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Hepatitis C Update: key issues along the care continuum

Hepatitis C Update: key issues along the care continuum. Oluwatoyin ( Toyin ) Adeyemi, MD Director, CORE Viral hepatitis Clinic Senior director for HIV services, Cook County Health. Triple Threat 11: HIV, HCV & Opiods Dusable Museum , June 25, 2019.

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Hepatitis C Update: key issues along the care continuum

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  1. Hepatitis C Update: key issues along the care continuum Oluwatoyin ( Toyin) Adeyemi, MD Director, CORE Viral hepatitis Clinic Senior director for HIV services, Cook County Health Triple Threat 11: HIV, HCV & Opiods Dusable Museum , June 25, 2019

  2. Treatment Cascade for People With Chronic HCV InfectionUS 2003−2013 Identified Chronic HCV-Infected Population, % RNA, ribonucleic acid; SVR, sustained virologic response. Yehia B. PLoS One. 2014;9(7):e101554.

  3. Multidisciplinary Hepatitis clinic established at CORE in Sept 2001 • The CORE Center is 1 of 7 sites where we provide HIV care and 1 of 3 where we treat HCV. • 1stfibroscan in the state of Illinois in 2014. • HCV birth cohort (1945-1965) testing system-wide in October 2016. Reflex HCVRNA testing in late 2017. • 910 (another 40 to start)HCV patients treated at the CORE hepatitis clinic. SVR (cure) 96% to date Ruth M. Rothstein CORE Center, Cook County Health

  4. Lecture Overview • Epidemiology • Who needs to be screened? • How do you make the diagnosis? Assess severity? • What are the treatment options and cure rates? • After the cure, now what?

  5. 1 slide Bottom line • Many with HCV infection don’t know. • Simple blood test (or oral swab)*to diagnose HCV • Untreated HCV can lead to liver failure, liver cancer and death in some patients. • Effective , well tolerated oral agents available that can CURE HCV in over 95% of people. • HCV cure reduces risk of liver decompensation by 90%, Liver cancer by 70% and improves overall quality of life. • We have the tools to eliminate HCV infection in the US

  6. HCV Burden Is Higher in Marginalized Populations • These populations experience: • High burden of comorbidities • Inconsistency of HCV testing • Limited access to HCV care Implementation of research strategies and interprofessional collaborative efforts are essential to target these populations Denniston M, et al. Ann Int Med. 2014;160(5):293–300; Edlin BR, et al. Hepatology. 2015;62(5):1353–1363; Grebely J, et al. Inl J Drug Policy. 2015;26(10):1028–1038; Maier MM, et al. 2016;106(2):353–358; Galbraith JW, et al. Hepatology. 2015;61(3):776–782; Backus L, et al. Fed Pract. 2018;35(2):S8–S12.

  7. High Seroprevalence of HCV in Certain Subpopulations Baby boomers represent 75% of those living with HCV and 78% of deaths attributed to HCV. More than 15,000deaths/year1 HCV prevalence is 6.7% among HIV+ MSM who do not inject drugs;prevalenceis 40% among HIV+ MSM who inject drugs2 MSM Baby BoomerBirth Cohort People in Prisons and Jails HCV prevalence in corrections is estimated to be between ~10% and 45%4,5 HCV prevalence among PWID is estimated to be 70%−77%3 Among migrants from intermediate and high endemic countries, HCV seroprevalence of >2% is reported: a level higher than that reported for most host populations6 PWID Migrants

  8. But the Face of HCV Is ChangingAn Increasingly Bimodal Age Distribution Baby Boomers: Born Between 1945 and 1965 Younger Adults: Born Between 1975 and 1995 180 160 100 140 120 80 60 40 20 0 Newly Reported HCV Diagnoses in 2012 and 2016 by Year of Birth, Chicago Diagnosis Year 2012 2016 Diagnoses, N 1911 1915 1919 1922 1925 1979 1982 1985 1988 1991 1994 1997 2000 1928 1931 1934 1937 1940 1943 1946 1949 1952 1955 1958 1961 1964 1967 1970 1973 1976 2004 2007 Year of Birth CDPH. Hepatitis C Surveillance Report ‒ Chicago, 2016. 2018. https://www.chicago.gov/content/dam/city/depts/cdph/CDPH/Healthy%20Chicago/2016ChicagoHCVReport_FINAL_07272018b.pdf. Accessed May 20, 2019.

