Hepatitis C Pre-Treatment Assessment: The Role of the Primary and HCV Provider

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2 Hepatitis C Pre-Treatment Assessment: The Role of the Primary and HCV Provider David C. Wolf, MD, FACP, FACG, AGAF, FAASLD Medical Director of Liver Transplantation Westchester Medical Center Professor of Clinical Medicine New York Medical College

3 Objectives Review HCV basics: Prevalence and incidence. Natural history of HCV infection. Discuss responsibilities of the primary provider. Screening for HCV infection. Discuss responsibilities of the HCV provider.

4 HCV Basics: Prevalence 200 million infected individuals. 0.5 million deaths per year. 5 million infected individuals. 20% of patients develop cirrhosis. > 12,000 deaths per year. Incidence, 1990: ~ 180,000 new cases / year. Incidence, 2011: ~ 16,500 new cases / year. Incidence, 2014: ~ 30,500 new cases / year. Mohd Hanafiah K et al. Hepatology 2013;57: Accessed April 10, 2017.

5 HCV Basics: Risk Factors 1980s 2017 Injection drug use Unknown Household Occupation Injection drug use Other Transfusion Other high risk behavior Transfusion Sexual Sexual

6 HCV Basics: Risk Factors Injection drug use Other 1980s 2017 Unknown Household Occupation Prevalence Injection drug General population: 1% use PWIDs 80-90% Transfusion Incarcerated 15% HIV-infected Other 30% high risk behavior Transfusion Sexual Sexual

7 HCV Basics: Natural History Acute Chronic Cirrhosis Liver HCC Hepatitis Hepatitis Failure > 30,500 / year 85% ~ 20% 15% 1-5% Years

8 HCV Basics: Curing HCV Improves Outcomes Sustained Virologic Response â liver-related mortality. â all-cause mortality. â incidence of liver cancer. Backus LI et al. Clin GastroenterolHepatol. 2011;9:509; van der Meer AJ et al. JAMA. 2012;308: ; Morgan RL et al. Ann Intern Med. 2013;158:329; Kimer N et al. BMJ Open. 2012;2.

9 HCV Treatment: What Should Physicians & Patients Expect? Improved symptoms. Improved liver chemistries Sustained virological response (i.e. cure). Reversal of fibrosis. Stabilize compensated cirrhosis. Reverse decompensated cirrhosis. Probably. Probably. ~ 97% likelihood. Maybe. Hopefully. Probably not.

10 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care. The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

11 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care.

12 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care.

13 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If The HCV OLD Ab positive standard. à confirm Symptoms with HCV RNA testing. Nausea, abdominal pain, jaundice. Fatigue, loss of appetite. Linkage to care. Abnormal liver chemistries.

14 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If The HCV NEW Ab positive standard. à confirm Risk with factors. HCV RNA testing. Birth cohort. Linkage to care.

15 Candidates for HCV Screening 1998 Recommendations 1 Persons who have injected illicit drugs in the recent and remote past Persons with conditions associated with a high prevalence of HCV infection 2012 Additional Recommendations 2 Birth Cohort Screening Adults born during should receive one-time testing for HCV without prior ascertainment of HCV risk Prior recipients of transfusions or organ transplants prior to July 1992 Children born to HCV-infected mothers Health care, emergency medical and public safety workers after a needle stick injury or mucosal exposure to HCV-positive blood Current sexual partners of HCVinfected persons 1. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-39; 2. Centers for Disease Control and Prevention. MMWR RecommRep. 2012;61 (RR-4):1-32.

16 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care. HCV Ab (ELISA)

17 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care. HCV Ab (ELISA) Abbott HCV EIA 2.0 Advia Centaur HCV ARCHITECT Anti-HCV AxSYM Anti-HCV OraQuick HCV Rapid Antibody Test Ortho HCV Version 3.0 EIA VITROS Anti-HCV

18 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care. Hepatitis C Virus RT PCR Assay Baxter UltraQual HCV RT PCR Assay National Genetics Institute COBAS AmpliScreen HCV Test, ver 2.0 Roche Versant HCV RNA 3.0 Siemens

19 Hepatitis C: Provider Responsibilities The primary provider Screen patients at risk. If HCV Ab positive à confirm with HCV RNA testing. Linkage to care.

20 Hepatitis C: Provider Responsibilities Consider HCV RNA testing in: sss Patients with possible exposure to HCV within the past 6 months. sss Patients who are immunocompromised. Consider repeating an HCV RNA test. MMWR Morb Mortal Wkly Rep. 2013;62:362-5.

