HCV Training Workshop

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Version 12.3www.hcvadvocate.org

People Who Make a Difference

C.D. Mazoff

Lucinda Porter

Rose Christensen

Liz Highleyman

Leslie Hoex

Version 12.3

• Irina Gavrilova

• Clara Maltras

• Kate Frye

• Patrick Daniel

www.hcvadvocate.org

•Web site average :•Average 550,000 hits/week

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

Numbers

Version 12.3

Legend: Completed; Planned

www.hcvadvocate.org

•HCSP Educators: more than 10,000

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

•Ultimate goal: • Improved education, support and services

Effect on HCV Community

The Liver

• About 3 lbs (men) – size of a football

• Located in the upper right side – beneath the rib cage

• 1.5 quarts of blood flow through it every minute

• Chemical factory > 500 functions

• Bile-regulates hormones- immune system cells

• 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—grows or shrinks***

Liver Functions - continued

•Healthy people—no more than: • 2 alcoholic drinks a day for men; 1 alcoholic drink a day for women• HCV – NO ALCOHOL

•Be cautious about mixing drugs especially with alcohol—• Acetaminophen (Tylenol) – 600 products

• Over 56,000 emergency room visits & 500 deaths a year

• NSAIDs: • 16,500 annual deaths

•Eat a healthy, balanced diet:• www.choosemyplate.gov

Healthy People:

•Means: Inflammation of the liver

•Causes: • Viruses, toxins, genetic disorders,

bacteria and parasites

HEPATITIS

• US—New infections: 21,000 (US – 2009)

• 180, 000 in 1997

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

• Estimated 33% have been infected with HAV

• Resolves (not chronic)

• Transmission: fecal/oral

Hepatitis A (HAV)

•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

•US - 3,000 DEATHS A YEAR

•Worldwide 660,000 annual deaths

HEPATITIS B (HBV)

• 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

HBV Transmission

•Get vaccinated

•Do not share needles or works

•Safer sex

•Standard safety precautions

•Do not share personal items

•HBV-infected mother to child intervention

HBV Prevention

Chronic HBV

Chronic ~5-6% Adults – 90% Infants

*These drugs are recommended as first line of treatment

•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

HCV 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

Transmission/Prevention

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

grownVersion 12.3www.hcvadvocate.org

Safer Tattoos – www.hepatitistattoos.org

Little or no data…….

• Dental and other procedures before universal precautions

• Jet gun injections

• Transgender people• Sharing needles and operations

• Breast feeding• Food or water• Sharing eating utensils or drinking

glasses• Sneezing• Hugging

*Not spread by casual contact*

HCV is Not Spread by:

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

Prevention:

Prevention - more

•Do not share non-injection drug equipment

•Coke/crank straws•Crack pipes

•Tattoo / Piercing•Sterilization, autoclave, separate ink pot, new needles

•Sexual: 0-3%-monogamous partners– counsel • Safer sex – additional risk through sex:

• Multiple partners

• Coinfection with HIV or HBV

• Having herpes, lesions, sores, open cuts, wounds

• Sexually transmitted diseases

•MOTHER-TO-CHILD

Prevention - more

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…..

HCV IDENTIFIED IN 1989

HCV Diagnostic Tools

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

HCV IDENTIFIED IN 1989

HCV Diagnostic Tools

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

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

Estimated Prevalence by Age Group

Birth Year Group

1990+1980s1970s1960s1950s1940s1930s1920s<1920

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

Increased Diagnosis and Treatment

OraQuick HCV Antibody TestOraQuick HCV Antibody Test

•Finger Prick•Whole Blood Draw•Oral Swab

•Results available within 20 minutes

•More testing within clinics and mobile sites can lead to increased consultations about care, management and treatment

TemplatesAged-Based TestingAged-Based Testing

New HCV Treatments

•An HCV protease inhibitor combined with pegylated interferon, plus ribavirin increases the cure rates up to 79%

•Higher cure rates will mean more treatment naïve and prior non-responders will seek treatment

New Antivirals

The Centers for Disease Control has recommended a one-time test for persons born between 1946 and 1965

The Tipping Point?

