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Chronic hepatitis C guidelines for screening and treatment PowerPoint Presentation

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Slide 1-

Chronic hepatitis C: guidelines for screening and treatment Lisa M. Glass, MD Clinical Lecturer Division of Gastroenterology and Hepatology
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Hepatitis C Virus Flavivirus: RNA virus Dengue West Nile Yellow Fever Zika Heterogeneity: Polymerase lacks proofreading capability resulting in many mutations and significant viral diversity Allows escape from host immune system and medications as well as vaccines Genotypes: Six major genotypes (1-6) with >15 subtypes (ie 1a, 1b, 2a, 2b)
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HCV distribution
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Hepatitis C Virus Genome Morales, J. M. & Fabrizi, F. (2015) Hepatitis C and its impact on renal transplantation Nat. Rev. Nephrol. doi:10.1038/nrneph.2015.5
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Exposure
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Acute hepatitis C infection: Incidence in the United States is decreasing overall: 230K in 1980s  17K 2011  31K in 2014 Increasing in young populations: People <30 yrs (due to increased IVDU) Chronic hepatitis C: US prevalence of chronic hepatitis C (CHC) viral infection: 1999-2002: 1.3% or about 3.5 million people in the US Accounts for 8,000 to 13,000 deaths each year in the US Most common cause of hepatocellular carcinoma and indication for liver transplantation in the US Hepatitis C Epidemiology Smith BD et al. Am J Public Health. 2014
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Prevalence of CHC cirrhosis is rising Davis et al, Gastroenterology 2010;138:513
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Transmission: Percutaneous exposure to blood Vertical (mother-to-infant) Sexual Risk factors for CHC: History of illicit drug use other than marijuana Male gender Black race Low family income High-school education or less 10 lifetime sexual partners Incarceration (30% are HCV Ab +) CHC Epidemiology
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Risk-based screening for those who have: Ever injected illegal drugs Received clotting factors made before 1987 Received blood/organs before July 1992 Were ever on chronic hemodialysis Have evidence of liver disease (elevated alanine aminotransferase [ALT] level) Are infected with HIV Are healthcare and public safety workers after needle stick/mucosal exposure to HCV-positive blood Children born to HCV-positive women 1998 CDC Screening Guidelines:
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Failed to identify over 50% of CHC cases Without a change in screening policy it was forecasted that CHC-related death rate would almost triple from 13,000 to 35,000 annually Risk-based Screening Rein DB. Dig Liver Dis. 2011
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NHANES data from 1988-1994, 1999-2002: People born between 1945-1965 have a disproportionately high prevalence of HCV infection NHANES data from 1999-2008: 3.25% of people born from 1945-1965 are HCV antibody positive (5 times higher than those born at other times) Accounts for 76.5% of the anti-HCV prevalence in the United States Correlates with the high exposure incidence in the 1970-1980s Birth Cohort Screening
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110,000 cases reported 75,000 cases (68%) were among people born between 1945-1965 85,000 cases (77%) would be found using birth cohort and risk-based criteria 30,000 cases (27%) would be found using just risk-based criteria Review of HCV Ab + results from 4 enhanced hepatitis surveillance sites from 2004-2010 Mahajan R. Research and Practice. 2013
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Estimated cost per quality-adjusted life year gained: $35,700 based on 12 weeks of DAA plus Peg-IFN and RBV Rein DB. Annals of Int Med. 2012 Cost-effectiveness of birth-cohort screening:
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Screening is recommended for those who: Were born in the US between 1945 and 1965 without ascertainment of risk (birth cohort) Ever injected illegal drugs Received clotting factors made before 1987 Received blood/organs before July 1992 Were ever on chronic hemodialysis Have evidence of liver disease (elevated alanine aminotransferase [ALT] level) Are infected with HIV Are healthcare and public safety workers after needle stick/mucosal exposure to HCV-positive blood Children born to HCV-positive women 2012 CDC Screening Guidelines
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CHC Screening and Dx HCV Antibody: Detected 4–10 weeks after infection Present in >97% by 6 months after exposure Patients who clear infection will remain anti-HCV + HCV RNA: Detection of acute infection: Present 2–3 weeks after infection Confirmation of chronic infection No need to monitor HCV VL if not actively treating
