Download Hepatitis C Treatment in Corrections

Hepatitis C Treatment in Corrections:
New Medicine, New Challenges
Spencer Epps, MD, MBA,
Medical Director
Delaware Department of Correction
James Welch, RN, HNB-BC
Chief, Bureau of Healthcare Services
Delaware Department of Correction
Objectives
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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
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
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
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.
Hepatitis C. Centers for Disease Control & Prevention, 2011.
Hepatitis C Progression
Fibrosis & Disease Progression in Hepatitis C. Marcellin, et al. Hepatology, 2002
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
Hepatitis C. Centers for Disease Control & Prevention, 2011.
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
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
Hepatitis Treatment and Management. Mukherjee, et al. Medscape Reference, 2011
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)
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.
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.
Challenges of New Treatment
• Cannot be given alone or resistance will develop
• Same side effects plus additional side effects
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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)
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.
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
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
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
Conclusion
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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
Discussion
Hepatitis C Treatment in Corrections:
New Medicine, New Challenges
Spencer Epps, MD, MBA,
Medical Director
Delaware Department of Correction
James Welch, RN
Chief, Bureau of Healthcare Services
Delaware Department of Correction