Transcript (PPTX, 2.4MB)

HCV Training Workshop
MATTHEW ZIELSKE
HEPATITIS C EDUCATION & TRAINING CONSULTANT
DIRECTOR, UMBRELLAWAY.ORG
WWW.HCVADVOCATE.ORG
BLOG: HCVADVOCATE.BLOGSPOT.COM
Version 19.0
People Who Make a Difference
 C.D. Mazoff
• Irina Gavrilova
 Lucinda Porter
• Christine M. Kukka
 Rose Christensen
• Clara Maltras
 Liz Highleyman
• Kate Frye
 Leslie Hoex
 Jeanie Vogel
www.hcvadvocate.org
• Alan Franciscus
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www.hcvadvocate.org
www.hcvadvocate.org
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Numbers
•Website:
•Average 660,000 hits/week
•Educational Materials: 200,000 pieces
•
•
Not counting website downloads
Fact Sheets – 400-500 downloads weekly
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HCSP Hepatitis C
Training Certification
Map: 2002 - 2016
Legend: Completed
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Effect on HCV Community
•HCSP Educators: more than 15,000
•
50 people:
• In one year outcome is 750,000 people
•
Ultimate goal:
•
Improved education, support and services
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Hepatitis C
HEPATITIS C IS A
CURABLE
DISEASE!
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HCV Transmission / Prevention
Hepatitis C is spread by blood-to-blood
contact
HCV is the most common blood-borne
pathogen in U.S.
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HCV Transmission/ Survival
•
Sharing needles and drug preparation tools
•
HCV survives on surfaces:
•
At least 16 hours but no longer than 4 days
(CDC)
•
For up to 6 weeks (Journal of Infect Dis)
•
In syringes up to 63 days –
• Isn’t known if bleach will kill it in a syringe
•
Commercially available disinfectants kill HCV
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Transmission/Prevention
•
Sharing needles and drug preparation tools
•
Blood products & solid organ transplantation before
July 1992
•
Clotting factors before inactivation in 1987
•
Sexual transmission (0-3%)
•
Mother-to-child (~6%)
•
Healthcare workers (~2%)
•
Hemodialysis
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Possible Transmission Routes
•
Tattoo & piercing*
•
Personal care salons
•
Shared household (hygiene) items
•
Coke/crank straws & crack/meth pipes
•
10% of routes can not be identified
* Higher in unsafe non-commercial settings: prisons/mental institutions/on the streets/home grown
www.hcvadvocate.org
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Little or no data…….
• Dental and other procedures before
universal precautions
• Jet gun injections
• Transgender people
•
Sharing needles and re-assignment
surgeries
www.hcvadvocate.org
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HCV is Not Spread by:
•
•
•
•
•
Breast feeding
Food or water
Sharing eating utensils or drinking
glasses
Sneezing
Hugging
*Not spread by casual contact*
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Prevention:
•Do not share anything:
NEEDLES,
COOKERS, COTTON, TOURNIQUETS, WATER,
WATER CONTAINERS, ETC. – WASH HANDS
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Prevention – more
•Do not share non-injection drug
equipment
•Coke/Crank straws
•Crack/Meth pipes
•Tattoo / Piercing
•Sterilization, autoclave, separate ink pot,
new needles
www.hcvadvocate.org
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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
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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…..
www.hcvadvocate.org
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Lifecycle
•
Single-stranded RNA virus
•
Mainly infects liver cells—but also found in
other cells of the body
•
Cell culture discovered and available
www.hcvadvocate.org
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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
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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
•
OraQuick Rapid Antibody Test
•
Window period – 2-26 weeks
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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
•
Test given for:
•
Confirm Active infection
•
Used for treatment
•
Does not correlate with disease progression
www.hcvadvocate.org
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Genotype & Subtypes
 Blood
test – Treatment related
 Genotype:
1, 2, 3, 4, 5, 6 & 7
Genotype
1 – 70% of US population with HCV
Genotypes
2, 3 – 30% of US population with
HCV
 Subtype:
1a/b, 2a/b, etc.,
*given once unless someone is re-infected
www.hcvadvocate.org
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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)
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Why?
