An Approach to the Diagnosis and Treatment of Hepatitis C Virus Infection in Matthew McMahon, MD

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1 An Approach to the Diagnosis and Treatment of Hepatitis C Virus Infection in 2015 Matthew McMahon, MD

2 In the United States, million people are infected with the hepatitis C virus (HCV) Half unaware that they are infected Only 13-18% of persons with chronic HCV infection receive treatment

3 50-85% of patients infected with HCV develop chronic HCV infection 5-30% of patients with chronic HCV develop cirrhosis over 20 to 30 year period Hepatocellular carcinoma (HCC) occurs in patients with cirrhosis at a rate of 1-4% per year HCV is most common cause of liver disease and the most frequent indication for liver transplantation in the United States

4 Primarily transmitted through percutaneous exposure to blood Mother-to-infant Contaminated devices shared for non-injection drug use Risk of sexual transmission is low but does occur Higher risk among HIV-infected men who have unprotected sex with men 29% of incarcerated persons in North America are infected with HCV

5 Whom to Test for HCV Infection Anyone born from 1945 through 1965 Injection drug use Intranasal illicit drug use Long term hemodialysis Anyone who received a tattoo in an unregulated setting Healthcare workers after needle-stick or mucosal exposure to HCV-infected blood

6 Whom to Test for HCV Infection Children born to HCV-infected women Recipient of a blood transfusion before 1992 HIV infection Unexplained liver disease or elevated liver tests Solid organ donors

7 Diagnosis of HCV Infection Anti-HCV antibody If positive -> HCV RNA PCR to confirm active, ongoing infection HCV RNA in persons with negative anti-hcv antibody who are immunocompromised HCV RNA in persons who might have been exposed HCV within the previous 6 months Genotype

8 HCV genotypes Six genotypes Genotype 1 is the most common in the U.S., followed by genotypes 2 and 3 Genotypes 4, 5, and 6 are rare in the U.S.

9 Clinical Manifestations Asymptomatic or minimally symptomatic Most common complaint is fatigue Cirrhosis Ascites/lower extremity edema Variceal bleeding Hepatic encephalopathy Need for liver transplant HCC

10 Extrahepatic manifestations Cryoglobulinemia Lymphoma Thyroiditis Autoantibodies Porphyria Cutanea Tarda Leukocytoclastic Vasculitis Lichen Planus Diabetes mellitus Membranoproliferative glomerulonephritis and membranous nephropathy

11 Miscellaneous Minimize alcohol Alcohol use leads to more rapid progression of liver fibrosis and development of HCC Nonalcoholic fatty liver disease Accelerates fibrosis progression Weight loss encouraged for patients with BMI > 25 Check for HIV antibody and Hepatitis B surface antigen Co-infected patients have poorer prognosis

12 Treatment

13 Treatment is recommended for all patients with chronic HCV infection except those with life expectancy less than 12 months due to nonliver-related comorbid conditions Goal of treatment is to achieve a sustained virologic response (SVR) Continued absence of detectable HCV RNA 12 or more weeks after completion of therapy

14 Benefits of Achieving an SVR HCV-related injury/inflammation stops Regression of fibrosis in most patients Reversal of cirrhosis in a number of patients 90% reduction in risk of liver-related mortality and liver transplantation 70% reduction in the risk of HCC Patients with cirrhosis remain at risk for developing HCC, though the risk is lower Improvement in extrahepatic manifestations

15 Previous Treatment Regimens Combination of daily ribavirin and weekly injections of pegylated interferon (PEG-IFN) Low SVR rates Approximately 50% for genotype 1 Long treatment duration 48 weeks for genotype 1 24 weeks for genotypes 2 and 3

16 Previous Treatment Regimens Significant side effects and patient intolerance PEG-IFN Leukopenia, thrombocytopenia, anemia, thyroid dysfunction, worsening depression and increased suicidality, extreme fatigue, flu-like symptoms Ribavirin Anemia, teratogenic

17 New Direct-Acting Antivirals (DAAs) Target specific steps within the HCV life cycle Target specific nonstructural proteins of the hepatitis C virus

