HCV Training Workshop Alan Franciscus Executive Director, Hepatitis C Support Project EditorinChief,

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HCV Training WorkshopAlan FranciscusExecutive
Director, Hepatitis C Support ProjectEditor-in-Ch
ief, HCV Advocate Web site
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HCSP Staff

• C.D. Mazoff
• Lucinda Porter
• Rose Christensen
• Liz Highleyman
• Leslie Hoex
• Clara Maltras
• Irina Gavrilova

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(No Transcript)
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Numbers

• Web site Average 450,000 hits/week
• Educational Materials 500,000 pieces
• Not counting web site downloads
• Fact Sheets 400-500 downloads weekly

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Over 200 workshops conducted throughout the
U.S.
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Effect on HCV Community

• 6000 HCSP Trained Educators
• 50 people
• In one year outcome is 300,000 people
• Ultimate goal improved support and services

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• THE LIVER

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The Liver
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The Liver
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Liver Functions
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Liver Functions - continued
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Filters Substances
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Keep Your Liver Healthy Healthy People
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Keep Your Liver Health Healthy People -
continued
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Fibrosis / Cirrhosis
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Hepatitis
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Viral Hepatitis Hepatitis A

• 36,000 infections annually (U.S.-2006)
• 180,000 infections in U. S. 1997
• Estimated that 33 of people in U.S. have been
  infected with HAV
• Resolves does not become chronic infection
• Fecal/Oral Route of transmission
• Vaccination available (started 1995)
• Two dose series at 0 and 6-months

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Viral Hepatitis Hepatitis B

• 46,000 new infections (CDC-U.S. 2006)
• 1.0-1.4 million American have chronic HBV
• 350 million worldwide
• 5,000 annual deaths U.S.
• 620,000 annual deaths worldwide
• Vaccination available (started 1982)
• -Three dose series at 0, 1 and 6 months

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HBV - Transmission
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Chronic Hepatitis B Treatment
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HCV Transmission Prevention
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Transmission/Prevention

• Hemodialysis

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Possible Transmission Routes
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HCV is Not Spread By
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Little or no data-------

• Dental and other procedures before universal
  precautions

• Jet Gun Injections

• Transgender people
• Sharing needles and procedures

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Injection Drug Equipment
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Prevention
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Cleaning needles (is it realistic?)

• Preparation Two clean cups or bottles one for
  the bleach solution and one for the water. Do
  not contaminate the water when flushing out the
  solution.
• Draw up the water into the needle and flush it
  down the sink (try to get out as much water from
  the syringe as possible). Dont flush the this
  water into the bottles with water or bleach
  solution.
• Repeat the above 3 times
• The third time you draw up the bleach solution
  let it stand for 3-10 minutes
• Draw up cold water 2-3 times into the syringe to
  remove any remaining bleach solution

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Prevention - more
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Prevention - continued
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More Prevention
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HCV Diagnostic Tools
Hepatitis C Virus Identified in 1989
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Lifecycle
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matu
1) Virus Entry
2) Uncoating
3) Protein Synthesis
4) Cleavage
8) Re-infection
5) RNA Replication
7) Maturation
6) Packaging
Adapted from Pawlotsky JM, Gish RG. Future
therapies for Hepatitis C. Antivir Ther.
200611397-408.
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HCV Antibody Tests
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HCV RNA - Viral Load
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How is Viral Load Used?
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Genotype / Quasi-species
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Liver Biochemical/Function Tests
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Liver Biopsy
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Liver Biopsy Scoring - Metavir
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Laboratory Tests
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HCV Symptoms, Disease Progression and Management

• Living with HCV is often easy, often difficult
  and sometimes impossible
• Peter Mare Latham

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U.S. HCV Predictions for 2010-20191

• HCV related deaths 208,500
• Direct medical care cost
• -up to 14.1 billion
• Societal Costs
• -up to 75.5 billion

1JB Wong et al, Am J Public Health.
2000901562-1569
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Drug Based Therapies
Social Stigma
Health Policies
Housing
Support
HCV Positive
Health Access
Mental Health
Addiction
HAV HBV Vaccine
CAM
What may be needed even before considering
treatment
Ann Shindo
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Acute
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Chronic HCV Infection
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Chronic Symptoms

• Fatigue mild to severe
• Flu-like symptoms (muscle/joint/fever)
• Brain Fog
• Depression

• Liver Pain
• Loss of appetite
• Headaches
• Gastro Problems
• And more..

