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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.
 

 
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Hepatitis C & Commercial Sterilants and Disinfectants

Applied and Environmental Microbiology, September 1999, p. 4255-4260, Vol. 65, No. 9
0099-2240/99/$04.00+0

Bacterial Spores Survive Treatment with Commercial Sterilants and Disinfectants
Jose-Luis Sagripanti* and Aylin Bonifacino
Molecular Biology Branch (HFZ-113), Division of Life Sciences, Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland


ABSTRACT

This study compared the activity of commercial liquid sterilants and disinfectants on Bacillus subtilis spores deposited on three types of devices made of noncorrodible, corrodible, or polymeric material. Products like Renalin, Exspor, Wavicide-01, Cidexplus, and cupric ascorbate were tested under conditions specified for liquid sterilization. These products, at the shorter times indicated for disinfection, and popular disinfectants, like Clorox, Cavicide, and Lysol were also studied. Data obtained with a sensitive and quantitative test suggest that commercial liquid sterilants and disinfectants are less effective on contaminated surfaces than generally acknowledged.

TEXT

Different reports agree that 5 to 10% (1.75 to 3.5 million) of the 35 million patients annually admitted to hospitals in the United States acquire an infection during hospitalization (5, 6, 22). More than 850,000 of these have been estimated to be implant- and device-related infections (2). Abundant data linking the transmission of various diseases (including AIDS, tuberculosis, and Creutzfeldt-Jakob disease, as well as hospital epidemics of infections with Pseudomonas, Serratia, and Bacillus species) to medical devices suggest that the effectiveness of disinfection and sterilization practices has been overestimated (21).

The capacity to kill bacterial spores determines how a commercial product will be marketed. Disinfectants are not expected to kill all bacterial spores and are used to decontaminate devices that ordinarily do not penetrate tissues or that touch only intact skin (3, 16, 25). Sterilants are expected to kill all microorganisms, including bacterial spores, and are used to treat devices that penetrate tissue or present a high risk if unsterile. Viable spores still attached to various materials could remain undetected by current sporicidal tests (1), resulting in overestimation of the sporicidal activity of sterilizing agents (4, 7, 11, 12, 14, 15). The goal of this study was to compare the sporicidal activities of commercial liquid sterilants under manufacturer-specified conditions by using a sensitive method able to quantitatively account for the survival of all spores on contaminated carrier devices.

Selection of carrier devices. The device to which spores are attached might alter the sporicidal activity of some germicidal agents (19). Therefore, the criteria used to select the carrier devices that we tested were based on the following practical considerations: (i) diverse material composition, (ii) geometry representative of medical devices, (iii) similar spore load capacities, (iv) size amenable to microtesting, and (v) cost. Miniature stainless steel machine screws (no. 0/80, pan head, 1.5 mm in diameter, and 12.5 mm long) were purchased at a local hardware store (Home Depot, Rockville, Md.) or from Thompson & Cooke (Bladensburg, Md.). Dental burs (FG 557) made of carbon steel were manufactured by Midwest Dental Products Corporation (Des Plaines, Ill.). Medical-grade silicone rubber tubing, 3.1-mm outer diameter and 1.5-mm inner diameter (Silastic; catalog no. 602-285), was manufactured by Dow Corning Corporation Medical Products (Midland, Mich.) and used in 12.5-mm-long sections. All devices were cleaned prior to use by washing with detergent, rinsing three times with distilled water, washing once in acetone, and rinsing again in distilled water before sterilization by autoclaving. The devices were immersed 5 mm deep in spore-loading suspensions. This procedure contaminated areas of 20, 40, and 78 mm2 on dental burs, screws, and tubing, respectively. Likely due to differences in geometry and materials, the test described below loaded similar numbers of spores onto the three devices in spite of the different immersed areas. The miniature stainless steel screws and small sections of medical-grade silicone rubber tubing were small enough to fit our microtest format and inexpensive (costing 6 and 3 cents each, respectively). Easy availability of tubing, burs, and screws made custom manufacturing of carriers unnecessary. Their low cost allowed these carriers to be used only once and then discarded, thus preventing spore carryover and the need to wash and sterilize the carriers between tests.

