What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45%...

14
5/16/2018 1 Lisa Sullivan, NP Digestive Disease Medicine of Central New York Discover the increasing burden of hepatitis C virus (HCV) Understand that HCV is a curable disease Consider your role in screening, diagnosing, and referring patients Today’s Presentation Goals What Is HCV?

Transcript of What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45%...

Page 1: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

1

Lisa Sullivan, NPDigestive Disease Medicine of Central New York

• Discover the increasing burden of hepatitis C virus (HCV) 

• Understand that HCV is a curable disease

• Consider your role in screening, diagnosing, and referring patients

Today’s Presentation Goals 

What Is HCV?

Page 2: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

2

• An RNA virus that used to be known as non‐A,  non‐B hepatitis until it was discovered in 19881

• No vaccine available

• First therapy approved in 19912

• Before 2011, HCV treatment could last as long as a year, with cure† (SVR) rates of 40%–50%3*

• Since that time, scientific advances have made HCV treatment shorter (as few as 12 weeks) and more effective4

• Interferon‐free treatment options are available that have shown cure rates of approximately 95% in clinical studies4,5†

†Cure, also known as sustained virologic response (SVR), is defined as no detectable  HCV in the blood at least 12 weeks after completion of therapy4,5

*For most genotypes in the United States

1. CDC. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19):1-39. 2. Swartz ML. Gastroenterol Nurs. 1991;14(1):40-43. 3. Ghany MG et al. Hepatology. 2011;54(4):1433-1444. 4. AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http:/www.hcvguidelines.org. Accessed July 18, 2016. 5. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. May 2016.

HCV History

• HCV Genotypes

‐ 6 HCV Genotypes and varies by geography

Genotype 1 most common in the United States and accounts 

for about 76% of HCV infections.

Genotype 2 is about 12%

Genotype 3 is about 10%

Genotypes 4,5 & 6 about 2%

Impact of HCV

Page 3: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

3

HCV Is Underdiagnosed and Undertreated

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

AN ESTIMATED 3.5 MILLION AMERICANS HAVE CHRONIC HCV1

Meta-analysis from articles published between January 2003 and July 2013

*Successfully treated = Achieved cure

EPIDEMIOLOGY AND DISEASE IMPACT

BABY BOOMERS ARE AT HIGH RISK FOR HCV1

References: 1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. Allison WE et al. J Emerg Med. 2016;50(6):825-831.e2. 3. USPSTF. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-c-screening. Accessed December 14, 2016. 4. AASLD, IDSA, IAS-USA. http://www.hcvguidelines.org. Accessed September 21, 2017.

OF PATIENTS INFECTED WITH HCV ARE BABY BOOMERS

(born 1945–1965)1

60% don’t know they are infected2

The CDC, USPSTF, and AASLD recommend a one-time screening of all baby boomers1,3,4

CDC = Centers for Disease Control and Prevention USPSTF = US Preventive Services Task Force AASLD = American Association for the Study of Liver Diseases

8

Liver Complications Due to HCV Are Continuing to Increase1

1. CDC. MMWR Morb Mortal Wkly Rep. 2013;62(18):357-361. 2. Davis GL et al. Gastroenterology. 2010;138(2):513-521.3. El-Serag HB. Gastroenterology. 2012;142(6):1264-1273.e1.

30% of untreated HCV patients will

progress to cirrhosis by 20159

• In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302

• HCV is a progressive disease.2

Patients who develop cirrhosis are at greater risk for developing liver cancer and other liver‐related complications3

Page 4: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

4

1. Kim WR et al. Am J Transplant. 2014;14(suppl 1):69-96. 2. CDC. http://www.cdc.gov/nchhstp/newsroom/docs/HCV-TestingFactSheetNoEmbargo508.pdf. Accessed July 18, 2016. 3. Biggins SW et al. Liver Transpl. 2012;18(12):1471- 1478. 4. El-Serag HB. Gastroenterology. 2012;142(6):1264-1273.e1. 5. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32.

Liver Complications also Contribute to a Shorter Life Span for HCV Patients5

In the United States, HCV is the Leading Cause of Liver Transplantation1 and Liver Cancer2

• 41% of patients registered for liver transplants have HCV3

• 50%–60% of patients with hepatocellular carcinoma are infected with HCV4

HCV ECONOMIC BURDEN OF DISEASE

~25%

ESLD = end-stage liver disease

HCC = hepatocellular carcinoma

The percentages above are estimated.

References: 1. Sebastiani G et al. World J Gastroenterol. 2014;20(32):11033-11053. 2. Klevens RM et al. Clin Infect Dis. 2012;55(S1):S3-S9. 3. Biggins SW et al. Liver Transpl. 2012;18(12):1471-1478.