•HCV ELISA III (EIA), CIA: DETECTS ANTIBODIES

• Signal to cut off ratio = 95% chance true antibody positive

• Home Access test kit

• Window period – 2-26 weeks

HCV Antibody Tests

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

• ORAL SWAB – PENDING FDA AND CLIA APPROVAL – 2012?

OraQuick HCV Rapid Antibody Test

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

• Confirm active infection

• Soft predictor of treatment response

• Confirm HCV medications are working and

dictate treatment duration

***Does Not Correlate with Disease Progression***

How is Viral Load Used?

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 Genotypes 2,3 – 30% of US population with

Quasi-speciesHigh error prone virus – mutates quickly

• 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)

Liver Tests

Liver Biopsy

*Measures liver health

*Treatment decisions

*Benchmark

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

No activity Severe activity

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

PETER MARE LATHAM

HCV Symptoms, Disease Progression & Management

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]

Drug Based Therapies

HCV Positive

SupportHousing

AddictionMen

Health

Social Stigma

Health

Access

BV Vaccine

Ann Shindo

What may be needed even before considering treatment

•GASTROENTEROLOGIST

•HEPATOLOGIST

•THE FUTURE?• Primary care, infectious disease specialists

and others

Liver Specialists

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

•LONGER THAN 6 MONTHS• Does not mean severe disease progression

•CDC ~75%–85% OF CASES BECOME CHRONIC

•STUDIES – 55% TO 85% BECOME CHRONIC

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

• Fibrosis / Cirrhosis / Steatosis

Chronic Infection

Fatigue – mild to severe

“Brain Fog”

Flu-like symptoms

Depression

Liver pain

Loss of appetite

Headaches

Gastro problems

And more….

Symptoms don’t necessarily correlate with disease progression with the exception of end-stage liver disease

Chronic Symptoms

Hadziyannis SJ. J Eur Acad Dermatol Venereol. 1998;10:12-21.

HCV Infection: Extrahepatic Manifestations

Hematologic• Mixed cryoglobulinemia• Aplastic anemia• Thrombocytopenia• Non-Hodgkin’s -cell lymphoma

Dermatologic• Porphyria cutanea tarda• Lichen planus• Cutaneous necrotizing

vasculitis

Renal• Glomerulonephritis• Nephrotic syndrome

Endocrine• Anti-thyroid antibodies• Diabetes mellitus

Salivary• Sialadenitis

Ocular• Corneal ulcer• Uveitis

Vascular• Necrotizing vasculitis• Polyarteritis nodosa

Neuromuscular• Weakness/myalgia• Peripheral neuropathy• Arthritis/arthralgia

AutoimmunePhenomena• CREST syndrome

•NEW (ACUTE) INFECTIONS: 16,000

•TOTAL CHRONIC INFECTIONS: UP TO 3.9 MILLION

•~15,000 DEATHS ANNUALLY

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

U. S. Statistics: CDC

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

Disease Management Lifestyle Changes

•HEPATITIS A & HEPATITIS B VACCINE

•AVOID RAW & UNDERCOOKED SHELLFISH• HAV / Vibrio vulnificus

•EXERCISE• Moderation—balance activity with rest

Disease Management

SUPPLEMENTS

Avoid high doses of vitamins and supplements

General recommendations: Vitamin supplement (daily requirements with no

Always check-in with a medical provider

Discrimination & Stigma

Americans with Disabilities Act—allows for certain protections

Call the ADA (800-949-4232)

