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7/29/2018 1 Hepatitis C: Closer to Cure LYNN RAPSILBER DNP APRN ANP-BC FAANP NP WELLNESS CARE NPAA CONFERENCE SEPTEMBER 14, 2018 RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 1 Disclosures Speaker for: Gilead No financial support for this presentation RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 2 Objectives 1) What hepatitis C is and who is at risk 2) Identify testing as part of the work-up for hepatitis 3) Identify the long term complications of hepatitis C 4) Knowledge of the current treatments and management options for hepatitis C 5) Management of cured patient with cirrhosis RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 3

Hepatitis C: Closer to Cure · Acute Hepatitis C Acute hepatitis C refers to the first 6 months after infection with HCV. 25% of the patients will spontaneous clear virus without

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Page 1: Hepatitis C: Closer to Cure · Acute Hepatitis C Acute hepatitis C refers to the first 6 months after infection with HCV. 25% of the patients will spontaneous clear virus without

7/29/2018

1

Hepatitis C: Closer to CureLYNN RAPSILBER DNP APRN ANP-BC FAANP

NP WELLNESS CARE

NPAA CONFERENCE

SEPTEMBER 14, 2018

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 1

DisclosuresSpeaker for:

Gilead

No financial support for this presentation

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 2

Objectives1) What hepatitis C is and who is at risk

2) Identify testing as part of the work-up for hepatitis

3) Identify the long term complications of hepatitis C

4) Knowledge of the current treatments and management options for hepatitis C

5) Management of cured patient with cirrhosis

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION 3

Page 2: Hepatitis C: Closer to Cure · Acute Hepatitis C Acute hepatitis C refers to the first 6 months after infection with HCV. 25% of the patients will spontaneous clear virus without

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What is Hepatitis C?

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What is Hepatitis C?Identified in 1989

First tests approved in 1992 by the FDA

Known as Non A, Non B Hepatitis

Looked at cause of liver disease in patient who received transfusions in the 1970’s

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Hepatitis C Virus(2017, April 22). Retrieved from https://www.google.com/imgres?imgurl=https://fthmb.tqn.com/I7W68jDfM6B9xxzcVOvCmuFumgs%3D/768x0/filters:no_upscale()/about/GettyImages-462126629-56

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Page 3: Hepatitis C: Closer to Cure · Acute Hepatitis C Acute hepatitis C refers to the first 6 months after infection with HCV. 25% of the patients will spontaneous clear virus without

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Facts About the Virus

Hepatitis C virus can be detected 2 weeks after exposure

Can be detected in >97% by 6 months

Virus can live @ room temperature on surface for 3 weeks

Clean surfaces with 1: 9 bleach and water

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Acute Hepatitis CAcute hepatitis C refers to the first 6 months after infection with HCV. 25% of the patients will spontaneous clear virus without

treatment.Between 60% to 70% develop no symptoms during the

acute phase.

In the minority of patients who experience acute phase symptomsmild and nonspecific75%-85% of acute hep c will persist with chronic infection

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(2017, April 23) Retrieved from: https://www.cdc.gov/hepatitis/statistics/2014surveillance/commentary.htm#bkgrndC

9

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What are the signs and symptoms of acute HCV infection?

Fever

Fatigue

Dark urine

Clay-colored stool

Abdominal pain

Loss of appetite

Nausea

Vomiting

Joint pain

Jaundice

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(2017, April 23). Retrieved from: https://www.cdc.gov/hepatitis/hcv/cfaq.htm#cFAQ11

10

Most Common Signs and Symptoms of Acute Hepatitis C (If Present)

Time Frame Wks from Exposure

2-12 weeks•Exposure and symptoms if present

4-10 weeks •Seroconversion

4-12 weeks•Elevated or fluctuating ALT (sign of liver injury)

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSION(2017, April 23). Retrieved from: http://www.who.int/mediacentre/factsheets/fs164/en/

11

Treatment Acute Hepatitis C

Interferon and Ribavirin

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Treatment Acute Hepatitis C

Interferon and Ribavirin

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Treatment Acute Hepatitis C

No longer treat

Wait to convert to Chronic

Treatments are curative

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Chronic Hepatitis C Infection

Was know as “Hepatitis non-A non-B”

Not recognized until asymptomatic persons are identified as HCV-positive:when screened for blood donationwhen elevated alanine aminotransferase (ALT, a

liver enzyme) levels are detected during routine examinations

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Chronic HCV infection

Many have chronic liver disease◦ range from mild to severe

◦ cirrhosis and liver cancer

Chronic liver disease in HCV-infected persons is◦ usually insidious

◦progresses slowly without any signs or symptoms for several decades.

