Presentation on theme: "Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera."— Presentation transcript:
Challenges of Treatment of Hepatitis C in the Incarcerated US Population USPHS Scientific and Training Symposium June 23, 2011 Dr William Resto-Rivera MD, USPHS Kiesha Resto Pharm D, USPHS
Objectives # 1) Compare Hepatitis C Virus (HCV) infections in prison population versus the regular population. #2) Analyze the challenges of identifying and treating prison population. #3) Review common & rare side effects that are related to Hepatitis C therapy. #4) Discuss challenges in treating patients with co-morbid conditions. #5) Review recent FDA approved medications for HCV.
US Hepatitis Statistics 1.3% US population infected Hepatitis C Virus (HCV) 29-43% People infected with HCV will pass through US prison system every year 16-40% US Prison population infected with HCV Reference #4
Population Baby boomers account for 2 out of 3 cases of HCV patients. Peak prevalence men born in early 1950’s HCV is over-represented in African Americans. Reference #5
Every 100 people infected with HCV 75-85 develop chronic infection 60-70 develop chronic liver disease 5-20 develop cirrhosis 1-5 die from cirrhosis or liver cancer
Center of Disease Control & National Institutes of Health Convention January 2003 identified 5 optimal approaches to Screening & treating HCV in US prisons #1 Testing of HCV in Prisons would identify many Infected Americans #2 Prison Substance Abuse programs would decrease HCV infections & future prisons cost #3 Patients can be Selected using Published Guidelines #4 Prisons Treatment Reflects Community Standards and Require Sufficient Medical Workforce #5 Collaboration Between Correctional & Public Health Systems is Needed Reference #14
Factors for Treatment Screening Screening and Diagnosis of Hepatitis C individuals. Screening for candidates for treatment Safety, Efficacy & Cost Monitoring Laboratories and ADR Patient Tolerate treatment Viral Response to treatment EVR/SVR Source of funding
Hepatitis C Not a Routine Universal Screening Routine screening based on 4 criteria: Amenable to treatment Interfere with activities of daily living Progress without treatment during time of incarceration Risk of transmission Reference # 14
To Screen or to Not Screen Rhode Island State Corrections Screened all incoming inmate 4263 Males – 23% + HCV 499 Females – 40% HCV Out of inmates who tested + HCV 66% did not report high risk behaviors Wisconsin State Corrections 91% HCV infected inmates identified through testing 27% of population with risk factor IVDA Indiana State Corrections Universal testing found 13% of population HCV (+) Reference #16Reference #14
USA and territories Incarcerated population 2008 Total 2,424,279 Federal & State Prisons1,518,559 Territorial Prisons13,576 Local Jails 785,556 ICE Facilities9,957 Military Facilities1,651 Jails in Indian Country2,135 Juvenile Facilities92,845 Reference #3
Break down of 2,424,279 US prison population infected with HCV 387,884 -- 969,711 16-40% Progress to end stage liver disease 3,878 -- 29,091 1 to 3 %
Medicare Disease StatesCommercialAge<65Age >65 Chronic HCV Infection (without Cirrhosis) $174 more than avg $525 more than avg$460 more then avg Compensated Cirrhosis without Complication $370 more than avg$772 more then avg$611 more than avg Decompensated Cirrhosis 0- 6 months$13,900$7,100 Decompensated Cirrhosis + 6 months$12,700$4,200 Hepatocellular Carcinoma 0-6 months $5,500$2,400 Hepatocellular Carcinoma + 6 months $4,900$2,100 Liver Transplant 0- 6 months $38,900$24,700 Liver Transplant 6- 18 months $5,600$3,800 Liver Transplant + 18 months $3,900$2,200 Summary of Assumptions of Paid Cost per Patient Per Month (PPPM) as of 2008 Reference #22
Missed Opportunity Lower cost in long run for HCV treatment Stable living environment Accessible medical care High Risk Population Direct Observed Medication Abstinence from Substance abuse Coordination between Rehabilitation programs and treatment Benefits for treatment during Incarceration
Hepatitis C Multiple Genotypes 1 Most common (US) Approx. 80% 2/3 US Approx 20% 4 Egypt RNA Virus Family Flavovirus ( Denque, yellow fever)