Direct measurement of spores loaded onto carriers. Spores of Bacillus subtilis subsp. globigii (Spordex) were purchased from AMSCO American Sterilizer Co. (Erie, Pa.) with a reported D value for dry-heat killing at 160°C of 2.2 min and a D value for ethylene oxide killing (600 mg/liter at 54°C) of 3.5 min, respectively. The number of spores loaded onto carriers was determined by using radioactively labeled spores. A method that produces dry-heat-resistant spores in synthetic medium (8, 13, 23) was modified in our laboratory so that it would result in maximum incorporation of radiolabeled precursor as previously described (19). A rapidly growing culture (106 bacteria in 5 ml) was inoculated into 300 ml of synthetic sporulating medium in which methionine was replaced with radioactive L-[methyl-14C]methionine (0.33 Ci/ml; NEC165H; 50 mCi/mmol; New England Nuclear, Boston, Mass.). After 5 days of incubation at 32°C in a shaker operating at 140 rpm, cultures were chilled in ice and spores were pelleted by centrifugation for 30 min at 900 × g in a Beckman TJ-R refrigerated centrifuge. After five cycles of centrifugation and resuspension in new Luria-Bertani (LB) broth, the radioactivity in the supernatant was reduced to less than 2% of the radioactivity in the pellet containing the spores. Samples from each batch of spores radioactively labeled and concentrated in our laboratory or nonradiolabeled spores obtained commercially (Spordex) were microscopically examined and exposed to acid for confirmation of spore morphology and chemical resistance as previously described (18). No vegetative cells (rods) were observed during the counting of 1,000 radioactively labeled or nonlabeled spores. Spores were exposed for various time periods to either deionized, glass-distilled, autoclave-sterile water (controls) or hydrochloric acid (2.5 N). After exposure they were neutralized with ice-cold LB broth (Advanced Biotechnology IC, Columbia, Md.) and titrated onto broth-agar (LB broth [Miller-Difco, Detroit, Mich.], 1.5% Agar Select [Gibco-BRL, Paisley, Scotland]) plates 100 mm in diameter. Typical spore survival in hydrochloric acid for 5 and 10 min was 100 and 88%, respectively.

Spores labeled with [14C]methionine were diluted in LB broth, and identical aliquots were either titrated for viability or counted for radioactivity. The specific activity of each spore preparation was obtained from the slope of the regression line of spore number (as determined by titration) versus incorporated 14C label (measured by scintillation counting). We transferred various devices to Eppendorf polypropylene tubes (1.5 ml) containing 50 µl of 14C-labeled spores at different concentrations. Each device was immersed in a separate spore-loading suspension for 30 min. The devices were then removed from the loading suspension with forceps and dried for 10 min under vacuum (Speed Vac; Savant, Farmingdale, N.Y.). Each 50-µl suspension was used once and then discharged.

The spore load on each device was estimated by immersing the loaded devices in scintillation liquid, measuring radioactivity, and multiplying this value by the specific activity of the preparation. One large batch with a specific activity of 1.7 × 103 ± 0.3 × 103 spores per cpm was used for final calibration of all devices. The number of spores attached to no. 0/80 stainless steel screws (ranging from 6.0 × 106 to 6.5 × 106) was comparable to that loaded into medical-grade silicone rubber tubing (3.8 × 106) immersed in a spore suspension with a similar spore concentration (1.7 × 109/ml). The increase in the number of spores loaded onto the stainless steel screws or silicone rubber tubing was approximately linear with increasing concentrations of the loading suspension in the range of 107 to 1010 spores/ml. This contaminating procedure loaded, on average, 3 spores per 1,000 spores/ml of the loading suspension.