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Chronic HCV InfectionOf those infected…

25-30% will-develop Cirrhosis

Of those >25% will develop either:◦end stage liver disease requiring liver transplantation

◦hepatocellular carcinoma (HCC)

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Seeff LB. Natural history of chronic hepatitis C, Hepatology , 2002, vol. 36 Suppl 1(pg. S35-46)

17

Prevalence

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Prevalence of Hepatitis Cin the US

CDC uses data from the National Health and Nutrition Examination Survey (NHANES).

During 1988–2002, an estimated 2.4–3.9 million persons chronic infection

Seroprevalence highest among adults aged 40–49 years (4.3%), males (2.1%), and black non-Hispanics (3.0%).

NHANES data indicate that a cohort of new infections during 1980s higher prevalence of chronic infection decades later among persons born from 1940 to 1965.

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Armstrong GL, Wasly A, Simard EP, McQuillan GM, Kuhnet WL, Alter MJ.The prevalence of hepatitis C virus infection in the United States, 1999 through 2002, Ann Intern Med , 2006, vol. 144 (pg. 705-14) 19

More People Die from HCV than from 60 Other Infectious Diseases Combined (Including HIV, Pneumococcal Disease, and Tuberculosis)

ANNUAL NUMBER OF HCV-RELATED DEATHS VS. OTHER

NATIONALLY NOTIFIABLE INFECTIOUS CONDITIONS

IN THE UNITED STATES, 2003-2013

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Source: Centers for Disease Control and Prevention. Annual number of HCV-related deaths vs. other nationally notifiable

infectious conditions in the United States, 2003-2013

20

Underdiagnosed and UndertreatedOf those infected…

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Yahya BR et al. PLoS One. 2014;9(7):1-7.

21

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Underdiagnosed and UndertreatedOf those infected…

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Yahya BR et al. PLoS One. 2014;9(7):1-7.

18%

22

Only 9%-18% are treated!!!!

We need to do a better job of identifying

patients!!

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Transfusions 10% / Tissue organ transplant before 1992

Organs of HCV +

Mother to Infant *

(*higher viral ct and co-HIV)

Clotting factors before 1987 (99%)

Chronic Hemodialysis Patient

High risk sexual activity (15-20%)

IVDA 84% / INC

Sharing personal items

Tattoos /Body piercings

Nosocomial / occupational exposures

Endoscopy

Transmission of Hepatitis C

(2017, April 27). Retrieved from: http://www.hepatitisc.uw.edu/pdf/screening-diagnosis/epidemiology-us/core-concept/all

24

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Blood Testing

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Blood testing

First available in 1992

Only way to know if have Hepatitis C

Antibody Test◦ HCV antibody testing is sensitive and inexpensive

◦ Positive results should be confirmed with repeat antibody test

◦ Signal-to-cutoff ratio may be used to “confirm”

◦ Positive test results are often reportable

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Fingerstick in the OfficeRapid Results

Point-of-care testing results in 20 minutes

Laboratory Accuracy

Greater than 98% accurate

Tests for multiple HCV genotypes

Easy-to-Use

Fingerstick and venipuncture whole blood collection

CLIA-waived

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(2017, April 23). Retrieved from: http://www.orasure.com/products-infectious/products-infectious-oraquick-hcv.asp

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HCV Antibody TestingHCV RNA**Preferred Supple-mentalTesting

HCV ribonucleic acidQualitative (yes or no) Quantitative (how much virus) Measures virus in the blood streamA negative cannot determine status

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Blood testing: beyond the positive antibody testHCV PCR RNA or viral load◦ Amount of measurable virus in the blood

◦ Confirm spontaneous clearance 15-45%◦ Remain antibody positive

Liver function tests◦ AST/ALT (30% will have normal levels)

Genotyping◦ Genotype 1,2 and 3 are most common in US

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Genotypes 1-11

Genotypes 1-3 have a worldwide distribution.

