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azad.haleem@uod.ac
Dr.Azad A Haleem AL.Mezori
MRCPCH,DCH, FIBMS
Assistant Professor
University Of Duhok
College of Medicine
Pediatrics Department
Respiratory Syncytial Virus in
children
Scan
For
Contact
Thank You
Key points
• Introduction.
• Epidemiology.
• Transmission.
• Risk Factors & child at risk.
• Signs & Symptoms.
• Diagnosis
• Management.
• Prophylaxis.
INTRODUCTION
• RSV is a respiratory virus and one of the most
common causes of childhood illness.
• RSV is one of the viruses responsible for what is
called the “common cold” in adults and healthy
children.
• It is the single most important cause of lower
respiratory tract infection during infancy and
early childhood worldwide.
• RSV was discovered in 1956.
Epidemiology of RSV: Incidence
• 90% of children are infected with RSV in the
first 2 years of life.
• RSV accounts for approximately 50% of all
cases of pneumonia.
• Approximately 50% will have been infected
twice.
Epidemiology of RSV
Increased Risk for
Hospitalisations
• An average length of hospital stay for uncomplicated RSV in children is ~3 days
–Represents a major challenge for hospital services, requiring substantial investment and
seasonal planning of human resources, relevant medicines, and supplies for pediatric
care.
RSV causes ~33 million
serious respiratory
infections a year
~60,000 children <5
years old died;
46% of deaths occurred
in infants <6 months old
RSV hospitalizations are
6 to 14 times higher
than for influenza
3.2 million hospital
admissions annually :
~45% <6 months old
Epidemiology of RSV: Seasonality
• Seasonality of Infection Pattern:
• Globally, RSV epidemics are seasonal and last on
average of 5 to 6 months. Their start is typically
aligned with winter months:
• In temperate climates, RSV regularly produces
yearly outbreaks between late fall and spring.
• Humid countries have their seasonal wave during
the rainy season.
Begins September
to December
in the Northern
Hemisphere
Begins March to
June
in the Southern
Hemisphere
RSV Occurs During Cold Seasons
Epidemiology of RSV: Situational
Changes
• Possible Changes in RSV Seasonal Transmission:
• Data show changes in humidity and precipitation
may affect RSV timing and outbreak.
• Increases in humidity driven by higher temperatures
shown to reduce the scope of seasonal transmission
vs dry conditions that drive larger seasonal
transmission changes, resulting in cycles becoming
more annual and shallower on average.
Changing climate
may affect weather-related drivers of RSV
transmission
Transmission
• RSV is contagious and spreads just like a
common cold virus through:
• Direct person-to-person contact with saliva, mucus, or
nasal discharge when kissing, sharing cups, and other
forms of close contact
• Unclean hands—RSV can survive 30 minutes or more
on unwashed hands.
• Unclean objects or surfaces—RSV can survive up to
6 hours on surfaces, toys, keyboards.
Epidemiology of RSV: Risk Factors
• Factors That Increase the Risk of RSV:
• Premature baby, <6 months of age.
• Small size for gestational age
• Male
• Malnutrition
• Family history of atopy or asthma
• Indoor smoke pollution , Maternal smoking .
• Crowded living conditions & in day care.
RSV Symptom Appearance
• The incubation period of RSV respiratory
disease ranges from 2 to 8 days, but most
commonly 4 to 6 days.
• RSV can cause a range of respiratory illnesses
and symptoms, from mild upper respiratory
infections to life-threatening bronchiolitis and
pneumonia.
RSV Symptoms
• In healthy infants, RSV usually causes mild cold-like signs
and symptoms, including: Congested or runny nose, dry
cough, low-grade fever, sore throat, and mild headache
• lower respiratory tract signs usually appear 1 to 3 days after
onset of rhinorrhea, representing viral spread into the bronchi
and bronchioles.
• In severe cases, signs and symptoms may include: Fever,
severe cough, wheezing, difficulty breathing and cyanosis.
