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HCV Training Workshop

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					                        HCV Training Workshop



                                ALAN FRANCISCUS
   E X E C U T I V E D I R E C T O R , H E PAT I T I S C S U P P O R T P R O J E C T
           E D I T O R - I N - C H I E F, H C V A D V O C AT E W E B S I T E

                      W W W. H E PAT I T I S TAT T O O S . O R G

     J O I N M E O N T W I T T E R & FA C E B O O K – H C VA D V O C AT E

                 B L O G : H C VA D V O C AT E . B L O G S P O T. C O M /



www.hcvadvocate.org                                                            Version 12.2
                     HCSP STAFF


 C.D. Mazoff           • Irina Gavrilova

 Lucinda Porter
                        • Clara Maltras
 Rose Christensen

                        • Aidan Coffino
 Liz Highleyman


 Leslie Hoex           • Torin Coffino

 Kate Frye
                                            Version 12.2
www.hcvadvocate.org




                      Version 12.2
                      Numbers

 •Web site average :
   •Average 500,000 hits/week


 •Educational Materials: 600,000 pieces
     •   Not counting web site downloads
     •   Fact Sheets – 400-500 downloads weekly



www.hcvadvocate.org                               Version 12.2
www.hcvadvocate.org   Version 12.2
       Effect on HCV Community

•HCSP Educators: more than 10,000


   •   50 people:
       • In one year outcome is 500,000 people


   •   Ultimate goal:
       •   Improved education, support and services

www.hcvadvocate.org                            Version 12.2
                      The Liver




www.hcvadvocate.org               Version 12.2
                      •   About 3 lbs (men) –size of a
       T                  football
       H
                      •   Located in the upper right side
       E                  – beneath the rib cage

                      •   1.5 quarts of blood flow
       L                  through it every minute
       I
                      •   Chemical factory > 500
       V                  functions
       E
                           •   Bile-regulates hormones-
       R                       immune system cells

www.hcvadvocate.org                                  Version 12.2
            Liver Functions - continued


 •   Sugar & fat metabolism & Nutrient storage

 •   Stores some vitamins & minerals
     • Fat soluble vitamins: A,D,E, & K
     • Minerals: copper & iron


 •   Clotting factors: makes proteins to help the blood clot

 •   Filters – breathed in the air, absorbed through the skin and
     taken by mouth

                      *** Regenerates—grow or shrink***
www.hcvadvocate.org                                        Version 12.2
            Healthy People:
•H e a l t h y p e o p l e — n o m o r e t h a n :
   •   2 alcoholic drinks a day for men; 1 alcoholic drink a day for women
   •   HCV – NO ALCOHOL

•B e c a u t i o u s a b o u t m i x i n g d r u g s e s p e c i a l l y w i t h
alcohol—
  • acetaminophen (Tylenol) – 600 products
  • Over 56,000 emergency room visits & 500 deaths a year


•E a t a h e a l t h y , b a l a n c e d d i e t :

   •   www.choosemyplate.gov
www.hcvadvocate.org                                                                Version 12.2
                      HEPATITIS

•Means:
            Inflammation of the liver


•Causes:
    •   Viruses, toxins, genetic disorders,
        bacteria and parasites

www.hcvadvocate.org                           Version 12.2
                      Hepatitis A (HAV)
  •   US—New infections: 21,000 (US – 2009)

      •   180, 000 in 1997

      •   Vaccine available since 1995 –2 doses (0 & 6 mos)

      •   Estimated 33% have been infected with HAV

  •   Resolves (not chronic)

  •   Transmission: fecal/oral
www.hcvadvocate.org                                           Version 12.2
                      HEPATITIS B (HBV)

•US - 38,000 new infections (CDC – 2009)

  •Vaccine available since 1982 - 3 doses (0,1, & 6 months)
•US chronic: 800,000 –1.4 MILLION

  •   Worldwide: 350-400 million
•U S - 3 , 0 0 0 D E A T H S A Y E A R

  •   Worldwide 660,000 annual deaths

www.hcvadvocate.org                                  Version 12.2
                      HBV Transmission

    •   Blood borne –can live outside the body for at least 7
        days
    •   Highly infectious in semen and vaginal
        secretions-50% - sexual transmission
    •   Sharing needles to inject drugs
    •   Needle stick and blood exposure accidents
    •   Sharing personal items
    •   Mother-to-child transmission
www.hcvadvocate.org                                      Version 12.2
                      HBV Prevention