Types 1a and 1b are the most common, accounting for about 60% of global infections.

They predominate in Northern Europe and North America, and in Southern and Eastern Europe and Japan, respectively.

Someone could be infected with more than one genotype

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Genotypes

Genotype 2 is less frequently represented than type 1.

Genotype 3 is endemic in south-east Asia and is variably distributed in different countries. Worse prognosis******

Genotype 4 is found in the Middle East, Egypt, and central Africa.

Genotype 5 is almost exclusively found in South Africa

Genotypes 6-11 are distributed in Asia

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(2017, April 22). Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303918/figure/fig01/32

Genotypes: US Distribution Genotype 1 is the most common in the United States and accounts for approximately 76% of HCV infections

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(2017, April 23). Retrieved from: http://www.hepatitisc.uw.edu/pdf/screening-diagnosis/epidemiology-us/core-concept/all

76%1

2

34,5,6

12%

10%2%

Messina JP et al. Hepatology. 2015;61(1):77-87.

33

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Genotype 1 Subtypes

GT 1a 55%

GT 1b 35%

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Screening

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Ghany MG, et al. Hepatology. 2009;49:1335-1374.

Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-39.

Groups Recommended for HCV Testing by AASLD and USPHS (Class 1 Level B)*

Recent/past injection drug users—even if only used once

Groups with high HCV prevalence

◦ HIV-infected individuals

◦ Hemophiliacs treated with clotting factor concentrates before 1987

◦ Hemodialysis recipients

◦ Patients with unexplained aminotransferase abnormalities

◦ Recipients of transfusion or transplantation before July 1992

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Ghany MG, et al. Hepatology. 2009;49:1335-1374.

Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-39.

Groups Recommended for HCV Testing by AASLD and USPHS (Class 1 Level B)*

Children born to women infected with HCV

Healthcare, public safety, and emergency medical personnel

◦ needle injury or mucosal exposure to HCV-infected blood

Current sexual partners of individuals infected with HCV

◦ MSM

Persons who have used illicit drugs by noninjection routes

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Grading of Recommendations, Assessment, Development and Evaluation (GRADE)

Criteria Strength of Recommendation (CLASS)

◦ Strong [1]Factors influencing the strength of the recommendation included the quality of the evidence, presumed patient-important outcomes, and cost

◦ Weak [2]Variability in preferences and values, or more uncertainty. Recommendation is made with less certainty, higher cost or resource consumption

Quality of Evidence (LEVEL)

◦ High [A]Further research is unlikely to change confidence in the estimate of the clinical effect

◦ Moderate [B]Further research may change confidence in the estimate of the clinical effect

◦ Low [C]Further research is very likely to impact confidence on the estimate of clinical effect

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(2017, April 22). Retrieved from: http://www.gradeworkinggroup.org/

38

CDC Recommendations (2012) (Class 1 Level B)Individuals born between 1945 and 1965

Three-fourths of all chronic HCV

Accounts for 75% of HCV mortality (55-64 yrs)

35% who are undiagnosed, already progressed to advanced stages of liver disease and hepatocellular carcinoma

One-time testing is recommended without prior ascertainment

90% of people awaiting transplant

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https://www.cdc.gov/hepatitis/statistics/2014surveillance/commentary.htm#bkgrndC

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DTC AdvertisingGilead TV Spot, 'Hepatitis C and Baby Boomers' Original

Baby Boomers: Why You Need to Get Tested for Hep C

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Forget Me Not | HepCHope.com

Hepatitis C: The Hidden Epidemic

Why have so many baby boomers

developed hepatitis C? For some of

them, the answer goes back to

youthful experimentation during the

hippie era.

By Judith Horstman, M.L.A.

40

AASLD Guideline Recommendations for Screening and Counseling“As part of a comprehensive health evaluation, all persons should be screened for behaviors that place them at high risk for HCV infection

Persons who are at risk should be tested for the presence of HCV infectionUniversal testing is not justifiable by current measures of

HCV prevalence, disease burden, and treatment effectiveness

Persons infected with HCV should be counseled on how to avoid HCV transmission to others”

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSIONGhany MG, et al. Hepatology. 2009;49:1335-1374.

