Managing Hepatitis C: An Unprecedented Correctional Healthcare Challenge

ASCA/CCHA meetingPhoenix, AZ

RADM Newton E. KendigAssistant Director/Medical DirectorFederal Bureau of PrisonsAssistant Surgeon General, USPHS

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

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

Treatment of Chronic HCV Infection Historical Perspective

Unknown transfusion-related liver diseaseHCV 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 medicationMajor side effectsAnd populations overrepresented in corrections – genotype one patients and ethnic minorities were poor responders to treatment

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

Treatment of Chronic HCV InfectionSecond 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

Treatment of Chronic HCV InfectionWhat lies ahead?

• An all oral regimen that that can be taken as one pill with minimal side effects for 8 weeks or less!

National Guidelines EstablishedTreatment of HCV Infection

• January 29th, 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.”

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!

Treatment of Chronic HCV InfectionBurden 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

Treatment of Chronic HCV InfectionWhat is the BOP currently doing?

• Issued updated hepatitis C clinical practice guidelines – June, 2014 – www.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

Treatment of Chronic HCV InfectionUnprecedented 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

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