•Get vaccinated

•Do not share needles or works

•Safer sex

•Standard safety precautions

•Do not share personal items

•HBV infected mother to child intervention
www.hcvadvocate.org                          Version 12.2
                               Chronic HBV

                       Chronic ~5-6% Adults----90% Infants




*These drugs are recommended as first line of treatment
 www.hcvadvocate.org                                         Version 12.2
    HCV Transmission / Prevention



               •The    hepatitis C virus lives for at least 16 hours, but

               no longer than 4 days outside the body



               •In    syringes up to 63 days




www.hcvadvocate.org                                                 Version 12.2
               Transmission/Prevention

  •   Sharing needles and drug preparation tools
  •   Blood products & solid organ transplantation before 1992

  •   Clotting factors before inactivation in 1987
  •   Sexual transmission (0-3%)
  •   Mother-to-child (~4-5%)
  •   Healthcare workers (~2%)
  •   Hemodialysis

www.hcvadvocate.org                                     Version 12.2
    Possible Transmission Routes
•   Tattoo & piercing*


•   Personal care salons


•   Shared household (hygiene) items


•   Coke/crank straws & crack pipes


•   10% of routes can not be identified
* Higher in unsafe non-commercial settings: prisons/mental institutions/on the streets/home grown

                                                                                         Version 12.2
Safer Tattoos – www.hepatitistattoos.org
          Little or no data…….

• Dental and other procedure before universal
 precautions

• Jet gun injections


• Transgender people
 •   Sharing needles and operations

                                        Version 12.2
               HCV is Not Spread by:

  •   Breast feeding
  •   Food or water
  •   Sharing eating utensils or drinking
      glasses
  •   Sneezing
  •   Hugging
                      *Not spread by casual contact*
www.hcvadvocate.org                                    Version 12.2
                      Prevention:

•Do not share anything:        NEEDLES,
COOKERS, COTTON, TOURNIQUETS, WATER, ETC –
WASH HANDS




www.hcvadvocate.org                  Version 12.2
           Prevention - more

•Do not share non-injection drug
equipment
 •Coke/crank straws
 •Crack pipes


 •Tattoo / Piercing
  •Sterilization, autoclave, separate ink pot,
  new needles
                                          Version 12.2
                       Prevention - more

•S e x u a l : 0 - 3 % - m o n o g a m o u s p a r t n e r s – c o u n s e l
  •   Safer sex – additional risk through sex:
      •   Multiple partners
      •   Coinfection with HIV or HBV
      •   Having herpes, lesions, sores, open cuts, wounds
      •   Sexually transmitted diseases

•M O T H E R - T O - C H I L D

 www.hcvadvocate.org                                              Version 12.2
            More Prevention

•Health care workers
 •blood borne pathogen protection

•Razors / toothbrushes covered

•Cover all wounds

•Transfusions – estimated that less than one per 2
million transfused units of blood tainted with HCV

•People with HCV: Do not donate blood, sperm, eggs
or organs – EXCEPTIONS…..

                                               Version 12.2
                      HCV Diagnostic Tools


HCV IDENTIFIED IN 1989




   Important: Interpretation of test results and decisions about healthcare are a
              collaboration between a medical provider and a patient

www.hcvadvocate.org                                                       Version 12.2
                  Lifecycle

•   Single stranded RNA virus

•   Mainly infects liver cells—but also found in
    other cells of the body

•   Difficult to culture—complete lifecycle is
    unknown

                                           Version 12.2
           Baby Boomers Account for the Majority of HCV
                     Cases in United States
             Estimated Prevalence by Age Group

                          1.6
Number With Chronic HCV




                          1.4
                          1.2
                          1.0
                          0.8
                          0.6
(millions)
Infection




                          0.4
                          0.2
                           0
                                <1920   1920s                                        1970s   1980s   1990+
                                                1930s      1940s     1950s   1960s


                                                        Birth Year Group

www.hcvadvocate.org                                                                                          Version 12.2
     Increased Diagnosis and Treatment
The Tipping Point?
   Aged-Based Testing   OraQuick HCV Antibody Test         New Antivirals
    Templates