Diagnosing RSV
• Assessment, Confirmation, and Ruling Out Other Conditions.
o RSV diagnosis is generally based on history, physical examination and the time of
year symptoms occur.
o Laboratory and imaging tests aren’t usually needed but can help confirm a
diagnosis of RSV complications or rule out other conditions that may cause similar
symptoms.
• Tests may include:
– Blood tests (may not be specific to RSV) to check white cell counts or to look for
viruses, bacteria, and other germs
– Chest x-rays to check for lung complications.
– Swab of secretions from the mouth or nose to check for the virus.
RSV Treatment: Supportive Care
o Supportive care is the mainstay of therapy
for RSV
• Treatment options for RSV are limited
• Healthy infants infected with RSV do not usually
need to be hospitalized.
o Supportive care at home or outpatient settings
may include: Acetaminophen or ibuprofen, good
hydration & nutrition , and follow up.
RSV Treatment: Hospital Care
• Hospitalization Depends on RSV Severity
o When a hospital stay is required:
• If the RSV infection is severe and the child is in
respiratory distress, dehydrated, especially infants <6
months old.
o Treatments at the hospital may include:
• Humidified oxygen
• IV fluids for dehydration.
• Mechanical ventilation (breathing machine)
• Inhaled form of an antiviral medicine called ribavirin *
for immunocompromised infants.
*The only antiviral approved for treatment of RSV, but its use is limited because of side
effects and lack of efficacy.
RSV prophylaxis is essential to help reduce RSV impact
on high-risk children
• Critical Need to Minimize the Consequences of Severe RSV LRTI.
o Severe RSV LRTI is responsible for:
• Significant hospitalizations, morbidity, and mortality in infants
<24 months old who have chronic lung disease, congenital heart disease, and
compromised respiratory or immune systems.
• Recurrent wheezing and asthma during the years following the
first severe RSV LRTI or RSV bronchiolitis.
• Early childhood wheeze after RSV infection has a high prevalence, influences
quality of life, and generates substantial health care costs.
RSV: Reduce RSV Impact
RSV Prophylaxis: Risk Reduction
• Approaches to Reduce the Risk of RSV:
o Reduce the spread: Disinfection with alcohol-based
rubs and hand washing with alcohol-based rubs or
soap and water are highly effective in reducing the
spread of RSV.
o Limit transmission: Gloves and gowns can help in
limiting transmission.
o Use safe and effective passive prophylaxis: Perhaps
the most important success in the war against RSV so
far has been the development of safe and effective
passive prophylaxis.
• Immunization
• Immunization is the process of inducing
immunity against a specific disease.
• Immunity can be induced either
• passively through administration of antibody-
containing preparations or
• actively by administering a vaccine or toxoid.
Immunization
PRODUCT MAJOR INDICATIONS
Immune globulin for intramuscular injection
Replacement therapy in primary immunodeficiency disorders
Hepatitis A prophylaxis
Measles prophylaxis
Intravenous mmunoglobulin (IVIG)
Replacement therapy in primary immune-deficiency disorders
Kawasaki disease
Immune-mediated thrombocytopenia
Pediatric HIV infection
Hypogammaglobulinemia in chronic B-cell lymphocytic leukemia
Hematopoietic cell transplantation in adults to prevent graft-versus host
disease and infection
May be useful in a variety of other conditions
Hepatitis B immune globulin (IM)
Postexposure prophylaxis
Prevention of perinatal infection in infants born to HBsAg+ mothers
Rabies immune globulin (IM) Postexposure prophylaxis
Tetanus immune globulin (IM)
Wound prophylaxis
Treatment of tetanus
Varicella-zoster immune globulin (VZIG) (IM) or
IVIG
Postexposure prophylaxis of susceptible people at high risk for
complications from varicella
Cytomegalovirus IVIG Prophylaxis of disease in seronegative transplant recipients
Palivizumab (monoclonal antibody) (IM) Prophylaxis for infants against respiratory syncytial virus (RSV)
Vaccinia immune globulin (IV)
Prevent or modify serious adverse events following smallpox vaccination
due to vaccinia replication
Botulism IVIG human Treatment of infant botulism
Diphtheria antitoxin, equine Treatment of diphtheria
Trivalent botulinum (A,B,E) and bivalent (A,B)
botulinum antitoxin, equine
Treatment of food and wound botulism
Palivizumab (Synagis® )
• Palivizumab (Synagis) is a humanized
monoclonal antibody developed to prevent
severe RSV disease in high-risk infants.
