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HCV Training Workshop ALAN FRANCISCUS E X E C U T I V E D I R E C T O R , H E PAT 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 AT E W E B S I T E W W W. H E PAT I T I S TAT T O O S . O R G J O I N M E O N T W I T T E R & FA C E B O O K – H C VA D V O C AT E B L O G : H C VA D V O C AT E . B L O G S P O T. C O M / www.hcvadvocate.org Version 12.2 HCSP STAFF C.D. Mazoff • Irina Gavrilova Lucinda Porter • Clara Maltras Rose Christensen Liz Highleyman • Aidan Coffino Leslie Hoex • Torin Coffino Kate Frye Version 12.2 www.hcvadvocate.org Version 12.2 Numbers •Web site average : •Average 500,000 hits/week •Educational Materials: 300,000 pieces • Not counting web site downloads • Fact Sheets – 400-500 downloads weekly www.hcvadvocate.org Version 12.2 Effect on HCV Community •HCSP Educators: more than 10,000 • 50 people: • In one year outcome is 500,000 people • Ultimate goal: • Improved education, support and services www.hcvadvocate.org Version 12.2 The Liver www.hcvadvocate.org Version 12.2 • About 3 lbs (men) –size of a T football H • Located in the upper right side E – beneath the rib cage • 1.5 quarts of blood flow L through it every minute I • Chemical factory > 500 V functions E • Bile-regulates hormones- R immune system cells www.hcvadvocate.org Version 12.2 Liver Functions - continued • 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—grow or shrink*** www.hcvadvocate.org Version 12.2 Healthy People: •H e a l t h y p e o p l e — n o m o r e t h a n : • 2 alcoholic drinks a day for men; 1 alcoholic drink a day for women • HCV – NO ALCOHOL •B e c a u t i o u s a b o u t m i x i n g d r u g s e s p e c i a l l y w i t h alcohol— • acetaminophen (Tylenol) – 600 products • Over 56,000 emergency room visits & 500 deaths a year •E a t a h e a l t h y , b a l a n c e d d i e t : • www.choosemyplate.gov www.hcvadvocate.org Version 12.2 HEPATITIS •Means: Inflammation of the liver •Causes: • Viruses, toxins, genetic disorders, bacteria and parasites www.hcvadvocate.org Version 12.2 Hepatitis A (HAV) • US—New infections: 22,000 (US – 2008) • 180, 000 in 1997 • Vaccine available since 1995 –2 doses (0 & 6 mos) • Estimated 33% have been infected with HAV • Resolves (not chronic) • Transmission: fecal/oral www.hcvadvocate.org Version 12.2 HEPATITIS B (HBV) •US - 38,000 new infections (CDC – 2008) •Vaccine available since 1982 - 3 doses (0,1, & 6 months) •US chronic: 800,000 –1.4 MILLION • Worldwide: 350-400 million •U S - 3 , 0 0 0 D E A T H S A Y E A R • Worldwide 660,000 annual deaths www.hcvadvocate.org Version 12.2 HBV Transmission • 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 www.hcvadvocate.org Version 12.2 HBV Prevention •Get vaccinated •Do not share needles or works •Safer sex •Standard safety precautions •Do not share personal items •HBV infected mother to child intervention www.hcvadvocate.org Version 12.2 Chronic HBV Chronic ~5-6% Adults----90% Infants *These drugs are recommended as first line of treatment www.hcvadvocate.org Version 12.2 HCV Transmission / Prevention •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 www.hcvadvocate.org Version 12.2 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 www.hcvadvocate.org Version 12.2 Safer Tattoos – www.hepatitistattoos.org 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 grown Version 12.2 Little or no data……. • Dental and other procedure before universal precautions • Jet gun injections • Transgender people • Sharing needles and operations Version 12.2 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 Version 12.2 Prevention: •Do not share anything: NEEDLES, COOKERS, COTTON, TOURNIQUETS, WATER, ETC – WASH HANDS www.hcvadvocate.org