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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

Home
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Military Hepatitis History  
Understanding The Liver 
VA Flow Sheet for Cirrhosis
VA Defines Risk Factors
 
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Need to know-Grassroots Research
 
Blog Another12Weeks
One Vets' Journey Though Treatment
 

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 What Would Veterans Do?
Blog for VA Claims
 


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

 

Version- 1995

FDA/ORA Compliance Program Guidance 7342.006 CHAPTER 42 - BLOOD AND BLOOD PRODUCTS

This compliance program combines and replaces the compliance programs for licensed allergenics (7345.001), licensed vaccines (7345.002), plasma derivatives (7342.006) and therapeutic drugs (7341.001). This program represents a continuing compliance and surveillance activity conducted to ensure that CBER-regulated biological drug products for human use are safe, pure, potent, effective, and appropriately labeled. The inspection of a facility is performed to ensure that manufacturers are making products that:

Meet the standards described in applicable provisions of the regulations. These include regulations in 21 CFR Parts 600, 601, 610, 640, 660, 680, and 1271, CGMP regulations in 21 CFR Part 200, 201, 210 and 211.

Meet any additional conditions of licensure in the approved Biologics License Application (BLA) and/or supplements, if manufacturing a licensed product, and other applicable standards.

ATTACHMENTS - Product Guidance

 ATTACHMENT 1: FRACTIONATORS

Plasma Fractionation

Blood plasma contains a mixture of hundreds of different kinds of proteins, only a few of which are of therapeutic interest. To make plasma derivative products, plasma can be treated with a variety of substances to separate the desired proteins from others, in a process called fractionation. Fractionation of plasma, from pools often derived from thousands of donors, was developed during World War II by Cohn and co-workers at Harvard Medical School. Today, most plasma derivative manufacturers use a modified Cohn method developed by Oncley (Cohn-Oncley fractionation process) or further variants of this method, that permit manufacture of additional products.

Fractionation by the Cohn-Oncley method relies on precipitation of plasma proteins by a combination of cold alcohol (usually ethanol)-water mixtures and adjustments of pH, ionic strength, temperature, and protein concentration. Alternatively, some manufacturers separate plasma derivatives by column chromatography using ion exchange, gel filtration, or affinity methods, without alcohol. In all cases, fractions of plasma are separated sequentially, with the product from one step, such as the precipitate and/or supernatant, becoming the starting material for the next step in the fractionation process. If each step is not done properly, subsequent fractions can be adversely affected. Thus, the integrity of each final product is dependent on all of the preceding steps in the process.

After fractionation, derivatives undergo further processing to purify and concentrate proteins and to inactivate or remove (clearance) any bacterial or viral contaminants. While early steps in the manufacturing process are not performed aseptically, all final products are sterile. Types of viral clearance include those steps that are part of the fractionation process itself, e.g., pH4/pepsin or polyethylene glycol (PEG) fractionation, or those steps that are deliberately added, e.g., solvent/detergent treatment or viral filtration. In some instances more than one viral clearance step is used for a given product. Plasma derivatives are similar to other biological products in that they are protein-based and subject to denaturization at high temperatures. These products are usually filled by using aseptic processing techniques, and cannot be terminally sterilized, although in some instances they can be heat-treated in the final container to effect viral or bacterial inactivation.

A few plasma proteins may also be manufactured by recombinant DNA methods.

Fractionation Products

Each plasma fraction is enriched in specific protein components and is used for a different purpose. In the Cohn-Oncley method, Fraction I contains mostly fibrinogen (not a licensed product), the main protein component of blood clots. Fraction II+III has a high concentration of immunoglobulins (antibodies). Some manufacturers use Fraction IV to prepare licensed products; others consider it a by-product. Fraction IV-1 is the source material for Alpha-1-proteinase Inhibitor (Human); Fraction IV-4+V is the source of Plasma Protein Fraction (Human). Fraction V is the source of Albumin (Human). Most of these products, but not all are intravenously administered. A description of some of the major plasma derivatives follows:

Antihemophilic Factor (Human) (AHF, Factor VIII). AHF protein, one component of the cryoprecipitate fraction of plasma, is used to treat classical hemophilia (hemophilia A). Cryoprecipitate is the solid material that remains after frozen plasma is thawed at a near freezing temperature; it serves as the source of AHF. After the cryoprecipitate dissolves upon warming, the AHF in it can be purified to a high degree, subjected to various viral clearance procedures, and prepared as a lyophilized concentrate. AHF is administered intravenously. NOTE: Even though the clinically active ingredient is the same, AHF is not the same product as Cryoprecipitated AHF, a single donor product prepared in blood banks.

Factor IX Complex (Human) is adsorbed from the plasma fraction remaining after cryoprecipitate removal. It is a heat- or solvent/detergent-treated, lyophilized preparation containing factors II, VII, IX, and X. It is administered intravenously for the prevention and control of bleeding caused by Factor IX deficiency (hemophilia B), and other coagulation disorders.

Coagulation Factor IX (Human) is a highly purified factor IX product that contains negligible amounts of other coagulation factors, and is used to treat hemophilia B.

Immune Globulin (Human) (IG) is a solution of immunoglobulin G (IgG) indicated for prophylaxis of hepatitis A, prevention or modification of measles (Rubeola), and for immunoglobulin deficiency. It is administered intramuscularly.

Additional specific immune globulins for intramuscular administration are obtained from donors whose plasma contains selected high titer antibodies. Products are available for use in the passive prophylaxis of varicella-zoster, tetanus, hepatitis B, rabies, and other infections. Another product, Rho(D) Immune Globulin (Human), is for the prevention of sensitization to the Rho(D) antigen and hemolytic disease of the newborn. Some of the intramuscular immunoglobulin products have been subjected to heat- or solvent/detergent-treatment.

Immune Globulin Intravenous (Human) (IGIV) is a lyophilized preparation that contains intact, unmodified, immunoglobulin. It is often stabilized with monosaccharide (sucrose, glucose, or mannose) and/or Albumin (Human) or glycine. It is indicated for patients with primary immunodeficiency, immune thrombocytopenia and Kawasaki's disease. Additional specific IGIV products are also available and used for such indications as prevention of hemolytic disease of the newborn, or passive prophylaxis of cytomegalovirus or respiratory syncytial virus. All IGIV products have been subjected to viral inactivation/removal procedures by either fortuitous or deliberate methods.

FDA/ORA Compliance Program Guidance 7342.006
CHAPTER 42 - BLOOD AND BLOOD PRODUCTS
http://www.fda.gov/ora/cpgm/42_006.html

  1. FDA Guide to Inspections of Blood Banks - BloodBook, Blood ...
    Aug 30, 1985 ... Refer to Compliance Program 7342.001, Inspection of License and Unlicensed ... "Guideline for Collection of Blood or Blood Products from Donors with ..... A copy of the chapter concerning biosafety level 2 precautions can ... FDA on the internet at http://www.fda.gov/ora/inspect_ref/igs/blood.html