Hepatitis B in Travellers

Transcription

1 Hepatitis B in Travellers Please find product Prescribing Information at the end of this presentation

2 Hepatitis B A serious blood-borne liver infection, which can cause both acute and chronic disease 1,2 Caused by the hepatitis B virus (HBV) 1-3 The risk of HBV infection for travellers is usually low 2 However, risk increases with certain behaviours and activities, particularly in areas of intermediate or high endemicity 2,3 240m Estimated number of people worldwide that are chronically infected WHO. Fact sheet no Hepatitis B. Available at Accessed May Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May Centers for Disease Control and Prevention. Hepatitis B in the Yellow Book. Available at Accessed May 2016.

3 How can travellers get the disease? HBV is spread to travellers by contact with the infected blood or body fluids of an infected person 1-3 Semen Blood Saliva Tears Urine Menstrual Vaginal The highest concentrations of virus are found in the blood. Lower concentrations are found in saliva, tears, urine, vaginal secretions and semen 2 HBV life outside body 7days During this time, the virus can still cause infection if it enters the body of an unvaccinated person 4 1. Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May CDC. The Pink Book Hepatitis B. Available at Accessed May Department of Health. The Green Book Chapter 18: Hepatitis B. Available at Accessed May WHO. Fact sheet no Hepatitis B. Available at Accessed May 2016.

4 High and intermediate risk areas for travellers Where 2% of the population are known to be persistently (or chronically) infected.1 Many of the infected population will be asymptomatic carriers of the virus and constitute a reservoir for further transmission to others.2 8% of the adult population is chronically infected3 Between 5-7% of the general population is chronically infected3 Prevalence of Hepatitis B3 High: 8% High Intermediate: 5% 7% Low Intermediate: 2% 4% Low: < 2% The diagram is for illustrative purposes only and should not be used for individual risk assessment. 1. Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May WHO. Hepatitis B. Available at Accessed May Adapted from: Centers for Disease Control and Prevention. Hepatitis B in the Yellow Book. Available at Accessed May 2016.

5 Certain behaviours and activities can increase the risk of infection in travellers Particularly in areas of intermediate to high risk 1,2 Long stay travellers Participation in contact sports Visiting friends and relatives Undergoing medical or dental procedures using contaminated equipment Unprotected sexual intercourse with new (infected) partners abroad Exposure to contaminated blood or bodily fluids (healthcare work) Sharing hygiene items with an infected person Tattooing and body-piercing using contaminated equipment Sharing drug injection equipment 1. Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May Department of Health. The Green Book Chapter 18: Hepatitis B. Available at Accessed May 2016.

6 SYMPTOMS of hepatitis B Acute hepatitis B is often asymptomatic, although approximately 50% of infected adults develop symptomatic disease 1 SYMPTOMS 1,2 Anorexia, Vomiting & Nausea Abdominal pain Dark urine & pale stools Malaise Skin rashes Jaundice Arthritis Fatigue 1. CDC. The Pink Book Hepatitis B. Available at Accessed May Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May WHO. Factsheet no Hepatitis B. Available at Accessed May 2016.

7 About 90% of infants infected during the first year of life develop chronic infections; Development of Chronic hepatitis B Many patients with mild or asymptomatic acute Hep B fail to rid themselves of the virus. If the virus persists for more than 6 month it is considered to be a chronic infection i.e. Chronic Hepatitis B CHRONIC DISEASE Healthy adults < 5% will develop chronic infection 1 Children < 6 years 30 50% will develop chronic infections 1 Infants 90% of infants infected during their first 1 year of life develop chronic infection 1. WHO. Factsheet no Hepatitis B. Available at Accessed May 2016.

8 Development of Chronic hepatitis B of patients with 25% chronic hepatitis B die prematurely due to infectionrelated liver cancer or cirrhosis 1 R.I.P 1. CDC. The Pink Book Hepatitis B. Available at Accessed May 2016.