 .Test everyone of a    • Finger Prick                 New HCV Treatments
 certain age. Pilot     •Whole Blood Draw
 programs are being     •Oral Swab                     •An HCV protease
 planned in:                                           inhibitor combined
                        •Results available within 20   with pegylated
 • New York,            minutes                        interferon, plus
                                                       ribavirin increases
 • Detroit, MI,         •More testing within clinics   the cure rates up to
                        and mobile sites can lead to   79%
 •Houston, TX,          increased consultations
                        about care, management and     •Higher cure rates will
 • Birmingham, AL       treatment                      mean more treatment
                                                       naive and prior non-
                                                       responders will seek
                                                       treatment

     Your own footer                                              Your Logo
                      HCV Antibody Tests
•H C V E L I S A I I I ( E I A ) , C I A : D E T E C T S A N T I B O D I E S


      •   Signal to cut off ratio = 95% chance true antibody
          positive
  •   Home Access test kit

  •   Window period – 2-26 weeks



www.hcvadvocate.org                                                  Version 12.2
 OraQuick HCV Rapid Antibody Test

• FINGERPRICK & WHOLE BLOOD:
           FDA AND CLIA WAIVER APPROVED –
           2011

• ORALSWAB – PENDING FDA AND CLIA
   APPROVAL – 2012?



www.hcvadvocate.org                   Version 12.2
www.hcvadvocate.org   Version 12.2
www.hcvadvocate.org   Version 12.2
                  HCV RNA – Viral Load

•   PCR (polymerase chain reaction) –lowest range

•   TMA (transcription mediated amplification)—lowest range

•   DNA (bDNA) assay – highest range



•   Amount of virus per milliliter of blood

    •   International units

        •   Low – less than 800,000 IU/mL

        •   High –more than 800,000 IU/mL

                                                       Version 12.2
                How is Viral Load Used?

  •   Confirm active infection

  •   Soft predictor of treatment response

  •   Confirm HCV medications are working and

      dictate treatment duration

  ***Does Not Correlate with Disease Progression***
www.hcvadvocate.org                             Version 12.2
            Genotype & Quasi-species


   Six major genotypes (plus sub-types)
     Genotypes numbered 1,2,3,4,5,6, (1a, 1b, etc)
       Genotype 1 – 70% of US population with HCV

       Genotype 2,3 – 30% of US population with HCV



     Quasi-species
       High   error prone virus – mutates quickly




                                                     Version 12.2
                          Liver Tests

   •   ALT: a non-specific marker of liver
       inflammation

           •   Not a good test to monitor people with HCV

   •   AST, AP, GGT, Bilirubin, platelet, prothrombin
       time (PT)
www.hcvadvocate.org                                  Version 12.2
 Liver Biopsy


*Measures liver
health

                       Metavir Scoring System – 0, 1, 2, 3, 4

*Treatment            No activity              Severe activity
decisions


*Benchmark

www.hcvadvocate.org                                        Version 12.2
             HCV Symptoms, Disease
            Progression & Management



                      “LIVING WITH HCV IS OFTEN EASY, OFTEN
                      DIFFICULT AND SOMETIMES IMPOSSIBLE”

                                         PETER MARE LATHAM




www.hcvadvocate.org                                    Version 12.2
                      Future Disease Burden

 *Institute of Medicine (IOM) Report – 2010

 **Milliman Report-Annual cost of advanced liver disease
 to $85 billion in the next two decades and Medicare costs
 will increase 500%, from $5 billion to $30 billion

 ***Aging of the Hepatitis C Virus-Infected Persons
 in the United States: A Multiple Cohort Model of
 HCV Prevalence and Disease Progression --
 Progression to cirrhosis will peak at 1.0 million in 2020
 *http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-
     and-Control-of-Hepatitis-B-and-C.aspx
 **http://www.milliman.com/expertise/healthcare/publications/rr/pdfs/consequences-hepatitis-c-
     virus-RR05-18-09.pdf
 ***GL Davis and colleagues; PMID: 19861128 [PubMed - as supplied by publisher]

                                                                                     Version 12.2
 Drug Based Therapies




                                               Health Access
                          HCV Positive




What may be needed
even before considering
treatment                                Ann Shindo
www.hcvadvocate.org                         Version 12.2
                      Liver Specialists

