Penny R. Thayer, FNP, BC

Gastro/Hepatology NP

James H. Quillen, VAMC

OBJECTIVES

PREVALENCE IDENTIFY RISK FACTORS TREATMENT OPTIONS COMMON SIDE EFFECTS OF

ANTIVIRAL THERAPY APPROPRIATE CODING

FACES OF THE DISEASE

PREVALENCE NHANES IV (1999-2002)1

1.6% anti-HCV positive (95% CI 1.3-1.9%) = 4.1 million persons (95% CI 3.4-4.9 million)

1.3% chronic infection = 3.2 million personsPeak prevalence age 40-49 (4.3%)Three characteristics identified 85.1% all

infections: abnormal serum ALT, ever IVDU, transfusion <1992

Most persons born 1945-1964

Armstrong GL, Wasley A, Simard E, et al. Ann Intern Med 2006; 144: 705-14.

TESTING FOR HCV AB Recent/past injection drug

users—even if only used once

Groups with high HCV prevalence

HIV-infected individuals

Hemophiliacs treated with clotting factor concentrates before 1987

Hemodialysis recipients

Patients with unexplained aminotransferase abnormalities

Recipients of transfusion or transplantation before July 1992

Children born to women infected with HCV

Healthcare, public safety, and emergency medical personnel following needle injury or mucosal exposure to HCV-infected blood

Current sexual partners of individuals infected with HCV

Persons who have used illicit drugs by noninjection routes

DIAGNOSIS

Positive Hepatitis C antibody-exposure Positive Hepatitis C RNA (PCR) RIBA Generally asymptomatic Acute Hepatitis C

PROGRESSION

ACUTE HEPATITIS C15-40% will spontaneously resolve, generally

within the first 6-18 months after acute onset.60-85% will progress to chronic infection

CHRONIC85-90% stable10-15% progress to cirrhosis

PROGRESSION

CIRRHOSIS75% slowly progressive25% progress to HCC2-4% liver failure

HCCRisk increases for every year for a patient

with chronic hepatitis C.Patients without signs of cirrhosis can

develop HCC

PREDICTIONS BY 2019 193,000 HCV deaths

720,700 million years of advanced liver disease 1.83 million years of life lost

$11 billion in direct medical care costs

$21.3 and $54 billion societal costs from premature disability and mortality

RISK FACTORS

IVDU-Even ONCE ETOH ABUSE-includes binge drinking Multiple sex partners Tattoos Snorting cocaine-Even ONCE Blood transfusions before 1991 Dialysis

INITIAL WORKUP

CBC CMP TSH HCV PCR (VIRAL LOAD) HCV GENOTYPE Hepatitis A and Hepatitis B vaccine panel HIV AFP Liver Ultrasound

MELD SCORE

http://www.mayoclinic.org/meld/mayomodel6.html

survival probability of a patient with end-stage liver disease is estimated based on the following variables.

INR, Bilirubin, Creatinine, on dialysis twice per week

Score greater 11

GENOTYPES Genotype 1

Treatment naïveRelapse, partial response, null responder

Genotype 2 & 3Treatment naïve, usually 24 weeksRelapse, partial response, null response

Genotype 4Treatment naïve, 48 weeksRelapse, partial response, null responder

*Those not treatment naïve, treated on a case by case basis.

TREATMENT

MonitoringUltrasound every 6 monthsCBC, CMP, PT/INR, AFP every 6 monthsEGD or ESO cam to check for varices at least

onceEducationLiver biopsy?Every patient gets treatment, not every patient is

a candidate for antiviral treatment

TREATMENT Antiviral Treatment

Goal is achieving SVRAsk ‘when’ not ‘if’ a candidate for treatmentNo marijuana or other illicit drug useAbstinence from ETOH for at least 3 monthsHCV PCR (viral load)Depression screening before and during

treatmentLiver biopsy if not already done for GT 1Education class to review expectations of

frequent visits, labs and possible side effects.