9 travellers on how to reduce the Advice for risk of acquiring hepatitis B All travellers should avoid contact with blood and bodily fluids to reduce their risk of HBV infection 1 Sexual transmission is an important factor in travelrelated cases particularly in unvaccinated individuals 1,2 Travellers with multiple sex partners 2 1. Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May WHO. Factsheet no Hepatitis B. Available at Accessed May Travellers who have contact with sex workers 2 Men who have sex with men 2

10 What can travellers do to prevent getting hepatitis B? Hepatitis B vaccine is recommended for all travellers to areas of high or intermediate prevalence who place themselves at risk of HBV infection when abroad 2 The mainstay: hepatitis B vaccination 1 Several well-tolerated hepatitis B vaccines, including combined hepatitis A/B products, are available in the UK for travellers 3 1. WHO. Factsheet no Hepatitis B. Available at Accessed May Department of Health. The Green Book Chapter 18: Hepatitis B. Available at Accessed May Travel Health Pro Factsheet. Hepatitis B. Available at Accessed May 2016.

11 Hepatitis B vaccines for travellers 1 Ambirix Hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed) Engerix B 20 Hepatitis B (rdna) vaccine (adsorbed) (HBV) 2 dose schedule given 6-12 months apart Children from 1 to 15 years 3 doses: 0,1 and 6 months From 16 years (dose 20mcg). Accelerated schedule: 0,1 and 2 months and a 4th dose at 12 months Exceptional schedule of 4 doses: 0, 7 and 21 days; 4 th dose at 12 months. This schedule is only licenced in adults 18 and over Exceptional schedule: Adults, 18 years and above In children aged years: 2 doses of the adult dose at 0 and 6 months Engerix B 10 Hepatitis B (rdna) vaccine (adsorbed) (HBV) HBVAXPRO 5mcg Hepatitis B vaccine (rdna) HBVAXPRO 10mcg Hepatitis B vaccine (rdna) Twinrix Adult Hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed) Twinrix Paediatric Hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed) 3 doses: 0, 1 and 6 months From birth to 15 years (dose 10mcg) Accelerated schedule: 0,1 and 2 months (with a 4 th dose at 12 months) 3 doses: 0, 1 and 6 months From birth to 15 years Accelerated schedule: 0,1 and 2 months (with a 4 th dose at 12 months) 3 doses: 0, 1 and 6 months 16 years and older Accelerated schedule: 0,1 and 2 months (with a 4 th dose at 12 months) 3 doses: 0, 1 and 6 months Adults and children from 16 years Exceptional schedule of 4 doses: 0, 7 and 21 days; 4 th dose at 12 months Adults, 18 years and above 3 doses: 0, 1 and 6 months Children from 1 to 15 years Please refer to the individual summary of product characteristics for full details. 1. Electronic Medicines Compendium (emc). Available at Accessed May 2016.

12 Engerix B Hepatitis B vaccines for travellers 1 Hepatitis B (rdna) vaccine adsorbed (HBV) WHAT? WHO? Engerix B 20 mcg / 1 ml is for adult travellers 16 years and over. Engerix B 10 mcg / 0.5 ml is for children from birth to 15 years 3 doses: 0, 1 and 6 months, administered intramuscularly. An accelerated schedule can be given with 3 doses at 0, 1 and 2 months. A 4 th booster dose is recommended 1 year after the 1 st dose HOW? Common adverse events Injection site reactions, fatigue, irritability, headaches, drowsiness, GI symptoms, appetite loss, fever, malaise 1. Engerix B Summary of Product Characteristics. Available at Accessed May 2016.

13 Twinrix Adult / Twinrix Paediatric Hepatitis A & B combination vaccines for travellers 1,2 Combined hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed) WHAT? WHO? Twinrix Adult (720 ELISA HA/20 μg HBsAg) is for travellers 16 years and over. Twinrix Paediatric (360 ELISA HA/10 μg HBsAg) is for children aged 1 15 years 3 doses: 0, 1 and 6 months, administered intramuscularly. An accelerated schedule can be given to adults with 3 doses at 0, 7 and 21 days. A 4 th booster dose is recommended 1 year after the 1 st dose HOW? Common adverse events Headache, injection site reactions, fatigue, drowsiness, irritability, GI symptoms, malaise 1. Twinrix Adult Summary of Product Characteristics. Available at Accessed May Twinrix Paediatric Summary of Product Characteristics. Available at Accessed May 2016.

14 Ambirix Hepatitis A & B combination vaccine for travellers 1 Combined hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed) WHAT? WHO? From 1 year up to and including 15 years of age Two 1.0 ml doses (720 ELISA HA/20 μg HBsAg), given 6-12 months apart, administered intramuscularly HOW? Common adverse events Headache, appetite loss, injection site reactions, fatigue and irritability, drowsiness, GI symptoms, fever 1. Ambirix Summary of Product Characteristics. Available at Accessed May 2016.

