • Schreiber GB, Busch MP, Kleinman SH, et al. The risk of transfusion-transmitted viral infections. N Engl J Med. 1996;334: 1685-1690. estimated the risk of transfusion-transmitted HCV as 1 in 103,000 units transfused.

As a result of the HCV infections occurring from immunoglobulin preparations that had not undergone viral inactivation, regulatory agencies have mandated that manufacturers include viral inactivation in the production of therapeutic immunoglobulin.

  • Lee HH, Allain JP. Genomic screening for blood-borne viruses in transfusion settings. Vox Sang. 1998;74(suppl 2):119-123.
     
  • NUCLEIC ACID AMPLIFICATION TESTING: THE NEW INFECTIOUS DISEASE TESTING METHOD FOR DONOR BLOOD Moyne Treat Kornman, MD, German Leparc, MD, and Kaaron Benson, MD From the Florida Blood Services, Tampa, Fla (MTK, GL) and the Pathology Service at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla (KB)...
     
  • Brown AE, Tomlinson JP, Brundage JF, et al. The U.S. Army HIV testing program: the first decade. Mil Med 1996;161:117–22.[ISI][Medline]
     
  • Tong MJ, El-Farra NS. Clinical sequelae of hepatitis C acquired from injection drug use. West J Med 1996;164:399–404.[ISI][Medline]
     

Ramsey PW, McConnell P, Palmer BH, Glenn LL. Nurses' compliance with universal precautions before and after implementation of OSHA regulations. Clin Nurse Spec. 1996;10:234–239. doi: 10.1097/00002800-199609000-00008. [PubMed]

MJA 1996; 164: 533-536 Conclusions: Reuse of medical devices labeled "single use only" is common... Most devices appear to be unsuitable for reuse. Complete cessation of this practice of reusing single-use medical devices would stop potential cross-infection, but this would cost an estimated $2.5 million or more per case prevented

 

1997

Did Shots Cause Hepatitis C? Officials Downplay Concerns
(Star Tribune) "Former Surgeon General C. Everett Koop said more research is needed on all possible transmission routes for hepatitis C - including immune globulin inoculations."

A four-year review of patients with hepatitis C antibody in Department of Veterans Affairs facilities. VA health care system in the Pacific Northwest were tested for anti-HCV antibodies, and 8,230 (21.7%) were positive. 21% had markers of hepatitis C virus infection... 45.8% of the seropositive veterans were between the ages of 40 and 49 years.

There were 6,600 HCV cases reported in the VA system in 1991. By 1994, this number had increased to 18,854. Over the next four years, the annual number of newly identified cases increased steadily to 20,203 in 1995, 21,424 in 1996, 24,850 in 1997, and 29,799 in 1998. Since March 1999, over 69,000 additional cases have been identified. VA officials expect this number to continue to increase substantially.

  • Roselle GA, Danko LH, Mendenhall CH. A four-year review of patients with hepatitis C antibody in Department of Veterans Affairs facilities. Mil Med. 1997;162(11):711-714.
     
  • Department of Veterans Affairs. Veterans Health Administration. Washington, D.C. 1998
    Kralovic S, Roselle GA, Simbartl L, et al. Hepatitis C virus antibody (HCAb) positivity in Department of Veterans Affairs (VA) facilities. Presented at the Ninth Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA). San Francisco, California. 1999. A large multi-center VA study involving twenty six Medical Centers and approximately 5,800 patients was initiated by the San Francisco VA Medical Center to study demographic factors and treatment response in VA patients.
     
  • Spolarich AW, Russo B. Hepatitis C and veterans. December 1998/January 1999. The VVA Veteran®... screening program that tested 200 apparently healthy leaders of the Vietnam Veterans of America found 9% of those tested were infected with HCV. A more recent screening at a Vietnam Veterans’ stand down found 36% of those screened tested positive for HCV.
     
  • Army Medical Surveillance Activity. Guidelines for use of specimens stored in the DoD serum repository. June 25, 1997. (http://amsa.army.mil/AMSA/amsa_home.htm).
1998

March 5, 1998
 

CNN- Millions unaware they have hepatitis C
 
The newly appointed surgeon general, David Satcher, speaks to the House subcommittee "We know that many Americans infected ...unaware that they have the disease,"
 
§Former surgeon general Koop
§"Many with hepatitis C virus have no reason to believe they are infected,“
§"Many of those at high risk are average people – §middle-aged housewives who had a cesarean section delivery, §young adults who had transfusions as high-risk babies or §middle-aged men who served in Vietnam." ...

Letters will be sent to anyone who received blood from a donor who later tested positive for hepatitis C

Rep. Christopher Shays ¡Public concerns about hepatitis C have been overshadowed by AIDS.

For too long it has been ... characterized as a disease confined to intravenous drug users..." "It wasn't five years ago. Our guard wasn't up

Late M. Action urged to stem hepatitis C. US Med 1998;34:3, 42, 43.

July 19, 1998
House Committee On Veterans' Affairs Subcommittee On Benefits
Statement Of LEONARD B. SEEFF, M.D.
National Institutes Of Diabetes, Digestive, And Kidney Diseases
National Institutes Of Health
And Former Chief, Gastroenterology & Hepatology
Veterans Affairs Medical Center, Washington, D.C.

The only large, population-based screening study in the VA of which I am aware is one that was conducted at my VA Medica2355l Center here in Washington, DC over a 6-week period at the beginning of 1994. The intent of our study was to screen 1,000 consecutive patients who were admitted to the facility, regardless of which section they entered, for the presence of hepatitis B and hepatitis C markers. We accomplished our aim in 839 patients and were astonished to find that, whereas 3% were infected with hepatitis B, 21% had markers of hepatitis C virus infection....Furthermore, test procedures were changing during this period and the data did not take into account the important issue, at that time, of false-positive results....persons seen in the emergency room at Johns Hopkins University, in which a prevalence figure of 18.5% was noted. The populations studied in these two screening surveys both derived from the "inner city" and both identified parenteral drug abuse as the apparently most common risk factor....Obviously, these results cannot be applied to other VA Medical Centers...

NAT- the false positive Hepatitis C test for batch blood testing- Approximately 50% of the samples found to be NAT-positive are expected to be false positive (ie, no positive individual donation can be identified).

