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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

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Page 1: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

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, USPHSKiesha Resto Pharm D, USPHS

Page 2: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

ObjectivesObjectives#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.

Page 3: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

US Hepatitis Statistics

US Hepatitis Statistics

Reference #4

Page 4: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Population 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

Page 5: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera
Page 6: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Center of Disease Control & National Institutes of Health Convention January 2003 identified 5 optimal approaches to Screening & treating HCV in US prisons

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

Page 7: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Factors for TreatmentFactors 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

Page 8: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Hepatitis C Not a Routine Universal

Screening

Hepatitis C Not a Routine Universal

ScreeningRoutine 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

Page 9: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

To Screen or to Not ScreenTo Screen or to Not ScreenRhode Island State

Corrections

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

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 (+)

Reference #16 Reference #14

Page 10: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

USA and territories Incarcerated population 2008

USA and territories Incarcerated population 2008

Total 2,424,279

Federal & State Prisons 1,518,559

Territorial Prisons 13,576

Local Jails 785,556

ICE Facilities 9,957

Military Facilities 1,651

Jails in Indian Country 2,135

Juvenile Facilities 92,845

Reference #3

Page 11: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Break down of 2,424,279

Break down of 2,424,279

Page 12: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

MedicareDisease States Commercial Age<65 Age >65

Chronic HCV Infection (without Cirrhosis) $174 more than avg $525 more than avg $460 more then avg

Compensated Cirrhosis without Complication$370 more than avg $772 more then avg $611 more than avg

Decompensated Cirrhosis 0-6 months $13,900 $7,100 $7,100

Decompensated Cirrhosis + 6 months $12,700 $4,200 $4,200

Hepatocellular Carcinoma 0-6 months $5,500 $2,400 $2,400

Hepatocellular Carcinoma + 6 months $4,900 $2,100 $2,100

Liver Transplant 0-6 months $38,900 $24,700 $24,700

Liver Transplant 6-18 months $5,600 $3,800 $3,800

Liver Transplant + 18 months $3,900 $2,200 $2,200

Summary of Assumptions of Paid Cost per Patient Per Month (PPPM) as of 2008

Reference #22

Page 13: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Missed OpportunityMissed Opportunity

•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

Benefits for treatment during Incarceration

Page 14: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Hepatitis CHepatitis C• Multiple Genotypes

• 1 Most common (US) Approx. 80%

• 2/3 US Approx 20%

• 4 Egypt

• RNA Virus

• Family Flavovirus ( Denque, yellow fever)

Page 15: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

US Hepatitis C Statistics US Hepatitis C Statistics

• Genotype 1 40-50% Successful SVR at 12 months

• Genotype 2/3 70-80% Successful SVR at 12 months

Page 16: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Contraindications to Ribavirin

Contraindications to Ribavirin

1. Thalassemias (sickle cell anemia) or other hemoglobinopathy.

2. Significant cardiac disease (arrhythmias, angina, CABG, MI) in the past 12 months.

3. Renal dialysis or creatinine clearance < 50 mL/min.

4. Hypersensitivity to ribavirin

5. PregnancyReference #1

Page 17: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Ribavirin Side Effects

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

Page 18: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Contraindication Peg-Interferon

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 diseaseReference #1

Page 19: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Adverse Event Carswell 2007-2010

Statistical Data: Annals Internal

Medicine 2004 (6)

Statistical Data: Hematology 2002 (7)

Headache26% 55% 64%

Pruritis63% 25%

Decrease Appetitie 63% 21% 32%

Nausea / vomiting42% 35% 43%

Fatigue63% 48% 64%

Mood Changes 42% 26% 35%

Gastro-intestinal 21% 20%

Anemia42% 22%

Neutropenia21% 20%

Thrombocyto21% 4%

Reference # 6 & #7

Page 20: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Management of Side Effects

Management of Side Effects

• Headaches/ Body aches

• Tylenol

• FLUIDS, FLUIDS, FLUIDS

• NSAIDS!!!???

• Nausea & Vomiting

• Promethazine

Page 21: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Hemoglobin adjustmentHemoglobin adjustment

     10-11 g/dl If no or minimal symptoms, then no dose

modificationIf symptomatic, decrease ribavirin by 200 mg/day

8.5-10 g/dl Peginterferon alfa 2b ( Peg-Intron) Reduce 25-

50% Ribavirin ↓ to 600 mg daily (200 mg AM & 400mg PM)

<8.5 g/dl

Peginterferon alfa 2b (Peg-Intron) Discontinue until resolved.Ribavirin Discontinue until resolved.

If hemoglobin is <12g/dL for over 4 weeks at the reduced/adjusted dose then discontinue ribavirin

Reference #1

Page 22: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Absolute Neutrophil Count (ANC) Adjustment

Absolute Neutrophil Count (ANC) Adjustment

<750 Peginterferon alfa 2b (Peg-Intron) Reduce to a 25% -50% dose

<500 Peginterferon & Ribavirin Discontinue both until resolved

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

Page 23: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Platelet AdjustmentPlatelet Adjustment

<50,000

Peginterferon alfa 2b (Peg-Intron) Discontinue until resolved. Ribavirin If on Peg-Intron, then discontinue ribavirin.

<30,000

Peginterferon Discontinue until resolved.Ribavirin Discontinue until resolved.

Reference #1

Page 24: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Serious Adverse Reaction

Serious Adverse Reaction

• Auto immune

• Arrhythmias

• Depression / Psychosis

• CHF

• Permanent thyroid dysfunction

Page 25: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Patients with Co-morbid conditionsPatients with Co-morbid conditions

• Pre-exiting Cardiac Condition

• Renal Disease

• Autoimmune Disease

• Depression

Page 26: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Case Studies

Reference # 8-#10

Page 27: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

New Treatment Options

New Treatment Options

Page 28: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Telaprevir (Incivek)Telaprevir (Incivek)

Reference #20

Page 29: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Boceprevir (Victrelis)Boceprevir (Victrelis)

Reference #21

Page 30: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

Adverse EffectsAdverse Effects

Page 31: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

SummarySummary• 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

Page 32: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

SummarySummary• 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.

Page 33: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

ReferencesReferences1. Federal Bureau of Prisons Clinical Guideline Prevention of Hepatitis C and Cirrhosis June 2009

2. 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)

3. http://en.wikipedia.org/wiki/Incarceration_in_the_United_States (Accessed 9/24/10)

4. Jennifer A. Tan, Tom A. Joseph, Sammy Saab, Treating hepatitis C in the prison population is cost-saving ,Hematology . 2008; 48: 1387-1395

5. 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 )

6. Hadziyannis, S. Peginterferon-2a and Ribaviriin Combination Therapy in Chronic Hepaitits C. Annals of Internal Medicine. 2004 ;140: 346-357

7. Fried, M. Side Effects of Therapy of Hepaptitis C and Their Management. Hepatology. 2002: 36.

Page 34: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

ReferencesReferences8 . 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

Page 35: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

ReferencesReferences14. Spaulding A, Weinbaum C. A Framework for Management of Hepatitis C in Prisons. Annals of

Internal Medicine 2006; 144: 762-769

15. 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)

Page 36: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

ReferencesReferences• 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.

Page 37: Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera

QUESTIONS ??