41

Complications of HCV

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Consequences of Hepatitis CChronic Hepatitis

Hepatic Fibrosis

Cirrhosis

Hepatocellular Carcinoma

End-Stage Liver Disease requiring Transplant

Extrahepatic manifestations

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Liver Scarring: Fibrosis and Cirrhosis

◦Hepatitis C causes inflammation

◦ fibrosis > scarring

◦affect liver function > progresses to cirrhosis

◦ liver failure > transplant

◦Ultrasound can identify this process

◦Liver biopsy can stage this process

◦Non invasive options are available

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Progression of fibrosis to cirrhosis

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http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/natural-history/core-concept/all

45

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(2017, April 23). Retrieved from: http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/natural-history/core-concept/all

46

Who is at greater risk?Genotype 3 associated with more fibrosis

Rapid progression from stage to stage

Liver failure 5 % (children)

25-30% (adults) of HCV population will develop cirrhosis

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Cirrhosis of the Liver

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Cirrhosis of the Liver

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Cirrhosis

Compensated

vs

Decompensated

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Symptoms of Cirrhosisfatigue

weight loss

nausea

abdominal pain

pruritus

jaundice (yellow discoloration of the skin and eyes)

ascites

hepatic encephalopathy

bleeding

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(2017, April 23). Retrieved from: http://hepc.liverfoundation.org/what-is-hepatitis-c/what-can-happen-complications-of-hep-c/

51

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Hepatocellular Carcinoma (HCC)Risk increases with Cirrhosis

3% of HCV population will develop◦ Increase in incidence over last 2 decades

Identify by◦ imaging studies MRI best

◦S/S such as jaundice

◦Alpha Fetoprotein is elevated

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Hepatocellular Carcinoma

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Hepatocellular Carcinoma (HCC)10%-20% of tumors are surgical resection or ablation /offer best chance of cure

Ablation procedures more common

Introduce heat into the tumor

Liver transplant can increase survival

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Radio Frequency AblationMinimally invasive

Repeatable procedure

High rate to tumor necrosis

Great long term survival data

Performed under US or CT guidance

Needle inserted into liver

Heat generated by rapidly agitating cells causing necrosis

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Liver tumor before RFA

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(2017 December 15). Retrieved from: http://emedicine.medscape.com/article/1390475-overview#a2

56

After RFA

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http://emedicine.medscape.com/article/1390475-overview#a2

57

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Extrahepatic ManifestationsHematologic◦ Anemia, lymphoma

Dermatologic

◦ Lichen planus, Vasculitits

Renal◦ Glomerular nephritis,

nephrotic syndrome

Endocrine◦ Hypothyroidism,DM

Neuropsychiatric

Ocular◦ Corneal ulcer, uveitis

Vascular

◦ Polyarteritis, necrotizing vasculitis

Neuromuscular

◦ Arthralgias, myalgias

Autoimmune◦ CREST syndrome

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End Stage Liver Disease Signs and Symptoms

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Advanced Liver Disease in Chronic HCV–Infected US Population: 2009-2028

▪ Total number of patients with advanced liver disease in 20 yrs projected to

be > 4-fold higher than today

Milliman, Inc. Consequences of HCV: costs of a baby boomer epidemic, 2009. Graphic reproduced with

permission.

Assuming no changes in standard of care

0

50,000

100,000

150,000

200,000

250,000

Indiv

iduals

2009 2012 2015 2018 2021 2024 2027

Yr

Hepatocellular

carcinoma

Decompensated

cirrhosis

Liver

transplantation

60

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Annual US Medical Costs for Chronic HCV Infection: 2009-2028

▪ Total medical costs for patients with HCV infection expected to more than

double, from $30 billion to > $85 billion USD, over the next 20 yrs

0

60

100

US

D$,

Bill

ions 80

40

20

2009 2012 2015 2018 2021 2024 2027

MedicareUninsuredVAMedicaidCommercial

Assuming no changes in standard of care

Yr

Milliman, Inc. Consequences of HCV: costs of a baby boomer epidemic, 2009. Graphic reproduced with

permission. 61

Prevention

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Avoiding Transmission to Others(Class 1 Level C)