  • NUCLEIC ACID AMPLIFICATION TESTING: THE NEW INFECTIOUS DISEASE TESTING METHOD FOR DONOR BLOOD Moyne Treat Kornman, MD, German Leparc, MD, and Kaaron Benson, MD From the Florida Blood Services, Tampa, Fla (MTK, GL) and the Pathology Service at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla (KB)...
     

  • NAT Implementation. Bethesda, Md: American Association of Blood Banks; 1999. American Association of Blood Banks Association Bulletin #99-3 NAT could theoretically close the window period of HCV from the current 70 to 80 days to approximately 10 to 30 days. This would reduce the risk of transfusion-transmitted HCV from approximately 1 in 100,000 units transfused to 1 in 500,000-1,000,000 units transfused.

October 15, 1998
House Report 105 HR 820

DAN BURTON, Indiana, Chairman-
Seventh Report By The Committee On Government Reform And Oversight
51 351 CC Union Calendar No. 461 105th Congress, 2d Session

HEPATITIS C: SILENT EPIDEMIC, MUTE PUBLIC HEALTH RESPONSE

Between 1995 and 1997 the annual number of newly identified persons rose from 20,203 to 21,424 to 24,850. In 1998 an additional 29,799 unique cases were recorded within the VA. Of all veterans in the VA system testing positive for hepatitis C, 64% were Vietnam Era veterans. The mean age of HCV infected veterans is 49 years.

VA researcher Dr. Gary Roselle reports HCV infection in VA has increased 285% during the 4 year period Roselle states; “Since most veterans are not treated in VA medical facilities, the actual incidence of HCV infected veterans is undoubtedly much greater.”
 
  • Former Surgeon General C. Everett Koop – ¡HCV screening program for all U.S. military personnel… ¡all possible transmission routes for hepatitis C - including ¡more research is needed on immune globulin inoculations...begin screening troops for hepatitis C.

    "You've got a demon on your hands," he said. "You'd better find out where that's coming from if you can."
     

 

  • Senator Richard Shelby (R AL) asked the Pentagon to look further into the possibility that immune globulins may have spread HCV. The Pentagon did not agree to study the issue and Senator Shelby inserted the following report language in the 1998 Department of Defense Appropriations bill: ``The Department of Defense shall determine rates of hepatitis C infection among personnel who served in deployments overseas or who received blood plasma products from individuals infected with hepatitis C and provide counseling and access to treatment for personnel as needed.''\33\

November 1998 Presentation of Gay Roselle to the Veterans of Foreign Wars. April 9, 1999. Washington, DC. ~ Spolarich AW, Russo B. “Hepatitis C infection in apparently healthy Vietnam Era veterans.” Submitted for publication.

1998

  • Bray RM (project director). 1998 Department of Defense survey of health related behaviors among military personnel. Research Triangle Park, NC: Research Triangle Institute, February 1999.
     

  • Bachman JG, Freedman-Doan P, O'Malley PM, et al. Changing patterns of drug use among US military recruits before and after enlistment. Am J Public Health 1999;89:672–7.[Abstract/Free Full Text]

October 16, 1998 CDC MMWR, Recommendations and Reports: / 47(RR19);1-39 Enclosure 3 Proposed Hepatitis C Virus (HCV) Antibody Screening Policy

Hepatitis C is transmitted primarily by injections of contaminated blood. The following are the possible sources of hepatitis C infection. If you can answer "yes" to any of these risk factors and have not previously been tested for hepatitis C, you should receive a simple blood test to determine if you could have hepatitis C.

  • Receiving a transfusion of blood or blood products before 1992

  • Ever injecting illegal drugs, including use once or a few times many years ago

  • Receiving clotting factor concentrates produced before 1987

  • Having been on chronic (long-term) hemodialysis

  • Being told that you have persistently abnormal liver enzyme tests (alanine aminotransferase) or an unexplained liver disease

  • Receiving an organ transplant before July 1992

  • Having a needlestick, sharps or mucosal exposure to potentially HCV-infected blood as part of your occupational duties

  •  

Please note and compare the current CDC plan.

CDC Recommendations for Prevention and Control
2001 National Hepatitis C Prevention Strategy

"Most risk factors associated with transmission of HCV in the United States were identified in case-control studies conducted during 1978-1986.

Risk factors included:
  • Blood transfusion,
  • Injecting-drug use
  • Employment in patient care
  • Clinical laboratory work
  • New Exposure to a sex partner
  • New Household member
  • New Multiple sex partners
  • New Low socioeconomic level
     

It's your fault your sick:(

CDC state in both reports: "These studies reported no association with military service or exposures resulting from medical, surgical, or dental procedures, tattooing, acupuncture, ear piercing, or foreign travel. If transmission from such exposures does occur, the frequency might be too low to detect"

NOTE: 2004 Statement Of Lawrence R. Deyton, Md, Msph- Chief Consultant, Public Health Strategic Health Care Group- Veterans Health Administration- Department Of Veterans Affairs- VA efforts in hepatitis C have benefited from close collaboration and partnership with Veterans Service Organizations and other veteran and non-profit groups, as well as with other government agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Federal Bureau of Prisons (FBOP).

The CDC continues to state there is no association with military service and Hepatitis C.
Also note:
Red Cross Risk Factors

March 5, 1998
The newly appointed surgeon general, David Satcher, speaks to the House subcommittee "We know that many Americans infected ...unaware that they have the disease," "Many with hepatitis C virus have no reason to believe they are infected," Koop said. "Many of those at high risk are average people -- middle-aged housewives who had a cesarean section delivery, young adults who had transfusions as high-risk babies or middle-aged men who served in Vietnam."
 

  • Hepatitis C standards for provider evaluation and testing. Under Secretary for Health information letter (IL 10-98-013). Under Secretary for Health's issues information letter outlined standards for provider evaluation and testing for hepatitis C in VHA. Kizer KW. Department of Veterans Affairs. Veterans Health Administration. Washington, D.C.
     
  • Projected veteran population as of July 1,1998. Office of the Deputy Assistant Secretary for Policy, Department of Veterans Affairs Document.

