when hcv treatment is deferred - west virginia clinical...
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WHEN HCV TREATMENT IS DEFERRED
WV HEPC ECHO PROJECT
October 13, 2016
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WHEN HCV TREATMENT IS DEFERRED
� Reminder - treatment is recommended for all patients with chronic HCV infection
� Except short life expectancies that cannot be remediated by treating HCV or transplantation
� Abandon the “triage approach”
� Due to cost concerns of HCV treatments, prioritizing patients who may benefit most from HCV antiviral treatment had been advised previously
� Based on the degree of liver disease, extra-hepatic manifestations, risk of transmission
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WHEN HCV TREATMENT IS DEFERRED
� Reasoning behind the current treatment recommendations: � (i.e. why to treat most patients …)
� Prevent progression of liver fibrosis and resultant chronic liver disease and risk for development of hepatocellular cancer
� Decreased all-cause morbidity and mortality
� Quality-of-life improvements for patients treated regardless of baseline fibrosis
� Improve or prevent extra-hepatic complications
� Diabetes mellitus, cardiovascular disease, renal disease, and B-cell non-Hodgkin lymphoma, etc.
� Prevention HCV transmission
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WHEN HCV TREATMENT IS DEFERRED
� HCVGuidelines.org
� “Deferral practices based on fibrosis stage alone are inadequate and shortsighted”
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WHEN HCV TREATMENT IS DEFERRED
� Despite current guidance to “treat everyone”, patient selection should still be individualized after appropriate patient centered evaluation:
Example of issues that might impact patient selection for treatment:
� Patient capacity to comply with treatment
� Risk of re-infection
� Medication interactions
� Pregnancy and/or willingness to avoid getting pregnant while on treatment (esp. if ribavirin used)
� Safety to patient (concern if decompensated cirrhotic)
� Failure of prior treatment regimens
� Access to medication (insurance)
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WHEN HCV TREATMENT IS DEFERRED
� Care for the HCV infected individual
� Ongoing education
� Natural hx
� Transmission prevention
� Address risk factor for HCV acquisition
� Update labs
� HCC / Varices Screening if needed
� Vaccination
� Assess for symptoms
� Hepatotoxin avoidance
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WHEN HCV TREATMENT IS DEFERRED
� Hepatitis C Natural History Education � AASLD guidelines: the risk of developing cirrhosis ranges from 5 to
25% over a period of 25 to 30 years
� Can often alleviate fears with education – usually “decades not days” needed for Hepatitis C to cause significant liver damage
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WHEN HCV TREATMENT IS DEFERRED � Transmission prevention education
� Blood donation
� Patients should be advised to never donate blood or semen
� Transmission to household contacts
� Avoid sharing toothbrushes, other dental devices, sharp items used for personal hygiene, cover any bleeding wounds
� Drug use
� Cessation of drug use, avoid reusing or sharing syringes and needles/paraphernalia
� Sexual transmission
� Especially men who have sex with men
� Pregnancy
� Risk of vertical transmission
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WHEN HCV TREATMENT IS DEFERRED � Address risk factor for HCV acquisition
� Often it is the patient’s addiction that causes the most harm
� A 2011 study showed that the leading cause of death in patients with Hepatitis C was not liver-related illnesses1