18 New Direct-Acting Antivirals Ledipasvir/Sofosbuvir (Harvoni) Paritaprevir/ombitasvir/ritonavir plus dasabuvir (Viekira pak) Simeprevir Daclatasvir

19 Advantages Over Previous Therapy All-oral regimens SVR rates >90% Shorter duration of therapy 12 to 24 weeks Safety profiles are excellent Most side effects are mild Less than 1% of patients without cirrhosis discontinued treatment early Discontinuation rates 2% for patients with cirrhosis

20 Side Effects Ledipasvir/Sofosbuvir Fatigue, headache, insomnia, nausea Paritaprevir/ombitasvir/ritonavir plus dasabuvir Fatigue, headache, pruritis, asthenia, insomnia, hyperbilirubinemia, elevations in AST and ALT Simeprevir Fatigue, headache, nausea, photosensitivity, rash Daclatasvir Headache, fatigue, nausea

21 Drug Interactions Ledipasvir/Sofosbuvir P-glycoprotein inducers reduce concentrations of ledipasvir and sofosbuvir Rifampin St. John s wort Anticonvulsants Acid reducers decrease ledipasvir concentrations Avoid If unavoidable, use lowest possible dose and space out Amiodarone (Symptomatic bradycardia and fatal cardiac arrest)

22 Drug Interactions PrOD Anticonvulsants, rifampin, St. John s wort, certain oral contraceptives, statins, antiarrhythmics Inhaled solmeterol (Increased risk of cardiovascular adverse events including QT prolongation) Simeprevir Drugs that are significant inducers or inhibitors of CYP3A4 Daclatasvir Drugs that are significant inducers or inhibitors of CYP3A Digoxin

23 Concomitant Medications Daclatasvir Ledipasvir Paritaprevir / Ritonavir / Ombitasvir + Simeprevir Dasabuvir Sofosbuvir Acid-reducing agents* X X Alfuzosin/tamsulosin X Amiodarone X X X X X Anticonvulsants X X X X X Antiretrovirals* See HIV section See HIV section See HIV section See HIV section See HIV section Azole antifungals* X** X X Buprenorphine/naloxone X Calcineurin inhibitors* X X Calcium channel blockers* X X X Cisapride X X Digoxin X X X Ergot derivatives X Ethinyl estradiol containing products X Furosemide X Gemfibrozil X Glucocorticoids* X X (inhaled, intranasal X Herbals St. John s wort Milk thistle X X X X X X Macrolide antimicrobials* X** X Other antiarrythmics* X X Phosphodiesterase type 5 inhibitors* X X Pimozide X Rifamycin antimicrobials* X X X X X Salmeterol X Sedatives* X X Simeprevir X Statins* X X X X

24 Treatment regimens Daily fixed-dose combination of ledipasvir (90mg) and sofosbuvir (400mg) Daily fixed dose combination of paritaprevir (150mg), ritonavir (100mg), and ombitasvir (25mg) plus twice daily dosed dasabuvir (250mg) (PrOD) With or without Ribavirin Daily Sofosbuvir (400mg) plus Simeprevir (150mg) Daclatasvir (60mg) plus sofosbuvir (400mg)

25 Genotype 1a Treatment-naive Daily fixed-dose Ledipasvir/Sofosbuvir Combination for 12 weeks PrOD plus weight-based ribavirin for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) Ribavirin 1000mg daily if <75kg, 1200mg daily if > 75kg Daily daclatasvir and sofosbuvir for 12 weeks (no cirrhosis) or 24 weeks with or without weight based ribavirin (cirrhosis)

26 Genotype 1a Treatment-naive Daily sofosbuvir plus simeprevir with or without weight-based ribavirin for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) Patients with cirrhosis and HCV genotype 1a with the NS3 Q80K polymorphism had lower SVR rates after treatment with sofosbuvir and semiprivir than those who did not harbor the Q80K polymorphism Avoid in patients with Q80K variant

