1. 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

2. 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

3. 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

4. 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

6. 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.

8. Hepatitis C. Centers for Disease Control & Prevention, 2011.

9. Hepatitis C Progression
Fibrosis & Disease Progression in Hepatitis C. Marcellin, et al. Hepatology, 2002

10. 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

11. Hepatitis C. Centers for Disease Control & Prevention, 2011.

12. Hepatitis C Trends
Most patients infected 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

13. 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

14. Hepatitis Treatment and Management. Mukherjee, et al
Hepatitis Treatment and Management. Mukherjee, et al. Medscape Reference, 2011

15. 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)

16. 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.

17. 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.

18. 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)

19. 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.

20. 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

21. 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

22. 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

23. 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

24. Discussion

25. 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