Hepatitis C Update. Geri Brown, M.D. Associate Professor Department of Internal Medicine March 24, 2011

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1 Hepatitis C Update Geri Brown, M.D. Associate Professor Department of Internal Medicine March 24, 2011

2 Outline n Educational Objectives Epidemiology and Natural History of Hepatitis C Current Treatment of Hepatitis C Predictors and Limitations of Current HCV Therapy Emerging Therapies of Hepatitis C

3 Epidemiology and Natural History

4 Background n The hepatitis C virus (HCV) is a leading cause of chronic liver disease. n An estimated 180 million people are infected worldwide. In the United States (U.S.), the prevalence of HCV n In the United States (U.S.), the prevalence of HCV infection between the years 1999 and 2002 was 1.6%, equating to about 4.1 million persons positive for antibody to hepatitis C (anti-hcv), 80% of whom were estimated to be viremic.

5 Prevalence of HCV Infection United States, Anti-HCV Est. Infections Percent of Group Positive millions (95% CI) Infections Total 1.8% 3.9 ( ) 100% Race/ethnicity White 1.5% 2.4 ( ) 61% Black 3.2% 0.8 ( ) 20% Mex American 2.1% 0.3 ( ) 7% Other 2.9% 0.5 ( ) 13% Source: NEJM 1999;341:556-62

6 n HCV is a small, enveloped, singlestranded RNA virus n The virus mutates rapidly, changing its envelope protein evading the immune system n There are at least 6 major genotypes Hepatitis C Virus

7 Sources of Infection for Persons with Hepatitis C Injecting drug use 60% Sexual 15% Transfusion 10% (before screening) *Nosocomial; Health-care work; Perinatal Source: Centers for Disease Control and Prevention Other* 5% Unknown 10%

8 Transmission of HCV n Percutaneous- Injection drug use n Permucosal Sexual Transmission of HCV low prevalence (1.5%) among long-term partners Male/female - more efficient Perinatal Transmission of HCV HCV-RNA positive at delivery Average rate of infection - 6% Higher (17%) if woman coinfected with HIV No association with Delivery method Breastfeeding* n Nosocomial Primarily in outbreaks Contaminated equipment Hemodialysis, endoscopy Unsafe injection practices plasmapheresis phlebotomy multiple dose med vials

9 Occupational Transmission and Post Exposure Management n Occupational Average incidence 1.8% following needle stick Prevalence 1-2% among health care workers 10 times lower than for HBV infection n Postexposure Management for HCV Ig, antivirals not recommended for prophylaxis Follow-up after needlesticks exposures Test source for anti-hcv Test worker if source anti-hcv positive Anti-HCV and ALT at baseline and 4-6 mos For earlier diagnosis, HCV RNA by PCR at 4-8 wks n Refer infected worker to specialist for medical evaluation and management n AASLD Practice Guidelines

10 Screening Recommendations Persons who have injected illicit drugs Persons with conditions associated with a high prevalence: HIV infection Hemophilia - Received clotting factor concentrates Hemodialysis Abnormal aminotransferases Prior recipients of transfusions or organ transplants prior to July 1992 Children born to HCV-infected mothers Current sexual partners of HCV-infected person AASLD Practice Guidelines

11 Serologic Pattern of Acute HCV Infection Symptoms +/- anti-hcv HCV RNA Ti iter ALT Normal Years Months Time after Exposure

12 Features of Hepatitis C Virus Infection Incubation period Average 6-7 weeks Range weeks Acute illness (jaundice) Mild (<20%) Case fatality rate Low Chronic infection 75%-85% Chronic hepatitis 70% (most asx) Cirrhosis 10%-20% Mortality from CLD 1%-5%

13 Natural History of HCV Infection 1 Resolved Exposure (Acute Phase) 15% 85% Chronic 5-year survival in patients with HCC is < 5% 2 20% Cirrhosis ~20 year progression rate accelerated with HIV, HBV, alcohol 6%/yr ESLD 4%/yr HCC Transplant/death 3% to 4%/yr Time (yr) HCC = hepatocellular carcinoma ESLD = end-stage liver disease Adapted from: Hoofnagle J. Hepatology. 1997;26(suppl 1):15S-20S. 2. NIH. NIH Consens State Sci Statements. 2002;19:1-46.

