Management of the Patient with Chronic Hepatitis C LAUREN MYERS MMSC, PA-C OREGON HEALTH & SCIENCE UNIVERSITY

Transcription

1 Management of the Patient with Chronic Hepatitis C LAUREN MYERS MMSC, PA-C OREGON HEALTH & SCIENCE UNIVERSITY

2 Disclosures Nothing to disclose

3 Management of the Patient with Chronic Hepatitis C Communicate risk reduction strategies to patients and their families regarding HCV transmission risk Identifying appropriate candidates for antiviral therapy and identifying appropriate timing of when to initiate therapy Recognize other co-morbidities that may precipitate liver disease in patient with HCV

4 AASLD/ISDA HCV Guidelines Recommendations for When and in Whom to Initiate Treatment Treatment is recommended for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Patients with short life expectancies owing to liver disease should be managed in consultation with an expert. Rating: Class I, Level A

5 ( Oregon Medicaid PA Criteria

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7 Caring for the patient with Chronic Hepatitis C A case based approach 1. Chronic Hepatitis C 1.1. Risk Factors: 1.2. Prior liver decompensation? (ascites/sbp, variceal bleeding, or HE) 1.3. Imaging: 1.4. Prior Liver Biopsy? Prior Fibrosis staging? 1.5 Genotype: treatment naïve or experienced? 1.6. HAV, HBV and HIV status 2. Co-morbidities? (Diabetes, Obesity, Mental Health? Renal?) 3. Psychosocial: Alcohol Use (last use): Recreational Drug Use (last use): History of Formal Drug/Alcohol Counseling/Rehab? Tobacco Use

8 Case scenario 1: 30 yo F who comes to discuss Hepatitis C treatment. She is interested in having another child and is concerned about transmission risks 1. Chronic Hepatitis C 1.1. Risk Factors: unknown, suspect vertical transmission. No IVDU or INDU, no tattoos or hx of blood transfusion 1.2. No prior decompensation (ascites/sbp, variceal bleeding, or HE) 1.3. Imaging: none to date 1.4. Prior Liver Biopsy: none 1.5 Genotype 2, treatment naïve 1.6. Prior vaccination HAV, and HBV, HBsAg/HBcAb negative, HIV negative 2. Depression, Headaches, Hx of gestational diabetes, Obesity (BMI 46), umbilical hernia repair, hx of c-section 3. Psychosocial: Married, young daughter Alcohol Use (last use): Yes, 2-3 drinks monthly Recreational Drug Use (last use): No Tobacco Use: No

9 Minimizing transmission risks for HCV Avoid sharing toothbrushes, razors, nail clippers Cover cuts and sores Clean up any blood exposures with bleach solution (1 part bleach: 9 parts water) Stop injection drug use Do not share needles or drug use/preparation paraphernalia Sexual transmission is rare in monogamous heterosexual couples Risk increases in MSM, heterosexual persons with multiple partners and those with co-infection of HIV in which barrier protection is recommended CDC.gov/hepatitis

10 Maternal risks of HCV transmission HCV-positive women do not need to avoid pregnancy or breastfeeding Risks of 6 out of 100 infants born to HCV-infected mothers are infected with the virus at time of birth. Risks are 2-3x greater if mother is co-infected with HIV/HCV. Children born to HCV-positive mothers should have anti-hcv ab no sooner than 18 months due to potential circulating maternal antibodies HCV-positive mothers should avoid breastfeeding if their nipples are cracked or bleeding DAA therapy not studied in pregnancy currently. Ribavirin dosing is CONTRAINDICATED in pregnancy cdc.gov/hepatitis

11 Obesity and Diabetes in those with HCV Those who are overweight/obese may have faster fibrosis progression in HCV disease as well as an increased risk of developing other comorbidities Among those at high risk to develop diabetes, persons with HCV infection were >11x more likely to develop diabetes than those who were not infected with HCV Meta analyses of 34 studies further demonstrated excess risk of diabetes in those infected with HCV infection in comparison to non-infected controls. Greater risk for DM in those with HCV infection compared to those with HBV infection suggests a direct viral role in promoting DM risk Meta, S et al Hepatology 38(1)50-6 White, D et al J of Hepatology 49(5)

12 Case scenario 2 56 yo M who has seen the Harvoni commercials and is here to discuss treatment. He is concerned what medications to take with his liver 1. Chronic Hepatitis C 1.1. Risk Factors: Remote INDU 1.2. No prior liver decompensation (ascites/sbp, variceal bleeding, or HE) 1.3. Imaging: Ultrasound performed prior normal appearing liver and spleen 1.4. Prior Liver Biopsy? None 1.5 Genotype: 1a treatment naïve 1.6. Unclear status HAV, HBV, HIV 2. Co-morbidities? HTN/HLD, Knee and neck pain, multiple back surgeries 3. Psychosocial: On disability, prior house painter Alcohol Use (last use): None, prior heavy use with remote DUI, none since 2012 Recreational Drug Use (last use): None History of Formal Drug/Alcohol Counseling/Rehab? Yes Tobacco Use: 1 pack per day

