hcv training workshop
DESCRIPTION
HCV Training Workshop. Join us on Twitter & Facebook – HCVAdvocate BLOG: hcvadvocate.blogspot.com/. People Who Make a Difference. Irina Gavrilova Clara Maltras Kate Frye Patrick Daniel. C.D. Mazoff Lucinda Porter Rose Christensen Liz Highleyman Leslie Hoex. www.hcvadvocate.org. - PowerPoint PPT PresentationTRANSCRIPT
JOIN US ON TWITTER & FACEBOOK – HCVADVOCATE
BLOG: HCVADVOCATE.BLOGSPOT.COM/
HCV Training Workshop
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People Who Make a Difference
C.D. Mazoff
Lucinda Porter
Rose Christensen
Liz Highleyman
Leslie Hoex
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• Irina Gavrilova
• Clara Maltras
• Kate Frye
• Patrick Daniel
www.hcvadvocate.org
www.hcvadvocate.org
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•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
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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
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The Liver
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• 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
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• 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
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•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:
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•Means: Inflammation of the liver
•Causes: • Viruses, toxins, genetic disorders,
bacteria and parasites
HEPATITIS
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• 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)
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•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)
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• 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
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•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
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Chronic HBV
Chronic ~5-6% Adults – 90% Infants
*These drugs are recommended as first line of treatment
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•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
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• 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
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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
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Safer Tattoos – www.hepatitistattoos.org
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Little or no data…….
• Dental and other procedures before universal precautions
• Jet gun injections
• Transgender people• Sharing needles and operations
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• Breast feeding• Food or water• Sharing eating utensils or drinking
glasses• Sneezing• Hugging
*Not spread by casual contact*
HCV is Not Spread by:
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•Do not share anything: NEEDLES, COOKERS, COTTON, TOURNIQUETS, WATER, ETC. – WASH HANDS
Prevention:
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Prevention - more
•Do not share non-injection drug equipment
•Coke/crank straws•Crack pipes
•Tattoo / Piercing•Sterilization, autoclave, separate ink pot, new needles
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•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
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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…..
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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
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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
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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
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Estimated Prevalence by Age Group
0
Nu
mb
er W
ith
Ch
ron
ic H
CV
In
fect
ion
(mil
lio
ns)
Birth Year Group
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
1990+1980s1970s1960s1950s1940s1930s1920s<1920
Baby Boomers Account for the Majority of HCV Cases in United States
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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?
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•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
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• FINGERPRICK & WHOLE BLOOD:FDA AND CLIA WAIVER APPROVED – 2011
• ORAL SWAB – PENDING FDA AND CLIA APPROVAL – 2012?
OraQuick HCV Rapid Antibody Test
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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
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• 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?
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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
HCV
Quasi-speciesHigh error prone virus – mutates quickly
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• 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
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Liver Biopsy
*Measures liver health
*Treatment decisions
*Benchmark
Metavir Scoring System – 0, 1, 2, 3, 4
No activity Severe activity
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“LIVING WITH HCV IS OFTEN EASY, OFTEN DIFFICULT AND SOMETIMES IMPOSSIBLE”
PETER MARE LATHAM
HCV Symptoms, Disease Progression & Management
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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]
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Drug Based Therapies
HCV Positive
SupportHousing
AddictionMen
tal H
ealth
Health
Polic
ies
Social Stigma
Health
Access
HA
V & H
BV Vaccine
CAM
Ann Shindo
What may be needed even before considering treatment
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•GASTROENTEROLOGIST
•HEPATOLOGIST
•THE FUTURE?• Primary care, infectious disease specialists
and others
Liver Specialists
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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
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•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
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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
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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
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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
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Disease Management Lifestyle Changes
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•HEPATITIS A & HEPATITIS B VACCINE
•AVOID RAW & UNDERCOOKED SHELLFISH• HAV / Vibrio vulnificus
•EXERCISE• Moderation—balance activity with rest
Disease Management
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SUPPLEMENTS
Avoid high doses of vitamins and supplements
General recommendations: Vitamin supplement (daily requirements with no
iron)
Always check-in with a medical provider
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Discrimination & Stigma
Americans with Disabilities Act—allows for certain protections
Call the ADA (800-949-4232)
Social Security Disability
The effect of stigma
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•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
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HCV Medical Treatment
5152535455565758595
Mono INF INF + Riba Peg-Intron + Riba Pegasys + Riba Peg INF + Riba + PI
Percen
t
Genotype
HCV Medical Treatments
Genotype 1Genotype 2, 3
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•OVERALL HEALTH IS STABLE
•ACTIVE HCV INFECTION
•COMPENSATED LIVER DISEASE• Decompensated generally only in transplant
centers
General Treatment Guidelines
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•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
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VARIATION OF IL28B – GENOTYPE 1
Pre-Treatment Predictors of Treatment Response
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•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
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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
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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
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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)
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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
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•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
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Incivek (Telaprevir)Incivek, pegylated interferon, ribavirin taken for 12 weeks only—
followed by pegylated interferon/ribavirin
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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)
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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
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VictrelisVictrelis IncivekIncivek
Up to 50% – anemia
Taste changes especially metal taste
Up to 36% – anemia
Body rash
Anal itching
Diarrhea
Side-effects
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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
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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
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Clinical Trials
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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
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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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Turn In
Participant checklistPlan of action
EvaluationDemographic information
Order by fax form
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