14 n Current Treatment of Hepatitis C

15 Evaluation of Patients with Chronic Hepatitis C Initial Evaluation History and physical examination Assess severity of liver disease - CBC, (Alb,TB, PT) Assess other causes of CLD - HBsAg, ANA, ASMA, Ferritin, Transferrin, Iron, ceruloplasmin, A1AT, AMA Screen for HCC in pts with cirrhosis - AFP and U/S Vaccinate against hepatitis A and B Therapy evaluation Psychiatric disease and substance abuse Compliance/adherence Comorbid conditions and autoimmune diseases If diabetic, Ocular exam Pregnancy

16 Selection of Patients for treatment n Treatment is clearly indicated 18 years or older and HCV RNA in serum Liver bx - chronic hepatitis with significant fibrosis Compensated liver disease (TB1.5 g/dl; INR 1.5; albumin 3.4, Plt 75,000/mm) Lab indices (Hgb 13 g/dl for men and 12 g/dl for women; neutrophil count 1500 /mm3 and serum Cr mg/dl AASLD Practice Guidelines

17 Utility of Liver Biopsy n Liver biopsy provides: Information on the current status of the liver injury impact on decision to start TX n The biopsy is assessed for grade and stage of the liver injury Grade - extent of necroinflammatory activity, Stage - extent of fibrosis or the presence of cirrhosis. Scoring systems n AASLD Practice Guidelines

18 Virological Response Definitions Type of Response Rapid virological response (RVR) Early Virologic Response (EVR Sustained Virological Response Definition HCV RNA negative at treatment week 4 by a sensitive PCR based quantitative assay 2 log reduction in HCV RNA level compared - baseline HCV RNA level (partial EVR) or HCV RNA negative at wk 12 (complete EVR) HCV RNA negative 24 weeks after cessation of treatment Clinical Short length of tx for genotype 2 & 3 Predicts SVR Best long term predict

19 Treatment Recommendations Genotypes 1 and 4 48 wks - Peg IFN /Ribavirin D/C Tx with no EVR ( >2 log reduction in HCV RNA-wk 12) or If HCV RNA + at 24 wks, in pts with EVR Delayed virus clearance (HCV RNA test becomes negative -wks 12-24), consider extending tx to 72 wk Genotype 2 and 3 Treatment with peg IFN plus ribavirin - 24 wks HCC screen in pts HCV-related cirrhosis with SVR 6-12 mo

20 Pegylated interferon alfa-2b plus ribavirin: impact of HCV genotype IFN alfa-2b/r PEG IFN alfa -2b 0.5/R PEG IFN alfa -2b 1.5/R Genotype 1 Genotype 2/3 Manns MP, et al., Lancet 2001; 358:958

21 Pegylated interferon alfa-2a plus ribavirin PEG IFN/R PEG/R Genotype 1 Genotype 2/3 Fried MW, et al., N Engl J Med 2002; 347:975

22 n Flu-like symptoms Headache, pain Fatigue or asthenia Fever, chills n Neuropsychiatric disorders Depression, anxiety Mood lability Insomnia n Pruritus n Myalgia/Arthralgia n Alopecia Common Side Effects of Pegasys and Copegus 1. Pegasys (Peginterferon alfa-2a) [package insert]. Hoffmann-La Roche Inc., Nutley, NJ, Copegus (Ribavirin, USP) [package insert]. Hoffmann-La Roche Inc., Nutley, NJ, n Thyroiditis n Nausea, vomiting n Anorexia n Diarrhea n Injection-site reaction n Lab alterations Neutropenia Anemia Thrombocytopenia Lymphopenia