Social Security Disability

The effect of stigma

•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

Support Groups

HCV Medical Treatment

5152535455565758595

Mono INF INF + Riba Peg-Intron + Riba Pegasys + Riba Peg INF + Riba + PI

Percen

Genotype

HCV Medical Treatments

Genotype 1Genotype 2, 3

•OVERALL HEALTH IS STABLE

•ACTIVE HCV INFECTION

•COMPENSATED LIVER DISEASE• Decompensated generally only in transplant

centers

General Treatment Guidelines

•YOUNGER AGE – UNDER 40 YO

•LITTLE OR NO STEATOSIS, INSULIN RESISTANCE

•RACE• Asian• Caucasians• African Americans

•LOW HCV RNA (VIRAL LOAD)

•LITTLE OR NO SCARRING OF THE LIVER

Pre-Treatment Predictors of Treatment Response

VARIATION OF IL28B – GENOTYPE 1

Pre-Treatment Predictors of Treatment Response

•GOALS OF TREATMENT:• Clear virus out of the body• Improve inflammation & scarring• Slow disease progression, • Improve symptoms and quality of life• To put HCV behind and move on with life

•SUSTAINED VIROLOGICAL RESPONSE (SVR)• HCV is undetectable during and 6 months following HCV

medical therapy• 5 year follow-up >99% still HCV RNA undetectable

Treatment Goals & Success

Response to Therapy

• Adherence: Important 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

Treatment of Chronic HCV Genotype 2, 3

Treatment duration 24 weeks

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

Currently HCV protease inhibitors are not approved to treat genotypes 2 and 3

Treatment: Genotypes 2 and 3Pegylated and Ribavirin (FDA Package Insert)

Merck /Schering – PEG-Intron + Rebetol (800-1400mg) Genotypes 2 thru 6 – 75% (48 weeks)

One large multi-international study

Genentech/Roche – Pegasys + Copegus (1000-1200 mg)

Genotypes 2 & 3 – 82% SVR (24 weeks) Genotypes 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)

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 ribavirinRibavirin taken with food

The HCV protease inhibitors are taken every 7 to 9 hours with food: Boceprevir – light meal / Telaprevir –not low fat

•TREATMENT NAÏVE – GENOTYPE 1

• Up to 66% SVR• African Americans – up to 53% vs. 23% SVR

• Treatment duration either 28 or 48 weeks

•TREATMENT EXPERIENCED – GENOTYPE 1

• Prior non-responders–up to 66% SVR (null responders not studied)

• Treatment duration 36 or 48 weeks

Victrelis (Boceprevir)4-week lead in – Peg/Rbv

Incivek (Telaprevir)Incivek, pegylated interferon, ribavirin taken for 12 weeks only—

followed by pegylated interferon/ribavirin

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)

InterferonInterferon Ribavirin Ribavirin

Physical fatigue, muscle/joint

pain, headaches, dry skin, insomnia,

Anxiety, depression, mania

Low white blood cells

Low platelets

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

Low red blood cells

Side-effects

VictrelisVictrelis IncivekIncivek

Up to 50% – anemia

Taste changes especially metal taste

Up to 36% – anemia

Body rash

Anal itching

Diarrhea

Side-effects

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

Small frequent healthy meals

Programs

Patient Assistance Programs Partnership for Prescription Assistance

www.pparx.org

Needy Meds: www.needymeds.org

Genentech: www.genentechaccesssolutions.com

Merck: www.merck-cares.com

Vertex: www.vrtx.com

Kadmon: http://kadmon.com/Version 12.3www.hcvadvocate.org

Drugs in Development

Phase III Studies—DAA with PEG/RBV BI 201335 (protease inhibitor); BMS-790052 (NS5A Inhibitor),

GS-7977 (polymerase inhibitor)

Phase II Studies—DAA Combination with RBV 12 DAA drugs in combination with other DAA’s and with ribavirin

(no pegylated interferon)

It has been proven that HCV regimes that are interferon-free can cure HCV

HCV Advocate Drug Pipeline

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 Protease

Inhibitors (PI’s) (lowers PI drug levels)Caution: • Bupleurum should not be used by someone taking interferon

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

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