• Synagis is a seasonal immunoprophylaxis, not a
vaccine.
• First approval in 1998
Palivizumab (Synagis® )
• palivizumab can prevent severe disease from
respiratory syncytial virus (RSV) among
children with:
o chronic lung disease (CLD,bronchopulmonary
dysplasia)
o history of premature birth
o with congenital heart lesions.
o with neuromuscular diseases.
The American Academy of Pediatrics (AAP) has developed specific recommendations
for use of palivizumab
o Born prematurely:
o Born at 35 weeks of gestation or less and <6
months of age at the onset of the RSV season.
RSV Prophylaxis: Patients in Need
children who have Cardiac disease:
Children <2 yr of age with hemodynamically
significant congenital heart disease (heart
failure, cyanosis, pulmonary hypertension).
RSV Prophylaxis: Patients in Need
• Infants with BPD or Chronic Lung Disease (CLD)
• BPD may be defined by oxygen requirement at 36 weeks
corrected gestational age or at 28 days of age regardless of
the birth gestational age.
o Infants with BPD/CLD include those who are <24 months old
at the start or within 6 months of the RSV season.
o Infants with congenital abnormalities of the airways that
compromise respiratory function.
RSV Prophylaxis: Patients in Need
• Candidates to consider for RSV prophylaxis where decisions
regarding appropriateness of treatment must be
individualized
–Infants with severe neuromuscular disease affecting
respiratory function (e.g., muscular dystrophy, cerebral palsy).
RSV Prophylaxis: Patients in Need
Synagis® : How Available
• Synagis (palivizumab) solution for
injection is available in vials of either 0.5
mL or 1.0 mL
• Synagis 0.5 mL solution with a concentration of
100 mg/mL
• Synagis 1.0 mL solution a concentration of 100
mg/mL.
Synagis®: Weight-Based IM Injections
• The recommended dose is 15 mg/kg of body
weight, given once a month during anticipated periods of RSV
risk in the community (5 Monthly Seasonal Injections).
• Synagis® is administered by IM injection into anterolateral aspect (top) of
the thigh.
• Where possible, the first dose should be administered prior to the
commencement of the RSV season
• Subsequent doses should be administered monthly throughout the RSV
season
• Children receiving Synagis who are hospitalized with RSV should continue to
receive monthly doses throughout the RSV season
Synagis® : Impact-RSV
• Synagis® significantly reduced the length of hospital stay and days of
increased supplementary oxygen.
• Synagis significantly reduced the incidence of RSV-related hospitalization by
55%
– 78% fewer hospitalizations in premature infants.
– 39% fewer hospitalizations in children with BPD.
– 45 % fewer hospitalizations in children with Congenital Heart Disease
(CHD).
SYNAGIS SAFETY PROFILE
• Synagis® Safety Profile Is Well Established; The most serious adverse
reactions occurring with palivizumab are anaphylaxis and other acute
hypersensitivity reactions.
• Common adverse reactions occurring with palivizumab are fever, rash, and
injection site reaction
Undesirable effects in clinical studies and post marketing reports in pediatric
MedDRA System Organ Class Frequency Adverse Event
Blood and lymphatic
system disorders
Uncommon Thrombocytopenia*
Immune system disorders Not known
Anaphylaxis, anaphylactic shock (in some
cases, fatalities have been reported)*
Nervous system disorders Uncommon Convulsion*
Respiratory, thoracic, and
mediastinal disorders
Common Apnea*
Skin and subcutaneous
tissue disorders
Very common Rash
Uncommon Urticaria*
General disorders and
administrative site conditions
Very common Pyrexia
Common Injection site reaction
SYNAGIS SAFETY PROFILE
Special Warnings:
 A mild febrile illness, such as mild upper respiratory infection, is not usually
reason to defer administration of Palivizumab.