Version 12.2 Prevention - more •Do not share non-injection drug equipment •Coke/crank straws •Crack pipes •Tattoo / Piercing •Sterilization, autoclave, separate ink pot, new needles Version 12.2 Prevention - more •S e x u a l : 0 - 3 % - m o n o g a m o u s p a r t n e r s – c o u n s e l • Safer sex – additional risk through sex: • Multiple partners • Coinfection with HIV or HBV • Having herpes, lesions, sores, open cuts, wounds • Sexually transmitted diseases •M O T H E R - T O - C H I L D www.hcvadvocate.org Version 12.2 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….. Version 12.2 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 www.hcvadvocate.org Version 12.2 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 Version 12.2 Baby Boomers Account for the Majority of HCV Cases in United States Estimated Prevalence by Age Group 1.6 Number With Chronic HCV 1.4 1.2 1.0 0.8 0.6 (millions) Infection 0.4 0.2 0 <1920 1920s 1970s 1980s 1990+ 1930s 1940s 1950s 1960s Birth Year Group www.hcvadvocate.org Version 12.2 Increased Diagnosis and Treatment The Tipping Point? Aged-Based Testing OraQuick HCV Antibody Test New Antivirals Templates .Test everyone of a • Finger Prick New HCV Treatments certain age. Pilot •Whole Blood Draw programs are being •Oral Swab •An HCV protease planned in: inhibitor combined •Results available within 20 with pegylated • New York, minutes interferon, plus ribavirin increases • Detroit, MI, •More testing within clinics the cure rates up to and mobile sites can lead to 79% •Houston, TX, increased consultations about care, management and •Higher cure rates will • Birmingham, AL treatment mean more treatment naive and prior non- responders will seek treatment Your own footer Your Logo HCV Antibody Tests •H C V E L I 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 • Home Access test kit • Window period – 2-26 weeks www.hcvadvocate.org Version 12.2 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 Version 12.2 How is Viral Load Used? • Confirm active infection • Soft predictor of treatment response • Confirm HCV medications are working and dictate treatment duration ***Does Not Correlate with Disease Progression*** www.hcvadvocate.org Version 12.2 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 Genotype 2,3 – 30% of US population with HCV Quasi-species High error prone virus – mutates quickly Version 12.2 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 Version 12.2 Liver Biopsy *Measures liver health Metavir Scoring System – 0, 1, 2, 3, 4 *Treatment No activity Severe activity decisions *Benchmark www.hcvadvocate.org Version 12.2 HCV Symptoms, Disease Progression & Management ―LIVING WITH HCV IS OFTEN EASY, OFTEN DIFFICULT AND SOMETIMES IMPOSSIBLE‖ PETER MARE LATHAM www.hcvadvocate.org Version 12.2 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] Version 12.2 Drug Based Therapies Health Access HCV Positive What may be needed even before considering treatment Ann Shindo www.hcvadvocate.org Version 12.2 Liver Specialists •G A S T R O E N T E R O L OG I S T •H E P A T O L O G I S T •T H E F U T U R E ? • Primary care, infectious disease specialists and others www.hcvadvocate.org Version 12.2 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. Version 12.2 Chronic Infection •L O N G E R T H A N 6 M O N T H S • Does not mean severe disease progression •5 5 T O 8 5 % B E C O M E C H R O N I C •10 to 25% have serious disease progression over a 10 to 40 year period--disease progression is not linear • Fibrosis / Cirrhosis / Steatosis www.hcvadvocate.org Version 12.2 Chronic Symptoms Fatigue – mild to Liver pain severe 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 end-stage liver disease. www.hcvadvocate.org