LIVER DISEASES CAUSED BY HCVINCREASE IN SEVERITY OVER TIME

11

80%of those infected with HCV

may develop chronic disease1

10%–20%

of HCV patients

progress to cirrhosis within 20-30 years1

≥25%of HCV

cirrhotic patients may develop ESLD

or HCC2

1%–5%of HCV patients develop

HCC within 20–30 years1

41%of registrants

for liver transplantwere for

HCV-related liver disease3

1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. Ly KN et al. Ann Intern Med. 2012;156(4):271-278.3. Holmberg S, Ly KN, Xing J, Moorman AC. Rising mortality from hepatitis C virus in the United States, 2002-2013. Paper presented at: American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course; October 16-21, 2015; Honolulu, HI.

These Liver Complications Also Contributeto a Shorter Life Span for HCV Patients1

• In 2007, HCV patients died at a median age of 57 years. This is 20 years shorter than the average US life span1

• The HCV mortality rate surpassed that of HIV by 2007 and continued to rise2,3

HCV HAS A MORTALITY RATE THAT EXCEEDS HIVa

aExtended from: Ly KN et al. Ann Intern Med. 2012;156(4):271-278.

Page 5: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

5

1. Kim WR et al. Am J Transplant. 2014;14(suppl 1):69-96. 2. CDC. http://www.cdc.gov/nchhstp/newsroom/docs/HCV-TestingFactSheetNoEmbargo508.pdf. Accessed July 18, 2016. 3. Biggins SW et al. Liver Transpl. 2012;18(12):1471- 1478. 4. El-Serag HB. Gastroenterology. 2012;142(6):1264-1273.e1. 5. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32.

Liver Complications also Contribute to a Shorter Life Span for HCV Patients5

In the United States, HCV is the Leading Cause of Liver Transplantation1 and Liver Cancer2

• 41% of patients registered for liver transplants have HCV3

• 50%–60% of patients with hepatocellular carcinoma are infected with HCV4

1. Ly KN, Hughes EM, Jiles RB, Holmberg SD. Clin Infect Dis. 2016;62(10):1287-1288.

More People Die from HCV than from 60 Other Infectious Diseases Combined (Including HIV, Pneumococcal Disease, and Tuberculosis)1

ANNUAL NUMBER OF HCV-RELATED DEATHS VS. OTHER NATIONALLY NOTIFIABLE INFECTIOUS CONDITIONS

IN THE UNITED STATES, 2003-20131

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

Mixed cryoglobulinemia vasculitis

Lymphoproliferative disorders 

Peripheral neuropathya

Membranoproliferative glomerulonephritisa

Insulin resistance 

Cutaneous manifestations (eg, lichen planus,

porphyria cutanea tarda, palpable purpuraa)

aSecondary to mixed cryoglobulinemia vasculitis

HCV Is a Systemic Disease that May Affect Organs Other than the Liver1‐16

1. AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 18, 2016.2. Jacobson IM et al. Clin Gastroenterol Hepatol. 2010;8(12):1017-1029. 3. Adinolfi LE et al. World J Gastroenterol. 2015;21(8):2269-2280. 4. Younossi ZM et al. Aliment Pharmacol Ther. 2013;37(6):647-652. 5. Younossi ZM et al. Aliment Pharmacol Ther. 2014;39(5):518-531. 6. Park H et al. J Viral Hepat . 2015;22(11):897-905. 7. Molnar MZ et al. Hepatology. 2015;61(5):1495-1502. 8. Gonzalez HC et al. Dig Dis Sci. 2015;60(6):1820-1824. 9. Huang H et al. PLoS One. 2013;8(11):e81305. 10. Huang H et al. PLoS One. 2014;9(9):e106376. 11. Thames AD et al. Neurol Neuroimmunol Neuroinflamm. 2015;2(1):e59. 12. Wong RJ et al. Dig Dis Sci. 2014;59(7):1586-1593. 13. Pothineni NV et al. Am J Cardiol. 2014;114(12):1841-1845. 14. Lai JC et al. Dig Dis Sci. 2015;60(6):1813-1819. 15. White DL et al. J Hepatol. 2008;49(5):831-844. 16. Clifford DB et al. Neurology. 2015;84(3):241-250.

