HCV Update Worldwide Magnitude. Magnitude at home 9/25/2012. Screening guidelines Treatment guidelines New treatment agents

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1 HCV Update 2012 Screening guidelines Treatment guidelines New treatment agents Janice Voukidis, ANP The Oregon Clinic Portland GI Hepatology Division Worldwide Magnitude million persons with HCV infection worldwide [1] 3-4 million newly infected each year 1. WHO. 2. NIH. NIH Consens State SciStatements. 2002;19: MühlbergerN, et al. BMC Public Health. 2009;9:34. Magnitude at home Most common blood borne pathogen 3.9 million people in United States are infected (1.2 mil infected with HIV) Most common cause of liver disease 12,000+ deaths annually 35,000 new cases annually 1. WHO. 2. NIH. NIH Consens State SciStatements. 2002;19: MühlbergerN, et al. BMC Public Health. 2009;9:34. 1

2 Magnitude at home 75% of persons are baby boomers (born between see CDC recs) 50-75% are unaware Most have no symptoms Magnitude at Home In a survey of 4000 primary care providers, only 50% of 1400 respondents asked all patients about HCV risk factors. Gordon FD. Am J Med. 1999;107:36S-40S. 2. Culver DH, et al. Transfusion. 2000;40: Eurasian Harm Reduction Network. Comparative analysis of HCV prevalence across selected countries of Europe and the Mediterranean area. October HCV Infection Prevalence by Age Anti-HCV Positive (%) < Age Group 1999 NHANES data Alter MJ, et al. N Eng J Med. 1999;341:

3 Anti-HCV Positive (%) HCV Infection Prevalence by Race/Gender B, Blacks; F, female; H, Hispanic; M, male; W, Whites. W B H M F Race Sex Alter MJ, et al. N Eng J Med. 1999;341: Population At Risk CDC guidelines 2012 Healthcare workers upon accidental exposure Children born to anti-hcv positive mothers Sexual partners of HCVinfected persons Persons born between WHY SHOULD WE CARE ABOUT HCV? 3

4 Impact of HCV on Health-Related Quality of Life Patients with chronic HCV infection experience higher rates of depression Less social functioning Reduced ability to work Higher rates of suicide attempt Greater feeling of being stressed out Wilson MP, et al. Int J Psychiatry Med. 2010;40: Cost of Health Benefits for Employees With HCV Patients with chronic HCV infection have more lost days from work and more days of short-term disability Adjusted Mean Cost HCV Controls Sick leave $445 $364 Short-term disability $530 $256 Healthcare $4885 $2281 Medications $5801 $543 Total costs $12,111 $3758 Su J, et al. Hepatology. 2010;52: Other Symptoms of Chronic HCV Fatigue Arthralgias and myalgias 4

5 HCV Infection Natural History Acute HCV Resolved 15% (15%) Stable 80% (68%) Chronic HCV 85% (85%) Slowly progressive 75% (13%) Cirrhosis 20% (17%) HCC Liver failure 25% (4%) Complications of Advanced Liver Disease Clinical Portal hypertension Thrombocytopenia, varices, nodular liver Impaired hepatic function Albumin, bilirubin, INR Decompensation Encephalopathy Variceal hemorrhage Jaundice Sangiovanni A, et al. Hepatology. 2006;43: Approximate Percentage of Patients With Cirrhosis Chronic HCV Infection Progression to Cirrhosis Proportion of Patients Developing Cirrhosis According to Initial Level of Fibrosis Bridging (F3) Portal fibrosis (F 2) None Time (Years) Yano M, et al. Hepatology. 1996;23:

6 10-Year Cumulative Survival in Patients With Cirrhosis Decompensated Stable/Compensated 100 HCV and Alcohol Risk of Cirrhosis Cirrhosis (%) HCV HCV + alcohol Years Following Exposure Exessivealcohol intake characterized as > 40 g/day for women and > 60 g/day for men. Wiley TE, et al. Hepatology. 1998:28: SVR/Cure Improves Histologic Outcome 150 patients with SVR/cure 128 patients at 4-year follow-up, biopsy offered Of 49 patients with paired biopsies, 82% experienced decrease in fibrosis score, 92% decrease in activity index 20% had normal to near-normal histology on follow-up George S, et al. Hepatology. 2008;49:

7 REVIEW OF THE BASICS Hepatitis C Virus Genotypes in the USA Type 2 17% Type 1 72% Type3 10% All others 1% McHutchinson JG, et al. N Engl J Med. 1998;339: The Basics about Genotype No correlation between Genotype and severity of illness Genotype predicts Chance of Sustained Viral Response SVR (cure) Length of Treatment 7