15 Hepatitis B and hepatitis A & B combination vaccines Contraindications and special warnings Common contraindications* History of hypersensitivity to the active substance, or to any of the excipients Vaccination should be postponed in individuals with a severe febrile illness Pregnancy or breast-feeding* Only vaccinate if the possible advantages outweigh the possible risks to the foetus or child given the lack of data in these populations *Please refer to the individual Summary of Product Characteristics for full details.

16 Ambirix Prescribing Information Twinrix Adult and Twinrix Paediatric. Hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed). Uses: Active immunisation against hepatitis A and B virus infection. Dosage and administration: Three doses (at 0, 1 and 6 months). When necessary due to timing of travel, for more rapid protection in adults (18 years and above), use 0, 7 and 21 days schedule; fourth dose at 12 months. Adults and adolescents 16 years and above: 1 ml (720 ELISA HA/20 μg HBsAg) i.m. (deltoid); Children 1-15 years: 0.5 ml (360 ELISA HA/10 μg HBsAg) i.m (deltoid, or anterolateral thigh in infants). Contraindications: Hypersensitivity to any components, neomycin or hepatitis A or B vaccines. Acute severe febrile illness. Precautions: Not recommended for post-exposure prophylaxis. In haemodialysis patients and persons with an impaired immune system, anticipated immune response may not be achieved after the primary immunisation course and may therefore require additional doses of vaccine. Nevertheless, these patients may fail to demonstrate an adequate response. Consider serological testing of subjects at risk of not achieving seroprotection following a complete course of Twinrix Adult. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event. Avoid intradermal injection or intramuscular administration into gluteal muscle due to suboptimal response. Do not administer intravascularly under any circumstances. Subcutaneous administration may be considered for those with bleeding disorders. Interactions: For information on the concomitant use of Twinrix Paediatric/Adult with other vaccines please refer to the SPC. Use different injection sites if administering Twinrix Adult with other vaccines. Pregnancy: Only when clear risk of hepatitis B infection. Lactation: Caution in breast feeding. Adverse reactions: See SPC for full details. Common: headache, injection site reactions, fatigue, drowsiness, irritability, GI symptoms, malaise. Serious: anaphylaxis, thrombocytopenia, neurological disorders such as Guillain-Barré syndrome, encephalitis, encephalopathy, convulsions, angioneurotic oedema, meningitis, vasculitis, abnormal liver function tests, multiple sclerosis, optic neuritis. Legal category: POM Presentation and basic NHS cost: Twinrix Adult pre-filled 1.0ml syringe. 1, 33.31; 10, Twinrix Adult 1.0ml vial. 1, Twinrix Paediatric pre-filled 0.5ml syringe. 1, MA number: Twinrix Adult: EU/1/96/020/ , Twinrix Paediatric: EU/1/97/029/ , MA holder: GlaxoSmithKline Biologicals s.a, Rue de l Institut Rixensart, Belgium. For the UK, further information is available from Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontactuk@gsk.com; Freephone: For Ireland, please contact Twinrix is a registered trademark of the GlaxoSmithKline group of companies. Date of preparation: July UK/VAC/0075/15. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to GlaxoSmithKline on Please refer to the full Summary Product Characteristics before prescribing.

