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 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 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 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 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