 Measures
liver health
 Benchmark
 Insurance
• Liver Biopsy
 FibroScan
 FibroTest
 Various Blood Markers
Metavir Scoring System – 0, 1, 2, 3, 4
No activity
Severe activity
 Medicaid
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HCV Symptoms, Disease
Progression & Management
•
HCV REDUCES SURVIVAL BY MORE THAN 20
YEARS
•
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 (2010)
•
Progression to cirrhosis will peak at 1.0 million in
2020
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Acute Infections –
CDC - 2013 - 29,700 (23,500-101,400)*
*1% of the true numbers reported to the CDC
The Second Epidemic – HCV Outbreaks
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CHRONIC INFECTION
•CDC - Total chronic infections: 2.7 to 3.9 million (not
factored into above: prisoners, homeless, people in
mental institutions)
 U.S. Population - ~2%
 Baby Boomers – 3.25% (76% of HCV Population)
 PWID > 10 years - 90%
 PWID < 10 years - 66%
 Homeless persons – 19-69%
 Prisoners – 29%
 Mental illness – 20%
 Black American men
(40-50) – 10%
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Baby Boomers Account for the Majority of HCV
Cases in United States
Estimated Prevalence by Age Group
Number With Chronic HCV
Infection
(millions)
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
<1920
1920s
1930s
1940s
1950s
1960s
1970s
1980s
1990+
Birth Year Group
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Deaths from HCV
•
Annual Deaths: 2013 -19,368 – current information
indicates these represent a fraction of deaths attributable
in whole or in part to chronic hepatitis C —51% in age
group 55-64 yo.
• CHeCs study 2010 – 80,000 Deaths
• In the U.S. in 2007, the number of deaths attributed to hepatitis C
(more than 15, 000) surpassed the number of deaths caused by HIV
(more than 12,000)
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Acute/Chronic HCV
• Acute infection – up to 6 months
•
•
Most people have no symptoms
Flu-like—fatigue, nausea, fever, indigestion, loss of
appetite, night sweats, jaundice
• Acute – Treatment with HCV medications cured the
majority of acute infections
• Chronic – Longer than 6 months
Up to 75 to 85% of acute cases become chronic
www.hcvadvocate.org
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Chronic Symptoms
 Fatigue*– mild to
 Liver pain
severe
 Loss of appetite
 “Brain Fog”
 Flu-like symptoms
 Depression
 Headaches
 Gastro problems
 And more….
Symptoms don’t necessarily correlate with disease progression with the
exception of acute and end-stage liver disease
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DISEASE PROGRESSION
•10 to 25% have serious disease progression over a 10 to 40
year period – disease progression is not linear
•Inflammation
•Fibrosis
•Cirrhosis
•Steatosis
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Disease Progression
 Compensated cirrhosis—extensive scarring, but liver
is still working fairly well
 Decompensated cirrhosis—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: $577,100 – Annual costs of anti-
rejection medications: ~$30,000
www.hcvadvocate.org
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HCV Infection:
Extrahepatic Manifestations
Hematologic
Salivary
•
•
•
•
• Sialadenitis
Mixed cryoglobulinemia
Aplastic anemia
Thrombocytopenia
Non-Hodgkin’s b-cell lymphoma
Dermatologic
• Porphyria cutanea tarda
• Lichen planus
• Cutaneous necrotizing
vasculitis
Renal
• Glomerulonephritis
• Nephrotic syndrome
Endocrine
• Anti-thyroid antibodies
• Diabetes mellitus
Hadziyannis SJ. J Eur Acad Dermatol Venereol. 1998;10:12-21.
Ocular
• Corneal ulcer
• Uveitis
Vascular
• Necrotizing vasculitis
• Polyarteritis nodosa
Neuromuscular
• Weakness/myalgia
• Peripheral neuropathy
• Arthritis/arthralgia
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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
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Disease Management - Lifestyle Changes
• Avoid:
•
•
•
Alcohol, cigarettes, drugs or any substance that can harm
the liver
Raw or undercooked shellfish
High doses of vitamins or supplements except where
directed by a medical provider
 Eat a healthy balanced diet
• Get vaccinated against HAV and HBV if not already
protected
• Medical provider should check fat soluble vitamin levels
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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
www.hcvadvocate.org
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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 learn from peers
Support Group Manual / Lessons
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HCV Medical Treatment
ALL ORAL (INTERFERON-FREE)
THERAPIES ARE NOW
STANDARD OF CARE TREATMENT
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HCV Treatment
ALL ORAL DIRECT -ACTING
ANTIVIRAL MEDICATIONS
UP TO AND OVER 90% OF
PEOPLE WITH HEPATITIS C
CAN BE CURED!
