hepatitis c treatment in corrections.ppt

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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, RN, HNB-BCChief, Bureau of Healthcare Services

    Delaware 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 aflavivirus related toYellow Fever and WestNile Virus

    Most common chronicbloodborne infection inthe US

    Contagious liver diseasecausing mild illness toserious, lifelong illness ordeath

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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 chronicinfection

    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 7585 people will develop chronic Hepatitis C

    infection 6070 people will go on to develop chronic liver

    disease

    520 people will go on to develop cirrhosis over 20

    30 years 15 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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    8/25Hepatitis 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 offibrosis are poorly understood

    Rate of progression variable but slow in general

    Older age, male gender, excessive alcoholconsumption, overweight, and immunedeficiency associated with more rapidprogression

    Alcohol consumption controlled in correctionalenvironment

    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 beforevirus identification and screening

    Incidence decreasing but number of patients

    developing cirrhosis, cancer & end stage liverdisease 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), neuropsychiatriccomplications (i.e., memory and concentrationdisturbances, 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., hemolyticanemia), 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 proteaseinhibitors 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 previousinterferon and ribavirin therapy.

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    New Hepatitis C Treatment

    In previously untreated patients, 79% of thosereceiving telaprevir experienced a sustainedvirologic response (SVR) compared with less than50% 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 Medication

    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 Services

    Delaware Department of Correction