21 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

22 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Medical comorbidities Lung, heart, kidney disease. Obesity. Neuropathy. Rash. Itching. Pregnancy à Ribavirin is contraindicated. Psychiatric history. Social history. Marital history, social supports. Substance use and abuse. Cigarettes. Alcohol. Drugs.

23 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Prior treatment for hepatitis C. (i.e. Did the patient previously experience treatment failure?) Which medications? Complications or side effects? What was the outcome?

24 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Prescription medications and overthe-counter supplements Amiodarone. Sofosbuvir à bradycardia. Anti-acid agents. Ledipasvir, Velpatasvir à â absorption. Statins. Anti-epileptic medications. P-gp inducer à lower drug levels. Anti-HIV medications. St. John s wort P-gp inducer à lower drug levels. Rifampin. P-gp inducer à lower drug levels. Ethinyl estradiol. Cyclosporine, tacrolimus.

25 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history Points of disease. to remember Counsel This list to is prevent not all-inclusive. transmission. Obtain Refer to basic the blood package tests. insert. Rule Use outside coexisting resources: liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Prescription medications and over-the-counter supplements Amiodarone. Sofosbuvir à bradycardia. Anti-acid agents. Ledipasvir, Velpatasvir à â absorption. Statins. Anti-epileptic medications. P-gp inducer à lower drug levels. Anti-HIV medications. St. John s wort P-gp inducer à lower drug levels. Rifampin. P-gp inducer à lower drug levels. Ethinyl estradiol. Cyclosporine, tacrolimus.

26 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

27 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Lungs, heart. Gynecomastia. Abdomen. Hepatomegaly. Splenomegaly. Ascites. Caput medusa Skin. Jaundice. Spider angiomata. Palmar erythema. Terry s nails.

28 The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Lungs, heart. Gynecomastia. Abdomen. Hepatomegaly. Splenomegaly. Ascites. Caput medusa Skin. Jaundice. Spider angiomata. Palmar erythema. Terry s nails.

29 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Natural History of Hepatitis C Is a patient with cirrhosis destined to die from liver disease? No! Survival of patients with HCV cirrhosis 10 years after diagnosis (without liver transplant) is about 70%.

30 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Sex. Transmission in about 5% of monogamous couples. Risk factors for sexual transmission. Coinfection with HIV. Unprotected anal intercourse. Coincident ulcerative STDs (e.g. syphilis). Practices that predispose to bleeding. Drugs Risk factors: Sharing drug paraphernalia. Both for IVDU and snorting. Use clean needles. Household. Risk factors: Sharing razors, toothbrushes, nail clippers. Contact with blood. Clean up blood spills with bleach. Non-risk factors: Sharing utensils, plates, glassware. Casual contact: touching, hugging, kissing, sneezing, coughing. Maternal 5% transmission rate in from monoinfected mothers to infants. Breast feeding is safe.

31 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

32 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

33 Hepatitis C: Provider Responsibilities Cirrhosis Low platelet count. Low albumin. Elevated bilirubin. Elevated INR. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

34 Hepatitis C: Provider Responsibilities HIV positive? Decision to treat HIV or HCV first. HAV IgM: marker for acute HAV infection. HAV IgG: marker of prior exposure to HAV with subsequent immunity HAV Ab (total) positive à immune. HAV Ab (total) negative à vaccinate! CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

35 Hepatitis C: Provider Responsibilities HBcAb(total) positivity usually indicates prior exposure to hepaitis B. HBcAbIgM à marker of acute infection. [Would not order it unless acute infection is suspected or the patient is at risk of acute HBV infection]. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Important questions Do you need to order HBV DNA to see if there is active HBV replication? Does the patient need treatment for HBV? Is the patient at risk for reactivation of HBV? HBV and HCV compete for replicative space within the hepatocyte. Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir) Successful HCV Rx can lead to HBV reactivation. FDA requires a boxed warning urging close monitoring of HCV/HBV patients.

36 Hepatitis C: Provider Responsibilities CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

37 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. History Heart disease. Diabetes, obesity à NAFLD. Alcohol abuse à alcoholic liver disease. Family history of autoimmunity. Autoimmune hepatitis. Primary biliary cholangitis. Primary sclerosing cholangitis. Family history of liver disease. Hereditary hemochromatosis. Alpha-1 antitrypsin deficiency. Labs Antinuclear antibody (ANA) Antismooth muscle antibody (ASMA) Anti mitochondrial Ab (AMA) Fe / TIBC / Ferritin [Ceruloplasmin] [Alpha-1 antitrypsin level & phenotype] Alpha fetoprotein Scans Ultrasound

38 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

39 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. HAV Ab positive à Immune. Don t vaccinate. HAV Ab negative à Not immune. Vaccinate!