Symptoms dont necessarily correlate with disease
progression except in end-stage disease!
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U. S. Statistics CDC
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Cirrhosis
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Liver Cancer
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Perspective
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HCV Related Conditions- Extrahepatic
Manifestations

• Cryoglobulinemia
• Non-Hodgkins lymphoma
• Kidney

• Arthritis

• Fibromyalgia

• Thyroid Disease

• Various Skin disorders
• Lichen Planus

• Peripheral neuropathy

• Insulin resistance

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Disease Management-Lifestyle Changes

• Avoid Alcohol
• Lowers immune response
• Helps HCV replicate
• Lowers treatment response
• Triggers emergence of quasi-species
• Increases level of iron stored in the liver
• Contributes to fat in the liver

Avoid or reduce cigarette smoking, drugs or any
substance that can harm the liver
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Protect The Liver

• Hepatitis A Vaccine
• Coinfection with HAV/HCV potential for acute
  liver failure and death.1
• Hepatitis B Vaccine

• Avoid Raw/Undercooked shellfish
• HAV other viruses and bacteria

1 S.Vento and colleagues N Engl J. Med
1998338286-290
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Specialists

• Now - Liver Specialists
• Gastroenterologist
• Hepatologist

• The Future
• Primary Care, Infectious Disease Specialists,
  and others
• Gastro consultation

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Supplements

• Avoid megavitamins or supplements
• Vitamin A and Vitamin D should be avoided in high
  doses

• General recommendations vitamin supplement
  with daily requirements (no iron)

• Check-in with a medical provider

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Exercise Rest

• Moderate exercise recommended
• Except acute and end-stage disease

• Moderation

• Balance activity with rest

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Americans with Disabilities Act

• Allows for certain protections
• Not automatic with HCV
• More likely because of HCV Therapy
• Allows for reasonable accommodations

• Call ADA (800-949-4232)

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Support Groups

• Informational
• Some degree of emotional support
• Mainly speakers
• Emotional
• Emotional and informational support

• HCSP Support Group in a Bag Project

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HCV Medical Treatments

• All patients with chronic hepatitis C are
  potential candidates for antiviral therapy
• National Institutes of Health (NIH) Consensus
  Development Conference Statement management of
  hepatitis C

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General Treatment Guidelines

• Overall Health is Stable
• Active HCV Infection
• Elevated ALTs (exceptions)
• Compensated liver disease
• Decompensated-research only

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Optimal Response to Treatment

• Younger
• Female
• Low Viral load
• Minimal Liver Damage
• Genotype 2 or 3
• Lower Weight/ BMI
• Little or no Steatosis
• Without Metabolic Syndrome
• Without Insulin Resistance
• Race
• Side effect management
• Support

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Important Term!

• Sustained Virological Response (SVR)
• HCV is undetectable during and 6 months following
  HCV medical therapy
• Five year follow-up 99 still undetectable

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Goals of Treatment

• Clear virus
• Improve inflammation
• Improve liver healthscarring
• Slow disease progression
• Improve symptoms and quality of life
• To put HCV behind them and move on with their life

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Response to Therapy

• Adherence 80/80/80 rule (Controversial)
• 80 of interferon 80 of ribavirin 80 of the
  time
• 12 Week Rule - decrease (2 log drop) or
  elimination of virus at week 12 is thought to be
  predictive of sustained virologic response
• Example 10,000,000 to 100,000
• Stop Therapy?

