April 2014 - 1

Hepatitis C Overview

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Introduction

Advocacy & Self-Advocacy through Education

The information in this presentation is designed to help you understand and manage HCV and is not intended as medical advice. HCV medical care is a partnership between patients and their medical providers

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The Liver – A Chemical Factory

Largest internal organ Size of a football Approximately 3 lbs in the average

sized male 1.5 quarts of blood flow through it

every minute

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Liver Functions Chemical Factory-

>500 chemical

functions

Bile

Immune System

Detoxifies or Filters

Clotting Factors

Hormones

Regenerates Itself!

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Keep the Liver Healthy!

If you have HCV – Avoid Alcohol

Avoid mixing drugs – prescription, over- the-counter, herbs/supplements and street drugs

Eat a healthy, balanced diet based on MyPlate (www.choosemyplate.gov)

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Keep the liver healthy! Get vaccinated!

HAV and HBV vaccines

Avoid toxic substances / fumes

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Hepatitis C Statistics

U.S. Population

More than 3.9 million Americans chronically infected

HCV Populations ~1.5 % to 2% Mexican

Americans ~3 % African Americans

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HCV Antibody tests HCV Elisa II or III

Most common antibody test

OraQuick whole blood and fingerprick approved

A positive antibody test indicates exposure It does not indicate current hepatitis C

infection HCV viral load test performed to indicate active

HCV infection

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Viral Load Tests

Viral Load tests Hepatitis C RNA by PCR – > 5-10 IU/mL HCV RNA by branched DNA Assay – > 615 IU/mL TMA – > 5-10 IU/mL

Why Is a Viral Load Test Important? To confirm active infection Somewhat helps to predict treatment response & used to guide

treatment duration Indication that treatment is working

** Viral load does not correlate with disease progression**

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Genotype Test Genotype (1,2,3,4,5,6 and 7)

U.S. population 70% genotype 1 30% genotypes 2 & 3

Why Is a Genotype Test Important? Guide treatment, what drugs and

treatment duration

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Liver Biopsy

Test for Determining the Health of the Liver Measure inflammation, extent of scarring

(if any), Rule out other diseases Biopsy procedure

Non-invasive markers of liver inflammation – not yet perfected

FibroScan www.hcvadvocate.org

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Transmission- Prevention Direct blood-to-blood transmission

route

Can live on surfaces for up to 6 weeks

Bleach and other disinfectants kill virus, but probably not inside the needle

Not spread casually – need blood

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Transmission

Shared Needles

All Drug Paraphernalia

Blood Before 1992 - transfused, products, procedures

Sexual Transmission(1-3%)

Healthcare Workers – needle sticks

Shared House-hold items – razors & toothbrushes

Mother to Child 4-7%

Tattoos / Piercing

<10% of routes can not be identified

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Prevention Tips Injection and Non-Injection Drugs

Do not share needles, cookers, cottons, straws, pipes, water or any items that might come into contact with blood

Use bleach to clean – if no needle exchange is available

People in Stable Long-Term Monogamous Sexual Relationships CDC – no need to change current sexual

practices – but there is a risk

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Prevention Tips Safer Sex

For so called “high risk groups”

Multiple sexual partners, people with sexually transmitted diseases, infection with HIV or HBV

Any situation where blood is present

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Prevention Tips Mother-to-Child Transmission

Low risk – about 4-7% chance of hepatitis being transmitted to infant

Given the low rate of transmission, pregnancy should not be avoided.

Health-Care Settings Follow standard (universal)

precautions

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Prevention Tips Tattoos & Piercing

Considered a low/no risk in commercial setting that practices safety

Make sure disposable needles and separate ink pots are used and that general safety precautions are followed

Considered a higher risk in other settings

Non-commercial settings such as in prison, parties or on the streets

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Shared Personal Items Household

Cover cuts or sores Do not share personal hygiene items

(toothbrushes, razors, etc.)