40 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. HBcAb negative, HBsAg negative, HBsAb positive. Immune from prior vaccination. Don t vaccinate. HBcAb positive, HBsAg negative, HBsAb positive. Cleared HBV after prior infection. Don t vaccinate. HBcAb positive, HBsAg positive, HBsAb negative. Chronically infected. Don t vaccinate. HBcAb negative, HBsAg negative, HBsAb negative. Not immune. Vaccinate! HBcAb positive, HBsAg negative, HBsAb negative. 5-10% chance of active infection. Check an HBV DNA by PCR (quantitative).

41 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural Hepatitis history A vaccines of disease. Counsel to prevent transmission. Obtain basic Hepatitis blood tests. B vaccine Rule out coexisting liver disease. Vaccinate to Combined prevent HAV and HBV vaccine and HBV. Assess severity of disease. Non-cirrhotic Twinrix vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Vaccine Dosage Dosing and Route Havrix 1440 EL.U. 1 ml IM at 0 and 6-12 months. Vaqta 50 U 1 ml IM at 0 and 6-18 months Engerix 20 mcg 1 ml IM at 0, 1, and 6 months HAV 720 EL.U plus HBsAg: 20 mcg 1 ml IM at 0, 1 and 6 months or Accelerated 4-dose schedule: 1 ml IM on days 0, 7, and booster at month 12

42 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

43 Progression of Liver Disease Normal Chronic hepatitis Cirrhosis

44 Normal Liver Histology

45 Progression of Liver Disease Stage 1 Portal fibrosis Stage 2 Periportal fibrosis Stage 3 Septal fibrosis Stage 4 Cirrhosis

46 Stage 1 Stage 2 Stage 3 Stage 4

47 Hepatitis C: Implications of Advanced Fibrosis Very low chance of developing hepatocellular carcinoma (HCC, liver cancer). In HCV patients with advanced fibrosis, liver cancer develops in up to 3% of patients per year.

48 Liver Cancer 101 Liver cancer is curable if caught early. Resection cases: cure rate is about 50%. Transplant cases: cure rate is about 80%. Resection specimen Post-mortem specimen Bruix J, Sherman M. Management of hepatocellular carcinoma. AASLD Practice Guideline. Hepatology. July 2010; Wolf DC. Liver Transpl. 2003;9:682.

49 Liver Cancer 101 Liver cancer is curable if caught early. Resection cases: cure rate is about 50%. Transplant cases: cure rate is about 80%. Screening patients with cirrhosis is cost effective. Costs < $50,000 per quality adjusted life year saved. AASLD recommends: HCC surveillance should be performed in cirrhotic patients with ultrasound. Patients should be screened at 6 month intervals. Most N.Y. hepatologists recommend HCC surveillance for HCV patients with stage 3 fibrosis. Resection specimen Post-mortem specimen Bruix J, Sherman M. Management of hepatocellular carcinoma. AASLD Practice Guideline. Hepatology. July 2010; Wolf DC. Liver Transpl. 2003;9:682.

50 Liver Cancer 101 Liver cancer is curable if caught early. Resection cases: cure rate is about 50%. Transplant cases: cure rate is about 80%. Screening patients with cirrhosis is cost effective. Costs < $50,000 per quality adjusted life year saved. AASLD recommends: HCC surveillance should be performed in cirrhotic patients with ultrasound. Patients should be screened at 6 month intervals. Most N.Y. hepatologists recommend HCC surveillance for HCV patients with stage 3 fibrosis. If there is a suspected nodule on ultrasound à refer for MRI. Most HCC diagnoses are made radiologically. Bruix J, Sherman M. Management of hepatocellular carcinoma. AASLD Practice Guideline. Hepatology. July 2010; Wolf DC. Liver Transpl. 2003;9:682. Resection specimen Post-mortem specimen

51 Hepatitis C: Implications of Advanced Fibrosis Early fibrosis. Assess genotype Treat. Advanced fibrosis. Screen for HCC. Assess genotype Treat.

