HCV Training Workshop
ALAN FRANCISCUS
EXECUTIVE DIRECTOR, HEPATITIS C SUPPORT
PROJECT
EDITOR-IN-CHIEF, HCVADVOCATE.ORG
JOIN US ON TWITTER & FACEBOOK – HCVADVOCATE
BLOG: HCVADVOCATE.BLOGSPOT.COM
www.hcvadvocate.org
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People Who Make a Difference
 C.D. Mazoff
• Irina Gavrilova
 Lucinda Porter
• Christine M. Kukka
 Rose Christensen
• Clara Maltras
 Liz Highleyman
• Kate Frye
 Leslie Hoex
 Jeanie Vogel
www.hcvadvocate.org
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www.hcvadvocate.org
www.hcvadvocate.org
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Numbers
•Website:
•Average 660,000 hits/week
•Educational Materials: 200,000 pieces
•
•
Not counting website downloads
Fact Sheets – 400-500 downloads weekly
www.hcvadvocate.org
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HCSP Hepatitis C
Training Certification
Map: 2002 - 2014
Legend: Completed
www.hcvadvocate.org
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Effect on HCV Community
•HCSP Educators: more than 15,000
•
50 people:
• In one year outcome is 750,000 people
•
Ultimate goal:
•
Improved education, support and services
www.hcvadvocate.org
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HCV Transmission / Prevention
Hepatitis C is spread by blood-to-blood
contact
HCV is the most common blood-borne
pathogen in U.S.
www.hcvadvocate.org
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HCV Transmission/ Survival
•
Sharing needles and drug preparation tools
•
HCV survives on surfaces:
•
At least 16 hours but no longer than 4 days
(CDC)
•
For up to 6 weeks (Journal of Infect Dis)
•
In syringes up to 63 days
•
Commercially available disinfectants kill HCV
www.hcvadvocate.org
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Transmission/Prevention
•
Sharing needles and drug preparation tools
•
Blood products & solid organ transplantation before
July 1992
•
Clotting factors before inactivation in 1987
•
Sexual transmission (0-3%)
•
Mother-to-child (~6%)
•
Healthcare workers (~2%)
•
Hemodialysis
www.hcvadvocate.org
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Possible Transmission Routes
•
Tattoo & piercing*
•
Personal care salons
•
Shared household (hygiene) items
•
Coke/crank straws & crack/meth pipes
•
10% of routes can not be identified
* Higher in unsafe non-commercial settings: prisons/mental institutions/on the streets/home grown
www.hcvadvocate.org
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Safer Tattoos – www.hepatitistattoos.org
www.hcvadvocate.org
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Little or no data…….
• Dental and other procedures before
universal precautions
• Jet gun injections
• Transgender people
•
Sharing needles and re-assignment
surgeries
www.hcvadvocate.org
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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
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Prevention:
•Do not share anything:
NEEDLES,
COOKERS, COTTON, TOURNIQUETS, WATER,
WATER CONTAINERS, ETC. – WASH HANDS
www.hcvadvocate.org
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Prevention – more
•Do not share non-injection drug
equipment
•Coke/crank straws
•Crack/Meth pipes
•Tattoo / Piercing
•Sterilization, autoclave, separate ink pot,
new needles
www.hcvadvocate.org
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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
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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…..
www.hcvadvocate.org
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Lifecycle
•
Single-stranded RNA virus
•
Mainly infects liver cells—but also found in
other cells of the body
•
Cell culture discovered and available
www.hcvadvocate.org
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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
www.hcvadvocate.org
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Baby Boomers Account for the Majority of HCV
Cases in United States
Estimated Prevalence by Age Group
Number With Chronic HCV
Infection
(millions)
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
<1920
1920s
1930s
1940s
1950s
1960s
1970s
1980s
1990+
Birth Year Group
www.hcvadvocate.org
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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
•
OraQuick Rapid Antibody Test
•
Home Access test kit
•
Window period – 2-26 weeks
www.hcvadvocate.org
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HCV RNA – Viral Load
•
PCR (polymerase chain reaction) – lowest range
•
TMA (transcription mediated amplification) – lowest
range
•
DNA (bDNA) assay – highest range
•
Test given for:
•
Confirm Active infection
•
Used for treatment
•
Does not correlate with disease progression
www.hcvadvocate.org
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Genotype & Subtypes
 Blood
test – Treatment related
 Genotype:
1, 2, 3, 4, 5, 6 & 7
Genotype
1 – 70% of US population with HCV
Genotypes
2, 3 – 30% of US population with
HCV
 Subtype:
1a/b, 2a/b, etc.,
*given once unless someone is re-infected
www.hcvadvocate.org
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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
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Why?
 Measures
liver health
 Benchmark
 Insurance
• Liver Biopsy
 FibroScan
 FibroTest
 Various Blood Markers
Metavir Scoring System – 0, 1, 2, 3, 4
No activity
Severe activity
 Medicaid
www.hcvadvocate.org
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HCV Symptoms, Disease
Progression & Management
•
HCV REDUCE SURVIVAL BY MORE THAN 20 YEARS
•
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
•
Progression to cirrhosis will peak at 1.0 million in
2020
www.hcvadvocate.org
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U. S. Statistics
•C D C - N E W ( A C U T E ) I N F E C T I O N S :
21, 870
•C D C - T O T A L C H R O N I C I N F E C T I O N S :
2.7 TO 3.9
MILLION (not factored into above: prisoners,
homeless, people in mental institutions)
Annual Deaths: 15,000
• 2007: deaths from HCV (>15,000) surpassed deaths from
HIV (>12,000)
www.hcvadvocate.org
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Prevalence
 U.S. Population
 ~2%
 Baby Boomers
 3.25% (76% of HCV
 PWID > 10 yrs
 PWID < 10 yrs

