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Penny R. Thayer, FNP, BC Gastro/Hepatology NP James H. Quillen, VAMC. Hepatitis c: THE UP & COMING DISEASE IN YOUR primary care CLINIC. OBJECTIVES. PREVALENCE IDENTIFY RISK FACTORS TREATMENT OPTIONS COMMON SIDE EFFECTS OF ANTIVIRAL THERAPY APPROPRIATE CODING. FACES OF THE DISEASE.
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Penny R. Thayer, FNP, BC Gastro/Hepatology NP James H. Quillen, VAMC Hepatitis c:THE UP & COMING DISEASEIN YOURprimary care CLINIC
OBJECTIVES • PREVALENCE • IDENTIFY RISK FACTORS • TREATMENT OPTIONS • COMMON SIDE EFFECTS OF ANTIVIRAL THERAPY • APPROPRIATE CODING
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 persons • Peak 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 C • 15-40% will spontaneously resolve, generally within the first 6-18 months after acute onset. • 60-85% will progress to chronic infection • CHRONIC • 85-90% stable • 10-15% progress to cirrhosis
PROGRESSION • CIRRHOSIS • 75% slowly progressive • 25% progress to HCC • 2-4% liver failure • HCC • Risk 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 naïve • Relapse, partial response, null responder • Genotype 2 & 3 • Treatment naïve, usually 24 weeks • Relapse, partial response, null response • Genotype 4 • Treatment naïve, 48 weeks • Relapse, partial response, null responder • *Those not treatment naïve, treated on a case by case basis.
TREATMENT • Monitoring • Ultrasound every 6 months • CBC, CMP, PT/INR, AFP every 6 months • EGD or ESO cam to check for varices at least once • Education • Liver biopsy? • Every patient gets treatment, not every patient is a candidate for antiviral treatment
TREATMENT • Antiviral Treatment • Goal is achieving SVR • Ask ‘when’ not ‘if’ a candidate for treatment • No marijuana or other illicit drug use • Abstinence from ETOH for at least 3 months • HCV PCR (viral load) • Depression screening before and during treatment • Liver biopsy if not already done for GT 1 • Education class to review expectations of frequent visits, labs and possible side effects.
STANDARD ANTIVIRAL THERAPY • Pegylated interferon therapy (PegIFN) • Pegasys • PegIntron • Injections one time per week, duration based on genotype and response • Must be kept cool (in the fridge!) • Can be taken alone, although sustained viral response is diminished. • Ribavirin • Tablets taken every day, dose based on genotype • Not 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 responder • Lead 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 phase • Triple therapy for 12 weeks • RGT—generally done in 24 weeks • Relapse, partial responder, null responder • No lead in phase • Triple therapy for 12 weeks • RGT-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.
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