  9. US Trends for Acute HCV Casesand Drug Overdose-Related Deaths Reported Cases of Acute HCV (2001–2016) Drug Overdose Death Rates (1999–2017) Synthetic opioids other than methadone 3,500 Number of Cases 10 3,000 2,500 Deaths per 100,000 Standard Population 8 2,000 1,500 6 1,000 Heroin 500 4 0 2010 2001 2013 2004 2007 2016 2 Year Year ~69% of people with acute HCV infection reported injection-drug use 0 2001 2005 2007 2009 2015 2017 2003 2013 2011 1999 Centers for Disease Control and Prevention (CDC). Viral Hepatitis Surveillance – United States, 2016. https://www.cdc.gov/hepatitis/statistics/2016surveillance/pdfs/2016HepSurveillanceRpt.pdf. Accessed 5/8/2019; CDC. Drug Overdose Deaths in the United States, 1999–2017. https://www.cdc.gov/nchs/products/databriefs/db329.htm. Accessed 5/8/2019.

  10. HCV is increasing in the younger population:Incidence of acute hepatitis C, by age group — United States, 2000–2014 Source: CDC, National Notifiable Diseases Surveillance System (NNDSS)

  11. Circumstances and Risks Faced by PWIDRecognizing the Constellation Prevailing backdrop of economic, legal, and social hardships:Marginalization1,2 Polysubstance abuse4 Transactional sex6,7 Mental illness3 Intimate-partner violence (domestic abuse)5 Incarceration8,9

  12. Estimated 58,000 persons living with HCV in Illinois People Living With HCV in Chicago, 2016Distribution and Socioeconomic Correlates Cases per 100,000 Population HCV Prevalence • Highest impacted communities • Southside: Fuller Park, Washington Park, Grand Boulevard, Englewood, Douglas, West Englewood, Oakland, Woodlawn, Greater Grand Crossing • Westside: East Garfield Park, Near West Side, West Garfield Park, North Lawndale, Austin, Humboldt Park • Northside: Uptown • Per Healthy Chicago 2.0 • Higher rates of economic hardship, unemployment, blood lead levels among children, infant mortality, STIs, and firearm‐related homicides • Lower rates for child opportunity, high school graduation, and life expectancy 232.4-449.7 449.8-694.2 694.3-1034.5 1034.6-1357.1 1357.2-2260.1 STI, sexually transmitted infection. Chicago Department of Public Health (CDPH). Hepatitis C Surveillance Report ‒ Chicago, 2016. 2018. https://www.chicago.gov/content/dam/city/depts/cdph/CDPH/Healthy%20Chicago/2016ChicagoHCVReport_FINAL_07272018b.pdf. Accessed May 27, 2019.

  13. Other Demographic Characteristics and Prevalence of HCVNHANES and Chicago DPH Data NHANES: HCV Prevalence, by Demographic Characteristic, 2001‒20101 Chicago DPH: HCV Prevalence, by Selected Demographic Characteristic, 20162 All Patients Identified as Having HCV, % Patient Characteristic AI/AN, American Indian/Alaska Native; H, Hispanic; HIV, human immunodeficiency virus; NHB, non-Hispanic black; NHW, non-Hispanic white; Neg, negative; NHANES, National Health and Nutrition Examination Survey 2001 through 2010; PIR, poverty index ratio; Pos, positive. 1. Ditah I, et al. J Hepatol. 2014;60(6):691-698; 2. CDPH. 2018. https://www.chicago.gov/content/dam/city/depts/cdph/CDPH/Healthy%20Chicago/2016ChicagoHCVReport_FINAL_07272018b.pdf. Accessed May 27, 2019.

  14. African Americans and HCV infection • Africans Americans comprise approximately 11% of the U.S. population, but represent 25% of people with chronic hepatitis C infections • African Americans aged 20 to 59 are 1.6 times more likely to be chronically infected with hepatitis C compared to other races. • African Americans aged 60 and older are 10 times more likely to be chronically infected with hepatitis C compared to other races.