17 Engerix B 20 Engerix B 10 Prescribing Information Engerix B. Hepatitis B (rdna) vaccine adsorbed (HBV) Uses: Active immunisation against hepatitis B virus infection. Dosage and administration: For i.m. use in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. Adults and children 16 years and above: 20 micrograms (1 ml); Neonates and children 15 years and under: 10 micrograms (0.5 ml). Series of 3 injections required for primary immunisation; doses at 0, 1 and 6 months or accelerated schedule 0, 1 and 2 months with a fourth doseat12months.formorerapidprotectioninpatients 18 years and above, exceptional schedule of 0, 7 and 21 days with a fourth dose at 12 months. Booster dose only if official vaccination programmes require. Children from 11 up to and including 15 years: 20 micrograms (1 ml) can be used, doses at 0, 6 months (protection may not occur until after the second dose). Renal insufficiency including haemodialysis (patients up to 15 years of age): 10 microgram (0.5ml) at 0, 1, 2 and 12 months or 0, 1, 6 months; Renal insufficiency including haemodialysis (patients 16 years and above): 40 micrograms (2x 20 micrograms) at 0, 1, 2 and 6 months. Contra-indications: Hypersensitivity to any component of the vaccine, severe febrile illness. Precautions: Additional doses may be required for those who do not respond or have sub- optimal response. Potential risk of apnoea and need for respiratory monitoring in very premature infants (born 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. Vaccine should not be administered in the buttock or intradermally since this may result in a lower immune response. Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. Pregnancy and lactation: Used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus. No contraindication in lactation has been established. Adverse reactions: See SPC for full details. Common: injection site reactions, fatigue, irritability, headaches, drowsiness, GI symptoms, appetite loss, fever, malaise. Serious: Thrombocytopenia, encephalitis, encephalopathy, convulsions, paralysis, neurological disorders, (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), apnoea in very premature infants ( 28 weeks gestation), angioneurotic oedema, meningitis, vasculitis, anaphylaxis. Legal category: POM Presentation and basic NHS cost: 1ml prefilled syringe. 1, 12.99; 10, ml vial. 1, 12.34; 10, ml pre-filled syringe. 1, MA number 10592/ MA holder SmithKline Beecham Ltd. Trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT. Further information is available from: Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontactuk@gsk.com; Freephone Engerix B is a registered trademark of the GlaxoSmithKline group of companies. Date of preparation: July 2015 UK/VAC/0072/15. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to GlaxoSmithKline on Please refer to the full Summary Product Characteristics before prescribing.

18 Twinrix Adult Twinrix Paediatric Prescribing Information Twinrix Adult and Twinrix Paediatric. Hepatitis A (inactivated) and hepatitis B (rdna) (HAB) vaccine (adsorbed). Uses: Active immunisation against hepatitis A and B virus infection. Dosage and administration: Three doses (at 0, 1 and 6 months). When necessary due to timing of travel, for more rapid protection in adults (18 years and above), use 0, 7 and 21 days schedule; fourth dose at 12 months. Adults and adolescents 16 years and above: 1 ml (720 ELISA HA/20 μg HBsAg) i.m. (deltoid); Children 1-15 years: 0.5 ml (360 ELISA HA/10 μg HBsAg) i.m (deltoid, or anterolateral thigh in infants). Contraindications: Hypersensitivity to any components, neomycin or hepatitis A or B vaccines. Acute severe febrile illness. Precautions: Not recommended for post-exposure prophylaxis. In haemodialysis patients and persons with an impaired immune system, anticipated immune response may not be achieved after the primary immunisation course and may therefore require additional doses of vaccine. Nevertheless, these patients may fail to demonstrate an adequate response. Consider serological testing of subjects at risk of not achieving seroprotection following a complete course of Twinrix Adult. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event. Avoid intradermal injection or intramuscular administration into gluteal muscle due to suboptimal response. Do not administer intravascularly under any circumstances. Subcutaneous administration may be considered for those with bleeding disorders. Interactions: For information on the concomitant use of Twinrix Paediatric/Adult with other vaccines please refer to the SPC. Use different injection sites if administering Twinrix Adult with other vaccines. Pregnancy: Only when clear risk of hepatitis B infection. Lactation: Caution in breast feeding. Adverse reactions: See SPC for full details. Common: headache, injection site reactions, fatigue, drowsiness, irritability, GI symptoms, malaise. Serious: anaphylaxis, thrombocytopenia, neurological disorders such as Guillain-Barré syndrome, encephalitis, encephalopathy, convulsions, angioneurotic oedema, meningitis, vasculitis, abnormal liver function tests, multiple sclerosis, optic neuritis. Legal category: POM Presentation and basic NHS cost: Twinrix Adult pre-filled 1.0ml syringe. 1, 33.31; 10, Twinrix Adult 1.0ml vial. 1, Twinrix Paediatric pre-filled 0.5ml syringe. 1, MA number: Twinrix Adult: EU/1/96/020/ , Twinrix Paediatric: EU/1/97/029/ , MA holder: GlaxoSmithKline Biologicals s.a, Rue de l Institut Rixensart, Belgium. For the UK, further information is available from Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontactuk@gsk.com; Freephone: For Ireland, please contact Twinrix is a registered trademark of the GlaxoSmithKline group of companies. Date of preparation: July UK/VAC/0075/15. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to GlaxoSmithKline on Please refer to the full Summary Product Characteristics before prescribing.