 

1999

On January 27, 1999 the VA, “announced major initiatives to respond to the Hepatitis C virus (HCV) epidemic in a comprehensive and consistent manner across its (VA’s) nationwide health-care system.” The VA’s 5-point strategic initiative to respond to HCV included: patient education; health care provider education; epidemiologic assessment; treatment; and research. The plan in part called for “Two new ‘Hepatitis C centers of excellence,’ to be located at VA medical centers in Miami and San Francisco to coordinate treatment and research efforts, as well as develop education for patients and their families, health-care providers, and counselors who will advise patients prior to and following testing.”


On March 17, 1999, the Department of Veterans Affairs (VA) conducted a nationwide surveillance activity and tested over 26,000 veterans for hepatitis C. The testing revealed a prevalence rate of 6.6 percent with a wide variation by geography and era of military service.
NOTE: A paper published by Roselle et al. reported the findings from this surveillance activity

January 1999, VHA established two Centers of Excellence in Hepatitis C located at the VA Medical Center Miami, FL, and the VA Medical Center, San Francisco, CA.

Pueschel M. VHA hepatitis C costs placed at $250 million. US Med 1999;35:2, 52.

106 Congress-
Two House Bills

H. R. 1020 SNYDER
Veterans' Hepatitis C Benefits Act of 1999
establish a presumption of service connection for the occurrence of hepatitis C in certain veterans .
(1) Transfusion of blood or blood products before December 31, 1992.
(2) Blood exposure on or through skin or mucous membrane.
(3) Hemodialysis.
(4) Tattoo or body piercing or acupuncture.
(5) Unexplained liver disease.
(6) Unexplained abnormal liver function tests.
(7) Working in a health care occupation.

Referred to the Committee on Veterans' Affairs HR 4751 IH > H. R. 1020> HCON 130 IH –
 

nH. R. 5132 FRELINGHUYSEN
Veterans Comprehensive Hepatitis C Health Care Act
establish a comprehensive program for testing and treatment of veterans for the Hepatitis C virus.
(A) each veteran who served in the active military, naval, or air service during the Vietnam era and is enrolled to receive care under section 1710 of this title who requests the test or is otherwise receiving a physical examination or any care or treatment from the Secretary; and

(B) to any other veteran who requests the test.
(2) After the end of the one-year period referred to in paragraph (1), the Secretary shall provide a blood test for the Hepatitis C virus to any veteran who presents one or more risk factors for that virus and who requests the test.

Referred to the Committee on Veterans' Affairs H. R. 5132 >H. R. 639

Alter MJ, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 1999;341:556-562

 


1999

  • Kenny-Walsh E. Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin. Irish Hepatology Research Group. N Engl J Med 1999;340:1228–33.[Abstract/Free Full Text]


As ordered by Congress
Click here to read complete report
Results of DoD Investigations

  • Excerpt-
    Hepatitis C Virus Infection Among U.S. Military Personnel: An Assessment Of Risks and Screening Strategies

Office of the Assistant Secretary of Defense -- Health Affairs, the Pentagon; Washington, DC

Serological Survey

  1. Vietnam era personnel: 1000 personnel currently on active duty who had been serving in the military since January 1, 1974.
    (Note: This is the end of the Vietnam era, and right after the military stopped administering the reusable small pox needle and small pox vacation by Jetgun)

  2. Active duty retirees with at least 20 years of military service: 2000 individuals.
    (Note: at least = 1980)

(Note: . Rather than determining rates of hepatitis C infection among personnel who "served" in deployments overseas or who received blood plasma products as ordered by Congress, the 1999 Senate Armed Services Committee directed DoD to study the extent of service-connected hepatitis C infection...during separation and retirement physicals of active duty. The Vietnam Era is considered to have begun in 1964 and ended, some say, 1973. But the veterans, that served during the Vietnam era from 1964 until 1973, were basically excluded from these results. Nobody tested the immune globulin, the ingredient used in many different vaccines. In 1999 it was determined by scientists, the process to make immune globulin was inefficient at preventing the transmission of blood borne pathogens.)

New research show method for making immunoglobulins did not kill the Hepatitis C virus


 

 

  • Hepatitis C Virus Infection Among U.S. Military Personnel: An Assessment Of Risks and Screening Strategies- Office of the Assistant Secretary of Defense -- Health Affairs, the Pentagon; Washington, DC
    April 5, 1999
     

  • Hepatitis C Surveillance Day in the Veterans Health Administration of the Department of Veterans Affairs. Kralovic SM, et al. National Mil Med 2002;167:756-759. ...
     

  • Alter MJ, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 1999;341:556-562
    Data from the Third National Health and Nutrition Survey (1988-1994) estimate that there are approximately 3.9 million non-institutionalized, civilian Americans who have been infected with HCV. Of these, 2.7 million have chronic infection, making HCV the most common chronic blood-borne infection in the United States. Perhaps the majority of those infected are unaware of their infection because they do not currently have signs or symptoms of disease. The highest prevalence of infection is found among those with repeated, direct percutaneous exposures to blood...The estimated prevalence of infection varies greatly among different geographic locations and selected populations in the United States according to the varying prevalence of risk factors for infection.
     

  • House Committee on Veterans' Affairs ...testimony today on behalf of the Veterans Aimed Toward Awareness (VATA), a member-run organization of veterans and their families ... http://veterans.house.gov/hearings/schedule107/jun02/6-26-02/tbaker.html

    Bruskin-Goldring Research conducted a national survey commissioned by VATA of 504 veterans in 1999. Ages of those surveyed ranged from 40-60, with a mean age of 49. Following are some of the highlights from that survey.

    74.8% were “not very” or “not at all” concerned about their risk for HCV
    60.1% had not been tested for HCV
    58.3% were “not very” or “not at all” likely to be tested for HCV
    67.5% were “not very” or “not at all” familiar with the disease
    63.3% recognized flu-like symptoms, and 57.7% recognized yellow skin as possible symptoms of liver disease
    1.6% knew that hepatitis C often has no symptoms
    9% initially acknowledged they might be at risk for hepatitis C
    45% acknowledged they might be at risk after being informed of risk factors
    65.1% stated their greatest fear about HCV is the possibility of infecting a loved one
    62.9% stated their next greatest fear was the possibility of having a serious illness or dying from a serious illness

     

    These findings clearly indicate there is a need for HCV education. Veterans must be informed of their risk for hepatitis C, and about the seriousness of the disease.

