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Challenges of Treatment of Hepatitis C in the Incarcerated US Population

Challenges of Treatment of Hepatitis C in the Incarcerated US Population. USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera MD, USPHS Kiesha Resto Pharm D, USPHS. Objectives.

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Challenges of Treatment of Hepatitis C in the Incarcerated US Population

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  1. Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera MD, USPHS Kiesha Resto Pharm D, USPHS

  2. Objectives #1) Compare Hepatitis C Virus (HCV) infections in prison population versus the regular population. #2) Analyze the challenges of identifying and treating prison population. #3) Review common & rare side effects that are related to Hepatitis C therapy. #4) Discuss challenges in treating patients with co-morbid conditions. #5) Review recent FDA approved medications for HCV.

  3. US Hepatitis Statistics Reference #4

  4. Population • Baby boomers account for 2 out of 3 cases of HCV patients. • Peak prevalence men born in early 1950’s • HCV is over-represented in African Americans. Reference #5

  5. Center of Disease Control & National Institutes of Health Convention January 2003 identified 5 optimal approaches to Screening & treating HCV in US prisons • #1 Testing of HCV in Prisons would identify many Infected Americans • #2 Prison Substance Abuse programs would decrease HCV infections & future prisons cost • #3 Patients can be Selected using Published Guidelines • #4 Prisons Treatment Reflects Community Standards and Require Sufficient Medical Workforce • #5 Collaboration Between Correctional & Public Health Systems is Needed Reference #14

  6. Factors for Treatment • Screening • Screening and Diagnosis of Hepatitis C individuals. • Screening for candidates for treatment • Safety , Efficacy & Cost • Monitoring Laboratories and ADR • Patient Tolerate treatment • Viral Response to treatment • EVR/SVR • Source of funding

  7. Hepatitis C Not a Routine Universal Screening Routine screening based on 4 criteria: • Amenable to treatment • Interfere with activities of daily living • Progress without treatment during time of incarceration • Risk of transmission Reference # 14

  8. To Screen or to Not Screen Rhode Island State Corrections Wisconsin State Corrections 91% HCV infected inmates identified through testing 27% of population with risk factor IVDA Indiana State Corrections Universal testing found 13% of population HCV (+) Screened all incoming inmate • 4263 Males – 23% + HCV • 499 Females – 40% HCV Out of inmates who tested + HCV 66% did not report high risk behaviors Reference #16 Reference #14

  9. USA and territories Incarcerated population 2008 Reference #3

  10. Break down of 2,424,279

  11. Summary of Assumptions of Paid Cost per Patient Per Month (PPPM) as of 2008 Reference #22

  12. Missed Opportunity Benefits for treatment during Incarceration • Lower cost in long run for HCV treatment • Stable living environment • Accessible medical care • High Risk Population • Direct Observed Medication • Abstinence from Substance abuse • Coordination between Rehabilitation programs and treatment

  13. Hepatitis C • Multiple Genotypes • 1 Most common (US) Approx. 80% • 2/3 US Approx 20% • 4 Egypt • RNA Virus • Family Flavovirus ( Denque, yellow fever)

  14. US Hepatitis C Statistics • Genotype 1 40-50% Successful SVR at 12 months • Genotype 2/3 70-80% Successful SVR at 12 months

  15. Contraindications to Ribavirin • Thalassemias (sickle cell anemia) or other hemoglobinopathy. • Significant cardiac disease (arrhythmias, angina, CABG, MI) in the past 12 months. • Renal dialysis or creatinine clearance < 50 mL/min. • Hypersensitivity to ribavirin • Pregnancy Reference #1

  16. Ribavirin Side Effects Black Box Warnings: • Hemolytic Anemia Warning (primarily in the first two weeks of therapy) • Pregnancy Warning. Negative pregnancy test is required pre-therapy & at every evaluation • Respiratory Warning for patients requiring assisted ventilation Reference #1

  17. Contraindication Peg-Interferon • Serious concurrent medical diseases; severe hypertension, heart failure, coronary heart disease, COPD , autoimmune disorders, uncontrolled endocrine disorder • Decompensate cirrhosis, History of solid organ transplant • Platelet count <75,000/mm3 or ANC <1,500 cells/mm3 • Ongoing injection drug use or alcohol use • Severe uncontrolled psychiatric disease Reference #1

  18. Reference # 6 & #7

  19. Management of Side Effects • Headaches/ Body aches • Tylenol • FLUIDS, FLUIDS, FLUIDS • NSAIDS!!!??? • Nausea & Vomiting • Promethazine

  20. Hemoglobin adjustment Reference #1

  21. Absolute Neutrophil Count (ANC) Adjustment Granulocyte Colony Stimulating Factor (G-CSF): If the patient is responding to treatment and neutropenia persists despite reduced peginterferon dose, consider G-CSFDosage: Filgrastim 300 microgram subcu. daily. Goal: ANC >1500 Reference #1