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AASLD and IDSA Treatment
Guidelines
“TREATMENT IS RECOMMENDED FOR ALL PATIENTS WITH
CHRONIC HCV INFECTION, EXCEPT THOSE WITH SHORT
LIFE EXPECTANCIES THAT CANNOT BE REMEDIATED BY
TREATING HCV, BY TRANSPLANTATION, OR BY OTHER
DIRECTED THERAPY. PATIENTS WITH SHORT LIFE
EXPECTANCIES OWING TO LIVER DISEASE SHOULD BE
MANAGED IN CONSULTATION WITH AN EXPERT.”
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Visit HCV Advocate for Current Detailed
Information on HCV Medications
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Caution!
RIBAVIRIN—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 posttreatment
DIRECT ACTING ANTIVIRALS HAVE NOT
BEEN TESTED ON PREGNANT WOMEN
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Epclusa (sofosbuvir /velpatasvir)
Epclusa (one pill – once-a-day) for 12 weeks – no ribavirin
in patients (treatment naive and treatment experienced)
without cirrhosis or with compensated cirrhosis.
Cure Rates by Genotype
Geno 1
Geno 2
Geno 3
Geno 4
Geno 5
Geno 6
98% *
99.5%
95%
100%
97%
100%
(237/238
pts)
(528/553
pts)
(116/116
pts)
(34/35
pts)
(41/41
pts)
(323/328
pts)
Epclusa for 12 weeks – no ribavirin in patients (treatment naive and treatment
experienced) without cirrhosis or with compensated cirrhosis:
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Epclusa (sofosbuvir /velpatasvir)
Epclusa plus ribavirin for 12 weeks in treatment naive
and treatment experienced patients with decompensated
cirrhosis:
Genotype
Cure Rates
1a
94% (51/54 pts)
1b
100% (14/14 pts)
2
100% (4/4 pts)
3
85% (11/13 pts)
4
100% (2/2 pts)
Note: no genotype 5 or 6 patients were included in the above study of
decompensated cirrhotic patients.
The most common side effect were headache and fatigue
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Zepatier (elbasvir/grazoprevir)
Genotype 1: Zepatier (one pill – once-a-day) for 12 or 16
weeks – taken with and without ribavirin.
Patient Characteristics
Genotype 1a: Treatment naïve or
PegIFN/RBV-experienced without
baseline NS5A polymorphisms (RAVs)
Genotype 1a: Treatment-naïve or
PegIFN/RBV-experienced with
baseline NS5A polymorphisms (RAVs)
Genotype 1b: Treatment-naïve or
PegIFN/RBV-experience
Genotype 1a or 1b: PegINF/RBV/PIexperienced
Medications/Duration
Cure Rates
Zepatier for 12 weeks
92% to 100%
Zepatier plus ribavirin for
16 weeks
100%
Zepatier for 12 weeks
92% to 98%
Zepatier plus ribavirin for
12 weeks
100%
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Zepatier (elbasvir/grazoprevir)
Genotype 4: Zepatier (one pill – once-a-day) for 12 or 16
weeks – taken with and without ribavirin.
Patient Characteristics
Treatment-naïve
Treatment-experienced
Medications/Duration
Cure Rates
Zepatier for 12 weeks
97%
Zepatier plus ribavirin for
16 weeks
100%
The most common side effects of Zepatier that occurred in more than 10% of
patients in the clinical trials were fatigue and headache.
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Viekira Pak & Viekira XR*
Recommended Treatment Duration – Cure Rates
Genotype 1:
Patient Characteristics
Medications /Duration
Cure Rates
Genotype 1a, without cirrhosis
Viekira/ribavirin for 12 weeks
94% to 100%
Genotype 1a, with compensated
cirrhosis
Viekira/ribavirin for 24 weeks
93% to 100%
Genotype 1b, with or without
compensated cirrhosis
Viekira for 12 weeks
100%
The most common side effects in more than 5% of people were nausea,
itching and insomnia.
*ombitasvir (twice-a-day); paritaprevir/ritonavir (taken once-a-day); dasabuvir (once-a-day).
Viekira XR extended release taken twice a day. Viekira is taken with and without ribavirin.
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Harvoni (ledipasvir/sofosbuvir)
Harvoni (one pill - once-a-day) is taken for 8, 12 or
24 weeks. It is taken with and without ribavirin.
