hepatitis c treatment in corrections: new medicine, new challenges spencer epps, md, mba, medical...
TRANSCRIPT
![Page 1: Hepatitis C Treatment in Corrections: New Medicine, New Challenges Spencer Epps, MD, MBA, Medical Director Delaware Department of Correction James Welch,](https://reader035.vdocuments.site/reader035/viewer/2022062511/551b6e8d550346ae7a8b61cf/html5/thumbnails/1.jpg)
Hepatitis C Treatment in Corrections:New Medicine, New Challenges
Spencer Epps, MD, MBA, Medical Director
Delaware Department of Correction
James Welch, RN, HNB-BCChief, Bureau of Healthcare ServicesDelaware Department of Correction
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Objectives
• Discuss Hep C Infection & Current Treatment• Describe Hep C Treatment in Corrections• Explain New Medications for Hep C• Outline Challenges Presented by New Medications• Propose Strategies to Address these Challenges
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Hepatitis C
• Hepatitis C (HCV) is a flavivirus related to Yellow Fever and West Nile Virus
• Most common chronic bloodborne infection in the US
• Contagious liver disease causing mild illness to serious, lifelong illness or death
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Hep C Transmission
• Spread by blood to blood contact:– IV drug use– Mother to child transmission– Can be sexually transmitted but less common– Since 1992, screening has limited spread through
transfusions and transplants • For most, acute infection leads to chronic
infection • There is no vaccine for Hepatitis C
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Hep C Statistics• 3.2 million persons chronically infected• 1.8% prevalence in the free world• Of every 100 people with Hep C – 75–85 people will develop chronic Hepatitis C
infection– 60–70 people will go on to develop chronic liver
disease– 5–20 people will go on to develop cirrhosis over 20–
30 years – 1–5 people will die from cirrhosis or liver cancer
• 8000 to 10,000 deaths each year in US• Majority unaware of infection- not clinically ill
Hepatitis C. Centers for Disease Control & Prevention, 2011.
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Hepatitis C. Centers for Disease Control & Prevention, 2011.
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Fibrosis & Disease Progression in Hepatitis C. Marcellin, et al. Hepatology, 2002
Hepatitis C Progression
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Hepatitis C Progression• Mechanisms associated with progression of
fibrosis are poorly understood • Rate of progression variable but slow in general• Older age, male gender, excessive alcohol
consumption, overweight, and immune deficiency associated with more rapid progression
• Alcohol consumption controlled in correctional environment
• Treatment of overweight & HIV is critical
Fibrosis & Disease Progression in Hepatitis C. Marcellin, et al. Hepatology, 2002
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Hepatitis C. Centers for Disease Control & Prevention, 2011.
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Hepatitis C Trends
• Most patients infected 20-40 years ago before virus identification and screening
• Incidence decreasing but number of patients developing cirrhosis, cancer & end stage liver disease increasing (peak 2020 to 2030)
• Total cost of care for untreated Hep C will continue to increase over next 20 years
• Consensus on when and how Hep C will be treated in Corrections is needed now
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Current Hepatitis C Treatment
• PEG-Interferon– Increases expression of proteins that interfere
with Hep C viral replication
• Ribavirin– Enhances the antiviral effect of interferon– Precise mechanism of action uncertain
• Treatment lasts for one year; if successful, induces cure
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Hepatitis Treatment and Management. Mukherjee, et al. Medscape Reference, 2011
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Side Effects Current Hep C Treatment
• INTERFERON - Hematologic complications (i.e., neutropenia, thrombocytopenia), neuropsychiatric complications (i.e., memory and concentration disturbances, visual disturbances, headaches, depression, irritability), flulike symptoms, metabolic complications (i.e., hypothyroidism, hyperthyroidism, low-grade fever), gastrointestinal complications (i.e., nausea, vomiting, weight loss), dermatologic complications (i.e., alopecia), and pulmonary complications (i.e., interstitial fibrosis)
• RIBAVIRIN - Hematologic complications (i.e., hemolytic anemia), reproductive complications (i.e., birth defects), and metabolic complications (i.e., gout)
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New Hepatitis C Treatment
• FDA recently approved two new protease inhibitors for treatment of Hep C– Boceprevir– Telaprevir
• Are added to, do not replace, original therapy• Indications: – treatment of chronic Hep C genotype 1 – with compensated liver disease, including cirrhosis– previously untreated or who have failed previous
interferon and ribavirin therapy.
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New Hepatitis C Treatment• In previously untreated patients, 79% of those
receiving telaprevir experienced a sustained virologic response (SVR) compared with less than 50% with peginterferon alfa and ribavirin treatment alone.
• Cure rate for patients treated with telaprevir across all studies, and across all patient groups, was between 20-45% higher than current regimen.
• Course of treatment decreased from 48 weeks to 24 weeks.
US Food and Drug Administration (FDA). FDA approves Incivek for hepatitis C. May 23, 2011.
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Challenges of New Treatment• Cannot be given alone or resistance will develop• Same side effects plus additional side effects– Anemia– Neutropenia– Thrombocytopenia– Severe Rash
• Logistical Challenges in the correctional environment:– Must be given at same time every day– Must be given with fatty food (e.g., ice cream)
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Cost of New Treatment
• Both boceprevir and telaprevir are priced for cure
• $45,000 to $75,000 per patient• Prevalence of Hep C higher in correctional
patient population• In Delaware, 800/7000 patients with Hep C• Treatment of entire population with new
regimen would cost up to $60,000,000. • Entire healthcare budget = $55,000,000.
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Strategies for Hep C Treatment
• The Federal Bureau of Prisons uses the following criteria for limiting Hep C treatment– PEG-interferon contraindicated– Incarceration period insufficient for treatment– Inmate has unstable medical or mental health
condition– Patient refuses treatment
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Strategies for Hep C Treatment
• Monitoring early stages of Hep C rather than treatment acceptable and occurs in free world
• Treatment based on progression:– Liver function tests– Liver biopsy– Other factors: age, co-infection with HIV, etc.
• Monitor patients with earlier stages of fibrosis & sentences under 5 years & coordinate with community providers for potential treatment
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Consensus on Use of New Medications
• If fibrosis progression indicates treatment, patients are tried on current therapy first
• If therapy found to be futile at 12 weeks, patients are tried on new medical regimen, provided there are no contraindications
• As with current practice, patients should be involved in the decision to treat whether using old or new regimen
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Conclusion
• Discussed Hep C Infection & Current Treatment• Described Hep C Treatment in Corrections• Explained New Medications for Hep C• Outlined Challenges Presented by New Medications• Proposed Strategies to Address these Challenges
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Discussion
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Hepatitis C Treatment in Corrections:New Medicine, New Challenges
Spencer Epps, MD, MBA, Medical Director
Delaware Department of Correction
James Welch, RNChief, Bureau of Healthcare ServicesDelaware Department of Correction