Sterilants and disinfectants. Cidexplus (3.4% glutaraldehyde, pH 8.0; Johnson and Johnson Medical Inc., Arlington, Tex.) was activated as specified and used full strength at 21°C over a period of either 10 h, for sterilization, or 20 min, as indicated for high-level disinfection. Exspor (Alcide Corp., Redmond, Wash.), containing 1.52% sodium chlorite, was activated daily before experiments by mixing 1 part base concentrate, 4 parts water, and 1 part activator (yielding a pH between 2.3 and 2.7). The label prescribes the treatment of medical items with an Exspor-activated solution for 10 h to achieve sterilization and for 1 to 3 min for killing of Mycobacterium sp. and other bacteria, pathogenic fungi, and viruses on hard surfaces. Renalin (Renal Systems Division of Minntech Corp., Minneapolis, Minn.), a mixture of 20.0% hydrogen peroxide and 4.0% peroxyacetic acid, was used as recommended for sterilization at a dilution of 1:5 (final dilution; pH 1.8) in sterile, deionized, and glass-distilled water for an 11-h exposure. Wavicide-01 (2% glutaraldehyde; Wave Energy Systems, Wayne, N.J.) was used full strength for 10 h at 21°C as a sterilant or at a 1:4 dilution for 10 min (at room temperature [21°C]), as specified for killing of vegetative bacteria and viruses. Clorox (5.25% sodium hypochlorite, manufactured by The Clorox Company, Oakland, Calif.) was used at a 1:21 dilution, as recommended for disinfection. Lysol I.C. (7.24% o-benzyl-p-chlorophenol and 2.23% o-phenylphenol; National Laboratories, Montvale, N.J.) was used at the 1:128 dilution specified for use in hospitals, nursing homes, dental offices, and other institutional facilities as a germicidal, tuberculocidal, pseudomonacidal, staphylococcidal, fungicidal, and virucidal compound. Cavicide (15.30% isopropanol and 0.25% diisobutyl phenoxyethoxyethyl dimethyl benzyl ammonium chloride; Micro Aseptic Products, Inc., Palatine, Ill.) was used full strength, as specified for disinfection of noncritical medical instruments. Cupric chloride (CuCl2 · 2H2O; Mallinckrodt Specialty Chemicals, Paris, Ky.), L-ascorbic acid, and (30% wt/vol) hydrogen peroxide (both from Aldrich Chemical, Milwaukee, Wis.) were used in a mixture (0.5% cupric ions [as cupric chloride]-0.1% ascorbic acid-0.003% hydrogen peroxide, pH 2.9).

 

Hepatitis C Survives Treatment with Commercial Sterilants and Disinfectants
http://www.safetec.com/sanizide.php3 
2001

SAFETEC SANIZIDE PLUSTM

Germicidal Solution SaniZide PlusTM is a ready-to-use, hospital grade, hard surface disinfectant/deodorizer. Our Quaternary Ammonium, alcohol free formulation is non-flammable making SaniZide PlusTM safe to ship, as well as, non-corrosive. Choosing SaniZide PlusTM helps you to comply with the OSHA Bloodborne Pathogens Standard, which requires the use of an "appropriate disinfectant" that is tuberculocidal and virucidal against HIV-1 and HBV. For use on: glass, porcelain, ceramic, metal, polyethylene, polypropylene, vinyl, polyester, rubber, bakelite, and many more hard surfaces. For use in: industrial, institutional, commercial, medical and residential facilities, equipment and vehicles. EPA Registered. Now effective against Hepatitis C Virus (HCV)!