  15. “The National Viral Hepatitis Action Plan 2017-2020 includes a focus on African Americans as one of the priority populations impacted by viral hepatitis. One of our national goals is to reduce health disparities in viral hepatitis, including reducing deaths among African Americans related to viral hepatitis infection. Only by working together and in the communities most impacted by viral hepatitis can we achieve this goal and improve the health and lives of people across the nation”. GTZillinois.HIV/plan Goal 20 – Reduce STIs and viral hepatitis Reduce the burden of sexually transmitted infections (STIs) and Viral Hepatitis, among people living with or vulnerable to HIV. Strategy 66– Cure 50% of hepatitis C cases among people living with HIV.

  16. ↓90% new HCV infections ↓60% New HCV infections ↑22% Persons aware of HCV status National Goals for HCV Elimination ↓65% HCV-related deaths ↓25% HCV-related deaths ↓ Health disparities across HCV patient populations DHHS—National Viral Hepatitis Elimination Goals by 2020 National Academies of Sciences—Viral Hepatitis Elimination Goals by 2030 Department of Health and Human Services (DHHS). National Viral Hepatitis Action Plan 2017–2020. www.hhs.gov. Accessed 5/17/19; The National Academies of Sciences, Engineering, and Medicine. A National Strategy for the Elimination of Hepatitis B and C: Phase 2 Report. Washington, DC: The National Academies Press; 2017.

  17. Deaths From Hepatitis C Have Surpassed Deaths From HIV Infection Age-adjusted Mortality Rates of HIV and Hepatitis C: United States, 1999-2010 Ly K.N et al., Annals of Int. Med, 2012: 157 (9)

  18. Projected Cases of Hepatocellular Carcinoma and Decompensated Cirrhosis Due to HCV 160,000 Peak incidence: 145,000 cases/year in 2020 140,000 Decompensated cirrhosis 120,000 100,000 Number of cases 80,000 Peak incidence: 14,000 cases/year in 2019 60,000 Hepatocellular cancer 40,000 20,000 0 1950 1960 1970 1980 1990 2000 2010 2020 2030 Year Davis GL, et al. Gastroenterology. 2010;138(2):513-521

  19. Complications of Cirrhosis HepaticDecompensationEvents Ascites/Peritonitis Variceal Hemorrhage Hepatic Encephalopathy PrimaryLiverCancer Hepatocellular Carcinoma (HCC)

  20. Pathogenesis of HIV/HCV Co-infection

  21. Screening for Hepatitis C

  22. 2012 CDC Birth Cohort HCV Testing Recommendations • CDC now recommends: • Age-based testing: All adults born during 1945–1965 should have 1-time testing without prior ascertainment of HCV risk • All persons identified with HCV should receive: • Alcohol screening • Intervention as clinically indicated • Referral to appropriate care • Post-test counseling CDC = Centers for Disease Control and Prevention. MMWR. 2012;61(RR04):1–18.

  23. Who needs to get screened for HCV?

  24. Sometimes, providers need (a lot of)Help. Figure I. Number of baby boomers screened for anti-HCV and percent increase, by site, pre- and post-implemention of eCDS, Cook County Health, August 2015 – September 2017

  25. How about Pregnancy?

  26. Testing for HCV- simple blood test

  27. Linkage to care

  28. Chronic HCV Counseling • Hepatitis A, B immunizations if non-immune • Pneumococcal vaccination for cirrhotics • Anti-HBV treatment if HBV-coinfected • Abstain from alcohol • Maintain BMI <25 kg/m2 • Limit acetaminophen to <2 gm/day • Avoid raw seafood (Vibrio infection) www.hcvguidelines.org

  29. Counseling Recommendations forHCV-Infected Individuals To Prevent HCV Transmission Additional Recommendations • Avoid sharing toothbrushes and dental or shaving equipment • Prevent blood contact with others • Stop using illicit drugs; those who continue to inject drugs should take precautions to avoid viral transmission • Risk of sexual transmission is low, but practice “safe sex” • Avoid alcohol consumption • Excess alcohol may lead to progressive liver disease, increased HCV RNA replication, and reduced response to treatment • Vaccinate for hepatitis A and B • Get tested for HIV • Encourage family members to get screened *If patient meets generally accepted indications for HCV treatment. Adapted from Ghany MG, et al. Hepatology. 2009;49:1335-1374.