8 No Correlation between HCV RNA level and Fibrosis (Viral level/amt of Damage) Log HCV RNA (copies/ml) Genotype 0 No Fibrosis Portal Fibrosis Bridging Fibrosis Cirrhosis Ferreira-Gonzalez A, et al. Use of Diagnostic Testing for Managing Hepatitis C Virus Infection. SeminLiver Dis. 2004;24(Suppl2):9-18. Reprinted by permission. SVR Sustained viral response is equivalent to Viral cure Is Liver Biopsy Necessary? NO Patient wants treatment even if no fibrosis Patient does not want treatment or treatment contraindicated even if advanced fibrosis Labs and radiographic studies do not suggest cirrhosis Patient achieves SVR YES Patient would only accept treatment if advanced fibrosis Labs or radiographic studies suggest cirrhosis may be present Patient fails to achieve SVR and no recent biopsy available 8

9 HCV Infection Liver Biopsy 10% of patients with cirrhosis have normal LFTs Only test that can accurately assess Severity of inflammation Degree of fibrosis CURRENT STANDARD OF CARE Current SOC Genotype 1a or 1b PegIFN---1 injection 1x per week Ribavirin---2x daily Telaprevir750 mg q 8 hr with 20 gm fat (x 12 weeks fixed) (May 2011) OR Boceprevir800mg TID. (May 2011) (12, 24, or 36 weeks) Total length of PegIFNand ribabased on fibrosis score and response at 4 weeks. (24-48 wks) 9

10 Current SOC Genotype 2 or 3 PegIFN---1 injection per week Ribavirin---2 x daily 24 weeks 75-85% chance of SVR or Cure Genotype 4 or 6 PegIFN---1 injection per week Ribavirin---2 x daily 48 weeks 46-55% chance of cure Improved SVR Rates With Boceprevir or Telaprevir 100. SVR (%) Genotype 1 Treatment naïve patients 20 PoordadF, et al. N Engl J Med. 2011;364: Jacobson IM, et al. N EnglJ Med. 2011;364: PegIFN/RBV BOC or TVR + PegIFN/RBV Drug-Drug Interactions with Telaprevir or Boceprevir Drug Class Contraindicated With BOC [1] Contraindicated With TVR [2] Alpha 1-adrenoreceptor antagonist Alfuzosin Alfuzosin Anticonvulsants Carbamazepine, phenobarbital, phenytoin N/A Antimycobacterials Rifampin Rifampin Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine GImotility agents Cisapride Cisapride Dihydroergotamine, ergonovine, ergotamine, methylergonovine Herbalproducts Hypericum perforatum (StJohn s wort) Hypericum perforatum HMGCoA reductase inhibitors Lovastatin, simvastatin Atorvastatin, lovastatin, simvastatin Oral contraceptives Drospirenone N/A Neuroleptic Pimozide Pimozide PDE5 inhibitor Sildenafil or tadalafil whenused for tx of pulmonary arterial hypertension Sildenafil or tadalafil whenused for tx of pulmonary arterial hypertension Sedatives/hypnotics Triazolam; orally administered midazolam Orally administered midazolam, triazolam *Studies of drug-drug interactions incomplete. 1. Boceprevir [package insert]. May Telaprevir [package insert]. May

11 Boceprevir-Related Adverse Events in Clinical Trials Treatment-naive patients Adverse Event, % Boceprevir + PegIFN/RBV triple tx (n = 1225) PegIFN/ RBV Dual tx (n = 467) Anemia Hgb<10 Neutropenia ANC <0.5 or 500 Dysgeusia Boceprevir[package insert]. May Telaprevir-Related Adverse Events in Clinical Trials Treatment-naive patients Adverse Event, % Telaprevir + PegIFN/RBV Triple Tx (n = 1797) PegIFN/RBV Dual TX (n = 493) Rash Anemia HGB< Anorectal symptoms 29 7 Telaprevir [package insert]. May What s New??? 11

12 So What s new in HCV Screening guidelines Inclusion of baby boomer birth cohort SOC for genotype 1 Addition of telaprevir or boceprevir IL28 testing prediction for response Non-invasive liver markers Multitude of potential new agents in research IL28B testing Genetic polymorphism CC genotype strongly correlates with response to pegifn+ RBV Genotype 1 Only accounts for about 50% of disparity in response rates CC (can be cured) TT( tough to treat) CT (can be treated) Ge D, et al. Nature. 2009;461: Non-invasive liver markers Elastography by Ultrasound or Magnetic Resonance Elastography. Liver stiffness values are calculated from wave displacement Excellent accuracy in experienced centers for detecting cirrhosis, Accuracy is diminished Obesity, narrow rib interspaces, severe inflammation, cholestasis, and hepatic congestion Doris Nguyen1 and JayantA. Talwalkar2,3 Noninvasive Assessment of Liver Fibrosis,Heoatology, June

