4/8/16. Learning Objectives. Overview Hepatitis C. What IS Hepatitis C?? Overview Hepatitis C

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1 Hepatitis C what Primary Care Providers Need To Know: A 2016 Update Maria Steele, ARNP FNP-C Iowa Digestive Disease Center Clive, Iowa Learning Objectives To understand the trends in Hepatitis C transmission, disease & mortality To understand the health benefits of HCV testing, care and treatment To understand the strategies to screen patients for HCV infection Review treatment options How best to answer specific patient questions What IS Hepatitis C?? A) A type of bacteria that attacks the liver B) A type of virus that attacks the liver C) Is a curable disease D) 3-4 times as prevalent as HIV/AIDS E) B & D F) B, C & D Overview Hepatitis C MOST common chronic blood borne infection in the US 60-70% of newly infected Hep C patients have only a mild clinical illness or asymptomatic There have been incredible advances in Hep C treatment Previous Interferon based regimens NOW DAA medications all oral Shorter treatment More effective Little if any side effects Overview Hepatitis C HCVRNA / viral count (via PCR) is detected within 1-3 weeks after exposure HCV Antibody is produced within 8-9 weeks after exposure (seroconversion) What to do if accidental needlestick injury/acute exposure? Immediately get an HCVRNA to make sure patient didn t ALREADY have HCV and HCV Antibody (baseline) Repeat q 2 months x 6 months Hep C becomes chronic in 75-85% of HCV infected persons there is no remission 15-25% can spontaneously clear HCV NHANES Data: HCV: Many people are unaware of their infection Prevalence: million infected 45-60% are UNAWARE of their infection This does not include homeless & incarcerated persons, which is estimated at another 360,000 to 840,000! Incarceration is highest in the world (95% will be released) 1

2 Disease Development Of every 100 persons with Hep C: will go on to develop chronic infection will develop chronic liver disease 5-20 will develop cirrhosis over years 1-5 will die from liver cancer or cirrhosis History of Hepatitis C 1970s non A / non B Mid 1980s Universal Precautions implemented 1989 discovery of HCV 1992 HCV antibody (Anti HCV) test licensed & nation s blood supply tested 1998 CDC recommends screening for Hep C, those who are high risk (IV, IN drug use, blood products / transfusion before 1992) 2001 Needlestick Safety & Prevention Act 2012 CDC recommends screening ALL persons born between USPSTF recommends CDC guidelines as well Acute vs. Chronic Hep C Acute refers to the 1 st six months of infection Most are asymptomatic & goes undetected May have sx of acute liver problems, i.e. jaundice, nausea, dark urine, pale stools, RUQ pain Timing mean of 7-8 weeks for onset of symptoms Acute illness can last 2-12 weeks Liver enzymes X ULN & occur BEFORE HCV Ab are detected Total bilirubin levels can be elevated in the 3-4 range Treatment rarely given as it s rarely identified Extrahepatic Manifestations of HCV Hematologic Mixed cryoglobulinemia Renal Membranoproliferative glomerulonephritis Autoimmune disorders + ANA/other autoimmune markers, thyroiditis Skin conditions PCT (porphyria cutanea tardis), lichen planus Diabetes Mellitus Hep C arthritis Fatigue Global Hepatitis C Burden is Large Highest in Asia & Africa 3-4 million NEW infections each year million CHRONIC infections HIGHEST in the world is Egypt/ northern Africa Global Transmission Risks Health care exposures most common 2 million infections a year Diverse settings urban vs rural Poor infection control, i.e. dialysis, anesthesia Injection drug use 60-70% of NEW infections in the United States 2

3 Trends in HCV Associated Disease in the United States HCV is a major cause of liver disease in general 30% of persons on liver transplant list 50% of persons with liver cancer 2.5% annual increase Substantial HCV related costs 3 fold higher disability days $21,000 in annual health care costs vs. $5,500 for others Successful HCV treatment reduces health costs Kim, WR, et al Gastroenterology 2009 Kanwal, F. et al Gastroenterolgy 2011 Ly, K et al Ann Int Med 2012 Trends (con t) In the United States, in 2006, HCV passed HIV in terms of increased mortality Burden of health care costs in US is projected to continue to grow Development of decompensated cirrhosis Development of hepatocellular carcinoma (HCC) Death from HCV related complications Expected peak will be 2034 based on the Markov model of life time health outcomes Trends (con t) Many states reported increases in new HCV cases from : Midwest States with > 50% increase: Missouri, Michigan, Kansas Midwest States with 1-50 % increase: Oklahoma Midwest States with No change/decline: IOWA, Illinois, Minnesota Trends (con t) 70% IVDU Younger cohort (18-29) Predominantly white Female = male Suburban areas Previous prescription narcotic user True or False. In 2012, the CDC recommended that ALL persons born between regardless of risk factors have a one time screening test for Hepatitis C Baby Boomers Why test them? Vietnam vets Drug use Exposed to untested blood (before July 1992) May not want to admit to remote use of drugs 5 fold prevalence in this age group that any other Accounts for 73% of all HCV + adults 3