Version 12.2 HCV Infection: Extrahepatic Manifestations Hematologic Salivary • Mixed cryoglobulinemia • Sialadenitis • Aplastic anemia • Thrombocytopenia Ocular • Non-Hodgkin’s b-cell lymphoma • Corneal ulcer Dermatologic • Uveitis • Porphyria cutanea tarda • Lichen planus Vascular • Cutaneous necrotizing • Necrotizing vasculitis vasculitis • Polyarteritis nodosa Neuromuscular Renal • Weakness/myalgia • Glomerulonephritis • Peripheral neuropathy • Nephrotic syndrome • Arthritis/arthralgia Endocrine Autoimmune • Anti-thyroid antibodies Phenomena • Diabetes mellitus • CREST syndrome Hadziyannis SJ. J Eur Acad Dermatol Venereol. 1998;10:12-21. U. S. Statistics: CDC •N E W ( A C U T E ) I N F E C T I O N S : 18,000 •T O T A L C H R O N I C I N F E C T I O N S : UP TO 3. 9MILLION *NOT FACTORED INTO ABOVE: PRISONERS, HOMELESS, PEOPLE IN MENTAL INSTITUTIONS www.hcvadvocate.org Version 12.2 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 Version 12.2 Disease Management Lifestyle Changes •A V O I D A L C O H O L •Lowers immune response & HCV treatment response •Helps HCV to replicate and mutate •Increases level of iron and fat in the liver •A V O I D O R R E D U C E : •Cigarette smoking, drugs or any substance that can harm the liver • EAT A HEALTHY WELL BALANCED DIET WWW.CHOOSEMYPLATE.GOV www.hcvadvocate.org Version 12.2 Disease Management •H E P A T I T I S A & H E P A T I T I S B V A C C I N E •A V O I D R A W & U N D E R C O O K E D S H E L L F I S H • HAV / Vibrio vulnificus •E X E R C I S E • Moderation—balance activity with rest www.hcvadvocate.org Version 12.2 SUPPLEMENTS Avoid high doses of vitamins and supplements General recommendations: Vitamin supplement (daily requirements with no iron) Always check-in with a medical provider Version 12.2 Discrimination & Stigma Americans with Disabilities Act—allows for certain protections Call the ADA (800-949-4232) Social Security Disability The effect of stigma Version 12.2 Support Groups •I N F O R M A T I O N A L & E M O T I O N A L • One of the few places where people with HCV can connect, advocate, support and learns from peers •H C S P S U P P O R T G R O U P I N A B A G • Support group manual on web site www.hcvadvocate.org Version 12.2 HCV Medical Treatments 95 HCV Medical Treatment 85 75 65 Pe rce nt 55 Genotype 1 45 Genotype 2, 3 35 25 15 5 Mono INF INF + Riba Peg-Intron + Riba Pegasys + Riba Peg INF + Riba + PI Genotype www.hcvadvocate.org Version 12.2 General Treatment Guidelines •O V E R A L L H E A L T H I S S T A B L E •A C T I V E H C V I N F E C T I O N •E L E V A T E D A L T ’ S ( E X C E P T I O N S ) •C O M P E N S A T E D L I V E R D I S E A S E • Decompensated generally only in transplant centers www.hcvadvocate.org Version 12.2 Pre-Treatment Predictors of Treatment Response •Y O U N G E R A G E - UNDER 40 YO •L I T T L E O R N O S T E A T O S I S , I N S U L I N R E S I S T A N C E •R A C E • Asian • Caucasians • African Americans •L O W H C V R N A ( V I R A L L O A D ) •L I T T L E O R NO SCARRING OF THE LIVER www.hcvadvocate.org Version 12.2 Pre-Treatment Predictors of Treatment Response A VARIATION OF IL28B – GENOTYPE 1 www.hcvadvocate.org Version 12.2 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 • To put HCV behind them and move on with their 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 during and 6 months following HCV medical therapy • 5 year follow-up >99% still HCV RNA undetectable www.hcvadvocate.org Version 12.2 Response to Therapy • Adherence: • Important now 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 Version 12.2 HCV Protease Inhibitor (PI): Victrelis (Boceprevir) •A P P R O V E D F O R G E N O T Y P E 1 ONLY •D O S E D E V E R Y 7 T O 9 H O U R S — T A K E