 Homeless persons

 Prisoners

 Mental illness

 Black American men (40-50 yo)


www.hcvadvocate.org
population)
90%
66%
19-69%
29%
20%
10%
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Acute/Chronic HCV
• Acute infection – up to 6 months
•
•
Most people have no symptoms
Flu-like—fatigue, nausea, fever, indigestion, loss of
appetite, night sweats, jaundice
• Acute: Treatment with HCV medications cured the
majority of acute infections
• Chronic – Longer than 6 months
Up to 85% of acute cases become chronic
www.hcvadvocate.org
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Chronic Symptoms
 Fatigue*– mild to
 Liver pain
severe
 Loss of appetite
 “Brain Fog”
 Flu-like symptoms
 Depression
 Headaches
 Gastro problems
 And more….
Symptoms don’t necessarily correlate with disease progression with the
exception of acute and end-stage liver disease
www.hcvadvocate.org
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DISEASE PROGRESSION
•10 to 25% have serious disease progression over a 10 to 40
year period – disease progression is not linear
•Inflammation
•Fibrosis
•Cirrhosis
•Steatosis
www.hcvadvocate.org
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Disease Progression
 Compensated cirrhosis—extensive scarring, but liver
is still working fairly well
 Decompensated cirrhosis—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: $577,100 – Annual costs of anti-
rejection medications: ~$30,000
www.hcvadvocate.org
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HCV Infection:
Extrahepatic Manifestations
Hematologic
Salivary
•
•
•
•
• Sialadenitis
Mixed cryoglobulinemia
Aplastic anemia
Thrombocytopenia
Non-Hodgkin’s b-cell lymphoma
Dermatologic
• Porphyria cutanea tarda
• Lichen planus
• Cutaneous necrotizing
vasculitis
Renal
• Glomerulonephritis
• Nephrotic syndrome
Endocrine
• Anti-thyroid antibodies
• Diabetes mellitus
Hadziyannis SJ. J Eur Acad Dermatol Venereol. 1998;10:12-21.
Ocular
• Corneal ulcer
• Uveitis
Vascular
• Necrotizing vasculitis
• Polyarteritis nodosa
Neuromuscular
• Weakness/myalgia
• Peripheral neuropathy
• Arthritis/arthralgia
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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
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Disease Management - Lifestyle Changes
• Avoid:
•
•
•
Alcohol, cigarettes, drugs or any substance that can harm
the liver
Raw or undercooked shellfish
High doses of vitamins or supplements except where
directed by a medical provider
 Eat a healthy balanced diet
• Get vaccinated against HAV and HBV if not already
protected
• Medical provider should check fat soluble vitamin levels
www.hcvadvocate.org
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Discrimination & Stigma
 Americans with Disabilities Act—allows for certain
protections
 Call the ADA (800-949-4232)
 Social Security Disability
 The effect of stigma
www.hcvadvocate.org
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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 learn 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
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HCV Medical Treatment
ALL ORAL (INTERFERON-FREE)
THERAPIES ARE NOW
STANDARD OF CARE TREATMENT
www.hcvadvocate.org
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General Treatment Guidelines
•T R E A T M E N T I S R E C O M M E N D E D F O R
PATIENTS WITH CHRONIC HEPATITIS C
•
Highest priority:
•
•
•
At risk for severe complications
Severe fatigue
High risk for transmission
www.hcvadvocate.org
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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, life expectancy
To put HCV behind and move on with 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 12 or 24 week following HCV medical therapy
• 5 year follow-up >99% still HCV RNA undetectable
www.hcvadvocate.org
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Response to Therapy – Other Uses
• Adherence: Important for overall treatment
success—more important with new HCV inhibitors
• 4 Week HCV RNA negative
• 12 Week HCV RNA negative
• 12-24 week post treatment
www.hcvadvocate.org
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Treatment of Chronic HCV Genotype 2,
SOVALDI (sofosbuvir) plus ribavirin*
3
 SOVALDI – once daily - no food requirement
 Ribavirin dosed by body weight – twice daily- taken
with food
 Treatment duration:


Genotype 2 = 12 weeks
Genotype 3 = 24 weeks
 Cure rates:
 Genotype 2 = up to ~93%
 Genotype 3 = up to ~84%
*including HIV/HCV coinfection
www.hcvadvocate.org
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HARVONI – Genotype 1
 HARVONI (sofosbuvir/ledipasvir)
 Combined
 Taken
 Cure
www.hcvadvocate.org
into one pill/once-a-day
with or without food
rates – 90% to 100%
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Genotype 1: HARVONI (sofosbuvir/ledipasvir)
 HARVONI: one pill/once a day - 90 to 100% Cure
Rate
8
weeks: Treatment naïve, no cirrhosis, viral load
under 6 million IU/mL
12
weeks:
treatment naïve with or without cirrhosis
treatment experienced without cirrhosis
24
weeks: treatment experienced with cirrhosis
www.hcvadvocate.org
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HARVONI – Populations
 Aged 65 and older – no differences is
safety/effectiveness
 Kidney impairment – mild to moderate – no dose
adjustment
 Compensated – no dose adjustment
www.hcvadvocate.org
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HCV Populations
 Nursing Mothers – only if benefits out weigh risks
 Pediatric – not studied (currently under study)
 Note: recommendations for treating HCV in
someone with HIV/HCV coinfection are the same
as HCV moninfection noting drug-drug
interactions –AASLD/IDSA Guidance
www.hcvadvocate.org
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VIEKIRA PAK – Genotype 1
 VIEKIRA PAK
 Two
pills (ombitasvir, paritaprevir/r) once-a-day
 One pill (dasabuvir)– twice a day
 Taken
with ribavirin (twice-a-day) and
without ribavirin
 Taken
 Cure
www.hcvadvocate.org
with food
rates –90% to 100%
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VIEKIRA PAK
 VIEKIRA PAK: (ombitasvir, paritaprevir, ritonavir,
dasabuvir) with and without ribavirin (RBV)
 Genotype 1a:
Without cirrhosis: VIEKIRA PAK + RBV – 12
weeks
With cirrhosis: VIERIKA PAK + RBV – 24 weeks
 Genotype
1b:
without
cirrhosis: VIERIKA PAK -12 weeks
with cirrhosis: VIERIKA PAK + RBV – 12 weeks
www.hcvadvocate.org
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VIEKIRA PAK – Populations
 Liver transplant patients – normal liver function
with mild fibrosis – 24 weeks of treatment
 Not studied in pediatric patients
 Aged 65 and older – no difference in safety and
effectiveness
www.hcvadvocate.org
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HCV Populations
Kidney impairment – no adjustment with VIEKIRA
PAK – ribavirin may require dose adjustment
HIV/HCV Coinfection –dose same as
monoinfection
Note: recommendations for treating HCV in
someone with HIV/HCV coinfection are the same
as HCV monoinfection noting drug-drug
interactions - AASLD/IDSA Guidance
www.hcvadvocate.org
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Side Effects
Harvoni
Viekira /Ribavirin
 Fatigue
 Fatigue
 Headache
 Nausea
 Nausea
 Pruritus (itching)
 Diarrhea
 Skin reactions
 Insomnia
 Insomnia
www.hcvadvocate.org
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Pregnancy
HARVONI/VIEKIRA PAK
Should be used during
pregnancy only if the
potential benefit justifies
the potential risk to the
fetus.
www.hcvadvocate.org
RIBAVIRN
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.
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Managing Side Effects
 Drink water
 Daily moisturizing
 Low doses of
 Rest when tired
ibuprofen or
acetaminophen
 Small frequent healthy
meals
 Sleep medications
 BRAT
 Light exercise
www.hcvadvocate.org
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Programs
 AbbVie
– 1-844-2proCeed
https://www.viekira.com/proceed-program
Moderiba.com (ribavirin)1.844.MODERIBA
 Gilead—1-855-769-7284
 www.mysupportpath.com/
 See
HCV Advocate’s Fact Sheets on
Pharmaceutical Patient Assistance Programs
www.hcvadvocate.org
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Phase 3 – Interferon-Free
Genotypes 1- 6
 BMS
 Gilead
 Merck
See HCV Advocate Drug Pipeline
www.hcvadvocate.org
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Clinical Trials
www.hcvadvocate.org
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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 – Avoid with Olysio (simeprevir)
 May interact with and increase blood levels of some
substances
 St. John’s Wort – Avoid with HCV Inhibitors –
protease and polymerase inhibitors
www.hcvadvocate.org
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Complementary Practices
 Acupuncture