 


2000

To follow up on its initiative, the Veterans Health Administration (VHA) issued directive 2000-019 on July 19, 2000, mandating the installation and use of software on clinical reminders to support the Hepatitis C reporting process. (Attachment 4, p. 1)

The VA’s Emerging Pathogens Index (EPI) registry is used to track the incidence of HCV in the VA system. VA claims it is now able to track veterans who tested positive for HCV in each of the 22 Veterans Integrated Service Networks (VISNs) on a quarterly and annual basis. (Attachment 2, p. 7) However, VA admits, “the true prevalence of HCV in veterans who utilize medical care services is unknown.” (Attachment 2, p. 12) VA attributes this to “deficiencies in data (due to both gaps in our [VA] knowledge about the epidemiology of hepatitis C in the VA population as well as limitation in available data collection systems).” (Attachment 2, p. 11)

 

  • April 13, Testimony of Gary A. Roselle, M. D. - 81% of all Military attending VA clinics and positive for Hepatitis C are from the Vietnam and Post Vietnam Era.
    http://hcvets.com/data/hepatitis_c_in_vietnam_era_veter.htm
     

  • Under Secretary for Health designated an additional $20 million to be distributed to the 22 Veterans Integrated Service Networks (VISNs) for outreach, testing, counseling, and treating veterans with hepatitis
     

  • Public Health Strategic Health Care Group, the National Hepatitis C Program was created
     

  • National Hepatitis C Technical Advisory Group was created
     

  • Miss America 2000 Shuts Down Times Square in Honor of the American Hero - New York Is Next Stop for Hepatitis C Awareness Campaign
    NEW YORK, June 29
    /PR Newswire/ -- Miss America 2000, Heather French, will be in New York City's Times Square on Monday July 3 as part of her national disease awareness campaign entitled "Helping Veterans Fight a Silent Enemy: Hepatitis C." Miss French joins NYC 2000 and the New York City Mayor's Office as co-host of the "Salute the American Hero" music tribute to urge veterans to get tested for a potentially fatal virus, hepatitis C.
     

  • The Global Infectious Disease Threat and Its Implications for the United States
    NIE 99-17D,

    ...a White House-appointed interagency working group identified at least 29 previously unknown diseases that have appeared globally since 1973, many of them incurable... Alone or in combination, war and natural disasters, economic collapse, and human complacency are causing a breakdown in health care delivery and facilitating the emergence or reemergence of infectious diseases.
     

  • Risk factors for hepatitis C virus infection in United States ...
    Comment in: Hepatology. 2000 Mar;31(3):790-1. Click here to read Risk factors
    for hepatitis C virus infection in United States blood donors. ...
     

  • Risk factors for hepatitis C virus infection among blood donors in ...Risk factors for hepatitis C virus infection in United States. Hepatology. 2000; 31:756–762. [PubMed]; Thomas DL, Vlahov D, Solomon L, et al. All 6 versions
     

VA received $195 million for screening and treating patients with HCV for FY 2000. On June 28, 2000, Dr. Thomas Garthwaite, the Under Secretary for Health, granted an additional $20 million to be distributed to the 22 Veterans Integrated Service Networks (VISNs) in order to “ recognize the geographic differences in the prevalence of hepatitis C and to provide incentive to VA health care facilities to aggressively outreach, screen, diagnose and treat hepatitis C.” The letter stated:

  • “In order to recognize the geographic differences in the prevalence of Hepatitis C and to provide incentive to VA health care facilities to aggressively outreach, screen, diagnose, and treat Hepatitis C, I have made the decision to provide $20 million from the National Reserve Fund to the Veterans Integrated Service Networks (VISNs) based on each network’s Hepatitis C costs during the first two quarters of FY 2000. It is important to note that funds allocated under the Veterans Equitable Resource Allocation (VERA) will continue to be expended by each VISN to support the costs of veterans with Hepatitis C. This $ 20 million simply supplements those funds.” Letter to Chairman Shays from Dr. Garthwaite on additional funding for selected VISNs to supplement approved budgets for the Hepatitis C testing and treatment programs (6/28/00).

In recognition of the high cost of treating HCV infection, VA decided Hepatitis C patients on drug therapy would be funded at the complex care level, starting in FY 2001. This new classification will help medical centers offset the costs of treating Hepatitis C patients on drug therapy.

It was not until June 2000 when VA released $20 million from the National Reserve Fund to the Veterans Integrated Service Networks (VISNs) based on each network’s Hepatitis C costs during the first two quarters of FY 2000, that managers and providers became aware of funding for HCV costs. It is for this reason some believe funding for HCV expenses should be earmarked and separate from the general medical care resource distribution process.

VA spent $14 million of the $21 million budgeted for HCV screening and testing in FY 2000. VA believes the shortfall may be attributable to the use of “untested assumptions” in budget estimates regarding the number of veterans who would need to be screened for Hepatitis C. Or, the number screened may be underreported due to inadequate data systems. (Attachment 9 p. 3) However, these reasons do not explain why VA has still not been able to test more than 20% of patients using VA health facilities.

There are also concerns as to why VA did not make it a point to notify networks of the funds available to screen and test patients for HCV, since VA was aware network directors and providers were concerned about costs. VA has acknowledged concerns for HCV costs may effect the screening of patients. This was noted in VA’s White Paper to Inform Congress on Decisions for Hepatitis C Funding in which VA stated, “we cannot be certain that local choices regarding allocation of available resources amongst a number of critical patient care areas have not created potential disincentives to the diagnosis and treatment of hepatitis C infection.”

  • Department of Veterans Affairs, “White Paper to Inform Congress on Decision for Hepatitis C Funding” 2001.