* Alcohol-free formula
* Kills HBV, HIV, HCV and TB
* Ready-to-use hospital grade disinfectant
* Virucidal, Tuberculocidal, Fungicidal, Bactericidal
* Controls mold and mildew
* EPA registered
* Neutralizes odors and freshens in one step
* Helps you comply with the OSHA Bloodborne Pathogens standard


Vaccins et vaccination dans le monde, n°5, November 1997, p.2. WHO journal, pp. 2-4: "We must act now and take advantage of the new mass vaccination campaigns that are soon to be launched, to improve injection safety. If we fail, we will not only have a catastrophe on our hands, but we will have missed a golden opportunity to resolve this problem". The problem of dangerous injections had already been raised at the Yamoussoukro meeting in 1994, which in turn followed those of Bamako in 1974, Dakar in 1981, Niamey in 1987. Cf. Marchés tropicaux, n°628, 1 April 1994, p.628

2001
Read down to the 'Warnings' it's still not 100%


HEPATITIS B IMMUNE GLOBULIN (HUMAN)Rx
NABI-HB™ (Nabi)
Solvent/Detergent Treated and Filtered
DESCRIPTION
Hepatitis B Immune Globulin (Human), Nabi-HB™, is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol fractionation process 1,2 with two added viral reduction steps described below. Nabi-HB™ is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only.

The manufacturing steps for Nabi-HB™ are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri- n -butyl phosphate and Triton® X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) 3 . Virus filtration, using a Planova® 35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses 4 . The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table:

Table 1 Log Reduction of Test Viruses 5 Model Virus:
Envelope/Genome:
Manufacturing Step HIV
HIV
yes/RNA BVD
HCV
yes/RNA Test Virus
PRV
HBV
yes/DNA EMC
Hepatitis A
no/RNA PPV
PVB19
no/DNA
Precipitation of Cohn
Fraction III > 5.9 3.6 3.7 4.4 3.9
Cuno Filtration NT NT NT > 6.6 5.4
Solvent/Detergent > 4.2 > 6.9 > 6.4 NT NT
Nanofiltration > 7.4 > 6.9 > 5.7 3.0 0.7 *
Cumulative > 17.5 > 17.4 > 15.8 > 14.0 9.3
BVD = Bovine Viral Diarrhea Virus
EMC = Encephalomyocarditis Virus
HIV = Human Immunodeficiency Virus
PVB19 = Parvovirus B19
PPV = Porcine Parvovirus
PRV = Pseudorabies Virus
NT = not tested
* Value not included in cumulative clearance


Product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. Each milliliter (mL) of product contains greater than 312 IU anti-HBs. The potency of each milliliter of Nabi-HB™ exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (FDA). The U.S. reference has been tested by Nabi® against the WHO standard and found to be equal to 208 IU/mL.


CLINICAL PHARMACOLOGY
Hepatitis B Immune Globulin (Human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate of hepatitis B following use 6-9 .

Clinical studies 10,11 conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB™ indicate the advantage of simultaneous administration of hepatitis B vaccine and Hepatitis B Immune Globulin (Human). The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be provided in certain instances of exposure based upon the increased efficacy found with that regimen in neonates 12 . Cases of hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of concurrent hepatitis B vaccine and Hepatitis B Immune Globulin (Human) administration following parenteral exposure, mucous membrane contact, or oral ingestion in adults.

Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic carriers 13 . The risk is especially great if the mother is also HBeAg-positive 14 . Studies conducted with hepatitis B immune globulins similar to Nabi-HB™ indicated that for an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85-98% effective in preventing development of the HBV carrier state 15-17 . Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have a 70-90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has 50% efficacy 18 .

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection 19 .

Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within two weeks of the last sexual exposure to a person with acute hepatitis B 19 .

Pharmacokinetics
Pharmacokinetics trials 20 of Nabi-HB™, Hepatitis B Immune Globulin (Human), given intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert 21 . The half-life for Nabi-HB™ was 23.1 ± 5.5 days. The clearance rate was 0.35 ± 0.12 L/day and the volume of distribution was 11.2 ± 3.4 L.