US Hepatitis C Statistics Genotype 1 40-50% Successful SVR at 12 months Genotype 2/3 70-80% Successful SVR at 12 months
Contraindications to Ribavirin 1. Thalassemias (sickle cell anemia) or other hemoglobinopathy. 2. Significant cardiac disease ( arrhythmias, angina, CABG, MI) in the past 12 months. 3. Renal dialysis or creatinine clearance < 50 mL/min. 4. Hypersensitivity to ribavirin 5. Pregnancy Reference # 1
Ribavirin Side Effects Black Box Warnings: Hemolytic Anemia Warning (primarily in the first two weeks of therapy) Pregnancy Warning. Negative pregnancy test is required pre-therapy & at every evaluation Respiratory Warning for patients requiring assisted ventilation Reference #1
Contraindication Peg-Interferon Serious concurrent medical diseases; severe hypertension, heart failure, coronary heart disease, COPD, autoimmune disorders, uncontrolled endocrine disorder Decompensate cirrhosis, History of solid organ transplant Platelet count <75,000/mm3 or ANC <1,500 cells/mm3 Ongoing injection drug use or alcohol use Severe uncontrolled psychiatric disease Reference #1
Management of Side Effects Headaches/ Body aches Tylenol FLUIDS, FLUIDS, FLUIDS NSAIDS!!!??? Nausea & Vomiting Promethazine
Hemoglobin adjustment 10-11 g/dl If no or minimal symptoms, then no dose modification If symptomatic, decrease ribavirin by 200 mg/day 8.5-10 g/dl Peginterferon alfa 2b ( Peg-Intron) Reduce 25-50% Ribavirin ↓ to 600 mg daily (200 mg AM & 400mg PM) <8.5 g/dl Peginterferon alfa 2b (Peg-Intron) Discontinue until resolved. Ribavirin Discontinue until resolved. If hemoglobin is <12g/dL for over 4 weeks at the reduced/adjusted dose then discontinue ribavirin Reference #1
Absolute Neutrophil Count (ANC) Adjustment <750 Peginterferon alfa 2b (Peg-Intron) Reduce to a 25% -50% dose <500 Peginterferon & Ribavirin Discontinue both until resolved Granulocyte Colony Stimulating Factor (G-CSF): If the patient is responding to treatment and neutropenia persists despite reduced peginterferon dose, consider G-CSFDosage: Filgrastim 300 microgram subcu. daily. Goal: ANC >1500 Reference #1
Platelet Adjustment <50,000 Peginterferon alfa 2b (Peg-Intron) Discontinue until resolved. Ribavirin If on Peg-Intron, then discontinue ribavirin. <30,000 Peginterferon Discontinue until resolved. Ribavirin Discontinue until resolved. Reference #1
Tx 23 pre-existing heart disease patients with INF & Ribavirin 52% reached SVR, 39% relapse, 9% non responders EKG & Echo show no signs of progression of pre- exiting heart disease Digest of Liver Disease 2011 Tx 7 patients with vasculititis and GN successfully with INF & Ribavirin Nephrology, Dialysis, Transplant 2003 19 patient referred from PCP for polyarthritis, polyarthralgia, or positive rheumatoid factors where found to have hepatitis Journal of Rheumatology 1996 Case Studies Reference # 8-#10
New Treatment Options Boceprevir ( Victrelis) FDA approved May 13, 2011 Hepatitis C Genotype 1 Naïve & Relapse patients 800 mg tablets x 44 weeks after 4 week lead in Telaprevir (Incivek) FDA approved May 23, 2011 Hepatitis Genotype 1 Naïve and Relapse patient 750 mg tablets TID for first 12 weeks of therapy
Boceprevir (Victrelis) Treatment Naïve (1,097) Treatment Group 69% SVR Control Group 40% SVR African American Treatment 69%SVR Control 40% SVR SPRINT-2 Non-Responders and Relapsers (403) Treatment Group 66% SVR Control Group 21% SVR RESPOND- 2 Reference #21
Summary Prison are an ideal setting to treat a large population of HCV (+) people. Screening for HCV need to be examined cost/benefit per institution. Treating patient while incarcerated can be a cost saving to society HCV treatment is associated with multiple side effects that need an educated multidiscipline approach to manage
Summary Guidelines are established for screening and to help guide management of adverse events. Patient with co-morbidies are an increase challenge to treat but can be treated safely and effectively with proper monitoring. New Antiviral medications just approved will improve overall outcomes in the future.
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