27 Genotype 1b Treatment-naive Daily fixed-dose Ledipasvir/Sofosbuvir Combination for 12 weeks Daily fixed-dose PrOD for 12 weeks Daily sofosbuvir plus simeprevir for 12 weeks (no cirrhosis) or 24 weeks with or without weight-based ribavirin (cirrhosis) Daily daclatasvir and sofosbuvir for 12 weeks (no cirrhosis) or 24 weeks with or without weight-based ribavirin (cirrhosis)

28 Genotype 2 Treatment-naive Daily sofosbuvir and weight-based ribavirin for 12 weeks Extend to 16 weeks for patients with cirrhosis Daily daclatasvir and sofosbuvir for 12 weeks

29 Genotype 3 Treatment-naive Daily sofosbuvir and weight-based ribavirin plus weekly pegylated interferon (PEG-IFN) for 12 weeks for interferon-eligible patients Limited by side effects Daily sofosbuvir and weight-based ribavirin for 24 weeks for interferon-ineligible patients Daily daclatasvir and sofosbuvir for 12 weeks (no cirrhosis) or 24 weeks with or without weight-based ribavirin (cirrhosis)

30 Genotype 4 Treatment-naive Daily fixed-dose combination of ledipasvir/sofosbuvir for 12 weeks Daily fixed-dose combination of paritaprevir/ritonavir/ombitasvir and weight-based ribavirin for 12 weeks Daily sofosbuvir and weight-based ribavirin for 24 weeks

31 Genotype 4 Treatment-naive Daily sofosbuvir and weight-based ribavirin plus weekly PEG-IFN for 12 weeks

32 Genotype 5 or 6 Treatment-naive Daily fixed-dose combination of ledipasvir/sofosbuvir for 12 weeks Daily sofosbuvir and weight-based ribavirin plus weekly PEG-IFN for 12 weeks

33 Retreatment of Patients in Whom Previous Regimens Have Failed

34 Prior Failure with PEG-IFN and Ribavirin: Genotype 1a without cirrhosis Ledipasvir/sofosbuvir daily for 12 weeks PrOD and weight-based ribavirin for 12 weeks Daily sofosbuvir plus simeprevir for 12 weeks Daily daclatasvir and sofosbuvir for 12 weeks

35 Prior Failure with PEG-IFN and Ribavirin: Genotype 1b without cirrhosis Daily sofosbuvir/ledipasvir for 12 weeks PrOD for 12 weeks Daily sofosbuvir plus simeprevir for 12 weeks Daily daclatasvir and sofosbuvir for 12 weeks

36 Prior Failure with PEG-IFN and Ribavirin: Genotype 1a or 1b with compensated cirrhosis Daily ledipasvir/sofosbuvir for 24 weeks Daily daclatasvir and sofosbuvir for 24 weeks with or without weightbased ribavirin Daily ledipasvir/sofosbuvir plus weight-based ribavirin for 12 weeks

37 Prior Failure with PEG-IFN and Ribavirin: Genotype 1a or 1b with compensated cirrhosis PrOD plus weight-based ribavirin for 24 weeks (genotype 1a) PrOD without ribavirin for 12 weeks (genotype 1b) Daily sofosbuvir plus simeprevir with or without weight-based ribavirin for 24 weeks Avoid in patients with genotype 1a who have the Q80K variant

38 Prior Failure with PEG-IFN and Ribavirin: Genotype 2 Daily sofosbuvir plus weight-based ribavirin for 16 weeks or 24 weeks Daily sofosbuvir plus weight-based ribavirin plus weekly PEG-IFN for 12 weeks

39 Prior Failure with PEG-IFN and Ribavirin: Genotype 3 Daily sofosbuvir and weight-based ribavirin plus weekly PEG-IFN for 12 weeks Daily daclatasvir and sofosbuvir for 12 weeks (no cirrhosis) or 24 weeks with or without weight-based ribavirin (cirrhosis)