Maximum concentration of Nabi-HB™ was reached in 6.5 ± 4.3 days. The maximum concentration of anti-HBs and the area under the time-concentration curve achieved by Nabi-HB™ were bioequivalent to that of another licensed Hepatitis B Immune Globulin (Human) when compared in the same pharmacokinetics trial. Comparability of pharmacokinetics between Nabi-HB™ and a commercially available hepatitis B immunoglobulin indicate that similar efficacy of Nabi-HB™ should be inferred.


INDICATIONS AND USAGE
Nabi-HB™, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings:



Acute Exposure to Blood Containing HBsAg
Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Infants born to mothers positive for HBsAg with or without HBeAg 12 .
Sexual Exposure to HBsAg-positive Persons
Sexual partners of HBsAg-positive persons.
Household Exposure to Persons with Acute HBV Infection
Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient.


Nabi-HB™ is indicated for intramuscular use only.


CONTRAINDICATIONS
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB™, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB™ contains less than 100 micrograms per mL IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with Nabi-HB™ against the potential for hypersensitivity reactions.


WARNINGS
In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB™, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks.

Nabi-HB™ is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB™ manufacturing process includes a solvent/detergent treatment step (using tri- n -butyl phosphate and Triton® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB™ is filtered using a Planova® 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Nabi at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.


PRECAUTIONS
General
Nabi-HB™, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-exposure prophylaxis. The preferred sites for intramuscular injections are the anterolateral aspect of the upper thigh and the deltoid muscle. If the buttock is used due to the volume to be injected, the central region should be avoided; only the upper, outer quadrant should be used, and the needle should be directed anterior (i.e., not inferior or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve 22 .

The 50 healthy volunteers who received Nabi-HB in pharmacokinetic studies were followed for 84 days for possible development of anti-HCV antibodies. No subject seroconverted.


Drug Interactions
Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB™, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB™ shortly after live virus vaccination.

There are no available data on concomitant use of Nabi-HB™ and other drugs; therefore, Nabi-HB™ should not be mixed with other drugs.

Pregnancy Category C
Animal reproduction studies have not been conducted with Nabi-HB™. It is also not known whether Nabi-HB™ can cause fetal harm when administered to a pregnant woman or can affect a woman's ability to conceive. Nabi-HB™ should be given to a pregnant woman only if clearly indicated.

Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nabi-HB™ is administered to a nursing mother.

Pediatric Use
Safety and effectiveness in the pediatric population have not been established for Nabi-HB™. However, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children 12 .

Geriatric Use
Clinical studies of Nabi-HB™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

ADVERSE REACTIONS
Fifty male and female volunteers received Nabi-HB™, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials 20 . The number of patients with reactions related to the administration of Nabi-HB™ included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myalgia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB™: elevated alkaline phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events.

No anaphylactic reactions with Nabi-HB™ have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins 23 .


OVERDOSAGE
Although no data are available, clinical experience reported with other human immune globulins suggests that the only manifestations of overdose with Nabi-HB™, Hepatitis B Immune Globulin (Human), would be pain and tenderness at the injection site.


DOSAGE AND ADMINISTRATION
This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi-HB™, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately.

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine 11 .



Acute Exposure to Blood Containing HBsAg
Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear 12 . An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine.
For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose 12
Table 2 Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure 12 Exposed Person
Source Unvaccinated Vaccinated
HBsAg-positive 1. Hepatitis B Immune Globulin (Human) X 1 immediately *
2. Initiate HB vaccine series † 1. Test exposed person for anti-HBs
2. If inadequate antibody ‡ , Hepatitis B Immune Globulin (Human) X 1 immediately plus either HB vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later §
Known Source - High
Risk for HBsAg-positive 1. Initiate HB vaccine series
2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin (Human) X 1 1. Test source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) X 1 immediately plus either HB vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later §
Known Source - Low
Risk for HBsAg-positive Initiate HB vaccine series Nothing required
Unknown Source Initiate HB vaccine series Nothing required
* Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM.
† See manufacturers' recommendation for appropriate dose.
‡ Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay.
§Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four doses of vaccine.


Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg
Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer.
Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known 10,19 . Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected 12 .
Table 3 Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19 Age of Infant
Administer Infant Born to mother known
to be HBsAg-positive Infant born to mother not screened for HBsAg
First Vaccination * Birth (within 12 hours) Birth (within 12 hours)
Hepatitis B Immune
Globulin (Human) † Birth (within 12 hours) If mother is found to be HBsAg-
positive, administer dose to infant as soon as possible, not later than 1 week after birth
Second Vaccination * 1 month 1-2 months
Third Vaccination * 6 months ‡ 6 months ‡
* See manufacturers' recommendations for appropriate dose.
† 0.5 mL administered IM at a site different from that used for the vaccine.
‡ See ACIP recommendation.

Sexual Exposure to HBsAg-positive Persons
All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection 19 .
Household Exposure to Persons with Acute HBV Infection
Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine 19 .
HOW SUPPLIED
Nabi-HB™, Hepatitis B Immune Globulin (Human), is supplied as:

NDC Number Contents
59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert
59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert

STORAGE

Refrigerate between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.

REFERENCES
Cohn E.J., Strong W.L., Mulford D.J., Ashworth J.N., Melin M., Taylor H.L. Preparation and Properties of Serum and Plasma Proteins IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946, 68: 459-475.
Oncley J.L, Melin M, Richert D.A, Cameron J. W, Gross P.M. The separation of antibodies, issogglutinins, prothrombin, plasminogen and b1-lipoproteins into sub-fractions of human plasma. J Am Chem Soc 1949, 71:541-550.
Horowitz B: Investigations into the application of tri( n -butyl)phosphate/detergent mixtures to blood derivatives. Morgenthaler J (ed): Virus Inactivation in Plasma Products, Curr Stud Hematol Blood Transfus 1989; 56:83-96.
Burnouf T: Value of virus filtration as method for improving the safety of plasma products. Vox Sang 1996; 70:235-236.
Unpublished data on file, Viral Validation Study Reports, Nabi.
Grady GF, and Lee VA: Hepatitis B immune globulin - prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 1975; 293:1067-1070.
Seeff LB, et al. : Type B hepatitis after needle-stick exposure: Prevention with hepatitis B immune globulin. Ann Int Med 1978; 88:285-293.
Krugman S, and Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 1973; 288:755-760.
Hoofnagle JH, et al. : Passive - active immunity from hepatitis B immune globulin. Ann Int Med 1979; 91:813-818.
Beasley RP, et al. : Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo - controlled trial. Hepatology 1983; 3:135-141.
Szmuness W, et al. : Passive active immunisation against hepatitis B: Immunogenicity studies in adult Americans. Lancet 1981; 1:575-577.
Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22):313-335.
Shiraki Y, et al. : Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic carrier mothers. Am J Dis Child 1977; 131:644-647.
Beasley RP, et al. : The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 1977; 105:94-98.
Wong VCW, et al. : Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B immunoglobulin: Double-blind randomized placebo-controlled study. Lancet 1984; 1:921-926.
Poovorawan Y, et al. : Long term hepatitis B vaccine in infants born to hepatitis B e antigen positive mothers. Archives of Diseases in Childhood 1997; 77:F47-F51.
Stevens CE, et al. : Perinatal Hepatitis B virus transmission in the United States: Prevention by passive-active immunization. JAMA 1985; 253:1740-1745.
Jhaveri R, et al. : High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 1980; 97:305-308.
Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.
Data on file, Nabi®
Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular application in man. Develop Biol Standard 1983; 54:347.
Centers for Disease Control: General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994; 43:1-38.
Ellis EF, Henney CS: Adverse reactions following administration of human gamma globulin. J Allerg 1969; 43:45-54.
Manufactured by:

Nabi®

Boca Raton, FL 33487
U.S. License No. 1022
November 2001
3-440-1118

July 29, 2004
http://www.prweb.com/news/20040729/index.htm
NEW - Hepatitis C disinfectant just introduced in the Salon industry, could mean the end of O'L BLUE!