� 72% of deaths were the result of drug overdose or suicide
1. J. Hepatol, 2011 May; 54(5): 879-86. Trends in mortality after diagnosis of hepatitis B or C infection: 1992-2006.
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WHEN HCV TREATMENT IS DEFERRED
� Keep labs up to date � Routine Labs and Imaging -- see Jay’s intake form
� Ongoing screening for Co-infections
� Follow markers of Liver Fibrosis � Various modalities:
� Liver biopsy
� Serum biomarkers of fibrosis (examples: Fibrosure, FibroTest)
� Vibration-controlled transient liver elastography (example: FibroScan)
� AST-to-Platelet Ratio Index (APRI) or Fibrosis 4 score (FIB-4)
� Common approach to fibrosis assessment is to combine info from clinical assessment and non-invasive modalities
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WHEN HCV TREATMENT IS DEFERRED � Screening for hepatocellular cancer when warranted
� Patients with advanced fibrosis or cirrhosis (F3/F4)
� The 2010 American Association for the Study of Liver Diseases (AASLD) guideline on the management of hepatocellular carcinoma (HCC)
� Recommends that surveillance be performed using ultrasonography at six-month intervals
� The combined use of Alpha-fetoprotein (AFP) and ultrasonography is not recommended by the AASLD
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WHEN HCV TREATMENT IS DEFERRED � Vaccinations
� Patients with Hepatitis C should receive any immunization that is recommended for a healthy individual of their age
� Advisory Committee on Immunization Practices (ACIP) recommends the following for patients with chronic liver disease: � Hepatitis A
� Hepatitis B
� Pneumococcal vaccine
� Yearly influenza vaccine
� Tetanus, diphtheria, and acellular pertussis
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WHEN HCV TREATMENT IS DEFERRED � Assess for HCV symptoms
� Chronic HCV is usually asymptomatic
� The most frequent complaint in patients with chronic hepatitis C is fatigue
� Other common complaints include nausea, anorexia, myalgias, arthralgias, and abdominal pain
� Patients may also present with symptoms and signs of chronic liver disease and cirrhosis
� Chronic infection with hepatitis C has also been associated with many extra-hepatic manifestations
� Specific examples include cryoglobulinemia, porphyria cutanea tarda, leukocytoclastic vasculitis, glomerulonephritis, lymphoma, diabetes, and autoimmune disorders
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WHEN HCV TREATMENT IS DEFERRED
� Avoidance of Hepatotoxins � Alcohol and HCV act together to promoting progression to cirrhosis
and increasing the risk of hepatocellular carcinoma � A safe threshold of alcohol consumption has not been established � Therefore abstinence of alcohol in patients with chronic HCV is
suggested
� NSAIDS should be avoided in patients at risk for GI bleeding (cirrhotic patients)
� Acetaminophen, but should not exceed 2 g per 24 hours � Ask about herbal and alternative therapies or other supplement use
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WHEN HCV TREATMENT IS DEFERRED
� HCVGuidelines.org
� “Ongoing assessment of liver disease is recommended for persons in whom therapy is deferred.” Rating: Class I, Level C
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WHEN HCV TREATMENT IS DEFERRED
� Fibrosis progression varies markedly between individuals
� Variables:
� Host
� Environmental
� Viral
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WHEN HCV TREATMENT IS DEFERRED
Host ViralNon-modifiable Fibrosis stage Inflammation grade Older age at time of infection Male sex Organ transplant / immune suppression Modifiable Alcohol consumption Nonalcoholic fatty liver disease Obesity Insulin resistance
HCV genotype 3 Coinfection with hepatitis B virus or HIV
Note: Level of HCV RNA does not correlate with stage of disease
When and in Whom to Initiate HCV Therapy Table 1. Factors Associated With Accelerated Fibrosis Progression
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WHEN HCV TREATMENT IS DEFERRED
� Fibrosis may not progress linearly
� Some individuals may progress slowly for many years followed by an acceleration of fibrosis progression
� Often those aged >50 years
� Others may never develop substantial liver fibrosis despite longstanding infection
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WHEN HCV TREATMENT IS DEFERRED
� Presence of existing fibrosis is a strong risk factor for future fibrosis progression � Fibrosis results from chronic hepatic necroinflammation
� Watch for higher “activity grade” � Associated with more rapid fibrosis progression
� Liver biopsy or fibrosure
� Higher serum transaminase values
� However, even patients with normal ALT levels may develop substantial liver fibrosis
� Remember the limitations of non-invasive assessment of fibrosis � Even liver biopsy not perfect
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WHEN HCV TREATMENT IS DEFERRED
� Extraheptatic complications may not be tied to fibrosis stage
� Examples:
� Diabetes mellitus
� Cardiovascular disease
� Renal disease
� B-cell non-Hodgkin lymphoma
� So must be assessed for routinely when therapy deferred
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WHEN HCV TREATMENT IS DEFERRED
� How often to see/re-assess patients
� “An ideal interval for assessment has not been established”
� Annual evaluation is appropriate to discuss modifiable risk factors and to update testing for hepatic function and markers for disease progression
� For all individuals with advanced fibrosis, liver cancer screening dictates a minimum of evaluation every 6 month
� For individuals with risk factors for rapid progression, every 6 months seems reasonable