  30. How to Determine Liver Fibrosis Stage Liver Biopsy Serum Markers Transient Elastography HCV FibroSure age (years) x AST (U/L) platelets (109/L) x ALT (U/L) AST (U/L) / AST (upper limit normal) platelets (109/L) Ultrasound Liver stiffness (kPa) Liver fibrosis FIB-4 = APRI = X 100 Sterling RK. Hepatology 2006;43:1317-25. Kirk GD et al. Clin Infect Dis 2009;48:963-72. Chou R. Ann Intern Med 2013;158:807-20.

  31. TransientElastography

  32. Transient Elastography: HCV

  33. Fibrosis Staging in HCV Determining fibrosis level is important as it may affect treatment regimen,duration of treatment, and determines the need for HCC screening post-cure AASLD/IDSA Guidance Initiating therapy in patients with lower-stage fibrosis augments the benefits of SVR SVR = Sustained Viral Response Ghany MG, et al. Hepatology. 2009;49(4):1335–1374; AASLD/IDSA. Recommendations for Testing, Managing, and Treating HCV. www.hcvguidelines.org. Accessed 7/18/18.Images courtesy of Zachary Goodman, MD.

  34. Poynard A. Antivir Ther. 2010;15(3):281-291; Poynard, et al. Lancet. 1997;349(9055):825-832. Risk Factors Associated with Faster Fibrosis Progression in Chronic HCV HCC Cirrhosis Normal Liver Host/Viral Factors Disease State Factors • Male gender • Age • Obesity • Diabetes • Metabolic syndrome • HIV, HBV co-infection • Immune system compromise • Steatosis • Iron overload • Genotype 3 • Fibrosis stage • Inflammation grade • Persistently elevated ALT Lifestyle Factors • Heavy alcohol consumption • Tobacco use

  35. Strategies for Enhanced Linkage • Patient-navigation models • Peer navigators • Tester/navigators • Nonpeer navigators • CBO-based navigators • Clinic-based navigators • Embedded models; ie, care within SUD treatment programs • Nurse-led models • Physician-led models • Mobile care models • Mixed models CBO, community-based organization; SUD, substance use disorder. Bajis S, et al. Int J Drug Policy. 2017;47:34-46.

  36. Testing and Linkage to Care Protocol Rapid HCV antibody test reactive Blood draw for confirmatory HCV PCR HCV RNA not detected Patient navigator notifies patient and provides counseling HCV RNA detected Patient navigator notifies patient and provides counseling + insurance assessment Uninsured Insured with no known primary care provider Insured with a primary care provider Patient navigator facilitates appointment with clinical social worker Patient navigator facilitates PCP acquisition PCP Visit Obtain referral to subspecialist PCP, primary care provider; PCR, polymerase chain reaction. Protocol courtesy of Stacey Trooskin, MD, PhD. 2017.

  37. Treatment and CURE

  38. Barriers to care and cure include • Psychosocial comorbidities • Substance use disorder (SUDs) • Untreated mental health issues • Transportation • Incarceration • Homelessness or unstable housing • Drug-drug interactions • Complicated prior-approval processes and denials • Providers’ lack of awareness of Ryan White ADAP coverage of HCV treatment and/or lifting of fibrosis restrictions

  39. Benefits of Achieving SVR (CURE) SVR • Improved Hepatic Outcomes • Improved Extra-Hepatic Outcomes • Viral Eradication • Decreased Transmission • Improved liver histology • Reduced: • Decompensation/HCC/Transplantation • Liver-related mortality • Improved QOL/mental health • Reduced • Overall mortality • Non-liver malignancy • Diabetes/CVD/CKD QOL = Quality of Life; CVD = Cardiovascular Disease; CKD = Chronic Kidney Disease. Yoshida EM, et al. Hepatology. 2015;61(1):41–45; Thorlund K, et al. Clin Epidemiol. 2014;6:49–58; van der Meer AJ, et al. JAMA. 2012;308(24):2584–2593; Smith-Palmer J, et al. BCM Infect Dis. 2015;15:19; Negro F, et al. Gastroenterology. 2015:149(6):1345–1360; Arase Y, et al. Hepatology. 2009;49(3):739–744; Arase Y, et al. J Med Virol. 2014;86(1):169–175; Hsu YC, et al. Hepatology. 2014;59(4):1293–1302.