Professional Personal Care Settings Standard precautions Disposable equipment Bring own equipment (best advice)

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HCV CAN NOT BE SPREAD BY:

BREASTFEEDING

SNEEZING

HUGGING

COUGHING

FOOD OR WATER

SHARING EATING UTENSILS OR DRINKING GLASSES

CASUAL CONTACT

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Chronic Symptoms Fatigue – mild to

severe

Flu-like symptoms (muscle/joint/fever)

‘Brain Fog’

Liver pain

Loss of appetite

Headaches

Gastro problems

and more……

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Disease Progression 10-25% of HCV positive people

progress on to serious disease usually over 10-40 years Fibrosis

Light scarring Cirrhosis

Compensated vs. decompensated Steatosis

Fatty deposits in the liver

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Treatment Decisions General Treatment

Guidelines

Stable Health

Active HCV Infection

Compensated Liver

Disease

Optimal Response CC genotype Younger Low BMI & Weight Less Steatosis Low Viral Load Minimal Liver

Damage

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Clinical Data - Treatment

Prospective – well designed clinical trial with measurable outcomes Gold Standard

Retrospective – review of data from previous clinical trials Important for looking for trends and

for designing future studies

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Treatment What is interferon?

General antiviral – immune booster – injection

What is ribavirin? Antiviral - used only in combination with

interferon - pill or capsule

What is an HCV inhibitor Direct Acting Antiviral (DAA) – blocks viral

replication

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Approved Medications

Interferon – Pegylated (long-acting interferon)

Ribavirin

HCV Inhibitors Victrelis (boceprevir) – Merck Incivek (telaprevir) – Vertex Olysio (simeprevir) – Janssen Solvadi (sofosbuvir) – Gilead

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Treatment - Genotype 2 & 3

Standard of Care:

Sofosbuvir plus ribavirin

Genotype 2 – 12 weeks = 93% cure rate

Genotype 3 – 24 weeks = 84% cure rate

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Genotype 1 -

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• Standard of care:

• Cure rates up to 90%

• Treatment duration 12 to 48 weeks

• Simeprevir, pegylated interferon plus ribavirin

• Sofosbuvir, ribavirin with and without pegylated interferon

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Side-effects Fatigue Anemia Muscle/Joint pain Nausea Headaches Anxiety Depression Dry Skin Rashes Anal itching Photosensitivity

and more.....

Ribavirin can cause birth defects– black box warning:

Women of childbearing age, their partners and female partners of male patients taking ribavirin must practice two forms of effective contraception during to 6 months post-treatment

Note: the majority of side effects are from interferon and ribavirin

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Managing Side-Effects Inject before

bedtime Drink lots of water Low doses of

ibuprofen or acetaminophen

Pain medications

Light exercise Daily moisturizing Vary injection sites Anti-Depressants Plenty of rest Frequent small

meals

Key: support from medical providers, family, friends, work – all areas of life & side effect management

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Patient Assistance Programs

Partnership for Prescription Assistance www.pparx.org

Needy Meds: www.needymeds.org

HCSP Fact Sheet lists all the pharmaceutical patient assistance programs

Version 12.2www.hcvadvocate.org

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Experimental Therapies Sofosbuvir plus ledipasvir submitted to FDA for

approval (genotype 1) >90% cure rate AbbVie interferon-free therapy phase 3 trials

are completed and AbbVie is expected to apply for FDA approval soon. Approval expected 2014

HCV Advocate’s Drug Pipeline

www.clinicaltrials.gov – search button, type in: HCV

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Complementary Medicine Herbs – milk thistle, licorice root, etc.

Caution: St. Johns Wort should not be taken

with an HCV Protease Inhibitor; Milk Thistle

should not be taken with simeprevir/Olysio

Acupuncture / Acupressure

Traditional Chinese Medicine

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Lifestyle Changes That Help!

Alcohol – Avoid or reduce

Get vaccinated – Hep A & Hep B

Healthy balanced diet

Exercise

Stress Reduction

Support Groups

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Advocate for Yourself! Educate yourself

Establish a good relationship with your doctor

Bring an advocate for doctor’s visits

Ask questions

Keep copies of all medical tests

Keep a diary

Keep an open mind

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Resources –

• HCV Advocate Newsletter

• Education Materials in various languages

• Over 200 fact sheets & guides

• National Support Group Listing

• Recommended links

• Information on hepatitis C, hepatitis B, and HIV/HCV Coinfection

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