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Patients with new CHC diagnosis: Should be evaluated for: Evidence of advanced chronic liver disease Other blood-born pathogens: HBV and HIV Candidacy for potential treatment: Possible contraindications in patients with active IVDU or high risk of relapse or demonstrated medical noncompliance Should be protected from additional hepatotoxicity: Undergo hepatitis A and B vaccination if susceptible Reduce or discontinue alcohol consumption Avoid new medicines, including over-the-counter and herbal agents Should be counseled to reduce risk of transmission: Do not donate blood, tissue, or semen Do not share appliances that might come into contact with blood, such as toothbrushes, dental appliances, razors, and nail clippers
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Goal of Treatment: SVR12: negative (<12 IU/mL) HCV VL at 12 weeks after completion of therapy Reduce liver inflammation Reduce fibrosis and improve portal hypertension Reduce mortality
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Why treat CHC? Morgan, Hepatology 2010;52:833 HALT-C trial: advanced fibrosis (≥F3) and prior nonresponders Some patients who were retreated achieved SVR Comparison of outcomes among SVR, nonresponders (NR), or breakthrough/relapsers (BT/R)
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Prioritized Treatment: Highest Priority Patients: Advanced fibrosis: F3-4 (decompensating event annual risk 4-8% without tx) Organ transplant Extra-hepatic manifestations: Cryoglobulinemia with end organ damage, membranoproliferative glomerulonephritis, nephrotic syndrome High Priority: ≥F2 fibrosis Co-infection with HBV or HIV Other CLD Increased risk of transmission: Incarcerated people Active IVDU Healthcare workers Hemodialysis
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Is treatment cost-effective in the era of Direct Acting Antivirals? Hepatitis C Treatment Costs That Yielded Cost-Effectiveness Thresholds Stratified by Fibrosis Level: Leidner AJ. Hepatology. 2015
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Wholesale Acquisition Cost (WAC) for HCV DAAs in the US
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Pre-treatment Assessment: Assessment of liver fibrosis: Liver Bx Liver Transient Elastography (Fibroscan) APRI: >1.0 suggests F3/4 FIB-4: >3.25 suggests F3/4
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Transient Elastography:
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Sensitivity and Specificity of APRI and Fibroscan for Detecting Significant Fibrosis and Cirrhosis WHO HCV Guidelines April 2014 Table 6.5 Values in % (95% CI) Requires 3 hours of fasting Contraindicated in pregnancy Not reliable with ascites, extreme obesity, active inflammation (ALT >100), or congestion of the liver
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MI Medicaid Requirements for DAA Approval Metavir Score of F3-F4 documented by one of the following: APRI above 1.5 Fibrosure greater than or equal to 0.59 Fibroscan greater or equal to 9.5 Liver biopsy demonstrating F3 or F4 Ultrasound/MRI or CT of abdomen which demonstrates one of the following documented in the radiology report: cirrhosis, esophageal varices, ascites, splenomegaly Clinical decompensation
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CHC Treatment: HCV Replication Cycle and Drug Targets Simeprevir Paritaprevir Grazoprevir Ledipasvir Velpatasvir Ombitasvir Elbasvir Declatasvir Sofosbuvir (Nuc) Dasabuvir (non-Nuc) Kayali Z. Pharmgenomics Pers Med. 2014
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Potential mechanism of action of Ribavirin in CHC treatment Hepatitis Web Study. University of Washington.
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HCV Treatment Regimens: Use this link for updated AASLD/IDSA guidelines: http://www.hcvguidelines.org Potential drug interactions: http://hep-druginteractions.org
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Harvoni, GT1, Treatment-Naïve: Harvoni (ledipasvir (NS5A inhibitor)/sofosbuvir (NS5B inhibitor): Non-cirrhotic, low VL (<6 million IU/mL): 8 weeks; SVR12: 98% Non-cirrhotic, high VL (>6 million IU/mL): 12 weeks; SVR12: 97-99% Compensated Cirrhotic, any VL: 12 weeks; SVR12: 97%
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Harvoni, GT1, Treatment-Experienced: Harvoni: Non-cirrhotic: 12 weeks Cirrhotic: -RBV 24 weeks +RBV: 12 weeks
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Viekira, GT1, Treatment-Naïve, Non-cirrhotic: Viekira: 1A: + weight-based RBV 12 weeks 1B: -RBV 12 weeks Feld J, NEJM 2014, Ferenci P, NEJM 2014