  40. HCV Life Cycle and DAA Targets Adapted from Manns MP, et al. Nat Rev Drug Discov. 2007;6(12):991-1000.

  41. HCV DAAs Target Steps of HCV Life Cycle Slide credit: clinicaloptions.com 1. McCauley JA, et al. CurrOpinPharmacol. 2016;30:84-92. 2. Eltahla AA, et al. Viruses. 2015;7:5206-5224. 3. Gitto S, et al. J Viral Hepat. 2017;24:180-186.

  42. SVR12 (CURE) rates! We have come a long way….

  43. History and Evolving Landscape of HCV Therapy Approval Ledipasvir/Sofosbuvir OBV/PTV-R + DAS Approval pegIFN-alfa-2b Approval Telaprevir Boceprevir HCV Antibody Testing Approval Grazoprevir/Elbasvir Sofosbuvir/Velpatasvir Approval Glecaprevir/Pibrentasvir Genotype-Specific RGT Discovery of HCV (Chiron) Approval Ribavirin Approval Simeprevir Sofosbuvir Approval Sofosbuvir/Velpatasvir/ Voxilaprevir Approval Daclatasvir 1998 2016 2011 2014 2015 2013 1989 1992 1997 2017 2005 >90% SVR: 40% 6% 12% 20% 54% 65–75% pegIFN-alfa 2b = Peg-Interferon Alfa-2b; RGT = Response-Guided Therapy; OBV/PTV-R + DAS = Ombitasvir/Paritaprevir and Ritonavir+Dasabuvir (or 3D). Houghton M. Liver Int. 2009;29(Suppl 1):82–88; Carithers RL, et al. Hepatology. 1997;26(3 Suppl 1):S83–S88; Zeuzem S, et al. N Engl J Med. 2000;343(23): 1666–1672; Poynard T, et al. Lancet. 1998;352(9138):1426–1432; McHutchison JG, et al. N Engl J Med. 1998;339(21):1485–1492; Lindsay KL, et al. Hepatology. 2001;34(2):395–403; Fried MW, et al. N Engl J Med. 2002;347(13):975–982; Manns MP, et al. Lancet. 2001;58(9286):958–965; Poordad F, et al. N Engl J Med. 2011;364(13):1195–1206; Jacobson IM, et al. N Engl J Med. 2011;364(25):2405–2416; Lawitz E, et al. N Engl J Med. 2013;368(20):1878–1887; Jacobson IM, et al. Lancet. 2014;384(9941):403–413; Afdhal N, et al. N Engl J Med. 2014;370(20):1889–1898; Nelson DR, et al. Hepatology. 2015;61(4):1127–1135; Zeusem S, et al. Ann Intern Med. 2015;163(1):1–13; Feld JJ, et al. N Engl J Med. 2015;373(27):2599–2607; Foster GR, et al. N Engl J Med. 2015;373(27):2608–2617; Drygs@FDA: FDA Approved Drug products. https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed 5/9/2019.

  44. Factors to Consider in Selection of a DAA Regimen • HCV genotype: determines selection of DAA • Cirrhosis: duration of treatment • Drug-drug interactions: statins, PPI, ART(boosted/TDF) • Renal impairment: Mavyret and Zepatier(PI/NS5A) can be used safely • Prior treatment experience (Interferon, Ribavirin, DAAs): Resistance testing may be needed • SVR rates >95% among existing regimines • Insurance  Which DAA is on formulary?

  45. CORE hepatitis Clinic data (DAA experience 2015- through June 2019) • 923 HCV infected individuals treated (on rx/completed/SVR12) • 350 HIV/HCV co-infected • 733 have reached SVR with 96% SVR (cure) • Rapid increase in starts since 2019 ( Medicaid restrictions removed)

  46. After the Cure

  47. HCV Care Continues Past Achievement of SVR Diagnosis Linkage to care Treatment Cure • Persons at risk for infection: • Counseling • Harm reduction(injection and sex practices) • Surveillance for reinfection • Persons with advanced • fibrosis (stage 3/4) • Counseling • Harm reduction(alcohol and obesity) • Surveillance for HCC Falade-Nwulia O, J Hepatol, 2017.

  48. Harm Reduction www.hcvguidelines.org

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