13 HBV, HAV status and vaccination All patients should be tested for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAg) and Hepatitis A Antibody (total Hep A ab) Patients should be vaccinated if they have seronegative status An acute superinfection of Hepatitis A or Hepatitis B in those with Chronic Hepatitis C may cause acute fulminant hepatitis FDA issued a black box warning for the use of HCV DAA treatments with potential to cause flare of Hepatitis B in those previously infected with Hepatitis B. Vento et al NEJM 338:

14 Medications Statins: Not contraindicated in those with Hepatitis C, even those with cirrhosis Herbals and Supplements: Evaluate for possibility for hepatotoxicity, have patient avoid herbals (milk thistle, dandelion root, turmeric) while taking Hepatitis C therapy Acetaminophen: Limit to under 2 grams/24 hour period -especially those with alcohol abuse, F3/cirrhosis, gastric bypass NSAIDS: AVOID entirely in cirrhosis given risks of gastrointestinal hemorrhage, renal dysfunction

15 Case Scenario 3 63 year old female referred for HCV treatment, tearfully endorses she feels isolated and uses substances for pain control 1. Chronic Hepatitis C 1.1. Risk Factors: remote IVDU 1970 s 1.2. No prior decompensation (ascites/sbp, variceal bleeding, or HE) 1.3. Imaging: Ultrasound 2015: normal-appearing liver 1.4. Prior Liver Biopsy: 2005: G2S2, 2011: G1S3 1.5 Genotype 1a, treatment experienced: PEG/RBV 2006 non-responder 1.6. Immunity HAV, HBV, unknown HIV status 2. Chronic joint pain, Hx of MRSA osteomyelitis, Depression, Osteopenia 3. Psychosocial: Family lives out of state, lives alone in apartment Alcohol Use (last use): drinking a bottle of wine about every 2 days Recreational Drug Use (last use): Smoking cocaine several times a week Tobacco Use: No

16 Alcohol and HCV Alcohol consumption with chronic hepatitis C associated with faster progression of hepatic fibrosis and increased risks of all cause mortality as well as hepatocellular carcinoma Abstinence is always advised There has been no safe amount of alcohol established in those with Chronic Hepatitis C infections Assessment for harmful drinking and referral to alcohol rehabilitation/treatment programs Feld et al Hepatology 43 (2) S194-S206

17 Substance Use and HCV treatment Data are lacking to support exclusion of HCV-infected persons from considerations for hepatitis C therapy based on the amount of alcohol intake or the use of illicit drugs. Prior studies in Interferon based-treatments suggests that Sustained Viral Response (SVR) rates in drug users were comparable to those who did not use drugs Oregon Health Plan currently requires 6 months documented sobriety or engagement in rehab/under the care of an addiction specialist Aspinali et al Clin Infec Disease 57 (2) S80-89

18 Psychiatric Illness DAA regimens better tolerated than prior IFN regimens in those with psychiatric disease Treatments are simpler and shorter in duration and well tolerated It has been shown that integrated care involving multidisciplinary care coordination and patient case management have increased the proportion of patients with HCV infection and psychiatric illness or substance use who have achieved SVR without any serious adverse events Ho, S. et al Clin Gastro Hepatol

19 Practical Considerations for Timing of Rx Are there other medical co-morbidities outside the liver that may limit life expectancy? Can they physically swallow the medication? Can they take a pill daily? Any major life stressors upcoming? Any planned hospitalizations/surgeries? Do you have a way to get a hold of them for 3 months? Will they be able to get blood work monitoring? Do they have a safe place to receive shipments of medications?

20 Baseline Labs to check in Chronic HCV Complete Metabolic Panel Complete blood count, INR Hepatitis C Quantitative PCR Hepatitis C genotype Hepatitis A antibody (total or IgG) Hepatitis B serologies (HBsAb, HBsAb, HBcAb) HIV Urine Pregnancy test (in ladies of childbearing age) AFP Ns5a resistance panel (for those genotype 1a considering use of elbasvir/grazoprevir) Consider Iron studies

21 Imaging Important to check updated imaging of the liver! Davis et al, 2010 Gastroenterology

22 Imaging Ultrasound imaging is the standard screening tool. Abdominal Ultrasound is ideal as gets spleen as well as liver For those with suspected cirrhosis, those with large abdominal girth/pannus and those with Alcohol or Fatty-Liver risk factors consider cross-sectional imaging (CT triple phase or MRI abdomen) Higher screening failure on ultrasound for those with advanced cirrhosis (Childs B/C), obesity, and those with alcoholic or non-alcoholic fatty liver disease Simmons et al Alim Pharm & Thera 45: Poggio et al Hepatology 2014: 12 (11)

23 Awaiting insurance coverage? Deferring therapy Semi-annual LFTs evaluation, no need to recheck HCV PCR/GT in chronic HCV unless planning treatment, ongoing assessment of hepatotoxic agents /minimization of risk factors Annual non-invasive assessment for Fibrosis (ie Fibrosis panels or Fibroscan) Vaccination HAV/HBV. Pneumococcal for Cirrhotics Ongoing education/reminders on minimizing transmission risks