2001

On February 27, 2001, the VHA issued directive 2001-009 entitled “National Hepatitis C Program.” The purpose of the directive was to compile all VHA policies and programs on Hepatitis C and to outline specific requirements for implementing the program. The directive also states “each VA medical center Director must designate a Hepatitis C Lead Clinician to be the point of contact for all clinical Hepatitis C communication and reporting between the facility, the Hepatitis C Program office and other program offices.” (Attachment 5, p. 1-3)

Prevalence and Incidence of Hepatitis C Virus Infection in the US Military: A Seroepidemiologic Survey of 21,000 Troops
Kenneth C. Hyams1, James Riddle2, Mark Rubertone3, David Trump2, Miriam J. Alter4, David F. Cruess5, Xiaohua Han4, Omana V. Nainam4, Leonard B. Seeff6, John F. Mazzuchi2 and Sue Bailey2

Because of a high prevalence of hepatitis C virus (HCV) infection (10–20%) among veterans seeking care in Department of Veterans Affairs (VA) hospitals, current US military forces were evaluated for HCV infection. Banked serum samples were randomly selected from military personnel serving in 1997 and were tested for antibody to HCV (anti-HCV). Overall prevalence of anti-HCV among 10,000 active-duty personnel was 0.48% (5/1,000 troops);

On the basis of the findings from our study, which showed a consistently higher prevalence of HCV infection in older service members, DoD has implemented a targeted risk-based HCV screening program using Centers for Disease Control and Prevention screening guidelines for persons who are 35 years of age or older and are separating or retiring from military service (1

  • Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Morb Mortal Wkly Rep 1998;47:1–39.[Medline]
     

  • B. R. Burnham
    RE: "PREVALENCE AND INCIDENCE OF HEPATITIS C VIRUS INFECTION IN THE US MILITARY: A SERO-EPIDEMIOLOGIC SURVEY OF 21,000 TROOPS"
    Am. J. Epidemiol., April 15, 2002; 155(8): 778 - 779.
    [Full Text] [PDF]

Screening for risk factors involves asking a variety of questions. Current VHA policy enables veterans to be tested for HCV infection if they desire to be tested, or if they have one or more of the following risk factors:

  • 1.Vietnam-era veterans (as defined by dates of service or in the age range of 40-55 years)
    2. received a blood transfusion before 1992,
    3. past or present intravenous drug use,
    4. unequivocal blood exposure of skin or mucous membrane,
    5. history of multiple sexual partners (defined as more than 10 lifetime partners),
    6. history of hemodialysis,
    7. tattoo or repeated body piercing,
    8. history of intranasal cocaine use,
    9. unexplained liver disease,
    10. unexplained/abnormal ALT,
    11. intemperate or immoderate use of alcohol
    (defined as more than 50 g of alcohol per day for ten or more years.
     

  • “Screening Veterans for HCV Infection” and “HCV Risk Factor Assessment (Sample).”

n


2001
107 Congress

Veteran's own willful misconduct -
It must be taken into consideration that the Hepatitis C virus penetrates the blood-brain barrier causing an array of mental problems that impacts veterans lives. Greater than 60% of HCV patients suffer from conditions such as "brain fog," depression, to more sever disorders that include bipolar and schizophrenic behaviors. Higher numbers suffer from chronic fatigue and joint pain long before the diagnoses of Hepatitis C is obtained. Self medication though alcohol and other substances is common place. This form of self-help is a death warrant for the vet.

Senate version:

  • S 457 IS SNOWE
    PRESUMPTION OF SERVICE-CONNECTION FOR CERTAIN VETERANS WITH HEPATITIS C ...establish a presumption of service-connection for certain veterans with Hepatitis C

    (A) Period of service before December 31, 1992, a transfusion of blood or blood products.

    (B) Exposed to blood on or through the skin or a mucous membrane during a period of service.

    (C )Underwent hemodyalisis during a period of service.

    (D) Experienced a needle-stick accident or medical event involving a needle, not due to the veteran's own willful misconduct, during a period of service.

    (E) Diagnosed with unexplained liver disease during a period of service.

    (F) Experienced an unexplained liver dysfunction value or test during a period of service.

    (G) Served in a health-care position or specialty during a period of service under such circumstances as the Secretary shall prescribe for purposes of this subsection.

    Referred to the Committee on Veterans' Affairs S.2599.IS > S 457 IS > S 1846 IS


Congress version:
  • nH. R. 639 FRELINGHUYSEN

    Veterans Comprehensive Hepatitis C Health Care Act 2001...testing and treatment of veterans for the Hepatitis C virus.¡(2) shall provide appropriate treatment for that veteran in accordance with the national protocol for the treatment of Hepatitis C .

    n (A) each veteran who served in the active military, naval, or air service during the Vietnam era or who is considered to be `at risk,' and is enrolled to receive care under section 1710 of this title who requests the test or is otherwise receiving a physical examination or any care or treatment from the Secretary; and

    n(B) to any other veteran who requests the test.

    Referred to the Committee on Veterans' Affairs- H. R. 5132 >H. R. 639 > H. R. 73


     

  • The VA Hepatitis C Clinical Case Registry was created through the Center for Quality Management.
     

  • VA issued a solicitation for applications to establish Hepatitis C Resource Centers (HCRC). Four sites were funded: San Francisco, Northwest (Seattle, WA and Portland, OR), West Haven, CT, and Minneapolis, MN
     

  • Veterans’ National Hepatitis C Community Advisory Board was created with its first meeting in Washington DC
     

  • Briggs ME, Prevalence and risk factor for hepatitis C virus infection in an urban Veterans Administration medical center. Hepatology 34:1200-1205, 2001
    The demographics of hepatitis C in United States civilians and VA patients are important. Several epidemiological studies have found hepatitis C to be higher in U.S. males, African-Americans, lower socioeconomic groups and in those Americans in the 40 to 60 year old age groups

    We concluded that HCV is common in veterans. Risk factors independently associated with infection are IDU, prior transfusion, prior tattoo, combat medical work, incarceration, and multiple opposite sex partners. Infection with HCV among veterans is strongly associated with traditional risk factors for infection and less strongly associated with combat-related risk.
    PMID: 11732010 [PubMed - indexed for MEDLINE]

In 2001 the VA’s goal is to screen all veterans who have not been screened during routine clinic visits to VA medical centers, and provide treatment when it is appropriate. In fiscal year 2001, VA received $340 million to accomplish this goal, however VA does not believe it will spend the full $340 million, but instead will spend closer to $151 million. Since VA does not expect to spend $189 million of its FY 2001 budget allocations on HCV costs, it has lowered the request for fiscal year 2002 budget to $171 million to treat veterans who have HCV.

The cost of testing and treating patients for HCV is high. The Washington Post (1/27/99) quoted Dr. Kenneth Kizer, then the VA’s top doctor, as saying the new testing and treatment program will be a controversial “big ticket item” costing $12,000 to $15,000 per year per patient, or $250 million to $300 million in FY 1999 alone, and as much as $500 million in FY2000. “There is a huge cost that is involved,” Kizer was quoted as saying. “We acknowledge it, but I don’t know what choice we have.”