 A moderate to severe acute infection or febrile illness may warrant delaying &
the use of palivizumab, unless, in the opinion of the physician, withholding
palivizumab entails a greater risk.
 Palivizumab should be given with caution to patients with thrombocytopenia or
coagulation disorder.
Reference: 1. Synagis® (palivizumab). European Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co.; 2009.
THANKS FOR YOUR
Attention

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Respiratory Syncytial Virus in children

  • 1. azad82d@gmail.com azad.haleem@uod.ac Dr.Azad A Haleem AL.Mezori MRCPCH,DCH, FIBMS Assistant Professor University Of Duhok College of Medicine Pediatrics Department Respiratory Syncytial Virus in children Scan For Contact
  • 3. Key points • Introduction. • Epidemiology. • Transmission. • Risk Factors & child at risk. • Signs & Symptoms. • Diagnosis • Management. • Prophylaxis.
  • 4. INTRODUCTION • RSV is a respiratory virus and one of the most common causes of childhood illness. • RSV is one of the viruses responsible for what is called the “common cold” in adults and healthy children. • It is the single most important cause of lower respiratory tract infection during infancy and early childhood worldwide. • RSV was discovered in 1956.
  • 5. Epidemiology of RSV: Incidence • 90% of children are infected with RSV in the first 2 years of life. • RSV accounts for approximately 50% of all cases of pneumonia. • Approximately 50% will have been infected twice.
  • 6. Epidemiology of RSV Increased Risk for Hospitalisations • An average length of hospital stay for uncomplicated RSV in children is ~3 days –Represents a major challenge for hospital services, requiring substantial investment and seasonal planning of human resources, relevant medicines, and supplies for pediatric care. RSV causes ~33 million serious respiratory infections a year ~60,000 children <5 years old died; 46% of deaths occurred in infants <6 months old RSV hospitalizations are 6 to 14 times higher than for influenza 3.2 million hospital admissions annually : ~45% <6 months old
  • 7. Epidemiology of RSV: Seasonality • Seasonality of Infection Pattern: • Globally, RSV epidemics are seasonal and last on average of 5 to 6 months. Their start is typically aligned with winter months: • In temperate climates, RSV regularly produces yearly outbreaks between late fall and spring. • Humid countries have their seasonal wave during the rainy season. Begins September to December in the Northern Hemisphere Begins March to June in the Southern Hemisphere RSV Occurs During Cold Seasons
  • 8. Epidemiology of RSV: Situational Changes • Possible Changes in RSV Seasonal Transmission: • Data show changes in humidity and precipitation may affect RSV timing and outbreak. • Increases in humidity driven by higher temperatures shown to reduce the scope of seasonal transmission vs dry conditions that drive larger seasonal transmission changes, resulting in cycles becoming more annual and shallower on average. Changing climate may affect weather-related drivers of RSV transmission
  • 9. Transmission • RSV is contagious and spreads just like a common cold virus through: • Direct person-to-person contact with saliva, mucus, or nasal discharge when kissing, sharing cups, and other forms of close contact • Unclean hands—RSV can survive 30 minutes or more on unwashed hands. • Unclean objects or surfaces—RSV can survive up to 6 hours on surfaces, toys, keyboards.
  • 10. Epidemiology of RSV: Risk Factors • Factors That Increase the Risk of RSV: • Premature baby, <6 months of age. • Small size for gestational age • Male • Malnutrition • Family history of atopy or asthma • Indoor smoke pollution , Maternal smoking . • Crowded living conditions & in day care.
  • 11. RSV Symptom Appearance • The incubation period of RSV respiratory disease ranges from 2 to 8 days, but most commonly 4 to 6 days. • RSV can cause a range of respiratory illnesses and symptoms, from mild upper respiratory infections to life-threatening bronchiolitis and pneumonia.
  • 12. RSV Symptoms • In healthy infants, RSV usually causes mild cold-like signs and symptoms, including: Congested or runny nose, dry cough, low-grade fever, sore throat, and mild headache • lower respiratory tract signs usually appear 1 to 3 days after onset of rhinorrhea, representing viral spread into the bronchi and bronchioles. • In severe cases, signs and symptoms may include: Fever, severe cough, wheezing, difficulty breathing and cyanosis.