SaniGuard an emerging leader in infection control products has introduced a complete line of sanitization products for the beauty and barber industry's including SaniGuard PRO™ the Industry’s First Hospital Grade Disinfectant with a Hepatitis C Efficacy Claim and 4 patent pending color choices.

For salon and spa owners, providing services to their clients in clean and safe surroundings has to be their number one priority. Until now the choices have been limited with no real advances with sanitization in the beauty & barber industry. To help achieve a healthy environment, SaniGuard®, an emerging leader in the medical and health field, has introduced a new cutting edge professional line of salon sanitization products, SaniGuard Professional Salon Products.

The SaniGuard Professional Salon Products line encompasses seven products with their first product release and includes many firsts in the salon and spa industry, such as the first Hepatitis C efficacy claim and patent-pending colored disinfectants for salon tools and implements.

The SaniGuard Professional Salon Products line includes:

•SaniGuard PRO™ Concentrated Hospital Grade Disinfectant - The beauty and barber industry’s first EPA-registered hospital grade disinfectant with a Hepatitis C efficacy claim. SaniGuard PRO comes in four patent-pending colors (green, purple, red & yellow) and is virucidal, fungicidal, bactericidal and has been tested on and proven effective against TB, HIV 1 & 2, Hepatitis B & C, Herpes 1 & 2, Staph, Strep & over 50 other leading infection concerns including MSRA strains. It also does not contain dangerous phenols like other TB approved products in the beauty industry.

•SaniGuard Barrier Skin Cream™ - The most advanced barrier skin cream introduced to date. When applied it dries quickly without any sticky residue and will provide temporary protection for 3-4 hours repelling everything from chemicals and dyes to perm solutions and water. In many applications it is making latex or vinyl gloves a thing of the past.

•SaniGuard Dry Sanitizing Surface Spray™ - The world's first dry on contact spray sanitizer and deodorizer. Due to it's dry on contact properties, it safely sanitizes surfaces that ordinary wet products damage. Electronics, rubber, plastic, fabrics even paper, without damage!

•SaniGuard Total Release Fogger™ - The World's first disposable room fogger. It enables the user to quickly sanitize entire rooms in just minutes with the same "kill on contact" power of the conventional SaniGuard sprays. Each fogger treats up to 625 sq. ft. in one application.

•SaniGuard PRO™ Salon Disinfectant and Manicure Jar - Modern designed options for more efficent brush and tool disinfecting. SaniGuard's trademark square jar is quickly becoming the industries top choice nationwide.

•SaniGuard PRO Brush & Comb Tub™ - A one gallon plastic tub for large scale disinfecting, hair removal or sanitary storage of combs and brushes. SaniGuard Tubs provide an attractive design for any station and easy function for maintaining a sanitary service area.

“From SaniGuard PRO – the first high powered Hepatitis C rated liquid tool disinfectant with color options, to the industries first Total Release Fogger for effectively treating entire rooms in just minutes to the most advanced Barrier Skin Cream that the industry has seen to date, SaniGuard is your source for superior salon and spa sanitization essentials that are priced right,” says David Harried, V.P. of Marketing. “SaniGuard Professional Salon Products help to protect your customers and your employees, while making it easier to meet tough state regulations. It's time to say so long to the outdated old blue formula and replace it with advanced protection."

For more information on how SaniGuard Professional Salon Products can help you achieve the ultimate in clean for your salon or spa, please contact David Harried at 608.347.9003, sales@saniguardpro.com or visit us online at http://saniguardpro.com.

All Press Releases for July 29, 2004