Hepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity. Cody A. Chastain, MD

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1 Hepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity Cody A. Chastain, MD

2 Disclosures Research supported by Gilead Sciences Inc.: Site investigator for HIV/HCV SWITCH Registry Study Key faculty personnel for Gilead FOCUS HCV Screening Program through Vanderbilt University Medical Center Emergency Department

3 Objectives At the end of this lecture, the learner will be able to: Review trends in epidemiology of hepatitis C virus (HCV) Understand the indications for screening for HCV Identify the clinical manifestations of HCV Discuss the principles of and indications for treatment of HCV Discuss how the HCV epidemic and its management differs in correctional settings

4 GOOD PRISON HEALTH IS GOOD PUBLIC HEALTH Dublin Declaration on HIV and AIDS in Europe and Central Asia

5 What Is Your Role? Physician Advanced Practice RN Physician Assistant Pharmacist Nurse Social Worker / Case Manager Other

6 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

7 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

8 Hepatitis Hepatitis = inflammation of the liver Differential Diagnosis: Hepatitis viruses Hepatitis A (HAV) Hepatitis B (HBV) Hepatitis C (HCV) HIV Cytomegalovirus (CMV) Alcohol Drug and/or supplement toxicity Obesity [leading to non-alcoholic fatty liver disease (NAFLD)] Genetic disorders

9 Hepatitis C Virus (HCV) Single-strand, positive sense RNA flavivirus Spread through blood and body fluids Predominantly infects liver cells No latent reservoir

10 Word Cloud What word(s) come to mind when you think of hepatitis C?

11 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

12 HCV and Mortality in the USA Ly KN et al. Ann Int Med // Ly KN et al. Clin Infect Dis 2016.

13 HCV in the US million Americans have chronic HCV infection Davis GL et al. Gastroenterology // Ditah I et al J Hepatol 2014; Edlin BR et al Hepatology 2015

14

15

16 Courtesy of Michale Rickles, Tennessee Department of Health.

17 Yehia BR et al. PLoS One 2014.

18 WHAT ABOUT CORRECTIONAL FACILITIES?

19 HCV Prevalence in Dept of Corrections Varan AK et al. Public Health Reports 2014.

20 Natural History of HCV Epidemic and Prisons He T et al. Ann Int Med 2016.

21 Cascade of Care in Post-Incarceration Clinic Hawks L et al. JVH 2016.

22 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

23 Who is at Risk for HCV? IV drug users Tattoo/piercing recipients Blood/clotting protein recipients prior to 1992 Mother-to-child transmission from HCV+ mother Hemodialysis patients People with HIV Occupational exposures Born between ( baby boomer generation)

24 Knowledge Pearl #1 Screen patients for HCV based on risk factors and/or the baby boomer age cohort (born between 1945 and 1965).

25 Diagnostics Review HCV Antibody Tests for exposure Near 100% sensitivity once >6 months after infection HCV RNA Tests for active infection ~20% of patients spontaneously clear HCV HCV Genotype Defines genetic subtype for prognostic information and treatment guidance

26 Knowledge Pearl #2 Screen patients with an HCV antibody test. Confirm active/chronic infection with an HCV RNA polymerase chain reaction (PCR) test.

27 Are the Screening Guidelines Adequate? Hsieh Y-H et al. Clin Infect Dis 2016.

28 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

29 Manifestations of HCV Acute HCV (~20%) Fever Fatigue and anorexia Nausea and vomiting Abdominal pain Jaundice, dark urine, and claycolored stools Arthralgias Chronic HCV Often asymptomatic May cause fatigue, insomnia, depression, and mental status changes May cause extrahepatic manifestations including vasculitis and renal disease Long-term outcomes include cirrhosis, liver failure, and hepatocellular carcinoma

30 Agree or Disagree? HCV eventually results in cirrhosis and associated end stage liver disease and/or hepatocellular carcinoma in most patients.

31 Natural History of HCV Cirrhosis usually takes years to develop in the absence of comorbidities Timeline may be accelerated by comorbidities

32 Factors Associated with HCV Accelerated Fibrosis Progression

33 Outline Overview Epidemiology Screening and Diagnosis Natural History Advances in Treatment

34 Released January 29, 2014 Frequently updated Available at

35

36

37

38 Why Should We Treat HCV? Quality of life Work productivity Outcomes of related conditions (including cardiovascular and renal disease)? Liver-related and all-cause mortality

39 Why Should We Treat HCV? Van der Meer AJ et al. JAMA 2012.

40 Treatment Response in Direct Acting Antiviral (DAA) Era SVR (%)

41 HCV Approved Agents FDA Approved Therapies 1/2014 Interferon (1986) Ribavirin (1998) Pegylated Interferon (2001) Telaprevir (2011) Boceprevir (2011) Simeprevir (2013) Sofosbuvir (2013) Since Then Ledipasvir Paritaprevir Ombitasvir Dasabuvir Daclatasvir Elbasvir Grazoprevir Velpatasvir

42 FDA Approved HCV Therapies (7/2017) Nonspecific Antivirals Interferon (IFN) Ribavirin (RBV) Pegylated Interferon (PEG-IFN) NS3/4 Protease Inhibitors Telaprevir (TPV) Boceprevir (BPV) Simeprevir (SMV) Paritaprevir (PTV) Grazoprevir (GZP) NS5A Inhibitors Ledipasvir (LDV) Ombitasvir (OBV) Daclatasvir (DCV) Elbasvir (EBV) Velpatasvir (VEL) NS5B Polymerase Inhibitors Sofosbuvir (SOF) Dasabuvir (DBV)

43 FDA Approved DAA Regimens for HCV Genotype (GT) 1 Elbasvir + Grazoprevir (Zepatier ) +/- RBV x weeks Paritaprevir/ritonavir + Ombitasvir + Dasabuvir (Viekira Pak ) +/- RBV x wk Sofosbuvir (Sovaldi ) + Daclatasvir (Daklinza ) +/- RBV x weeks Sofosbuvir + Ledipasvir (Harvoni ) +/- RBV x 8-24 weeks Sofosbuvir (Sovaldi ) + Simeprevir (Olysio ) +/- RBV x weeks Sofosbuvir + Velpatasvir (Epclusa ) +/- RBV x 12 weeks

44 FDA Approved DAA Regimens for HCV GT 2 and 3 GT 2 Sofosbuvir (Sovaldi ) + Daclatasvir (Daklinza ) x 12 weeks Sofosbuvir + Velpatasvir (Epclusa ) +/- RBV x 12 weeks GT 3 Sofosbuvir (Sovaldi ) + Daclatasvir (Daklinza ) +/- RBV x weeks Sofosbuvir + Velpatasvir (Epclusa ) +/- RBV x 12 weeks

45 Knowledge Pearl #3 HCV treatment with new therapies is effective and safe; as such, evaluation and/or treatment is recommended for ALL people infected with HCV.

46 How New HCV Treatments Impact Correctional Settings Shorter courses of therapy Higher efficacy Less monitoring Treatment access and delivery Cost effective (even dominant) compared to older therapies Affordability

47 Treatment in VA Dept of Corrections Sterling R et al. AASLD 2016.

48 Opportunities Facing Correctional Facilities Evolving epidemic Effective screening Availability of treaters Cost of therapies Linkage to care

49 THANK YOU! QUESTIONS?

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