1. April 2014 - 1 Hepatitis C Overview www.hcvadvocate.org

2. 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. 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. 4 Liver Functions Chemical Factory- >500 chemical functions Bile Immune System Detoxifies or Filters Clotting Factors Hormones Regenerates Itself! www.hcvadvocate.org

5. 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. 6 Keep the liver healthy! Get vaccinated! HAV and HBV vaccines Avoid toxic substances / fumes www.hcvadvocate.org

7. 7 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 www.hcvadvocate.org

8. 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. 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. 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. 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. 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. 13 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 www.hcvadvocate.org

14. 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. 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. 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. 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. 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. 19 HCV CAN NOT BE SPREAD BY: BREASTFEEDING SNEEZING HUGGING COUGHING FOOD OR WATER SHARING EATING UTENSILS OR DRINKING GLASSES CASUAL CONTACT www.hcvadvocate.org

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

21. 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. 22 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 www.hcvadvocate.org

23. 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. 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. 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. 26 Treatment - Genotype 2 & 3 Standard of Care: Sofosbuvir plus ribavirin Genotype 2 – 12 weeks = 93% cure rate Genotype 3 – 24 weeks = 84% cure rate www.hcvadvocate.org

27. Genotype 1 - 27 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. 28 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 www.hcvadvocate.org

29. 29 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 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 Version 12.2 www.hcvadvocate.org

31. 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.clinicaltrials.gov www.hcvadvocate.org

32. 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. 33 Lifestyle Changes That Help! Alcohol – Avoid or reduce Get vaccinated – Hep A & Hep B Healthy balanced diet Exercise Stress Reduction Support Groups www.hcvadvocate.org

34. 34 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 www.hcvadvocate.org

35. 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