Extrahepatic Manifestations

Page 6: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

6

POSSIBLE INCREASED RISK FORb: Neurologic impairment/disorders Stroke

Coronary artery disease/ischemicheart disease

Associated Extrahepatic Conditions INCREASED RISK FOR: 

Depression 

Carotid atherosclerosis/atherothrombosis 

Type 2 diabetes mellitus 

Hypertension 

Congestive heart failure 

Chronic kidney disease 

End‐stage renal disease  

Kidney cancer 

Other renal manifestations (eg, glomerulonephritis, proteinuria)a

Low bone mineral density (BMD) 

Rheumatologic manifestations (eg, polyarthralgia, polyarthritis)a

Fatigue        

1. AASLD, IDSA, IAS‐USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 18, 2016. 2. Jacobson IM et al. Clin Gastroenterol Hepatol. 2010;8(12):1017‐1029. 3. Adinolfi LE et al. World J Gastroenterol.  2015;21(8):2269‐2280. 4. Younossi ZM et al. Aliment Pharmacol Ther. 2013;37(6):647‐652. 5. Younossi ZM et al. Aliment PharmacolTher. 2014;39(5):518‐531. 6. Park H et al. J Viral Hepat. 2015;22(11):897‐905. 7.Molnar MZ et al. Hepatology.  2015;61(5):1495‐1502. 8. Gonzalez HC et al. Dig Dis Sci. 2015;60(6):1820‐1824. 9. Huang H et al. PLoS One. 2013;8(11):e81305. 10. Huang H et al. PLoS One. 2014;9(9):e106376. 11. Thames AD et al. Neurol Neuroimmunol Neuroinflamm. 2015;2(1):e59. 12. Wong RJ et al. Dig Dis Sci. 2014;59(7):1586‐1593. 13. Pothineni NV et al. Am J Cardiol. 2014;114(12):1841‐1845. 14. Lai JC et al. Dig Dis Sci. 2015;60(6):1813‐1819. 15. White DL et al. J Hepatol. 2008;49(5):831‐844. 16.Clifford DB et al. Neurology. 2015;84(3):241‐250.111

aSecondary to mixed cryoglobulinemia vasculitisbConflicting or equivocal data from studies

HCV May Increase Risk for Diseases and Conditions Outside the Liver1‐16

HCV Can Be Cured

Unlike Some Chronic Conditions, HCV Can Be Cured 

DiabetesHypertensionHyperlipidemia1

HCVCURABLE

MANAGEABLE

1. Last AR, Ference JD, Falleroni J. Pharmacologic treatment of hyperlipidemia. Am Fam Physician. 2011;84(5):551-558.

Page 7: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

7

HCV does not integrate into the nuclei of infected cells, whereas HBV 

and HIV DNA are incorporated into the nucleus of the cell1

Why Is Cure Possible?

1. Soriano V et al. J Antimicrob Chemother. 2008;62(1):1-4.

*HBV cccDNA (covalently closed circular DNA): accumulates in hepatocyte nuclei, acting as a template for viral messenger RNA transcription.†HIV proviral DNA: integrates into the chromatin of infected cells, acting as the template for the transcription of viral genes.

Nucleus Host Cell Host DNA

Cure, also known as sustained virologic response (SVR), is defined as no detectable HCV in the blood at least 12 weeks after completion of therapy1,2

What Defines HCV Cure?

1. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. May 2016. 2. AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 18, 2016. 3. Swain MG et al. Gastroenterology. 2010;139(5):1593-1601.

• In some instances, HCV treatment does not result in cure, or SVR, because the virus does not reach undetectable levels or because it does not stay undetectable after therapy completion

• In one study, of those patients who reached SVR, 99% had undetectable levels of HCV RNA up to 5 years after cessation of treatment. These patients do not experience viral recurrence and may be considered to be cured3

• Achieving cure, or SVR, can lead to lower rates of hepatocellular carcinoma, as well as improvements in disease complications, such as ascites, hepatic encephalopathy, and variceal bleeding1,2* 

Cure Can Lead to Improvements in Disease Complications and Mortality

SVR is also associated with reduced risk of all-cause mortality3†

*Studies utilized SVR24, the standard protocol before 2013 for measuring attainment of SVR.4

†These data are from an international, multicenter, long-term follow-up study from 5 large tertiary-care hospitals in Europe and Canada. Patients with chronic HCV infection started an interferon-based treatment regimen between 1990 and 2003 (n=530).

1. Bruno S et al. Hepatology. 2007;45(3):579-587. 2. Singal AG et al. Clin Gastroenterol Hepatol. 2010;8(3):280-288.e1.3. van der Meer AJ et al. JAMA. 2012;308(24):2584-2593. 4. Scott JD. Goals for treatment and predicting response. Hepatitis C Online Web site. http://www.hepatitisc.uw.edu/go/evaluation-treatment/treatment-goals- predicting-response/core-concept/all#goals-rationale-treatment. Updated January 20, 2016. Accessed December 1, 2016.