Genotype 1*
Patient Characteristics
Medications/Duration
Cure Rates
Treatment naïve, no cirrhosis or
compensated cirrhosis
Harvoni for 12 weeks
96-99%
Treatment-experienced without
cirrhosis
Harvoni for 12 weeks
94-95%
Treatment-experienced with
compensated cirrhosis
Harvoni for 24 weeks
100%
Havoni plus ribavirin for 12
weeks
87-88%
Treatment naïve and treatment
experienced with decompensated
cirrhosis (Child-Pugh B or C)
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Harvoni (ledipasvir/sofosbuvir)
Genotype 1: continued –
The cure rates between genotype 1a and 1b were
similar
* Treatment-naïve genotype 1 patients with a viral
load (HCV RNA) under 6 million IU/mL and do not
have cirrhosis can be treated for 8 weeks. The cure
rates in clinical trials was 94%
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Harvoni (ledipasvir/sofosbuvir)
Genotype 4, 5, or 6:
Patient Characteristics
Treatment-naïve and treatmentexperienced without cirrhosis or
with compensated cirrhosis
Medications/Durati
on
Cure Rates
Harvoni for 12 weeks
Genotype 4: 93%
Genotype 5: 93%
Genotype 6: 96%
Genotype 1 and 4 Liver Transplant Patients
Patient Characteristics
Medications/Duration
Cure Rates
Treatment-naïve, no cirrhosis or
compensated cirrhosis
Harvoni for 12 weeks
96-99%
Treatment-experienced without
cirrhosis
Harvoni for 12 weeks
94-95%
Treatment-experienced with
compensated cirrhosis
Harvoni for 24 weeks
100%
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Genotype 4 - Technivie*
Recommended Treatment Duration – Cure Rate
Patient Characteristics
Medications/Duration
Cure Rate
Genotype 4, without cirrhosis
Technivie/ribavirin* 12 weeks
91% to 100%
*Technivie can be taken without ribavirin in patients who are treatment naïve
(never been treated) and who cannot tolerate ribavirin.
* Ombitasvir (NS5A inhibitor) + Paritaprevir (protease inhibitor)/ritonavir
(protease inhibitor)
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Older Direct-Acting Antivirals
• Sovaldi (sofobuvir)
• Olysio (simeprevir)
• Daklinza (daclatasvir)
• See HCV Advocate’s HCV Medications Blog
http://hepatitiscmedications.hcvadvocate.org/
for more information
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Managing Side Effects
 Drink water
 Daily moisturizing
 Low doses of
 Rest when tired
ibuprofen or
acetaminophen
 Small frequent healthy
meals
 Sleep medications
 BRAT
 Light exercise
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ADHERENCE & RAV’s
• ADHERENCE to taking HCV medications at
100/100/100 as possible with tools
• RAVs – resistance associated variants occur
naturally, during treatment with direct-acting antiviral
treatment and when treatment doesn’t work.
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Treatment Cost
WHOLESALE ACQUISITION COST
(WAC)
$54,600 TO 189,000 PER
TREATMENT
(8 TO 24 WEEKS OF
TREATMENT)
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Patient Assistance Programs
See
notes in individual direct-acting antiviral
slides for information about pharmaceutical
patient assistance programs
 See
HCV Advocate’s Fact Sheets on
Pharmaceutical Patient Assistance Programs
www.hcvadvocate.org
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Hepatitis C Drug Pipeline
• AbbVie – ABT-493 + ABT-530 Pan-Genotypic, once-daily
• Gilead –sofosbuvir+valaptasvir+Voxiapreivr, Pangenotypic, once-daily, rescue therapy
• Janssen, Achillion, Alios –simeprevir, odalasvir, AL-335
• Updated monthly – HCV Advocate Newsletter
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Print This Card
www.hcvadvocate.org
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Where Do I Get One?
 You can send a self-addressed stamped envelope to:

NeedyMeds Drug Discount Card
PO Box 219
Gloucester, MA 01931
 Or go online and print a card by visiting:
http://www.needymeds.org/drugcard/drugcard.pdf
www.hcvadvocate.org
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Help for Card Users
 Visit http://drugdiscountcardinfo.com
Or call (888) 602-2978
Additional Services:
 Information about patient assistance programs
 List of low cost medical clinics
 Webinars to explain services
www.hcvadvocate.org
Version 19.5