13 Serum Non-invasive fibrosis markers FibroTest. Fibro-sure Proprietary panel contains five variables including total bilirubin, haptoglobin,gamma glutamyl transpeptidase, a2-macroglobulin,and apolipoprotein A. Fibro-spect uses a combination of components in the fibrogenic cascade, such as hyaluronicacid, TIMP-1 (tissue inhibitor of metalloproteinase), and α-2- macroglobulin to calculate a composite score. New Horizons Fast pace current drug development Trials can be completed within 1 year. Significant interest Able to enroll within 3 months No control group Short duration of treatment Follow-up 12 weeks post completion 13

14 What Are the Key Elements of an Ideal HCV Regimen? Short duration, simple stopping rules Simple Regimen All Oral, Once daily, low pill burden High efficacy in challenging populations (ie, nulls, cirrhosis) Used across all genotypes Few or easily managed adverse effects Investigational agents A better understanding of the. of HCV (virus) has shown that targeting certain host molecules in the liver cell can remove some of the machinery required by the HCV to replicate. Overview of Emerging Agents for Treatment of Chronic Hepatitis C Virus Infection. Donald M. Jensen, MD, Mark S. Sulkowski, MD, David R. Nelson, MD, Jenny Schulz, PhD, Edward King, MA, Lisa Montoya Cockrell, PhD. Annual Update, New HCV Agents. Clinical Care Options 2012 HCV Life Cycle Illustration courtesy of Alison Jazwinski, MD. 14

15 Investigational agents DRUG Study # wks # Pts PEG/ IFN Ribavirin F-4 Trial Geno %SVR GS-7977 (ATOMIC) 12, , 24 12, 24 No III All >90 (ELECTRON) ,4,8,12 12 No III 2,3 Simeprevir (ASPIRE) Alisporivir (VITAL-1) BI , BI (SOUND-C2) Daclatasvir GS-7977 ABT-072,ABT-333 ABT 450, Ritonavir, (PILOT) 12, 24, , 24 12, 24 No III P T G-1 50%NR, 85%RL 57-75% PR , 18 0, 18 Hold 2,3 3/1800 pts pancreatitis None 0,16, 28, None 0, 24 No naïve 1,2, None 12 Naïve 1 (Co-PILOT) None 12 Naïve P T - Daclatasvir Asunaprevir F-4= cirrhosis NR= Non-reponder PR=Partial responder RL= Relapser PT= previously treated 43 None NR G % 91% 82% 94% 47% 77% Summary Individuals who were treated with interferon compared with individuals who received no treatment had half the risk of Dying Requiring liver transplant. Developing complications NiederauC, et al. Hepatology. 1998;28:

16 Primary care providers play key role in identifying risk factors and screening for HCV Population At Risk CDC guidelines 2012 Elevated LFTs Hxof IV drug use (including those I only did it once Hxof transfusion of blood products or organ transplant before 1990 History of hemodialysis or hemophilia HIV infection Healthcare workers upon accidental exposure Children born to anti- HCV positive mothers Sexual partners of HCVinfected persons Persons born between Birth cohort testing Estimations of this strategy vs. risk based testing Identify > 800,000 cases of HCV 416,000 more patients will receive treatment Reduce: future cases of decompensatedcirrhosis by 64,000 HCV-related deaths by 121,000 16

17 Rare ABSOLUTE contraindication Experienced provider can work with the patient and other providers to manage contraindications Uncontrolled depressive illness, psychosis, or epilepsy Untreatedanemia, neutropenia, thrombocytopenia Contraindications to HCV treatment Renal, heart, or lung transplantation Conditions known to be exacerbated by pegifnand RBV Decompensated cirrhosis Uninsured (pt assist programs) Unstable support system Ability to tolerate side effects GhanyMG, et al. Hepatology. 2009;49: EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. June What tests do I order? HCV Antibody 3 rd generation enzyme immunoassay (EIA) Positive HCV AB confirm HCV quantitative viral level recombinant immunoblotassay or an HCV RNA test CDC Recommendations ETOH Use no more than Women 1-2 ETOH servings/day 7 /week Men 2-3 ETOH servings /day 14/ week 5 servings is bingeing 1 bottle of wine Counseling Weight Loss (BMI > 25) HepA and B vaccination Refer to specialist as appropriate Evaluate for presense of advanced liver disease Treatment options 17

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