Page 8: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

8

Infected persons need to be promptly identified and given access to an HCV specialist to give them a potential chance for cure

• Approximately 1.75 million Americans are unaware of their chronic HCV infection1

• Risk‐based screening recommendations have proven ineffective at identifying all HCV patients, many of whom have no known exposure risk

Limited Success With Risk‐Based Screening

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

• 1 in 30 baby boomers has HCV4

• Chronic HCV is 5X more prevalent among baby boomers than any other adult age group5

• 60% of baby boomers with HCV don’t know they’re infected6

• Baby boomers experience more HCV-related morbidity and mortality7

• Over 90% of HCV-infected patients awaiting transplantation are baby boomers8

• 51% of HCV-related deaths in 2013 occurred among persons aged 55-64 years9

CDC, USPSTF, and AASLD Recommend the One‐Time Screening of All Baby Boomers, Regardless of Risk Factors1‐3

1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. USPSTF. http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm/. Accessed July 18, 2016. 3. AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 18, 2016. 4. Centers for Disease Control and Prevention. CDC now recommends all baby boomers receive one-time hepatitis C test [press release]. http://www.cdc.gov/nchhstp/newsroom/2012/HCV-Testing-Recs-PressRelease.html. Updated December 27, 2013. Accessed July 18, 2016. 5. Centers for Disease Control and Prevention. Hepatitis C: why people born from 1945-1965 should get tested. https://www.cdc.gov/ knowmorehepatitis/media/pdfs/factsheet-boomers.pdf. Updated 2016. Accessed October 6, 2016. 6. Allison WE, Chiang W, Rubin A, Oshva L, Carmody E. J Emerg Med. 2016;50(6):825-831.e2. 7. Ryerson AB, Eheman CR, Altekruse SF, et al. Cancer. 2016;122(9):1312-1337. 8. Perumpail RB et al. Current trends in l iver transplantation among HCV-infected baby boomer generation in the United States: a case for birth-cohort screening. Paper presented at: 66th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 13-17, 2015; Boston, MA. 9. Ly KN et al. Clin Infect Dis. 2016;62(10):1287-1288. 10. Centers for Disease Control and Prevention. Hepatitis C: proposed expansion of testing recommendations, 2012. http://www.cdc.gov/nchhstp/newsroom/docs/HCV-TestingFactSheetNoEmbargo508.pdf. Accessed July 18, 2016.

10

~

Baby boomers: born between 1945 and 1965

These patients may have been infected for 20 years or more10

Page 9: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

9

1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. USPSTF. http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm. Accessed July 18, 2016. 3. AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm. Accessed July 18, 2016.

In Addition to Baby Boomers, the CDC, USPSTF, and AASLD Recommend Screening Other High‐Risk Populations1‐3

Screen Regardless of Liver Enzyme Levels,Symptoms, or Risk Factors1,2

1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. USPSTF. http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm. Accessed July 18, 2016. 3. Healey CJ et al. Gut. 1995;37(2):274-278. 4. Puoti C et al. J Viral Hepat. 2012;19(4):229-235. 5. Allison WE, Chiang W, Rubin A, Oshwa L, Camody E. J Emerg Med. 2016;50(6):825-831.e2.

• Patients can have HCV but have normal LFT results3

• According to a review by Puoti et al, approximately 30% of patients with chronic HCV infection have persistently normal ALT levels4

LFT = Liver function testALT = Alanine transaminase

A study predicts that targeted screening of baby boomers can identify 800,000 new cases and could help prevent

120,000 deaths5

• HCV is screened using a simple blood test to detect the presence of antibodies against HCV

• A positive antibody test is an indicator of exposure to HCV

• Talk with the patient before screening

• Explain why he/she should be screened

• Tell the patient that HCV is a progressive disease1

• Describe the screening process 

How to Screen

1. Davis GL et al. Gastroenterology. 2010;138(2):513-521. 2. Feldstein A et al. J Am Geriatr Soc. 2006;54(3):450-457.

Consider selecting a lab’s ‘reflex-testing’ option at the screening step so an HCV RNA test will be run automaticallyif the antibody test is positive.

Enable an EHR flag or standing order as a reminder to screen patients.

Page 10: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

10

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

Next Steps After the HCV Antibody Test Results

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

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

• Approximately 20%-50% of patients clear HCV spontaneously1

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

To confirm the diagnosis, a blood test for the presence of HCV RNA is necessary

Confirm the Diagnosis

1. AASLD, IDSA, IAS-USA. Recommendations for testing, managing and treating hepatitis C. http://www.hcvguidelines.org.Accessed July 18, 2016.