23 n Predictors and Limitations of Current HCV Therapy

24 Factors Associated With Advanced Fibrosis Type of Factor Well-Established Factors Emerging Risk Factors Controversial Risk Factors Host n Age at infection n Duration of infection n Male gender n Elevated ALT n Baseline fibrosis n Insulin resistance n Steatosis n HLA class 2 polymorphisms n Race n Baseline necroinflammation n Other genetic polymorphisms Viral n HIV infection n HBV infection n HCV viral load n HCV genotype n Viral quasispecies External n Heavy alcohol use n Schistosomiasis n Smoking n Cannabis use Bialek SR, et al. Clin Liver Dis. 2006;10:

25 Early virological response (EVR) Week 12 (N = 453) Yes 2 log 10 decrease or neg HCV RNA n = 390 (86%) SVR No SVR n = 253 (65%) n = 137 (35%) No n = 63 (14%) SVR No SVR n = 2 (3%) n = 61 (97%) Fried MW, et al., N Engl J Med 2002; 347:975

26 Rapid Virological Response (RVR) RVR Undetectable HCV by Qual RNA - 4 wks of TX Percent who achieve an RVR Genotype 1-5% to 20% Genotype 2 and 3-66% Predictive value of an SVR in genotype 1 RVR - 91% Complete EVR 75% Neg HCV RNA at 24 wks - 45% Features predictive of an RVR Low baseline viral load (200,000 IU/mL) and HCV subtype 1b Genotype 2 and 3 - who fail to achieve an RVR Genotype 3 with high viral loads and bridging fibrosis or cirrhosis AASLD Practice Guidelines

27 Rapid Virological Response Week 4 Yes (15-20% OF PTS) SVR No SVR (91%) HCV RNA (9%) Not detected

28 IL-28B predicts SVR to Peg Interferon/Ribavirin therapy in patients with Chronic HCV n In a recent study of 1137 patients from the IDEAL trial, polymorphisms were noted upstream from the IL28B gene encoding IFN lambda 3.

29 Interleukin-28B SNP rs Prevalence by Race and SVR

30 Adherence and SVR Adherence to therapy demonstrates higher SVR when patient: Takes 80% of the prescribed IFN dose Takes 80% of the prescribed RBV dose Completes 80% the prescribed duration of therapy Quality of life may determine patient adherence Ferenci et al. AASLD; Novem ber 9 13, 2001; Dallas, Tex. M chutchison et al. Hepatology. 2000;32:223A. M chutchison et al. Gastroenterology. 2002;123:

31 Effects of Recognizing Depression with a Standardized Questionnaire vs. Patient Self-Reporting on Response of Treatment for Hepatitis C n Aim: Compare response and compliance rates between groups of patients using two methods of identifying depression Standard questionnaire (group A) or the self-report of symptoms (group B). n Methods: 129 patients were randomized to 2 arms. n Results: No significant differences in SVR or in overall compliance between groups (SVR-30% group A, 35% group B) ( IFN Compliance-44% group A and 40% group B). n Conclusion The use of a standardized questionnaire to recognize depression had no significant advantage over patient self-reporting of symptoms on outcomes or compliance n Phillips F et al, 2009 DDW

32 n Emerging Therapies of Hepatitis C

33 STAT-C: Specifically Targeted Antiviral Therapy for Hepatitis C Protease Inhibitors Polymerase Inhibitors Cyclophilin B inhibitors

34 n Conclusions Risk factors for Hepatitis C include blood transfusion, infection-drug use, employment in patient care or clinical laboratory work, exposure to sex partner or household member with history of hepatitis and exposure to multiple sex partners. n Occupational exposure is low following needle stick and post exposure management includes following HCV RNA and HCV ab. n The course of Hepatitis C disease is slow and progresses over years. n Current treatment includes Pegylated Interferon and Ribavirin. n Viral Loads, HCV genotype and liver fibrosis are viral and host factors that influence response to therapy. n RVR (clearance at 4 wks Tx) and EVR (clearance at 12 wks Tx) are the best predictors for therapeutic response to Pegylated Interferon/Ribavirin. n New therapies involving protease inhibitors and polymerase inhibitors will be available in the future.

35 Acknowledgements n Frances Phillips, MS, APRN n Catherine Grumbeck, CAPN n Anita Boyd, MSRN

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