•G A S T R O E N T E R O L OG I S T

•H E P A T O L O G I S T




•T H E F U T U R E ?
  •   Primary care, infectious disease specialists and
      others

www.hcvadvocate.org                               Version 12.2
                             Acute HCV

• Initial or acute infection
  • Many people have no symptoms

  • Flu-like—fatigue, nausea, fever, indigestion, loss of appetite,
    night sweats, jaundice
  • Lasts up to 6 months
     •   Spontaneous (natural) clearing by gender:
         • Women ~40%

         • Men ~19%



• Treatment of acute HCV—the majority of people with acute
  HCV can clear the virus with interferon monotherapy.

                                                              Version 12.2
                      Chronic Infection

•L O N G E R T H A N 6 M O N T H S
   •   Does not mean severe disease progression

•5 5 T O 8 5 % B E C O M E C H R O N I C


•10 to 25% have serious disease progression over a 10 to 40
year period--disease progression is not linear

       •   Fibrosis / Cirrhosis / Steatosis

www.hcvadvocate.org                                   Version 12.2
                      Chronic Symptoms

 Fatigue – mild to                      Liver pain
   severe
                                         Loss of appetite

 “Brain Fog”
                                         Headaches

 Flu-like symptoms
                                         Gastro problems

 Depression                                              And more….

   Symptoms don’t necessarily correlate with disease progression with the
                   exception of end-stage liver disease.
www.hcvadvocate.org                                               Version 12.2
                    HCV Infection:
              Extrahepatic Manifestations
Hematologic                                                   Salivary
•   Mixed cryoglobulinemia                                    • Sialadenitis
•   Aplastic anemia
•   Thrombocytopenia                                          Ocular
•   Non-Hodgkin’s b-cell lymphoma                             • Corneal ulcer
Dermatologic                                                  • Uveitis
• Porphyria cutanea tarda
• Lichen planus                                               Vascular
• Cutaneous necrotizing                                       • Necrotizing vasculitis
  vasculitis                                                  • Polyarteritis nodosa
                                                             Neuromuscular
Renal
                                                             • Weakness/myalgia
• Glomerulonephritis
                                                             • Peripheral neuropathy
• Nephrotic syndrome
                                                             • Arthritis/arthralgia
Endocrine                                                    Autoimmune
• Anti-thyroid antibodies
                                                             Phenomena
• Diabetes mellitus
                                                             • CREST syndrome



                                Hadziyannis SJ. J Eur Acad Dermatol Venereol. 1998;10:12-21.
                      U. S. Statistics: CDC

•N E W ( A C U T E ) I N F E C T I O N S :   16,000




•T O T A L C H R O N I C I N F E C T I O N S :   UP TO 3. 9MILLION

•1 2 , 0 0 0 D E A T H S A N N U A L L Y




*NOT FACTORED INTO ABOVE:              PRISONERS, HOMELESS, PEOPLE IN
MENTAL INSTITUTIONS

www.hcvadvocate.org                                                  Version 12.2
                       Disease Progression

 Compensated—extensive scarring, but liver is still
 working fairly well

 Decompensated—very extensive scarring and liver
 function has become severely compromised
    Conditions
        Portal Hypertension / Ascites & Edema / Varices / Encephalopathy
• Liver Cancer
 •   3% to 5% of people with chronic HCV will develop liver cancer - after
     severe fibrosis or cirrhosis
• Transplantation: 250,000 to $314,000 – up to
 $500,000--Annual costs of medications: ~$21,900
                                                                      Version 12.2
                           Disease Management
                            Lifestyle Changes
•A V O I D A L C O H O L

        •Lowers immune response & HCV treatment response
        •Helps HCV to replicate and mutate

        •Increases level of iron and fat in the liver

•A V O I D O R R E D U C E :

        •Cigarette        smoking, drugs or any substance that can harm the liver

•     EAT A HEALTHY WELL BALANCED DIET


              WWW.CHOOSEMYPLATE.GOV

    www.hcvadvocate.org                                                      Version 12.2
                      Disease Management

•H E P A T I T I S A & H E P A T I T I S B V A C C I N E


•A V O I D R A W & U N D E R C O O K E D S H E L L F I S H
  •   HAV / Vibrio vulnificus

