Hepatitis C Treatment in Corrections: New Medicine, New Challenges

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 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

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. 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 peginterferonalfa 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