4 Should also Screen (regardless of age) Other high risk patients IV or IN drug users even once, incarcerated persons HIV infected homemade tattoos chronic dialysis Children born to HCV mother (after 18 months) Sex partners positive Elevated ALT, AST HCV Transmission (con t) Intranasal drug use Perinatal ~ 3-4% risk 25% risk if mother is coinfected with HIV/HCV Sexual transmission Heterosexual transmission is rare < 3% Highest risk is coinfected MSM HOW to screen: Hepatitis C Antibody If NEGATIVE no further testing needed If POSITIVE need HCVRNA quantitative level via PCR (viral count) & liver profile (liver enzymes can be normal if Hep C) If this is positive THEN the patient has Hepatitis C & they should be referred to a specialist /or co-managed with a specialist What specialist will do: Additional testing Assess /review comorbid conditions Alcoholism/drug abuse Fatty liver Lab If LTs elevated will check for OTHER causes for liver disease Genotype determines treatment course Fibrosure vs. liver biopsy Coag studies Imaging Abdominal ultrasound Hepatitis C Genotype Genotype = subtype There are 6 Genotypes in the world Genotypes vary by region United States 1a, 1b, 2, 3 South America 1a, 1b, 2, 3 Africa 4, 5 Europe 1b, 2, 3 Asia 1b, 6 Soviet Union 1b, 3 Genotype determines choice of treatment medication (s) Coverage/cost of meds: Varies depending which drug Length of treatment Patients insurance plan Degree of fibrosis Iowa Medicaid In flux 3 new private companies Private pay Variable / copay assistance available / PANF VA 4

5 Treatment decisions Treatment Naïve vs. Treatment Experienced Other meds (PPIs, seizure meds, statins, etc) Viral load (for Harvoni this point) Genotype 1a or 1b 2, 3, 4 5 or 6? This will change end of June/new pan-genotypic drug to be released Degree of Fibrosis Mild to cirrhotic Insurance Coverage variable Treatment Naïve Patients Genotype 1a or 1b Harvoni - one table daily x 8-12 weeks 8 weeks if viral count/hcvrna is < 6 million 12 weeks if viral count > 6 million Viekira Pak 4 tabs daily, with/without Ribavirin 1a - needs twice daily Ribavirin (causes anemia, HA) o For 12 weeks 1b no need for Ribavirin o For 12 weeks Zepatier 12 week regimen 1a needs polymorphisms to be checked (NS5A and NS3) 1b no need to check polymorphism Treatment Naïve Patients Genotype 2 Sovaldi daily + Ribavirin x 12 weeks Genotype 3 Sovaldi daily + Ribaivirin x 24 weeks Sovaldi daily + Daklinza x 12 weeks Genotype 4 Harvoni x 12 weeks Technivie + Ribavirin bid x 12 weeks Zepatier daily x 12 weeks Treatment Naïve Patients Genotype 5 Harvoni x 12 weeks Genotype 6 Harvoni x 12 weeks Co-infected with HIV ***30% of patients who have HIV have Hepatitis C!!! ***Co-infected patients have a FASTER rate of progression of liver disease compared to mono infected patients (3x that compared to mono infected Hep C) ***Very important to screen (and treat) this cohort *** Counsel to avoid alcohol & barrier precautions ***Immunize against Hepatitis B Co-infected with HIV HCV (con t) Treatment can be complicated by drug-drug interactions, pill burden, etc. SVR (sustained viral response/cure) rates with new therapies now comparable to HCV monoinfected patients in noncirrhotic patients Specific therapies again depend on genotype, treatment naïve vs. prev tx & degree of fibrosis For most updated guidance: or 5

6 So why ISN T HCV screening being done?? Clinicians unaware of CDC guidelines Clinicians reluctant to ask about risks Clinicians deal with many other issues that have symptoms & Hep C often doesn t Patients unaware that they should be tested % of patients are unaware of HCV infection and/or CDC guidelines (2012) Typically no symptoms Stigma Benefits of Testing/screening for Hep C Reduces risk of liver cancer & mortality 70% reduction in liver cancer 50% reduction in all-cause mortality Can save over 320,000 HCV deaths Has been shown to improve diabetic outcomes Case # 1 Suzanne 45 year old woman seeing you to establish care In good health, active overall 136/84, 68, 172# Takes MV, glucosamine for her joints, wants to discuss the use of herbal supplements for weight control that she saw on Dr. Oz, golfs on the weekends Had a blood transfusion in 1990 after a car accident Does she need to be screened? Why or why not? Case #2 Frank 62 yom in for med check HTN, overweight, tells you he has volunteered to lead the Memorial Day service in his hometown of Adel as he served in Vietnam. He is a welder, married, no alcohol, several arm tattoos 142/85, 76, 225# ALT 44, AST 30 What are his risk factors for Hep C? Should he be screened? Why or why not? FAQs from patients Is this going to kill me? I thought only needle use could spread Hep C. I only snorted drugs 20 years ago What about alcohol? Do I have to quit? I don t have any symptoms, how can I really be sick?? How can I protect my family? FAQs from patients (con t) Will my insurance pay for the Hep C meds? Can someone become re-infected with HCV once they re cured? Do genotypes change? Is there a vaccine for Hep C? Should I be immunized against Hepatitis B? 6

7 FAQs from patients (con t) I m pregnant can I give this to my baby? Questions?? How soon should my baby be tested? Can I breastfeed if I have Hepatitis C? What is the risk from a needle-stick injury? If I have Hepatitis C, will I get fired from my job? Food industry? Health care worker? Thank you for your attention! 7