  • GAO testimony before the Subcommittee on VA, HUD, and Independent Agencies, Committee on Appropriations. “Veterans’ Health Care: Observations on VA’s Assessment of Hepatitis C Budgeting and Funding” GAO-01-661T

    DISCUSSION OF HEARING ISSUES

    1. Why has screening and testing for Hepatitis C been limited and inconsistent?

    GAO found several reasons why screening has been limited and inconsistent. According to GAO, local managers have adopted restrictive Hepatitis C screening policies because they were not aware specific funding was available to screen and test patients. GAO found instances where HCV screenings for risk factors were limited to a few clinics, on certain days of the week. In other instances, GAO found patient access to screening and testing was viewed as solely a matter of the individual physician’s judgment, not a matter of VA policy. In some cases providers were concerned about the costs of laboratory tests. As a result, they screened in primary care clinics on a rotating basis, one clinic per day.

    While visiting the Northport VA Medical Center (VAMC), in Long Island, NY, GAO found the director was concerned about pharmacy costs relating to HCV treatment and the increased patient load the facility might incur because of the closure of the Health Maintenance Organizations (HMO) in the area. The Northport VAMC had limited HCV screening in one clinic, and no screening in specialty care clinics prior to FY 2001, but has since expanded HCV screening.

    GAO’s visit to the Syracuse, New York VAMC found similar concerns about expenses. Syracuse providers expressed concerns about the cost of lab tests for HCV. As a result of these concerns, Syracuse patients were screened for HCV in primary clinics on a rotating basis, one clinic per day.

    A second reason for the low rate of screening and testing veterans for HCV is attributed to weaknesses in facilities’ risk assessment procedures. GAO is concerned the screening process may discourage veterans from being candid about risky behaviors. Veterans are asked a series of questions relating to their sexual practices and drug and alcohol history which some may find invasive and embarrassing. If a patient admits to a risk factor, the provider will order testing. However, if a patient is not forthcoming about risk factors, providers will not test the patient unless the patient requests to be tested. GAO also found instances of screening for risk factors being conducted near public areas where a veteran’s answers might be overheard. Too-quick, routine administration of the HCV questionnaire amidst other screening procedures may also result in veterans not understanding the risk factors.

    A third factor why many veterans remain undiagnosed, according to GAO, is weakness in testing procedures. GAO found instances of blood tests never ordered, or never completed, for veterans with risk factors.

    In order to improve screening performance, GAO is expected to recommend VA set performance targets to convince providers HCV screening and testing is a high priority, and that VA provide definitive implementation guidelines regarding who should be screened and how screenings should be conducted.

    Hearing witnesses from the VA will be asked what incentives are in place to encourage providers to increase the number of patients screened for HCV risk factors. VA is anticipated to testify the installation of the clinical reminder software will encourage providers to screen patients for HCV risk factors. However, while VA mandated clinical reminder software be installed by July 30, 2000, GAO found many instances where facilities were slow to turn on the software.

 

2002

 

2003

  • Department of Veterans Affairs’ recommendations for treatment of patients with cirrhosis were published on the VA’s Hepatitis C Web site
     

  • Toolkit for creating HCV support groups was published on the VA’s Hepatitis C Web site (www.hepatitis.va.gov).
     

  • Finally published after almost 2 years- VA Study 488- Elevated Prevalence of Hepatitis C Infection in Users of United States Veterans Medical Centers-
    No risks specifically associated with military service or military combat were identified. ..
    In summary, we (the VA) estimate that 5.4% of VA users are HCV-seropositive, exceeding ...the general population by more than 2-fold. Although Vietnam veterans had the highest prevalence (11%) in our sample, military-related exposures were not found to be significant risk factors. That this estimate differs considerably from some prior estimates used to determine health policy...

According to the study, spending 2 days in the local jail was a bigger risk factor than combat.

How the VA Used Study 488 to Deny Millions of Retired Military and Veterans Help.

The study 488 is used for the bases of a questionnaire that decides the need to test Retired Military and Veterans for Hepatitis C. The study results show 7% of Veterans attending VA clinics, reported having Hepatitis C and receiving a Jetgun injection during service. However, some clinics didn't get the right survey. The wrong survey data did not included the Jetgun option.

Both, the wrong and new surveys, did address the lifestyle risk involving multiple partners. Jason A. Dominitz, et al, reports 5.5% association to infection, if the patient had between 2 and 49 partners. Ironically, this risk is listed to determine the need to test Vets, but the Jetguns, with a higher occurrence rate (7%), are not.

Study 488 IS flawed and diminishes the real need to test all Retired Military and Veterans
http://hcvets.com/data/transmission_methods/study488.htm More

  • Lennox Jeffers, a professor at the School of Medicine 2003 Between 10 and 15 percent of U.S. veterans are infected with HCV, which is a much higher prevalence than in the private sector.
     

  • Statement Of Lawrence R. Deyton, Md, Msph- Chief Consultant, Public Health Strategic Health Care Group- Veterans Health Administration- Department Of Veterans Affairs

    Before The Committee On Government Reform
    U. S. House Of Representatives

    December 14, 2004

    The Hepatitis C Case Registry is another important tool for quality improvement and programmatic planning. The objectives of the Registry are to identify VA patients who have been tested or diagnosed as having hepatitis C,...Through the end of FY 2004, over 273,000 unique patients had been added to the Registry. Of these, 184,067 had at least one VA inpatient admission or outpatient encounter in FY 2003.
     

  • Study- A comparison of hepatitis C treatment and outcomes at academic, private and Veterans' Affairs treatment centers states veterans attending VAMC clinics (click on link) Results: Differences in treatment practice and use of diagnostic procedures were found. Genotype testing was under-utilized in non-academic sites (academic centres, 79.2%; private centres, 33.7%; Veterans' Affairs centres, 35.9%; P < 0.001). Liver biopsies were performed less often in private sites (academic centres, 95.8%; private centres, 80.0%; Veterans' Affairs centres, 92.2%; P < 0.01). End-of-treatment viral response (academic centres, 40.0%; private centres, 31.3%; Veterans' Affairs centres, 17.2%; P < 0.05) was lower than that found in published trial data. Multivariate analysis revealed genotype 1 as the single significant predictor of treatment failure (P < 0.01).