POSITIVE RESULTS FROM HCV ANTIBODY TEST

HCV RNA Not Detected HCV RNA Detected

• 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

Page 11: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

11

• The patient is not chronically infected with HCV

• No further medical evaluation for HCV infection is required

• Discuss the results with the patient

• Tell the patient that he/she is not chronically infected and no further testing or treatment is needed

• Confirm that he/she understands how the virus is spread and the situations in which he/she could be exposed

• Explain that he/she will always test positive for HCV antibodies1

What to Do if HCV RNA Is Not Detected

1. CDC. http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGettingTested.pdf. October 2013. Accessed July 18, 2016.

What to Do if HCV RNA Is Detected

• Patient is infected with HCV

• Consider ordering an HCV genotype test (optional)

• Refer patient to an HCV specialist for additional tests and treatment evaluation

• Discuss the diagnosis with the patient• Tell your patient that he/she is infected with HCV and will

be referred to a specialist for more tests and possible treatment

• Explain that HCV is a progressive disease that can lead to serious complications

• Emphasize that HCV can be curable, and treatment options are available

Page 12: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

12

Patients Should be Referred to an HCV Specialist for Treatment Evaluation Regardless of Symptoms or Test Results1

• Viral load is not an indicator of disease progression or severity2

• Liver function test results may be unreliable when evaluating disease progression2

• Liver damage is possible in the presence of low viral loads and normal ALT or AST levels3,4

Refer Diagnosed Patients to an HCV Specialist

1. USPSTF. http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm. Accessed July 18, 2016. 2. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 3. Heller T, Seeff LB. Hepatology. 2005;42(6):1261-1263. 4. Healey CJ et al. Gut. 1995;37(2):274-278.

Treatment has been shown to be more effective at early-stage disease1

• Patients without advanced fibrosis are more likely to have an earlier treatment response associated with higher SVR rates1

• Patients with advanced liver damage show a lower response to treatment1

• Progression of fibrosis is unpredictable, so patients should be evaluated by an HCV specialist2

Prompt Referral Is Vital: Give Your HCV Patients the Best Chance of Cure

1. Bruno S et al. Hepatology. 2010;51(2):388-397. 2. Poynard T et al. Lancet. 1997;349(9055):825-832.

25% to 50% of HCV patients miss their first appointment with a specialist1Patient nonadherence is a major barrier to specialist evaluation2

There are several common reasons:• Patients may not recognize the urgency of treating a disease with few symptoms2

• Lack of insurance coverage2

• Fear of social rejection and stigmatization2

Counseling your patient and providing a quality referral can help ensure that a patient will follow through to see his/her HCV specialist.

Patient Follow-Up After Referral

1. 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.

Page 13: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

13

A Quality Referral Can Help Overcome BarriersWhat Makes a Quality Referral?

• Confirmed diagnosis with an HCV RNA test

• Referring to a specialist with experience treating HCV

• Arranging the appointment for the patient

• Following up with the patient to ensure he/she attended the appointment

• Explain why referral is necessary

• Describe the liver complications that can arise from delaying treatment

• Tell your patient what to expect

• Make it clear that therapy can lead to cure

• Assure your patient that you will stay in contact

Discuss Referral With Your Patient

• HCV screening criteria have been expanded to include screening of all baby boomers(born between 1945 and 1965)1-3

• Treatment options have evolved

• Scientific advances have made HCV treatment shorter (as few as 12 weeks) and more effective3

• Interferon-free treatment options are available that have shown cure rates of approximately 95% in clinical studies3,4

• Cure, or SVR, is defined as no detectable HCV in the blood at least 12 weeks after completion of therapy3,4

HCV Management Has Evolved, Making Cure More Possible for Patients

1. Smith BD et al. MMWR Recomm Rep. 2012;61(RR-4):1-32. 2. USPSTF. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-c-screening. Accessed December 14, 2016. 3. AASLD, IDSA, IAS-USA. Recommendations for testing, managing,and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 18, 2016. 4. US Department of Health and Human Services, Center for DrugEvaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. May 2016.

Page 14: What Is HCV? · HCV patients will progress to cirrhosis by 20159 •In a study, approximately 45% of untreated HCV patients were projected to develop cirrhosis by 20302 •HCV is

5/16/2018

14

Rethink HCV

SCREEN all baby boomers and at-risk individuals for HCV antibodies.

DIAGNOSE all HCV antibody-positive patients with an HCV RNA test.

REFER diagnosed patients to an HCV specialist.