Avoid sharing toothbrushes

Avoid sharing shaving equipment i.e. razors

Avoid sharing nail files and clippers

Avoid tattoos and body piercings

Do not donate blood, organs, tissue, or semen

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Avoiding Transmission to Others

Cover bleeding wounds to prevent contact with others

Discontinue illicit injection drug use; if injection drug use continues:◦ Avoid reusing/sharing needles/syringes and other drug

paraphernalia and dispose of syringes/needles after single use in puncture-proof container

◦ Clean injection site with fresh alcohol swab

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Avoiding Transmission to OthersDue to low sexual transmission rate, barrier protection not needed in monogamous relationships; otherwise, safe sex practices warranted

Worry about other STI/STD

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Alcohol and Hepatitis C

Alcohol use should be avoided (Class 2a Level B)– > 50 grams* per day clearly increases HCV-fibrosis progression

–Alcohol consumption > 50 grams* per day appears to increase HCV RNA level[2]

Males 30 gms per day

Females 20 gms per day

Clean and/or sober at least 6 months

* 50 grams of alcohol is approximately 48 ounces of beer,

[2] 4.5 ounces of 80 proof, or 15 ounces of wine.

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Alcohol and Hepatitis C

Alcohol use should be avoided (Class 2a Level B)– > 50 grams* per day clearly increases HCV-fibrosis progression

–Alcohol consumption > 50 grams* per day appears to increase HCV RNA level[2]

Males 30 gms per day

Females 20 gms per day

Clean and/or sober at least 6 months

* 50 grams of alcohol is approximately 48 ounces of beer,

[2] 4.5 ounces of 80 proof, or 15 ounces of wine.

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Alcohol & Cirrhosis

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(2017, April 24). Retrieved from: http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/natural-history/core-concept/all

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Hepatitis can be CURED!!!!!

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Goals in Treating Hepatitis CVirologic Cure!!!!!!

Defined as SVR after HCV treatment

Finally possible with newer therapies!!!!!

****Patients with advanced fibrosis or cirrhosis need life long monitoring even after treatment (Shiffman 2009)****SVRhttp://www.inpractice.com/Textbooks/Hepatology/ch8_Mgmt_of_Hep_C_Infection/References/Shiffman%202009?view=token

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Targeted treatments work in the cell

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSIONIllustration courtesy of Alison Jazwinski, MD.

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What is a Cure?

Cure, also known as sustained virologic response (SVR), is defined as no detectable HCV in the blood at least 12 weeks after completion of therapy

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Initial Work-up: Lab

CBC with differential

Hepatic panel

Chemistry Panel

Thyroid studies

Pregnancy test

Screen: alcohol, drug use, depression

PT/INR

HIV

Hepatitis A Total AB

Hepatitis B core AB

Hepatitis B surface AG

Hepatitis B surface AB◦ Vaccinate

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Liver Biopsy

Fallen out of favor!

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Non-invasive measures of fibrosis: Now Recommended

◦FibroScan◦FibroTest◦Fibrosure◦APRI score◦Transient elastography

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Fibrosis Stage (FibroTest)

F0 - No fibrosis 0.00 - 0.21

F0 - F1 0.21 - 0.27

F1 - Portal fibrosis 0.27 - 0.31

F1 - F2 0.31 - 0.48

F2 - Bridging fibrosis with few septa 0.48 - 0.58

F3 - Bridging fibrosis with many septa 0.58 - 0.72

F3 - F4 0.72 - 0.74

F4 - Cirrhosis 0.74 - 1.00

Activity Grade (ActiTest)

A0 - No activity 0.00 - 0.17

A0 - A1 0.17 - 0.29

A1 - Minimal activity 0.29 - 0.36

A1 - A2 0.36 - 0.52

A2 - Moderate activity 0.52 - 0.60

A2 - A3 0.60 - 0.63

A3 - Severe activity 0.63 - 1.00

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Lab Corp. (2017, April 22). Retrieved from: http://www.hemophilia.co.il/documents/Fibrotest.pdf

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Apri Score

AST level

-----------------

APRI= ALT level X 100

_______________________

Platelet Count

76% sensitivity/ 72% specificity for predicting cirrhosis

(2017, April, 23). Retrieved from: http://www.hepatitisc.uw.edu/page/clinical-calculators/apri

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Shear Wave Elastography

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https://iame.com/online/breast_elastography/content.php

http://www.usa.philips.com/healthcare/resources/feature-detail/shear-wave-elastography

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What is Current Today?