2004

n

  • 108 Congress H. RES. 633 UDALL
    Expressing the sense of the House of Representatives 2004
    Expressing the sense of the House of Representatives that there is a critical need to increase awareness and education about hepatitis C .

    Mr. UDALL of New Mexico submitted the following resolution; which was "Whereas the majority of veterans infected are Vietnam era veterans , and the prevalence of infection is highest in this group"
    Referred to the Committee on Energy and Commerce
     
  • Statement Of Lawrence R. Deyton, Md, Msph- Chief Consultant, Public Health Strategic Health Care Group- Veterans Health Administration- Department Of Veterans Affairs

    Before The Committee On Government Reform
    U. S. House Of Representatives

    December 14, 2004

    ...As a result of these efforts, since 1999, over 4 million veterans in VA care have been screened for risk factors and over 200,000 were diagnosed with hepatitis C infection. During each of the past three years, screening and testing performance has been evaluated using the External Peer Review Program (EPRP), a national yearly review of approximately 50,000 medical records by trained, professional reviewers. The EPRP results have demonstrated steady improvement in screening and testing. In fiscal year 2004, over 98 percent of patients had been screened for risk factors, and over 90 percent of those at risk had been tested for or diagnosed with hepatitis C.

     

  • Study: Analysis of a hepatitis C screening for US Veterans Dept. of Preventive Medicine, HSC Level 3, Rm. 086, SUNY at Stony Brook, School of Medicine, Stony Brook, NY 11794-8036, USA. In the multivariate model developed... service during the Vietnam era, tattoo, and a history of abnormal liver function tests were independent predictors of HCV infection. Our data support considering a more targeted screening approach that includes five of the 11 risk factors.
     
  • Sloan KL, et al. Hepatitis C tested prevalence and comorbidities among veterans in the US Northwest. J Clin Gastroenterol 2004;38:279-284. 37,398 veterans from the VA health care system in the Pacific Northwest were tested for anti-HCV antibodies, and 8,230 (21.7%) were positive.(9) 45.8% of the seropositive veterans were between the ages of 40 and 49 years.
     
  • 55th Annual Meeting of the American Association for the Study of Liver Diseases- David Bernstein, MD- Hepatitis C -- Current State of the Art and Future Directions CME- - Prevalence and Natural History- Trends in Hepatitis C Prevalence in the United States - ...One of the major shortcomings of this study (NHANES III survey) is that it reports on the prevalence of the hepatitis C antibody, which may indicate previous exposure or active disease. This study does not report on disease prevalence, as prevalence of hepatitis C infection is defined by the presence of hepatitis C viral RNA in serum. Only 148 of the 15,079 participants had serum available for hepatitis C viral RNA testing, making any statements regarding disease prevalence, and not potential exposure to the disease, invalid.
     
  • Hepatitis C: Silent Alarm Patent agreement draws federal review
    ©2004 The Kansas City Star

    Chrion, like a dog with a bone when it comes to HCV, gets attention from Mike McGraw. Mike shows the federal lapse that allow a company to control a disease.
    View Full Message

2005
nLast attempt by congress for a veteran's Presumed Service Connection bill
  • 109 Congress H. R. 3434 ANDREWS
    PRESUMPTION OF SERVICE-CONNECTION FOR CERTAIN VETERANS WITH HEPATITIS C ...establish a presumption of service-connection for certain veterans with Hepatitis C

    (A) during a period of service before December 31, 1992, a transfusion of blood or blood products.
    (B) exposed to blood on or through the skin or a mucous membrane during a period of service.
    (C ) underwent hemodyalisis during a period of service.
    (D) experienced a needle-stick accident or medical event involving a needle, not due to the veteran's own willful misconduct, during a period of service.
    (E) diagnosed with unexplained liver disease during a period of service.
    (F) experienced an unexplained liver dysfunction value or test during a period of service.
    (G) served in a health-care position or specialty during a period of service under such circumstances as the Secretary shall prescribe for purposes of this subsection.

    Referred to the Committee on Veterans' Affairs
    HR 3455 IH > H. R. 3434
  • A CORRECTED ESTIMATE: FIVE MILLION AMERICANS INFECTED WITH THE HEPATITIS C VIRUS: A CORRECTED ESTIMATE- American Assoc for the Study of Liver Disease (AASLD) Nov 2005 Brian R. Edlin, Weill Medical College of Cornell University, New York, NY
     

  • General Hospital and Personal Use Devices Panel Meeting - August 9, 2005
    Charles E. Edmiston, Jr., Ph.D., Chairperson, presiding.

    During the panel meeting this question posed by Dr. Edmiston to MARTIN FRIEDE, Ph.D., Initiative for Vaccine Research, World Health Organization:

    CHAIRMAN EDMISTON: If the devices are used in a compliant manner the way they're meant to be used, do you think the devices are safe?

    DR. FRIEDE:
    The devices that we have seen without a protection cap, we have data from the calves and the data from the Hoffman study in Brazil to show that frequent contamination of the ejected did take place. And that contamination was clearly of a level of blood that we are convinced can carry disease. So the devices which do not have a protection cap which are to be used for giving intramuscular injection
    we are convinced that these carry a significant risk.

    Meeting Highlights
    Table of Contents

    Yellow Fever vaccine via a jet injector
    WHO- Jetguns Significant Risk
    If bleeding nozzle should be resterilize

     

  • Hepatology. 2005 Jan;41(1):88-96. Links
    Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Dominitz JA
    Epidemiologic Research and Information Center VA Puget Sound Health Care System, Seattle, WA 98108-1597, USA. jason.dominitz@med.va.gov

    Several studies suggest veterans have a higher prevalence of hepatitis C virus infection than nonveterans, possibly because of military exposures. The purpose of this study was to estimate the prevalence of anti-hepatitis C antibody and evaluate factors associated with infection among users of Department of Veterans Affairs medical centers... Military-related exposures were not found to be associated with infection in the adjusted analysis. In conclusion, the prevalence of hepatitis C in these subjects exceeds the estimate from the general US population by more than 2-fold, likely reflecting more exposure to traditional risk factors among these veterans.
     