40 Prior Failure with PEG-IFN and Ribavirin: Genotype 4 Ledipasvir/sofosbuvir for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) Paritaprevir/ritonavir/ombitasvir plus weight-based ribavirin for 12 weeks (no cirrhosis) Daily sofosbuvir plus weight-based ribavirin plus weekly PEG-IFN for 12 weeks Daily sofosbuvir and weight-based ribavirin for 24 weeks

41 Prior Failure with PEG-IFN and Ribavirin: Genotype 5 or 6 Ledipasvir/sofosbuvir for 12 weeks Daily sofosbuvir and weight-based ribavirin plus weekly PEG-IFN for 12 weeks

42 Prior Failure with PEG-IFN and Ribavirin and Telaprevir or Boceprevir Genotype 1a and 1b without cirrhosis Ledipasvir/sofosbuvir for 12 weeks Daily daclatasvir and sofosbuvir for 12 weeks Genotype 1a and 1b with cirrhosis Ledipasvir/sofosbuvir for 24 weeks Ledipasvir/sofosbuvir plus weight-based ribavirin for 12 weeks Daily daclatasvir and sofosbuvir for 24 weeks with or without weight-based ribavirin

43 Assessment Prior to Starting Therapy Assess potential drug-drug interactions CBC, INR, CMP, TSH (if using IFN) within 12 weeks of starting therapy HCV genotype, HCV viral load at any time prior to starting therapy

44 Monitoring During Therapy CBC and CMP after 4 weeks of treatment and as clinically indicated May need to monitor Hgb more frequently if receiving ribavirin TSH every 12 weeks if receiving IFN

45 Monitoring During Therapy Quantitative viral load after 4 weeks of therapy and at 12 weeks following completion of therapy If quantitative HCV viral load is detectable at week 4, repeat quantitative HCV viral load testing is recommended at week 6 If quantitative HCV viral load is increased by greater than ten fold on repeat testing at week 6, discontinuation of treatment is recommended

46 Unique Patient Populations

47 Decompensated Cirrhosis Child-Turcotte-Pugh class B or C Refer to medical practitioner highly experienced in the management of advanced liver disease and HCV treatment (ideally a liver transplant center)

48 Decompensated Cirrhosis Genotype 1 or 4 Ledipasvir/sofosbuvir and ribavirin (initial dose of 600mg, increased as tolerated) for 12 weeks Daily daclatasvir and sofosbuvir plus low dose ribavirin (initial dose of 600mg, increased as tolerated) for 12 weeks For patients with anemia or ribavirin intolerance, daily daclatasvir and sofosbuvir for 24 weeks Genotype 2 or 3 Daily sofosbuvir and weight-based ribavirin for up to 48 weeks Daily daclatasvir and sofosbuvir plus low dose ribavirin (initial dose 600mg, increased as tolerated) for 12 weeks

49 Renal Impairment Mild to moderate renal impairment (CrCl >30-80mL/min) No dosage adjustment necessary for daclatasvir, ledipasvir/sofosbuvir, PrOD, simeprevir Ribavirin egfr 30-50mL/min use 200mg or 400mg alternating every other day egfr < 30mL/min use 200mg daily Patients without cirrhosis and CrCl <30mL/min PrOD plus ribavirin 200mg thrice weekly to daily for genotype 1a Do not use ribavirin if Hgb <10 PrOD alone for genotype 1b Paritaprevir/ritonavir/ombitasvir for genotype 4 For genotypes 2, 3, 5, or 6 PEG-IFN and dose-adjusted ribavirin

50 HIV/HCV Coinfection Higher rate of HCV persistence, faster progression to cirrhosis, and higher HCV RNA levels Lower responses to PEG-IFN and ribavirin No difference in treatment responses between mono and coinfected patients with new DAAs

51 HIV/HCV Coinfection Treatment recommendations for HIV/HCV coinfected patients are the same as for those with HCV infection alone Drug-drug interactions with antiretroviral medications Collaboration with the HIV practitioner

52 Acute Hepatitis C Virus Infection Infection of < 6 months duration Spontaneously resolve in 15-50% of cases Monitor for spontaneous clearance for 6 months If HCV RNA present after 6 months, treat as for chronic HCV infection

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