challenges of treatment of hepatitis c in the incarcerated us population usphs scientific and...
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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, USPHSKiesha Resto Pharm D, USPHS
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.
US Hepatitis Statistics
US Hepatitis Statistics
Reference #4
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
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
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
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
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
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
Break down of 2,424,279
Break down of 2,424,279
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
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
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)
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
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
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
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
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
Management of Side Effects
Management of Side Effects
• Headaches/ Body aches
• Tylenol
• FLUIDS, FLUIDS, FLUIDS
• NSAIDS!!!???
• Nausea & Vomiting
• Promethazine
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
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
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
Serious Adverse Reaction
Serious Adverse Reaction
• Auto immune
• Arrhythmias
• Depression / Psychosis
• CHF
• Permanent thyroid dysfunction
Patients with Co-morbid conditionsPatients with Co-morbid conditions
• Pre-exiting Cardiac Condition
• Renal Disease
• Autoimmune Disease
• Depression
Case Studies
Reference # 8-#10
New Treatment Options
New Treatment Options
Telaprevir (Incivek)Telaprevir (Incivek)
Reference #20
Boceprevir (Victrelis)Boceprevir (Victrelis)
Reference #21
Adverse EffectsAdverse Effects
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
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.
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.
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
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)
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.
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