Hepatitis C Overview

1. Hepatitis C Overview www.hcvadvocate.org

2. 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 www.hcvadvocate.org

3. 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 www.hcvadvocate.org

4. Chemical Factory- >500 chemical functions Bile Immune System Detoxifies or Filters Clotting Factors Hormones Liver Functions Regenerates Itself! www.hcvadvocate.org

5. 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) www.hcvadvocate.org

6. Keep the liver healthy! • Get vaccinated! • HAV and HBV vaccines • Avoid toxic substances / fumes www.hcvadvocate.org

7. U.S. Population More than 3.9 million Americans chronically infected HCV Populations ~1.5 % to 2% Mexican Americans ~3 % African Americans Hepatitis C Statistics www.hcvadvocate.org

8. 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 www.hcvadvocate.org

9. 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** www.hcvadvocate.org

10. 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 www.hcvadvocate.org

11. 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

12. 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 www.hcvadvocate.org

13. Transmission www.hcvadvocate.org

14. 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 www.hcvadvocate.org

15. 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 www.hcvadvocate.org

16. 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 www.hcvadvocate.org

17. 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 www.hcvadvocate.org

18. 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) www.hcvadvocate.org

19. BREASTFEEDING SNEEZING HUGGING COUGHING FOOD OR WATER SHARING EATING UTENSILS OR DRINKING GLASSES CASUAL CONTACT HCV CAN NOT BE SPREAD BY: www.hcvadvocate.org

20. Fatigue – mild to severe Flu-like symptoms (muscle/joint/fever) ‘Brain Fog’ Liver pain Loss of appetite Headaches Gastro problems Chronic Symptoms • and more…… www.hcvadvocate.org

21. 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 www.hcvadvocate.org

22. 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 Treatment Decisions www.hcvadvocate.org

23. 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 www.hcvadvocate.org

24. 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 www.hcvadvocate.org

25. Approved Medications • Interferon – Pegylated (long-acting interferon) • Ribavirin • HCV Inhibitors • Victrelis (boceprevir) – Merck • Incivek (telaprevir) – Vertex • Olysio (simeprevir) – Janssen • Solvadi (sofosbuvir) – Gilead www.hcvadvocate.org

26. Standard of Care: Sofosbuvir plus ribavirin Genotype 2 – 12 weeks = 93% cure rate Genotype 3 – 24 weeks = 84% cure rate Treatment - Genotype 2 & 3 www.hcvadvocate.org

27. Genotype 1 - • 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 www.hcvadvocate.org

28. 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 Side-effects www.hcvadvocate.org

29. 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 Managing Side-Effects Key: support from medical providers, family, friends, work – all areas of life & side effect management www.hcvadvocate.org

30. 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 www.hcvadvocate.org

31. 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 www.hcvadvocate.org

32. 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 www.hcvadvocate.org

33. Alcohol – Avoid or reduce Get vaccinated – Hep A & Hep B Healthy balanced diet Exercise Stress Reduction Support Groups Lifestyle Changes That Help! www.hcvadvocate.org

34. 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 Advocate for Yourself! www.hcvadvocate.org

35. 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 www.hcvadvocate.org