WHEN HCV TREATMENT IS DEFERRED WV HEPC ECHO PROJECT October 13, 2016
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
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
HCVGuidelines.org Deferral practices based on fibrosis stage alone are inadequate and shortsighted
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)
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
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
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
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 illnesses 1 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.
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 noninvasive modalities
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
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
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 extrahepatic manifestations Specific examples include cryoglobulinemia, porphyria cutanea tarda, leukocytoclastic vasculitis, glomerulonephritis, lymphoma, diabetes, and autoimmune disorders
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
HCVGuidelines.org Ongoing assessment of liver disease is recommended for persons in whom therapy is deferred. Rating: Class I, Level C
Fibrosis progression varies markedly between individuals Variables: Host Environmental Viral
Host Non-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 Viral HCV genotype 3 Coinfection with hepatitis B virus or HIV Note: Level of HCV RNA does not correlate with stage of disease
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
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
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
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