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Treatment Advances 1991-Present
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Treatment Medications

• Interferon monotherapy
• Genotype 1 - 9 Genotype 2 3 30
• Intron-A, Roferon, Infergen
• Interferon plus ribavirin therapy
• INF 3 mu units, thrice weekly - Ribavirin
  800-1200 mg daily
• Genotype 1 48 weeks 29 SVR
• Genotype 2 3 24 weeks - 62 SVR

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Pegylated and Ribavirin

• Schering PEG-Intron Rebetol (800mg)
• Genotype 1- 41 SVR (48 weeks)
• Genotype 2 thru 6 75 (48 weeks)
• One large multi-international study
• Roche Pegasys Copegus (1000-1200 mg)
• Genotype 1 44-51 SVR (48 weeks)
• 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)
• FDA Package Insert

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Standard Protocol

• Pegylated (injected once a week)
• Ribavirin (pill or capsule oral twice a day)

• Genotype 1 48 weeks
• Pegylated injected once a week
• ribavirin 1,000/1200 mg/day
• Genotype 2,3 24 weeks
• Pegylated injected once a week
• ribavirin 800 mg/day

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Side-effects

• Ribavirin
• Anemia
• Rash
• Dry cough
• BLACK BOX WARNING-Women of childbearing age,
  their partners and female partners of male
  patients taking ribavirin must practice two forms
  of contraception during to 6 months
  post-treatment

• Interferon
• Physical
• Fatigue
• Muscle/Joint pain
• Nausea
• Headaches
• Dry Skin/rashes
• Insomnia
• Hair loss
• Psychological
• Anxiety
• Depression
• Mania
• And more..

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Managing Side-Effects

• Time injection
• Drink lots of water
• Low doses of ibuprofen or acetaminophen
• Pain/Sleep medications
• Light exercise

• Daily moisturizing
• Vary injection sites
• Anti-Depressants
• Plenty of rest
• Frequent small meals
• Model it to own needs

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Monitoring Therapy Potential Problems

• Neutropenia (low white blood cells)
• Neupogen
• Thrombocytopenia (low platelets)
• Anemia
• Procrit/ EPO

• Thyroid disease
• Depression / anxiety/Mania
• Treat with anti-depressants / anti-anxiety drugs
• General Health

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Did You Know?

• One in 1,000 compounds make it to human testing
• One in five of these receive marketing approval

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Experimental TherapiesHCV Advocate Drug Pipeline

• New therapies are not expected to be available
  for at least 2-3 years used with pegylated
  interferon and ribavirin
• Protease Inhibitors
• Telaprevir(VX-950)-entering phase III- 3/08
• Boceprevir (phase III) entering phase III 5/08
• Polymerase Inhibitors
• R1626 (Phase II)
• HCV-796 (Phase II on hold) Cancelled!
• Long Acting InterferonAlbuferon (phase III)

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Treatment Acute HCV

• Can be treated
• The majority of people with acute HCV can clear
  the virus with interferon monotherapy

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Introduction to Complementary Medicine
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Herbs

• Herbs can be unsafe
• Milk Thistle
• Most common herb used by people with HCV
• Potential to increase levels of anti-HCV drugs,
  anti-depressants, methadone
• Enzyme (CYP 450)
• Caution bupleurum should not be used by someone
  taking interferon

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Acupuncture / Acupressure

• Acupuncture thin needles inserted into
  acupuncture points to stimulate the flow of qi
• Acupressure points are stimulated with finger
  pressure

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Traditional Chinese Medicine

• Qi flow of vital energy
• Goal of TCM
• Restore Qi - balance
• Components of TCM
• Herbs, Qi gong, Tai Chi, Moxibustion,
  acupressure, acupuncture, massage

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Leave at back table

• Participant Checklist
• Plan of Action
• Evaluation
• Demographic
• Order by fax form