  • Dominitz, J., Boyko, E., Koepsell, T., Heagerty, P., Maynard, C., Sporleder, J. "VACooperative Study Group 488. Elevated Prevalence of Hepatitis C Infection in Users of United States Veterans Medical Centers," Hepatology. 41: 88-96: 2005
    ...Serving two days in jail, bigger risk factor than service
     
  • Study 488: Elevated Prevalence of Hepatitis C Infection in Users of United States Veterans Medical Centers
    Dr. Jason Dominitz of the VA Puget Sound Health Care System completes a national hepatitis C prevalence study using "supposedly" rigorous scientific methodology to produce a statistically valid sampling of veterans receiving health care from VA. The purpose of the study was to estimate the incident, which is different than prevalence, of anti-hepatitis C antibody and evaluate factors associated with infection among users of VA medical centers. Veterans' infection rates were slashed and no association to service was found. Medical journals would not publish the study for almost 2 years because the VA would not submit the data to verify the legitimacy of the study. See 2003- Study 488

2006
  • VA recommendations for treatment of patients with hepatitis C were published in the Journal of the American Gastroenterology Association
    http://vaww.hepatitis.va.gov/vahep?page=prtop04-gd-2006-00
     
  • A Veterans’ Hepatitis C Quality Management and Database Program that works with existing VA data systems, collecting and analyzing quantitative data on hepatitis C, utilization, and quality parameters in order to continually improve hepatitis C care and prevention. The Hepatitis C registry was launched in 2002 and provides facilities the ability to produce local reports and do their own quality control; the registry was revamped in 2006 to improve its utility for HCV clinicians. NOTE: Reports are available at: http://www.hepatitis.va.gov/vahep?page=prin-cmg-01
     
  • POLICY: It is VHA policy that each VA Medical Center Director must designate a Hepatitis C Lead Clinician to be the principal point-of-contact for all clinical hepatitis C program information and reporting between the facility, the Clinical Public Health Program office, and other facility program offices
n
2007
Since the beginning of the National Hepatitis C Program, data have been collected through the External Peer Review Program (EPRP), a national chart review to track and monitor efforts. Results show that over 95 percent of people who come into VA for care have been screened for risk factors and over 90 percent of those persons found to be at risk have been tested for hepatitis C.

What Are
VA Risk Factors for Hepatitis C

Red Cross Risk Factors

Risk factors for VA service connection: Hepatitis Questionnaire

The source of infection is unknown in about 10 percent of acute (less than 6 months) hepatitis C cases and in 30 percent of chronic hepatitis C cases.

According to the VA website, as of 2007- 225,000 veterans who have been identified as having hepatitis C infection in VHA. Funding of the four HCRC programs has been renewed for an additional 5 years (through Sept 30, 2011).

  • Am J Gastroenterol. 2007 Sep 25; [Epub ahead of print] Links
    Outcome of Screening for Hepatitis C Virus Infection Based on Risk Factors
    The prevalence of a positive HCV antibody in veterans who identified a risk factor was 7.3% (95% CI 6.6-8.0%). Among those diagnosed through the screening program (N = 260), 47% had chronic hepatitis C. Among patients with chronic HCV, 18% had evidence of advanced liver disease ...
    Forty-four percent were not immediate candidates secondary to medical or psychiatric comorbidities or active substance abuse.
     
  • Dig Dis Sci. 2008 Jun;53(6):1693-8. Links
    Hepatitis B and C among veterans on a psychiatric ward.
    Tabibian JH,...Department of Psychiatry, West Los Angeles Veteran's Affair's Hospital, David Geffen School of Medicine, University of California jhtabib@ucla.edu -...Several risk factors were associated with exposure. Inpatient psychiatric veterans seem to have increased rates of hepatitis B and C exposure.
     
  • Hepatitis C virus (HCV) six times likely to develop non-Hodgkin's lymphoma (NHL) Risk of Non-Hodgkin Lymphoma and Lymphoproliferative Precursor Diseases in US Veterans With Hepatitis C Virus- Hepatitis C virus infection confers a 20% to 30% increased risk of non-Hodgkin lymphoma overall, and a 3-fold higher risk of Waldenström macroglobulinemia, a low-grade lymphoma.

The Federal Response

110 Congress
These little pieces mean something when your writing legislation.

H. R. 2552 TOWNS - WILSON
Hepatitis C Epidemic Control and Prevention Act

Referred to the Committee on Energy and Commerce
HR 3539 > HR 1290 > H. R. 2552 >

S 1445 IS KENNEDY-HUTCHISON

Hepatitis C Epidemic Control and Prevention Act 2007
Referred to the Committee on Health, Education, Labor, and Pensions
S. 1143 > S 521 IS > S 1445 IS

Congress makes the following findings:
(8) Conservative estimates place the costs of direct medical expenses for Hepatitis C at more than $1,000,000,000 in the United States annually, and such costs will undoubtedly increase in the absence of expanded prevention and treatment efforts.
 

This section does not mention what type of expanded prevention and treatment effort, i.e., national level, high risk population or a well defined general population, etc. Veterans that do not attend VA health care centers will not be notified of the risk for the Hepatitis C virus infection. This act is no "federal response" to the hepatitis C epidemic:(
 
 
n

1 in 5 Vietnam era retired military and veterans have hepatitis C

Hepatitis C Investigation Graphic on How Patients were exposed



PUBLIC HEALTH CRISIS: Queries irk hepatitis patients

Attorneys telling clients not to reveal past drug, sexual activity


It was never the Southern Nevada Health District's intent to embarrass anyone when it determined what questions to ask former patients of two Las Vegas gastroenterology clinics regarding their past risk factors for hepatitis B, C and HIV.

But that's what attorneys for patients who tested positive for hepatitis C are saying could happen, and many are advising their clients to refuse to cooperate. Read More http://www.lvrj.com/news/30506469.html

_____________________________________________________________________________
Military Veterans should heed this advice when screening for hepatitis c compensations from the Veterans Administration. Be sure to point out reused vials were used along with the jetguns and all inoculations received in service.

_____________________________________________________________________________

And this is the Newer Improved Version of the Ped-O-Jet Jetgun used by the military with reusable vials- Vaccine. 2008 Mar 4;26(10):1344-52. Epub 2008 Jan 18. Preventing contamination between injections with multiple-use nozzle needle-free injectors: a safety trial.- The study ended early because the protector cap needle-free injector (PCNFI) failed to prevent contamination in the first batch tested (8.2% failure rate).

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