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HBV Training Workshop. Alan Franciscus Editor-in-Chief HBV Advocate / HCV Advocate. www.HBVAdvocate.org. www.hcvadvocate.org. www.hepatitistattoos.org. The Liver. About 3 lbs (men) – size of a football Blood organ Chemical factory > 500 chemical functions Metabolizes sugar and fat
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HBV Training Workshop Alan Franciscus Editor-in-Chief HBV Advocate / HCV Advocate WWW.HBVAdvocate.org
WWW.HBVAdvocate.org www.HBVAdvocate.org
WWW.HBVAdvocate.org www.hcvadvocate.org www.hepatitistattoos.org
WWW.HBVAdvocate.org The Liver • About 3 lbs (men) – size of a football • Blood organ • Chemical factory > 500 chemical functions • Metabolizes sugar and fat • Stores some vitamins and minerals
WWW.HBVAdvocate.org The Liver • Filters and Detoxifies • Breathed in the air, absorbed through the skin & by mouth • Makes proteins to help the blood clot • The liver can regenerate • Non-complaining organ
WWW.HBVAdvocate.org Keep the Liver Healthy • Be careful with alcohol and drugs • Healthy People: No more than 2 alcoholic drinks a day–men; no more than 1 alcoholic drink a day for women • People with HBV – avoid alcohol • Get vaccinated against HAV & HBV • Eat a healthy, balanced diet
HBV Transmission & Prevention WWW.HBVAdvocate.org HBV is 50 to 100 times more infectious than HIV
WWW.HBVAdvocate.org HBV Worldwide • 2 billion people worldwide are infected with HBV • An estimated 400-800 million people have chronic hepatitis B (CHB)2,3 • Complications from HBV are the 10th leading cause of death worldwide
§ Immigration From Endemic Areas Impacts CHB Prevalence In The United States • Majority of immigrants have never been vaccinated against HBV • CDC estimates 450,000 immigrants admitted to the USA between 1994-2003 were infected with hepatitis B
WWW.HBVAdvocate.org Estimates - HBV Statistics - U.S. • 43,000 new or acute infections • 2-3 million – chronic infections - ~65% unaware • 3,000-4,000 deaths a year • 70% of deaths are from liver cancer • ~1 of 8 Vietnamese Americans • ~1 of 10 Chinese Americans • ~1 of 12 Korean Americans
The Asian American community is projected to grow to 33.4 million people (or 8% of the total US population) by 2050 • 68.9% of Asian Americans living in US are foreign-born • Asian Americans are 2.7 times more likely to develop hepatocellular carcinoma (HCC) and 2.4 times more likely to die from HCC than their white counterparts Asian Population in the United States, 2000 = ~12 million4,5 Korean1,228,427 Chinese2,734,841 Taiwanese144,795 Asian Indian1,899,599 Hmong186,310 Laotian198,203 Filipino2,364,815 Vietnamese1,223,736 Samoan5133,281
WWW.HBVAdvocate.org HBV Transmission:Concentrations of HBV in Body Fluids
WWW.HBVAdvocate.org HBV Transmission (more) • Blood borne – can live outside the body for at least 7 days • Highly infectious in semen and vaginal secretions • Sharing needles and works to inject drugs • Needle stick accidents, Healthcare exposure • Household - sharing personal items • Horizontal – childhood – biting, scratching • Vertical-Mother-to-Child transmission at birth
More than 70% of acute infections reported in 2007 were attributed to sexual activity injection drug use (IDU) Sexual activity accounts for most HBV transmission in the US § Epidemiologic Characteristics of Patients With Acute Hepatitis B - US, 2007* *Values total > 100% because multiple risk factors could be reported for a single case Daniel D. Acute Viral Hepatitis in US, 2007. MMWR 2009;58(No.SS-3).
CDC Recommends Screening Adults at High Risk for HBV Infection § Weinbaum CM, et al. MMWR Recomm Rep. 2008;57(RR-8):1-20 16
WWW.HBVAdvocate.org Screen for HBV: US persons not vaccinated as infants whose parents were born in regions with HBV prevalence ≥8% (in red)
Screen for HBV: Persons born in regions with HBV prevalence ≥ 2% (in red) • > 2% - Intermediate to high risk • (should be screened with or w/o additional risk factors) • <2% - Low (not required to screen without additional risk factors) Centers for Disease Control and Prevention. MMWR. 2006;55(RR16). Accessed online October 16, 2007.
