HCV Training Workshop

A L A N F R A N C I S C U S E X E C U T I V E D I R E C T O R , H E P A T 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 A T E . O R G J O I N U S O N T W I T T E R & F A C E B O O K – H C V A D V O C A T E B L O G : H C V A D V O C A T E . B L O G S P O T . C O M

www.hcvadvocate.org

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People Who Make a Difference

 C.D. Mazoff  Lucinda Porter  Rose Christensen  Liz Highleyman  Leslie Hoex  Jeanie Vogel www.hcvadvocate.org

• Irina Gavrilova • Christine M. Kukka • Clara Maltras • Kate Frye Version 18

www.hcvadvocate.org

www.hcvadvocate.org

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Numbers

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Website:

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Average 660,000 hits/week

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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

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HCSP Educators: more than 15,000

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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

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Sharing needles and drug preparation tools

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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

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Tattoo & piercing*

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Personal care salons

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Shared household (hygiene) items

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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

Version 18 www.hcvadvocate.org

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:

N E E D L E S , C O O K E R S , C O T T O N , T O U R N I Q U E T S , W A T E R , W A T E R C O N T A I N E R S , E T C . – W A S H H A N D S

www.hcvadvocate.org

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Prevention – more

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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

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S e x u al : 0 -3% – m onog am ou s part ne rs – cou ns e l

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Safer sex – additional risk through sex:

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Multiple partners

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Coinfection with HIV or HBV

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Having herpes, lesions, sores, open cuts, wounds

•

Sexually transmitted diseases

•

MOTHER -TO -C HI LD

www.hcvadvocate.org

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More Prevention

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Health care workers

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blood borne pathogen protection

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Razors / toothbrushes covered

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Cover all wounds

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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 Version 18

Baby Boomers Account for the Majority of HCV Cases in United States

Estimated Prevalence by Age Group

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

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HC V E LI 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  Medicaid •  Liver Biopsy FibroScan   FibroTest Various Blood Markers

Metavir Scoring System – 0, 1, 2, 3, 4 No activity Severe activity

www.hcvadvocate.org

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HCV Symptoms, Disease Progression & Management

• H C V R E D U C E S U R V I V A L B Y M O R E T H A N 2 0 Y E A R S • A n n u a l c o s t o f a d v a n c e d l i v e r d i s e a s e t o $ 8 5 b i l l i o n i n t h e n e x t t w o d e c a d e s a n d M e d i c a r e c o s t s w i l l i n c r e a s e 5 0 0 % , f r o m $ 5 b i l l i o n t o $ 3 0 b i l l i o n • P r o g r e s s i o n t o c i r r h o s i s w i l l p e a k a t 1 . 0 m i l l i o n i n 2 0 2 0 www.hcvadvocate.org

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U. S. Statistics

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C D C - N E W ( A C U T E ) I N F E C T I O N S : 2 1 , 8 7 0

•

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 T O 3 . 9 M I L L I O N ( n o t f a c t o r e d i n t o a b o v e : p r i s o n e r s , h o m e l e s s , p e o p l e i n m e n t a l i n s t i t u t i o n s )

•

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 Baby Boomers PWID > 10 yrs PWID < 10 yrs Homeless persons Prisoners Mental illness Black American men (40-50 yo)         ~2% 3.25% (76% of HCV population) 90% 66% 19-69% 29% 20% 10% www.hcvadvocate.org

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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 severe  Liver pain  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 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 – severe fibrosis or cirrhosis after Transplantation: $577,100 – Annual costs of anti rejection medications: ~$30,000 www.hcvadvocate.org

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HCV Infection: Extrahepatic Manifestations

• • • •

Hematologic

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.

•

Salivary

Sialadenitis • •

Ocular

Corneal ulcer Uveitis • •

Vascular

Necrotizing vasculitis Polyarteritis nodosa • • •

Neuromuscular

Weakness/myalgia Peripheral neuropathy Arthritis/arthralgia Version 18

Liver Specialists

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GASTROENTEROLOGIST

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HEPATOLOGIST

•

THE FUTURE?

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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

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INFORMATIONAL & EMOTIONAL

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

HCSP SUPPORT GROUP IN A BAG

• Support group manual on web site www.hcvadvocate.org

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HCV Medical Treatment

www.hcvadvocate.org

A L L O R A L ( I N T E R F E R O N - F R E E ) T H E R A P I E S A R E N O W S T A N D A R D O F C A R E T R E A T M E N T

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General Treatment Guidelines

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TREATMENT IS RECOMMENDED FOR 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, 3 SOVALDI (sofosbuvir) plus ribavirin*  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 into one pill/once-a-day  Taken with or without food  Cure rates – 90% to 100% www.hcvadvocate.org

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Genotype 1: HARVONI (sofosbuvir/ledipasvir)

 HARVONI: one pill/once a day Rate 90 to 100% Cure  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 with food  Cure rates –90% to 100% www.hcvadvocate.org

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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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Harvoni

 Fatigue  Headache  Nausea  Diarrhea  Insomnia www.hcvadvocate.org

Side Effects

Viekira /Ribavirin

 Fatigue  Nausea  Pruritus (itching)  Skin reactions  Insomnia Version 18

Pregnancy

HARVONI/VIEKIRA PAK

Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

www.hcvadvocate.org

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 Drink water

Managing Side Effects

 Daily moisturizing  Low doses of ibuprofen or acetaminophen  Sleep medications  Light exercise  Rest when tired  Small frequent healthy meals  BRAT 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 Version 18

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

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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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