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Treat Now

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Where we came from…….

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HCV Treatment Has Evolved Over Time

1. Chen CH, Yu ML. Hepat Res Treat. 2010;2010:140953. 2. Franciscus A. HCV Advocate site. March 2012. 3. Lawitz E, et al. N Engl J Med. 2013;368(20):1878-1887. 4. Ferenci P, et al. N Engl J Med. 2014;370(21):1983-1992. 5. Afdhal N, et al. N Engl J Med. 2014;370(20):1889-1898. 6. Feld JJ, et al. N Engl J Med. 2015;373 (27):2599-2607. 7. Foster GR, et al. N Engl J Med. 2015;373(27):2608-2617. 8. US Department of Health and Human Services, Center for Drug Evaluation and Research. Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. November 2017.

First DAAs

approved1998 Ribavirin (plus IFN)

approved

1991 IFN approved

2011

2001Pegylated interferon

approved

~55% SVR1,2

PEG-IFN+RBV

66%-86% SVR2

PEG-IFN+RBV+PI~40% SVR1,2

~20% SVR1,2

• Scientific advances have led to all-oral, fixed-dose daily HCV regimens,

which are shorter (average of 12 weeks) and more effective8

• Cure, also known as sustained virologic response (SVR), is defined as no

detectable HCV in the blood at least 12 weeks after completion of therapy8

IFN, interferon; PEG-IFN, pegylated interferon; PI, protease inhibitor; RBV, ribavirin.

1990 1995 2000 2005 2010 2015

82

2013

-Present

All-oral

DAA agents

approved

≥90% SVR3-7

How Far Are We?

One Size . . . . . . Fits All?

Same treatment regardless of

fibrosis Same treatment regardless of

fibrosis level, previous treatment experience, or HCV

genotype?

Slide credit: clinicaloptions.com

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What are the treatment recommendations?GENOTYPE 1

Harvoni

Epclusa

Zepatier

Olysio & Sovaldi

Veikera

Mavyret

GENOTYPE 2

Sovaldi & Ribavirin

EPCLUSA

Mavyret

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(2017, April 23). Retrieved from: http://hepc.liverfoundation.org/treatment/the-basics-about-hepatitis-c-treatment/medication-regimens-according-to-genotype/

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What are the treatment recommendations?GENOTYPE 1

Harvoni

Epclusa

Zepatier

Olysio & Sovaldi

Veikera

Mavyret

GENOTYPE 2

Sovaldi & Ribavirin

EPCLUSA

Mavyret

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http://hepc.liverfoundation.org/treatment/the-basics-about-hepatitis-c-treatment/medication-regimens-according-to-genotype/

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What are the treatment recommendations?GENOTYPE 3

Daklinza & Sovaldi

EPCLUSA

Sovaldi & Ribavirin

Mavyret

Cost: $90K on average

GENOTYPE 4,5,6

Technivie (4)

EPCLUSA

Zepatier

Mavyret

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http://hepc.liverfoundation.org/treatment/the-basics-about-hepatitis-c-treatment/medication-regimens-according-to-genotype/

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What are the treatment recommendations?GENOTYPE 3

Daklinza & Sovaldi

EPCLUSA

Sovaldi & Ribavirin

Mavyret

GENOTYPE 4,5,6

Technivie (4)

EPCLUSA

Zepatier

Mavyret

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http://hepc.liverfoundation.org/treatment/the-basics-about-hepatitis-c-treatment/medication-regimens-according-to-genotype/

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What are the treatment recommendations?PANGENOTYPIC

EPCLUSA

12 weeks

1 pill once a day

Treating Heartburn

Renal Insufficiency

OPTIONS

Mavyret

8 weeks

3 pills once a day

Birth control

Renal insufficiency

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Response rates and side effectsRESPONSE RATES ARE 95-100% EVEN IN CIRRHOTIC PATIENTS!