N W I T H F O O D •M U S T B E T A K E N W I T H P E G Y L A T E D I N T E R F E R O N A N D RIBAVIRIN •4 - W E E K L E A D - I N W I T H P E G Y L A T E D I N T E R F E R O N A N D RIBAVIRIN www.hcvadvocate.org Version 12.2 Victrelis (Boceprevir) •T R E A T M E N T N A Ï V E – G E N O T Y P E 1 • Up to 66% SVR • African Americans – up to 53% vs. 23% SVR • Treatment duration either 28 or 48 weeks •T R E A T M E N T E X P E R I E N C E D – G E N O T Y P E 1 •Prior non-responders–up to 66% SVR (null responders not studied) •Treatment duration 36 or48 weeks www.hcvadvocate.org Version 12.2 HCV Protease Inhibitor (PI): Incivek (Telaprevir) •A p p r o v e d f o r g e n o t y p e 1 o n l y • Dosed every 7 to 9 hours- taken with food (not low fat) •M u s t b e t a k e n w i t h p e g y l a t e d i n t e r f e r o n a n d r i b a v i r i n •I n c i v e k , p e g y l a t e d i n t e r f e r o n , r i b a v i r i n t a k e n f o r 1 2 w e e k s only—followed by pegylated interferon/ribavirin www.hcvadvocate.org Version 12.2 HCV Protease Inhibitor: Incivek (Telaprevir) •T R E A T M E N T N A Ï V E – G E N O T Y P E 1 : • Up to 79% SVR • African American patients: 62% vs. 25% SVR • People with cirrhosis: 62% vs. 33% SVR • Treatment duration either 24 or 48 weeks. •T R E A T M E N T E X P E R I E N C E D – G E N O T Y P E 1 : • Up to 86% SVR depending on type of non-response (relapsers, non-responders, null responders) • Treatment duration 24 or 48 weeks www.hcvadvocate.org Version 12.2 Treatment: Genotype 2 and 3 Pegylated and Ribavirin (FDA Package Insert) Merck /Schering – PEG-Intron + Rebetol (800-1400mg) Genotype 2 thru 6 – 75% (48 weeks) One large multi-international study Genentech/Roche – Pegasys + Copegus (1000-1200 mg) Genotype 2 & 3 – 82% SVR (24 weeks) Genotype 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) Note: Genotype 2 and 3 treated for 24 weeks Version 12.2 Standard Protocol Pegylated (injected once a week) Ribavirin (pill or capsule – oral twice a day) Victrelis / Incivek (pill—every 7 to 9 hours) for genotype 1 only Treatment is guided by type of on- treatment response (week 4 and 12) Version 12.2 Side-effects Interferon Ribavirin Physical Anemia, rash, dry cough Black box warning: fatigue, muscle/joint Women of childbearing age, their pain, headaches, dry partners and female partners of skin, insomnia, male patients taking ribavirin must practice two forms of Anxiety, depression, contraception during to 6 months mania post-treatment Low white blood cells Low red blood cells Low platelets www.hcvadvocate.org Version 12.2 Side-effects Victrelis Incivek Up to 50% --anemia Up to 36% - anemia Body rash Taste changes especially metal taste Anal itching Diarrhea www.hcvadvocate.org Version 12.2 Managing Side Effects Time injection Daily moisturizing Drink lots of water Vary injection sites Low doses of ibuprofen or Anti-depressants acetaminophen Plenty of rest Pain/sleep medications Small frequent healthy Light exercise meals www.hcvadvocate.org Version 12.2 Programs Patient Assistance Programs Partnership for Prescription Assistance www.pparx.org Needy Meds: www.needymeds.org Genentech: www.genentechaccesssolutions.com Merck: http://www.merck-cares.com Vertex: http://www.vrtx.com Version 12.2 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 PI’s (lowers PI drug levels) Caution: • Bupleurum should not be used by someone taking interferon Version 12.2 Complementary Practices Acupuncture Thin needles are inserted into acupuncture points to stimulate the flow of 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 Version 12.2 Turn In Participant checklist Plan of action Evaluation Demographic information Order by fax form Version 12.2
"HCV Slides Sept 2011"