Thin needles are inserted into acupuncture points to
stimulate the flow 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, Qigong
www.hcvadvocate.org
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Turn In
 Participant checklist
 Plan
of action
 Evaluation
 Demographic
information
 Order by fax form
www.hcvadvocate.org
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NeedyMeds Drug
Discount Card
www.hcvadvocate.org
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What is the
NeedyMeds Drug Discount Card?
 A FREE drug discount card that can save users up to
80% off the cost of:

Prescription medications

Over-the-counter medications and medical supplies written as
a prescription

Pet prescriptions purchased at a pharmacy
www.hcvadvocate.org
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How Does it Work?
 No activation or registration needed
 Never expires
 No residency, income or insurance
guidelines.
 Accepted at over 63,000 pharmacies
including all the major and local chains.
 Bring the card into the pharmacy along with
a valid prescription from your doctor and
save!
www.hcvadvocate.org
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Are There Insurance Guidelines?
 No insurance guidelines
 The card cannot be combined with insurance
 Those who are uninsured can use the card
 Those that have a public (such as Medicare or
Medicaid) or private insurance plan can use the card
instead of their insurance if for example:

They have a medication not covered

They are in a coverage gap, like the “donut hole”

They have a high copay or deductible
www.hcvadvocate.org
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Print This Card
www.hcvadvocate.org
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Where Do I Get One?
 You can send a self-addressed stamped envelope to:

NeedyMeds Drug Discount Card
PO Box 219
Gloucester, MA 01931
 Or go online and print a card by visiting:
http://www.needymeds.org/drugcard/drugcard.pdf
www.hcvadvocate.org
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Help for Card Users
 Visit http://drugdiscountcardinfo.com
Or call (888) 602-2978
Additional Services:
 Information about patient assistance programs
 List of low cost medical clinics
 Webinars to explain services
www.hcvadvocate.org
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