  • 13. Diagnosing RSV • Assessment, Confirmation, and Ruling Out Other Conditions. o RSV diagnosis is generally based on history, physical examination and the time of year symptoms occur. o Laboratory and imaging tests aren’t usually needed but can help confirm a diagnosis of RSV complications or rule out other conditions that may cause similar symptoms. • Tests may include: – Blood tests (may not be specific to RSV) to check white cell counts or to look for viruses, bacteria, and other germs – Chest x-rays to check for lung complications. – Swab of secretions from the mouth or nose to check for the virus.
  • 14. RSV Treatment: Supportive Care o Supportive care is the mainstay of therapy for RSV • Treatment options for RSV are limited • Healthy infants infected with RSV do not usually need to be hospitalized. o Supportive care at home or outpatient settings may include: Acetaminophen or ibuprofen, good hydration & nutrition , and follow up.
  • 15. RSV Treatment: Hospital Care • Hospitalization Depends on RSV Severity o When a hospital stay is required: • If the RSV infection is severe and the child is in respiratory distress, dehydrated, especially infants <6 months old. o Treatments at the hospital may include: • Humidified oxygen • IV fluids for dehydration. • Mechanical ventilation (breathing machine) • Inhaled form of an antiviral medicine called ribavirin * for immunocompromised infants. *The only antiviral approved for treatment of RSV, but its use is limited because of side effects and lack of efficacy.
  • 16. RSV prophylaxis is essential to help reduce RSV impact on high-risk children • Critical Need to Minimize the Consequences of Severe RSV LRTI. o Severe RSV LRTI is responsible for: • Significant hospitalizations, morbidity, and mortality in infants <24 months old who have chronic lung disease, congenital heart disease, and compromised respiratory or immune systems. • Recurrent wheezing and asthma during the years following the first severe RSV LRTI or RSV bronchiolitis. • Early childhood wheeze after RSV infection has a high prevalence, influences quality of life, and generates substantial health care costs. RSV: Reduce RSV Impact
  • 17. RSV Prophylaxis: Risk Reduction • Approaches to Reduce the Risk of RSV: o Reduce the spread: Disinfection with alcohol-based rubs and hand washing with alcohol-based rubs or soap and water are highly effective in reducing the spread of RSV. o Limit transmission: Gloves and gowns can help in limiting transmission. o Use safe and effective passive prophylaxis: Perhaps the most important success in the war against RSV so far has been the development of safe and effective passive prophylaxis. • Immunization
  • 18. • Immunization is the process of inducing immunity against a specific disease. • Immunity can be induced either • passively through administration of antibody- containing preparations or • actively by administering a vaccine or toxoid. Immunization
  • 19. PRODUCT MAJOR INDICATIONS Immune globulin for intramuscular injection Replacement therapy in primary immunodeficiency disorders Hepatitis A prophylaxis Measles prophylaxis Intravenous mmunoglobulin (IVIG) Replacement therapy in primary immune-deficiency disorders Kawasaki disease Immune-mediated thrombocytopenia Pediatric HIV infection Hypogammaglobulinemia in chronic B-cell lymphocytic leukemia Hematopoietic cell transplantation in adults to prevent graft-versus host disease and infection May be useful in a variety of other conditions Hepatitis B immune globulin (IM) Postexposure prophylaxis Prevention of perinatal infection in infants born to HBsAg+ mothers Rabies immune globulin (IM) Postexposure prophylaxis Tetanus immune globulin (IM) Wound prophylaxis Treatment of tetanus Varicella-zoster immune globulin (VZIG) (IM) or IVIG Postexposure prophylaxis of susceptible people at high risk for complications from varicella Cytomegalovirus IVIG Prophylaxis of disease in seronegative transplant recipients Palivizumab (monoclonal antibody) (IM) Prophylaxis for infants against respiratory syncytial virus (RSV) Vaccinia immune globulin (IV) Prevent or modify serious adverse events following smallpox vaccination due to vaccinia replication Botulism IVIG human Treatment of infant botulism Diphtheria antitoxin, equine Treatment of diphtheria Trivalent botulinum (A,B,E) and bivalent (A,B) botulinum antitoxin, equine Treatment of food and wound botulism