•E X E R C I S E
  •   Moderation—balance activity with rest

www.hcvadvocate.org                                        Version 12.2
                   SUPPLEMENTS


 Avoid high doses of vitamins and supplements


 General recommendations:
    Vitamin supplement (daily requirements with no iron)

 Always check-in with a medical provider




                                                     Version 12.2
             Discrimination & Stigma

 Americans with Disabilities Act—allows for certain
 protections

 Call the ADA (800-949-4232)


 Social Security Disability


 The effect of stigma



                                                Version 12.2
                      Support Groups

•I N F O R M A T I O N A L & E M O T I O N A L


  •   One of the few places where people with HCV can
      connect, advocate, support and learns from peers

•H C S P S U P P O R T G R O U P I N A B A G
  •   Support group manual on web site

www.hcvadvocate.org                                      Version 12.2
                                           HCV Medical Treatments

              95      HCV Medical Treatment
              85
              75
              65
  Pe rce nt




              55                                                                                   Genotype 1
              45                                                                                   Genotype 2, 3
              35
              25
              15
               5
                   Mono INF   INF + Riba    Peg-Intron + Riba Pegasys + Riba Peg INF + Riba + PI
                                              Genotype
www.hcvadvocate.org                                                                                Version 12.2
        General Treatment Guidelines

•O V E R A L L H E A L T H I S S T A B L E


•A C T I V E H C V I N F E C T I O N


•C O M P E N S A T E D L I V E R D I S E A S E
  •   Decompensated generally only in transplant centers



www.hcvadvocate.org                                    Version 12.2
           Pre-Treatment Predictors of
              Treatment Response
 •Y O U N G E R A G E    - UNDER 40 YO

 •L I T T L E O R N O S T E A T O S I S , I N S U L I N R E S I S T A N C E


 •R A C E
     •   Asian
     •   Caucasians
     •   African Americans

 •L O W H C V R N A ( V I R A L L O A D )


 •L I T T L E O R     NO SCARRING OF THE LIVER
www.hcvadvocate.org                                                           Version 12.2
           Pre-Treatment Predictors of
              Treatment Response
A VARIATION OF IL28B – GENOTYPE 1




www.hcvadvocate.org                  Version 12.2
             Treatment Goals & Success
•G O A L S O F T R E A T M E N T :
  •   Clear virus out of the body
  •   Improve inflammation & scarring
  •   Slow disease progression,
  •   Improve symptoms and quality of life
  •   To put HCV behind them and move on with their life

•S U S T A I N E D V I R O L O G I C A L R E S P O N S E ( S V R )
  •   HCV is undetectable during and 6 months following HCV medical
      therapy
       • 5 year follow-up >99% still HCV RNA undetectable

www.hcvadvocate.org                                                  Version 12.2
                  Response to Therapy

• Adherence:
  • Important now for overall treatment success
    •   More important with new HCV protease inhibitors


• Rapid Virological Response (RVR)– 4 week HCV
 RNA negative

• Complete Early Virologic Response (cEVR)—12 week
 RNA negative

• Extended RVR (eRVR) HCV RNA—negative at week
 4 and week 12
                                                      Version 12.2
Treatment of Chronic HCV Genotype 2 thru 6


 Treatment duration 24 weeks


 Ribavirin fixed dose – 800 mg/daily
   Taken with high fat food



 Currently HCV protease inhibitors are not approved
 to treat genotype 2 and 3
           Treatment: Genotype 2 and 3
   Pegylated and Ribavirin (FDA Package Insert)

 Merck /Schering – PEG-Intron + Rebetol (800-1400mg)
    Genotype 2 thru 6 – 75% (48 weeks)
      One large multi-international study


 Genentech/Roche – Pegasys + Copegus (1000-1200 mg)
    Genotype 2 & 3 – 82% SVR (24 weeks)
    Genotype 2 thru 6 – 70% SVR (48 weeks)
      Two large multi-international studies


      * Also approved to treat compensated cirrhosis,
     HIV/HCV Coinfection, Renal (mono) and HBV (mono)



                                                  Version 12.2
            Treatment of HCV Genotype 1

 Protease combination therapy is only FDA approved
 for treatment of chronic HCV genotype 1