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Viekira, GT1, Treatment-Naïve, CTP A Cirrhosis: Viekira: 1A: + weight-based RBV x 24 weeks (alternative regimen) 1B: no RBV 12 weeks TURQUOISE-III: Abstract from EASL 06, 2015
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Viekira, GT1, Treatment-Experienced, Non-cirrhotic: Viekira: 1A: + weight-based RBV for 12 weeks 1B: -RV for 12 weeks Zeuzem S, NEJM 2014; Andreone P, Gastroenterology 2014
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Viekira: 1A: + weight-based RBV for 24 weeks (alternative regimen) 1B: -RBV for 12 weeks TURQUOISE-III: Abstract from EASL, 2015 Viekira, GT1, Treatment-Experienced, CTP A Cirrhosis:
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Zepatier, GT1, Treatment naïve, +/- Cirrhosis: Elbasvir (NS5A inhibitor)/Grazoprevir (second-generation NS3/4A protease inhibitor): GT1a without NS5A RAV: 12 weeks GT1a with NS5A RAV: + weight-based RBV x 16 weeks GT1b: 12 weeks
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Zepatier, GT1, Treatment naïve, +/- Cirrhosis: Zeuzem et al. Annals of Int Med. 2015 Genotype 1a: Patients with SVR12/Patients with specified result: With baseline RAVs 11/19 (58 [34-80]) No baseline RAVs 133/135 (99 [95-100])
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Zepatier, GT1, Treatment-Exp, +/- Cirrhosis: Elbasvir (NS5A inhibitor)/Grazoprevir (second-generation NS3/4A protease inhibitor): GT1a without NS5A RAV: 12 weeks GT1a with NS5A RAV: + weight-based RBV x 16 weeks GT1b: 12 weeks
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Epclusa, GT1, Treatment naïve/Treatment-Exp, +/- Cirrhosis: Sofosbuvir (NS5B inhibitor) /Velpatasvir (NS5A inhibitor) x 12 weeks
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Sofosbuvir/Velpatasvir x 12 weeks, GT1, Tx-Naïve/Tx-Exp, +/- Cirrhosis ASTRAL-1: Feld JJ, NEJM, 2015; 373: 2599
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Genotype 1 HCV:
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Special Population: GT1/4 decompensated cirrhosis (CTP B and C): Harvoni (ledipasvir/sofosbuvir)+ low-dose RBV for 12 weeks. RV should be started at 600mg and increased Q2 weeks as tolerated Epclusa (Velpatasvir/Sofosbuvir) + WB RBV x 12 weeks Flamm SL, Everson GT, Charlton M et al. Gastroenterology, 2015 ASTRAL-4: Curry MP, NEJM 2015
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Special Population: GT1/4, Advanced renal insufficiency (CrCl <30 mL/min): GT1a, Non-cirrhotic or CTP A cirrhosis, Tx-naïve or Tx-exp: Zepatier: [Elbasvir/grazoprevir] x 12 weeks C-Surfer Trial: Roth D et al. The Lancet, 2015.
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Epclusa, GT2, Tx-naïve/Tx-exp, +/- Cirrhosis Epclusa x 12 weeks
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Sofosbuvir/Velpatasvir x 12 weeks, GT2, Tx-Naïve/Tx-Exp, +/- Cirrhosis ASTRAL-1: Feld JJ, NEJM, 2015; 373: 2599
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Genotype 2 HCV
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Daclatasvir (NS5A inhibitor)/Sofosbuvir (NS5B inhibitor): Non-cirrhotics: 12 weeks Cirrhotics: 24 weeks (+/- RV) Daclatasvir/Sofosbuvir, GT3, Treatment-Naïve:
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Daclatasvir/Sofosbuvir, GT3, Treatment-Experienced: Daclatasvir/Sofosbuvir: Non-cirrhotics: 12 weeks Cirrhotics: +RV 24 weeks
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Epclusa, GT3, Tx-Naïve, +/- Cirrhosis Epclusa (Sofosbuvir/Velpatasvir): Non-cirrhotics: 12 weeks Cirrhotics*: 12 weeks *Test for NS5A Y93H RAV in treatment naïve patients with cirrhosis and in treatment experienced patients with no cirrhosis, if Y93H present, add RBV
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Epclusa (Sofosbuvir/Velpatasvir): Non-cirrhotics*: 12 weeks Cirrhotics: +WB RBV x 12 weeks Epclusa, GT3, Tx-Exp, +/- Cirrhosis *Test for NS5A Y93H RAV in treatment naïve patients with cirrhosis and in treatment experienced patients with no cirrhosis, if Y93H present, add RBV
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Genotype 3 HCV
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HCV Treatment in Special Populations
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+Optional, to consider in cirrhotics #For patients receiving RBV, Viekira Pak or Techivie Monitoring Patients During Treatment
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Birth Control During Treatment If RBV needed: Double methods of birth control during and for 6 months after stopping treatment, apply to both male and female HCV patients on treatment If RBV not needed, suggestion: Male patients: no birth control required of patient or partner Female patients of reproductive age: effective birth control during treatment and for 1 month afterwards, female patients on ethinyl estradiol containing contraceptives must stop before Viekira, can resume 2 weeks after completion of treatment, switch to alternate effective contraception during this period