  • 20. Palivizumab (Synagis® ) • Palivizumab (Synagis) is a humanized monoclonal antibody developed to prevent severe RSV disease in high-risk infants. • Synagis is a seasonal immunoprophylaxis, not a vaccine. • First approval in 1998
  • 21. Palivizumab (Synagis® ) • palivizumab can prevent severe disease from respiratory syncytial virus (RSV) among children with: o chronic lung disease (CLD,bronchopulmonary dysplasia) o history of premature birth o with congenital heart lesions. o with neuromuscular diseases. The American Academy of Pediatrics (AAP) has developed specific recommendations for use of palivizumab
  • 22. o Born prematurely: o Born at 35 weeks of gestation or less and <6 months of age at the onset of the RSV season. RSV Prophylaxis: Patients in Need
  • 23. children who have Cardiac disease: Children <2 yr of age with hemodynamically significant congenital heart disease (heart failure, cyanosis, pulmonary hypertension). RSV Prophylaxis: Patients in Need
  • 24. • Infants with BPD or Chronic Lung Disease (CLD) • BPD may be defined by oxygen requirement at 36 weeks corrected gestational age or at 28 days of age regardless of the birth gestational age. o Infants with BPD/CLD include those who are <24 months old at the start or within 6 months of the RSV season. o Infants with congenital abnormalities of the airways that compromise respiratory function. RSV Prophylaxis: Patients in Need
  • 25. • Candidates to consider for RSV prophylaxis where decisions regarding appropriateness of treatment must be individualized –Infants with severe neuromuscular disease affecting respiratory function (e.g., muscular dystrophy, cerebral palsy). RSV Prophylaxis: Patients in Need
  • 26. Synagis® : How Available • Synagis (palivizumab) solution for injection is available in vials of either 0.5 mL or 1.0 mL • Synagis 0.5 mL solution with a concentration of 100 mg/mL • Synagis 1.0 mL solution a concentration of 100 mg/mL.
  • 27. Synagis®: Weight-Based IM Injections • The recommended dose is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community (5 Monthly Seasonal Injections). • Synagis® is administered by IM injection into anterolateral aspect (top) of the thigh. • Where possible, the first dose should be administered prior to the commencement of the RSV season • Subsequent doses should be administered monthly throughout the RSV season • Children receiving Synagis who are hospitalized with RSV should continue to receive monthly doses throughout the RSV season
  • 28. Synagis® : Impact-RSV • Synagis® significantly reduced the length of hospital stay and days of increased supplementary oxygen. • Synagis significantly reduced the incidence of RSV-related hospitalization by 55% – 78% fewer hospitalizations in premature infants. – 39% fewer hospitalizations in children with BPD. – 45 % fewer hospitalizations in children with Congenital Heart Disease (CHD).
  • 29. SYNAGIS SAFETY PROFILE • Synagis® Safety Profile Is Well Established; The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. • Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction Undesirable effects in clinical studies and post marketing reports in pediatric MedDRA System Organ Class Frequency Adverse Event Blood and lymphatic system disorders Uncommon Thrombocytopenia* Immune system disorders Not known Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported)* Nervous system disorders Uncommon Convulsion* Respiratory, thoracic, and mediastinal disorders Common Apnea* Skin and subcutaneous tissue disorders Very common Rash Uncommon Urticaria* General disorders and administrative site conditions Very common Pyrexia Common Injection site reaction
  • 30. SYNAGIS SAFETY PROFILE Special Warnings:  A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of Palivizumab.  A moderate to severe acute infection or febrile illness may warrant delaying & the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk.  Palivizumab should be given with caution to patients with thrombocytopenia or coagulation disorder. Reference: 1. Synagis® (palivizumab). European Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co.; 2009.