WWW.HBVAdvocate.org HBV Prevention:CDC Strategy to Eliminate HBV • Vaccination at birth • Screening of all pregnant women • Vaccination of all previously unvaccinated children and adolescents • Vaccination of previously unvaccinated adults at risk for HBV infection
WWW.HBVAdvocate.org HBV Prevention:Recommended for Vaccination • Sexual exposure: • Sexual contacts of HBV positive persons • People who are sexually active with more than one sexual partner w/i the last 6 months • People seeking STD services • Men who have sex with men
WWW.HBVAdvocate.org HBV Prevention:Recommended for Vaccination • Blood/mucous exposure: • Current or recent IDU • Household contact • Residents and staff of facilities for developmentally disabled Americans • Healthcare and public safety workers who may come into contact with blood/bodily fluids • People with kidney disease – hemodialysis
WWW.HBVAdvocate.org HBV Prevention:Recommended for Vaccination • Others: • International travelers who travel to countries that have higher or intermediate levels of HBV • Persons with chronic liver disease • Persons with HIV • All persons seeking protection from HBV infection
WWW.HBVAdvocate.org HBV Prevention • HBV Vaccination – 3 dose series (Twinrix HAV & HBV) • Not all respond / not all countries have vaccines • Safer sex • Standard safety/universal precautions • Do not share needles or works to inject drugs • Needle Exchange! • Do not share personal items (razors, toothbrushes)
WWW.HBVAdvocate.org More Prevention — Mother to Child • Every pregnant woman should be screened for HBV • 1 in 5 not screened • Ok to breast feed infants born to HBV infected mothers • Up to 90% of infants born to mothers with chronic HBV will become chronic unless: • Infant is vaccinated and given immune globulin within 12 hours of birth – reduces chronic rate to ~10% • Treating pregnant women with HBV medications – no clear recommendations
Diagnosing HBV WWW.HBVAdvocate.org • HBV discovered in 1967 by Dr. Blumberg and colleagues • Dr. Blumberg awarded Nobel Prize in Medicine in 1976
WWW.HBVAdvocate.org Keep it Simple! • HBV Antibodies (proteins made by body) • HBV Antigens (HBV viral proteins) • No HBV surface antibody and no surface antigen – susceptible – vaccinate • HBV surface antibody – protected • HBV DNA (viral load) > 6 months – chronic • Gray areas????
WWW.HBVAdvocate.org HBV DNA — Viral Load • Expressed in ‘International Units’ – IU/mL • Previously reported in copies — • IU/mL = 5 - 6 copies • Range: 10 to millions or billions • Used to: • Confirm active infection • Monitoring • Treatment of chronic HBV
WWW.HBVAdvocate.org HBV Genotype • 8 different genotypes – A thru H • Not routinely performed • Genotypes A & B – pegylated interferon • Genotype C – increased risk for disease progression and liver cancer
WWW.HBVAdvocate.org Laboratory Tests • Liver tests (ALT/AST): Healthy ALT considered to be <19 for women and <30 for men • CBC, platelets, prothrombin time • Liver biopsy • AFP – liver cancer • Ultrasound/MRI/CTscan – screen for liver cancer (HCC)
Chronic HBV: Symptoms, Progression and Management WWW.HBVAdvocate.org HBV is the second most important carcinogen after tobacco
WWW.HBVAdvocate.org Symptoms Acute Chronic • Fever • Fatigue • Loss of appetite • Nausea • Vomiting • Dark urine • Clay-colored stools • Jaundice • And more…… • Children typically exhibit no symptoms • Fatigue • Fever • Abdominal pain • Muscle & joint pain • Nausea • And more……….. • Chronic – most people have no symptoms
WWW.HBVAdvocate.org Chronic Infection • ~90% of Infants born to HBV-infected Mothers • Intervention decreases chronic rate to ~10% • 25 to 50% of children aged 1-5 years • ~5-6% of Adults
WWW.HBVAdvocate.org Disease Progression • 3,000 – 4,000 deaths a year • ~15 - 25% develop serious disease progression including cirrhosis, liver failure or liver cancer • Usually after 20 to 30 years • Risk factors for disease progression • Host–male gender, advanced age, alcohol use & cigarette smoking • Other factors – persistent high viral load, coinfection (HIV or HDV), immunosuppression, HBV genotype C, HBV mutations, severity and frequency of ALT elevations • Family history of liver cancer increases risk by 2 fold
WWW.HBVAdvocate.org Managing Chronic HBV • Liver biopsy • Regular office visits and tests • Medical provider will set up a regular schedule of visits and tests • Common tests: ALT levels, HBV DNA (viral load), HBV viral markers, HBV genotype • Screen every 6 to 12 months for liver cancer (AFP / Ultrasound) • Avoid alcohol, tobacco and anything that can harm the liver
WWW.HBVAdvocate.org Managing HBV - continued • Exercise • Support • Healthy diet: • www.mypyramid.gov
Treatment of Chronic HBV WWW.HBVAdvocate.org
Goals of Treatment for Chronic HBV Overall Goals: • Prevent complications of chronic HBV: • Cirrhosis, hepatocellular carcinoma (HCC = liver cancer), death • Suppression of HBV Markers of Treatment Response: • Decrease serum HBV DNA (viral load) to low or undetectable levels • Improve liver histology • Lowering or normalization of ALT levels Lok ASF. Hepatology. 2004;39:857-861. Keeffe EB. Clin Gastroenterol Hepatol 2006;4:936-962.