 Treatment with an HCV protease inhibitor is only used
 in combination with pegylated interferon and ribavirin
      Ribavirin taken with food
 The HCV protease inhibitors are taken every 7 to 9
 hours with food:
    Boceprevir – light meal / Telaprevir –not low fat
                 Victrelis (Boceprevir)
               4-week lead in – Peg/Rbv

•T R E A T M E N T N A Ï V E – G E N O T Y P E 1

      •   Up to 66% SVR
            • African Americans – up to 53% vs. 23% SVR
      •   Treatment duration either 28 or 48 weeks

•T R E A T M E N T E X P E R I E N C E D – G E N O T Y P E 1

      •Prior non-responders–up    to 66% SVR (null responders not studied)
      •Treatment duration 36 or48       weeks


www.hcvadvocate.org                                                  Version 12.2
                      Incivek (Telaprevir)
   Incivek, pegylated interferon, ribavirin taken for 12 weeks only—followed by
                          pegylated interferon/ribavirin



•T R E A T M E N T N A Ï V E – G E N O T Y P E 1 :
           •   Up to 79% SVR
               • African American patients: 62% vs. 25% SVR
               • People with cirrhosis: 62% vs. 33% SVR

•T R E A T M E N T E X P E R I E N C E D – G E N O T Y P E 1 :
       •   Up to 86% SVR depending on type of non-response
           (relapsers, non-responders, null responders)

   *Treatment duration 24 or 48 weeks
www.hcvadvocate.org                                                      Version 12.2
              Standard Protocol


 Pegylated (injected once a week)

 Ribavirin (pill or capsule – oral twice a
 day) with food

 Victrelis / Incivek (pill—every 7 to 9 hours)
 for genotype 1 only with food

 Treatment is guided by type of on-
 treatment response (week 4 and 12)
                                              Version 12.2
                        Side-effects

Interferon                     Ribavirin

 Physical                     Anemia, rash, dry cough
                               Black box warning:
    fatigue, muscle/joint
                                   Women of childbearing age, their
     pain, headaches, dry           partners and female partners of
     skin, insomnia,                male patients taking ribavirin
                                    must practice two forms of
    Anxiety, depression,
                                    contraception during to 6 months
     mania                          post-treatment


    Low white blood cells
                               Low red blood cells
    Low platelets


www.hcvadvocate.org                                        Version 12.2
                           Side-effects

               Victrelis                  Incivek
 Up to 50% --anemia               Up to 36% - anemia

                                   Body rash
 Taste changes especially
   metal taste                     Anal itching

                                   Diarrhea




www.hcvadvocate.org                                 Version 12.2
                      Managing Side Effects

 Time injection                   Daily moisturizing


 Drink lots of water              Vary injection sites


 Low doses of ibuprofen or        Anti-depressants
   acetaminophen
                                   Plenty of rest
 Pain/sleep medications
                                   Small frequent healthy
 Light exercise                    meals


www.hcvadvocate.org                                        Version 12.2
                      Programs

 Patient Assistance Programs
  Partnership   for Prescription Assistance
    www.pparx.org

  Needy   Meds: www.needymeds.org

 Genentech: www.genentechaccesssolutions.com

 Merck: http://www.merck-cares.com

 Vertex: http://www.vrtx.com

 Kadmon: http://kadmon.com/
                                               Version 12.2
Clinical Trials
             Complementary Therapies

Herbs: Herbs can interact with other medications and have a
 potential to be unsafe
  Always check-in with medical provider and use a
   reputable herbalist
  Milk Thistle– the most common herb used by people
   with HCV
    May interact and increase blood levels of some
     substances
    St. John’s Wort – Must avoid with PI’s (lowers PI
     drug levels)
Caution:
• Bupleurum should not be used by someone taking interferon

                                                      Version 12.2
              Complementary Practices

 Acupuncture
   Thin needles are inserted into acupuncture points to
    stimulate the flow of and balance of qi (the flow of vital
    energy)
 Acupressure
   Finger pressure stimulated flow of qi



 Traditional Chinese Medicine
     Whole body concept to restore qi balance
       Acupuncture, acupressure, T’ai Chi, Moxibustion,
        massage
                                                         Version 12.2
                       Turn In

 Participant checklist
  Plan   of action

 Evaluation
  Demographic        information

 Order by fax form


                                    Version 12.2

				
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