1. Managing Hepatitis C: An Unprecedented Correctional Healthcare Challenge ASCA/CCHA meeting Phoenix, AZ RADM Newton E. Kendig Assistant Director/Medical Director Federal Bureau of Prisons Assistant Surgeon General, USPHS

2. Hepatitis C Virus (HCV) Transmission HCV is a bloodborne pathogen primarily transmitted by percutaneous exposures: - Any history of injection drug use - Blood transfusion prior to 1992 - Occupational exposures from needlesticks - Perinatal transmission Sexual transmission occurs but is rare CDC recommends that all adults born between 1945 and 1965 should be tested for HCV infection

3. HCV Infection Natural History HCV infects liver cells and replicates with high levels of viremia 25% of persons clear the infection naturally Of those who become chronically infected, serious liver disease or liver cancer develops in 20-25% - usually decades after initial infection HIV co-infection and alcohol use increase the risk of severe liver disease

4. Treatment of Chronic HCV Infection Historical Perspective Unknown transfusion-related liver disease HCV identified as culprit – late 1980s Interferons (1991-1997) (9-30% response rates) Interferon + ribavirin (1998) (29%-62% response rates) Pegylated interferon + ribavirin (2001-02) (29%-82%) Drawbacks: Injectable medication Major side effects And populations overrepresented in corrections – genotype one patients and ethnic minorities were poor responders to treatment

5. Advent of direct acting viral agents (DAAs) Medicines that attack the virus itself HCV Protease inhibitors (PIs), reminiscent of advances in the treatment of HIV infection, were approved by the FDA in 2011 in combination peginterferon/ribavirin Efficacy of treatment for HCV genotype one infections improved from 40% to (67% - 75%) The two drugs - boceprevir and telapravir, however, were complicated to administer and had significant side effects

6. Treatment of Chronic HCV Infection Second wave of DAAs approved by FDA Simeprevir (November, 2013) – Protease inhibitor with few side effects Sofosbuvir (December, 2013) – Polymerase inhibitor with few side effects And many more medications in the pharmaceutical pipeline for review and future approval

7. Treatment of Chronic HCV Infection What lies ahead? An all oral regimen that that can be taken as one pill with minimal side effects for 8 weeks or less!

8. National Guidelines Established Treatment of HCV Infection January 29 th, 2014 – IDSA/AASLD launches new website hcvguidelines.org and publishes “HCV Guidance” that give recommendations for antiviral treatments beyond current FDA indications Updated guidance identifies priority candidates for treatment but also states that patients should be treated “early in the course of their chronic HCV infection.”

9. Treatment of Chronic HCV Infection IDSA/AASLD HCV Tx Guidance – August, 2013 Public health indications: – Active injection drug use – Men who have sex with men – Hemodialysis patients – Incarcerated persons!

10. Treatment of Chronic HCV Infection Burden to the U.S. Health Care System 3.2 million Americans with HCV infection Mortality of hepatitis C now greater than HIV Treating all infected patients beyond the budgets of existing health care systems Corrections is a targeted setting for the diagnosis and treatment of chronic HCV infection - “Responding to hepatitis C through the criminal justice system,” Rich et al., NEJM May 15, 2014

11. Treatment of Chronic HCV Infection What is the BOP currently doing? Issued updated hepatitis C clinical practice guidelines – June, 2014 – www.bop.govwww.bop.gov Targeting inmates for treatment with the newly approved DAAs who have significant liver disease Holding on treating for all other infected inmates for now

12. Treatment of Chronic HCV Infection Unprecedented challenge for corrections First curable viral disease in the history of infectious diseases Numerically, the numbers to treat are enormous Treatment is extraordinarily expensive Alternative, cheaper treatments are toxic and less effective Myriad new drugs in the pipeline – whether or not prices will competitively decline is a question

13. Treatment of Chronic HCV Infection Risk Management Strategies Adapt clinical practice guidelines to your setting – AASLD/IDSA, BOP, VA Establish budget for treatment Centralize approval authority Consider “expert panel” of stakeholders to advise Prioritize care for highest risk inmates Quality control measures to ensure cost efficiencies Educate inmates about natural history of HCV infection and benefits of waiting for future treatment options for GT1 Consolidate/standardized grievance responses