  22. Platelet Adjustment Reference #1

  23. Serious Adverse Reaction • Auto immune • Arrhythmias • Depression / Psychosis • CHF • Permanent thyroid dysfunction

  24. Patients with Co-morbid conditions • Pre-exiting Cardiac Condition • Renal Disease • Autoimmune Disease • Depression

  25. Case Studies Reference # 8-#10

  26. New Treatment Options

  27. Telaprevir (Incivek) Reference #20

  28. Boceprevir (Victrelis) Reference #21

  29. Adverse Effects

  30. Summary • Prison are an ideal setting to treat a large population of HCV (+) people. • Screening for HCV need to be examined cost/benefit per institution. • Treating patient while incarcerated can be a cost saving to society • HCV treatment is associated with multiple side effects that need an educated multidiscipline approach to manage

  31. Summary • Guidelines are established for screening and to help guide management of adverse events. • Patient with co-morbidies are an increase challenge to treat but can be treated safely and effectively with proper monitoring. • New Antiviral medications just approved will improve overall outcomes in the future.

  32. References • Federal Bureau of Prisons Clinical Guideline Prevention of Hepatitis C and Cirrhosis June 2009 • Raison. Depression During Pegylated Interferon-Alpha Plus Ribavirin Therapy: Prevalence and Prediction. J Clin Psychiatry. 2005 January ; 66(1): 41–48.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1615913/pdf/nihms3152.pdf ( Accessed 4/11) • http://en.wikipedia.org/wiki/Incarceration_in_the_United_States (Accessed 9/24/10) • Jennifer A. Tan, Tom A. Joseph, Sammy Saab, Treating hepatitis C in the prison population is cost-saving ,Hematology . 2008; 48: 1387-1395 • Suzanne M. Kirchhoff, Economic Impacts of Prison Growth, Congressional Research Service, April 13, 2010. http://assets.opencrs.com/rpts/R41177_20100413.pdf (Accessed 9/24/10 ) • Hadziyannis, S. Peginterferon-2a and Ribaviriin Combination Therapy in Chronic Hepaitits C. Annals of Internal Medicine. 2004 ;140: 346-357 • Fried, M. Side Effects of Therapy of Hepaptitis C and Their Management. Hepatology. 2002: 36.

  33. References 8 . Bruchfeld, A. Lindahl, K. Interferon and Ribavirin treatment in patients with hepatitis C-associated renal disease and renal insufficiency. Nephrology Dialysis Transplantation, 2002;18, 1573-1580. http://ndt.oxfordjournals.org/content/18/8/1573.short ( Accessed 4/2011) 9. EL-Atrebi, K. El-Bassyouni, H. Management of rare side effects of peginterferon and ribavirin therapy during hepatitis C treatment: a case report. Case Journal 2009:2 : 7429 10. Lovy M.R, Starkemaum G. Hepatitis C Infection Presenting with Rheumatic Manifestations: Mimic of Rheumatoid. Journal of Rheumatology 1996; 23;979-983 11. Center of Disease Control Morbidity and Mortality Weekly Report. Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings. January 24, 2003 / Vol. 52 / No. RR-1 12. Durante-Mangoni E, Iossa D. Safey and efficacy of peginterferon alpha plus ribavirin in patients with chronic hepatitis C and coexisting heart disease. Dig Liver Dis 2011 [ pub ahead of print]. 13. Ghany M, Strader B. Diagnosis, Management, and Treatment of Hepatitis C: An Update. HEPATOLOGY 2009; 49: 1335-74

  34. References • Spaulding A, Weinbaum C. A Framework for Management of Hepatitis C in Prisons. Annals of Internal Medicine 2006; 144: 762-769 • 15. Kim R. The Burden of Hepatitis C in the United States. Hepatology 2002;36:S30-S34 16. Macalino G. A Missed Opportunity: Hepatitis C Screening of Prisoners. AM J Public Health. 2005;95: 1739-1740 17. Sutton A, Edmund J. Estamating the cost-effectiveness of detecting cases of chronic hepatitis C infection on reception into prison. BMC Public Health 2006;6;170 18. Mc Hutchinson J, Brunce B. Chronic Hepatitis C: An Age Wave of Disease Burden. Am J Manag Care 2005;11:S286-S295 19. Wong J, McQuillan G. Estimating Future Hepatitis C Morbidity Mortality, and Cost in the United States. Am J Public Health. 2000;90:1562-1569 20. http://www.hivandhepatitis.com/hep_c/news/2011/0524_2011_a.html ( Accessed 6/2/11) 21. http://www.hivandhepatitis.com/hep_c/news/2011/0517_2011_a.html ( Accessed 6/2/11)

  35. References • 22. B. Pyenson. Consequences of Hepatitis C virus (HCV): Cost of a Baby Boomer Epidemic of Liver Disease. Vertex Pharmaceuticals Incorporations. Miliman, Inc. May 2009.

  36. QUESTIONS ??

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