52 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

53 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

54 Hepatitis C: Provider Responsibilities CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

55 Hepatitis C: Provider Responsibilities HCV viral load A low viral load might lead to a shorter duration of therapy. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

56 Hepatitis C: Provider Responsibilities CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

57 Hepatitis C: Provider Responsibilities HCV genotype: Determines specific treatment regimen. Is a predictor of response. CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

58 Hepatitis C: Provider Responsibilities CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

59 Hepatitis C: Provider Responsibilities 1a 1b 2 3CBC, platelets Sofosbuvir+ Sofosbuvir Comprehensive + metabolic profile Sofosbuvir/ Sofosbuvir/ Sofosbuvir/ Ribavirin Ribavirin Ledipasvir +/-Renal function. Ledipasvir Ledipasvir Peg-IFN Liver chemistries. Sofosbuvir/ Ledipasvir PrOD* + Ribavirin Glecaprevir + pibrentasvir Elbasvir + Grazoprevir +/- Ribavirin Sofosbuvir + Velpatasvir +/- Ribavirin Sofosbuvir + Velpatasvir + Voxilaprevir PrOD* Glecaprevir + pibrentasvir Glecaprevir + pibrentasvir Glecaprevir + pibrentasvir Elbasvir + Grazoprevir Sofosbuvir + Velpatasvir +/- Ribavirin Sofosbuvir + Velpatasvir + Voxilaprevir *PrOD = paritaprevir ritonavir ombitasvir dasabuvir Sofosbuvir + Velpatasvir +/- Ribavirin Sofosbuvir + Velpatasvir + Voxilaprevir Sofosbuvir + Velpatasvir +/- Ribavirin Sofosbuvir + Velpatasvir + Voxilaprevir INR Viral studies Albumin PrO Ribavirin Total bilirubin Alkaline Glecaprevir phosphatase + Glecaprevir+ Aspartate pibrentasvir aminotransferase pibrentasvir Alanine aminotransferase Elbasvir + Grazoprevir +/ Ribavirin HIV AbSofosbuvir + HAV Ab Velpatasvir (total, not +/- IgM!) Ribavirin HBcAb (total, not IgM!) Sofosbuvir + HBsAgVelpatasvir + HBsAb Voxilaprevir (quantitative) Sofosbuvir/ Velpatasvir Sofosbuvir + Velpatasvir + Voxilaprevir Sofosbuvir/ Ledipasvir Glecaprevir + pibrentasvir Sofosbuvir/ Velpatasvir Sofosbuvir + Velpatasvir + Voxilaprevir Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

60 Hepatitis C: Provider Responsibilities CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

61 Hepatitis C: Provider Responsibilities Is there a drug-resistance mutation? CBC, platelets. Comprehensive metabolic profile Renal function. Liver chemistries. Albumin INR Viral studies Total bilirubin Alkaline phosphatase Aspartate aminotransferase Alanine aminotransferase HIV Ab HAV Ab (total, not IgM!) HBcAb (total, not IgM!) HBsAg HBsAb (quantitative) Hepatitis C studies HCV RNA (quantitative) HCV genotype NS5A resistance (for patients who are likely to be treated with elbasvir/grazoprevir)

62 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

63 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. We cannot afford noncompliance. Expense of medications. Risk of inducing drug-resistance mutations.

64 Hepatitis C: Provider Responsibilities The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

65 The Prior Authorization Process The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment.

66 The Prior Authorization Process The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Initial office visits History, PE, Labs. Review labs. Discuss medication. Discuss plan for follow-up. Prescription is processed Initiate prior authorization Send documents to insurance company Chart note. CBC / CMP Viral load. Genotype Fibrosis score Resistance testing

67 The Prior Authorization Process The HCV provider Take an excellent history. Perform an excellent physical exam. Explain the natural history of disease. Counsel to prevent transmission. Obtain basic blood tests. Rule out coexisting liver disease. Vaccinate to prevent HAV and HBV. Assess severity of disease. Non-cirrhotic vs. cirrhotic. Assess genotype. Assess patient s potential for treatment compliance. Prescribe and monitor treatment. Decision in 3-7 days. If approved Which pharmacy can provide the medication? If copay is > $50, is there a financial assistance program? If denied Appeal the decision. Prescription is approved. Medication is delivered.

68 Summary Review HCV basics: Prevalence, Incidence, and Natural history of HCV infection. Cure can be achieved in up to 97% of patients. Curing HCV saves lives and saves money. Responsibilities of the primary provider. Screening for HCV infection. HCV Ab positivity à HCV RNA testing.

69 Summary Responsibilities of the HCV provider: Take an excellent history; perform an excellent exam. Counsel the patient. Basic and specialized blood tests. Vaccinate against HAV and HBV as needed. Assess severity of liver disease. Assess genotype. Prescribe and monitor treatment.