WWW.HBVAdvocate.org Keep It Simple! • Treat: • Elevated ALT • Elevated HBV DNA • Treatment, however, is a complicated process that takes into account many factors – see next series of slides….
2008 US Algorithm Management of Chronic HBV Infection*HBeAg-positive HBeAg (+) ALT > ULN HBV DNA> 20,000 IU/mL ALT < ULN HBV DNA< 20,000 IU/mL ALT < ULN HBV DNA > 20,000 IU/mL • Liver biopsy optional • Treat • Q 3 mo ALT • Q 6 mo HBeAg • Consider biopsy if • persistent or age >35 • Treat if histology abnormal • Observe • Q 3 – 6 mo ALT • Q 6 – 12 mo HBeAg Keeffe EB. Et al Clin Gastroenterol Hepatol. December 2008 http://www.cghjournal.org/inpress
2008 US Algorithm Management of Chronic HBV Infection HBeAg-negative HBeAg (-) ALT > ULN; HBV DNA > 2,000 IU/mL ALT < ULN; HBV DNA > 2,000IU/mL ALT < ULN; HBV DNA < 2,000 IU/mL • Liver biopsy optional • Treat • Q 3 mo ALT & HBV DNA • Consider biopsy if • persistent DNA elevation • or age >35 • Treat if histology abnormal • Q 3 mo ALT x 3, then • Q 6 – 12 mo if ALT • still <1 x ULN Keeffe EB. Et al Clin Gastroenterol Hepatol. December 2008 http://www.cghjournal.org/inpress
2008 US AlgorithmManagement of Chronic HBV InfectionPatients with Cirrhosis Compensated Decompensated Detectable HBV DNA Undetectable HBV DNA HBV DNA <2,000 IU/mL HBV DNA ≥2,000 IU/mL Treat Observe Observe or Treat Treat Wait List for Transplant Keeffe EB. Clin Gstroenterol Hepatol. 2006;4:936-962. *Significant clinical consequences associated with LAM resistance in this population Keeffe EB. Et al Clin Gastroenterol Hepatol. December 2008 http://www.cghjournal.org/inpress
WWW.HBVAdvocate.org Approved HBV Medications
WWW.HBVAdvocate.org HBV Drugs and Resistance *Entecavir, peginterferon alfa-2a and tenofovir recommended as first line of treatment
WWW.HBVAdvocate.org HBV Treatment Side Effects • Direct antivirals: • Minimal side effects – fatigue, stomach, diarrhea, muscle weakness and pain • Need to monitor renal function for dosing • Pegylated interferon: • More severe type of side effects – moderate to severe fatigue, depression, anxiety, gastro, body aches and pains, insomnia, etc.
WWW.HBVAdvocate.org Chronic HBV Medications • 100% medications; 100% of the time • Resistance • Ask about adherence • Potentially produce a flare –up–small % fulminate • Need to take fasting (2hrs prior to or 2hrs after a meal): BARACLUDE/entecavir • Monitoring during treatment
WWW.HBVAdvocate.org Pregnancy Drug Categories
WWW.HBVAdvocate.org Complementary and Alternative Therapies • Herbs have the potential to cause damage and interact with other herbs and medications • Inform your medical provider • Use a reputable herbalist • Acupuncture & Acupressure • Traditional Chinese Medicine • Meditation, qi qong, tai chi, massage, acupuncture, acupressure, moxibustion.
WWW.HBVAdvocate.org Patient Assistance Programs • Needymeds.org • Partnership for Prescription Assistance • Gilead • Pegasys • GSK • BMS • Idenix/Norvartis