STANDARD ANTIVIRAL THERAPY Pegylated interferon therapy (PegIFN)

PegasysPegIntronInjections one time per week, duration based on

genotype and responseMust be kept cool (in the fridge!)Can be taken alone, although sustained viral

response is diminished. Ribavirin

Tablets taken every day, dose based on genotypeNot used as monotherapy

DIRECT ACTING ANTIVIRAL/ PROTEASE INHIBITOR ONLY GT 1 PATIENTS ARE

CANDIDATES NO PRESCRIPTIONS TO BE FILLED

WITHOUT FIRST CHECKING WITH PROVIDER WHO IS TREATING THE HEPATITIS C.

MULTIPLE SIDE EFFECTS AND DRUG INTERACTIONS.

DIRECT ACTING ANTIVIRAL/ PROTEASE INHIBITOR

BOCEPREVIR/VICTRELIS○ Treatment naïve

Lead in phase 4 weeks, response guided therapy, generally 28 weeks of triple therapy

○ Relapse, partial responder, null responderLead in phase 4 weeks, response guided therapy,

36-48 weeks of triple therapy

DIRECT ACTING ANTIVIRAL/ PROTEASE INHIBITOR

TELAPREVIR/INCIVEK○ Treatment naïve

No lead in phaseTriple therapy for 12 weeksRGT—generally done in 24 weeks

○ Relapse, partial responder, null responderNo lead in phaseTriple therapy for 12 weeksRGT-completed in 36-48 weeks

SIDE EFFECTS

Multiple side effects that can be mild to severe

Flu like symptoms, depression, dry skin, insomnia, hair loss, increased pain

Flu like symptoms most common Will make autoimmune disorders worse

i.e. Psoriasis—needs Derm monitoring Depression: increased risk for suicidal

ideation, worsening anxiety etc

ADDITIONAL SIDE EFFECTS WITH USE OF DAA/PI Profound anemia Increased risk of neutropenia Increased risk of significant rash Ano-rectal pain Dysguesia

**this is NOT intended to be a complete list, see prescribing information for these medications.

APPROPRIATE CODINGEIA RESULT

PCR RESULT

RIBA RESULT

HEP C STATUS

ICD-9 CODE

NEG NEG (w/o Tx)

NEG Negative, not exposed to HCV

NONE

NEG NEG(w/o Tx)

POS Previously exposed to Hep C, at time of testing, not chronically infected

V01.79

POS NEG(w/o Tx)

NEG False positiveAb-not exposed

NONE

APPROPRIATE CODINGEIA RESULT

PCR RESULT

RIBA RESULT

HEP C STATUS

ICD-9 CODE

POS NEG(w/o Tx)

POS Previously exposed to hepatitis C, at time of testing, not chronically infected

V01.9

ANY NEGWITH TX

ANY Cleared virus in response to treatment

070 series

ANY POS ANY Chronic Hepatitis C

070 series

NONE NONE NONE UNKNOWN If test ordered: V73.9Counseling: V65.49

RESOURCES

Several websites

www.hepatitis.va.gov

www.hepatitiscnewdrugs.blogspot.com

www.aasld.org Hepatitis C Resource Centers (HCRC)

www.hepatitis.va.gov

Support Groups

CASE STUDY # 1 48 yo african american male with Hepatitis

C type 1a, previously treated with peginterfon and ribavirin in 2009, relapsed within 3 months of stopping therapy, HCV PCR 500,000, PLT count 120, Albumin 3.2. Previous history of IVDU, marijuana, and ETOH use. Has been clean and sober for the last 5 years.

CASE STUDY #1 cont.

What treatment options would you discuss with him?

A. None—it is more likely he would not respond to treatment and the risks/benefits are too great.

B. Liver biopsy and consider treatment to include a direct acting antiviral.

C. Retreatment with standard therapy and continue for 72 weeks

??QUESTIONS??