Side effects are minimal as the effects of treatment are in the cell not systemic

LESS THAN 16%

Fatigue

Nausea

Diarrhea

Headache

Insomnia

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Who Should Be Treated for HCV Infection?Short answer: everyone

AASLD/IDSA: “the panel continues to recommend treatment for all pts with chronic HCV infection, except those with short life expectancies who cannot be remediated by treating HCV, by transplantation, or by other directed therapy”

RAPSILBER 2018 DO NOT REPRODUCE WITHOUT PERMISSIONSlide credit: clinicaloptions.comAASLD/IDSA. HCV guidance. September 2016.

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What is the treatment process?Assess patient for treatment readiness◦ Compliance◦ Substance abuse / ETOH

Genotype and viral load

Fibrotic score◦ F0-F4◦ cirrhosis

Urine tox screen***

Contraindicated medications

Vaccinate

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What is the treatment process?Prior authorization

Specialty Pharmacy

Foundation support

Coverage overall

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Who should be administering treatment?GI Specialist

Infectious Disease

Primary care◦Low risk

◦Compliant

◦Non-cirrhotic

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Can we reverse the effects of HCV damage on the liver?Achieving cure, or SVR

Lower rates of hepatocellular carcinoma

Improvements in disease complications: ◦ascites

◦hepatic encephalopathy

◦variceal bleeding

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Bruno S et al. Hepatology. 2007;45(3):579-587.Singal AG et al. Clin Gastroenterol Hepatol. 2010;8(3):280-288.e1

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Management of F3-F4 CuresFollowed every 6 months

US

Labs: PT, CMP, CBC

MELD◦Determines morality risk

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MELDDialysis at least twice in the past week

Creatinine: Norm: 0.7 - 1.3 mg/dL

Bilirubin: Norm: 0.3 - 1.9mg/dL

INR: Norm: 1 - 2

Sodium: Norm: 136 – 145 mEq/L

The four MELD levels are:◦ greater than or equal to 25

◦ 24-19

◦ 18-11

◦ less than or equal to 10

No Yes__

_________________

_________________

_________________

_________________

Average MELD for Transplant

26-33

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(2017, April 24). Retrieved from: https://www.mdcalc.com/meld-score-model-end-stage-liver-disease-12-older

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Management of CirrhosisLabs: q3-6 months

US/MRI HCC screening Q6 months

EGD: assess for varices

Alcohol

Vaccination

Hepatic Encephalopathy

Bleeding◦ Thrombosis

Paracentesis for ascites◦ Albumin

◦ SBP

◦ SBP prophylaxis

Weights

Diuretics

Sodium restriction

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Takeaways

Screen

Diagnose

Refer

Treat

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Screen

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Screen1945 – 1965

Ask about blood transfusions

Surgeries◦ GYN

◦ Ortho

Do not miss opportunities to screen

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10

~

100

ScreenRegardless of Liver Enzymes

• Patients can have HCV but have normal LFT results

• Approximately 30% of patients with chronic HCV infection have persistently normal ALT levels

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Healey CJ et al. Gut. 1995;37(2):274-278.Puoti C et al. J Viral Hepat. 2012;19(4):229-235.

101

Diagnose

If the Result Is Negative

• It is highly unlikely your patient has been exposed to HCV

• However, if exposure is suspected in the past 6 months, consider re-testing for HCV antibodies or ordering an HCV RNA test

If the Result Is Positive• Your patient has been exposed to HCV

• You will need to confirm a chronic HCV diagnosis with an HCV RNA test

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Diagnose

• The patient has been exposed to HCV but is not chronically infected

• Approximately 20%-50% of patients clear HCV spontaneously

• Such patients do not need further medical evaluation for HCV infection

POSITIVE RESULTS FROM HCV ANTIBODY TEST

• The patient should be referred to an HCV specialist for additional tests and treatment evaluation

• Further testing includes a genotype test and may include a liver biopsy and/or liver ultrasound to determine disease progression

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Refer to a SpecialistNP WELLNESS CARE, LLC

BRINGING TREATMENT TO THE PATIENT

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Always Follow Up25% TO 50% OF HCV PATIENTS MISS THEIR F IRST APPOINTMENT WITH A SPECIALIST

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. Holmberg SD et al. N Engl J Med. 2013;368(20):1859-1861. 2. McGowan CE, Fried MW. Liver Int. 2011;32(suppl 1):151-156.

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Thank [email protected]

[email protected]

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