July 28, 2014
News Review From Harvard Medical School -- RSV Drug Recommended for Fewer Babies
A large group of children's doctors says that only certain high-risk babies should receive a drug to prevent severe problems from a common virus. The American Academy of Pediatrics (AAP) says that evidence now shows other children are unlikely to benefit. But the new advice has led to a strong protest by the drugmaker. The drug is palivizumab (Synagis). It is given as a monthly shot to help prevent severe problems from respiratory syncytial virus (RSV). Nearly all children become infected with RSV by age 2. For most, it's a mild illness. But RSV is also the most common cause of pneumonia in babies. The new AAP statement narrows the definition of which "high-risk" babies should get the drug. It says that research shows benefit for only a few groups. They include infants born before 29 weeks of pregnancy, older premature babies with chronic lung disease, infants with heart problems and some other children under age 2. The drug is no longer recommended for some older children and those born less prematurely. The drugmaker, MedImmune, has placed full-page newspaper ads objecting to this change. The ads contend that it will leave babies born between 29 and 35 weeks "unprotected." The Associated Press wrote about the controversy July 28.
By Henry H. Bernstein, D.O., M.H.C.M.
Harvard Medical School
What Is the Doctor's Reaction?
The winter is coming. Your baby might get a runny nose and a cough. Maybe even a fever. Is it respiratory syncytial virus (RSV)? Could be. Almost all children are infected with RSV by the age of 2. RSV infections continue throughout life. RSV tends to be less of a concern as children get older.
RSV causes cold-like symptoms. When the upper airway is the problem, it is called an upper respiratory infection. When the lungs (lower airways) are the issue, it is called bronchiolitis. RSV infection can be more severe in certain babies who:
- Are very premature (born much earlier than expected)
- Have health conditions that affect the heart, lungs or immune system
There is one drug that may help certain babies. It is called palivizumab (pah-lih-VIH-zu-mahb). This drug is an antibody. It is made from a substance in blood that helps to protect against a specific disease. It is given as a series of monthly shots.
The American Academy of Pediatrics (AAP) has carefully analyzed all studies that have been published on RSV and palivizumab together. This includes:
- When RSV circulates in different parts of the United States
- What factors increase the risk of having problems with RSV
- How often babies have a hospital stay (or die) from RSV bronchiolitis
- How palivizumab works in the body
- How well this drug prevents wheezing in the future
- Drug resistance
Many other experts from around the country provided input. This complete science review guided the AAP's latest advice on the use of palivizumab. The journal Pediatrics just published the updated policy statement.
Palivizumab is not for all infants. Research suggests that it works best to reduce serious lung infections caused by RSV in babies who have an increased risk of severe disease. Therefore, the AAP now recommends palivizumab only for high-risk children who are most likely to benefit. These include:
- Infants born before the 29th week of pregnancy who are younger than 12 months at the start of RSV season
- Infants with chronic lung disease of prematurity (born earlier than the 32nd week of pregnancy and requiring extra oxygen for at least the first 28 days after birth)
- Infants with certain heart problems
- Children under 2 years old with severe immune problems during the RSV season
- Some Alaskan Native or American Indian infants
The AAP now has a much better understanding of which babies are at risk. As with any drug, it is important to use palivizumab in children most likely to benefit from it.
What Changes Can I Make Now?
If your baby is at increased risk of severe RSV disease, palivizumab during RSV season may help. It means going to the doctor each month to get a shot in the muscle. Remember that during these monthly visits, babies may be exposed to a different infection, such as influenza, by other children in the office. Your baby's doctor can help you decide if the baby might benefit from this drug.
The latest AAP advice means that a more focused group of children is eligible for palivizumab than in years past. But this does not mean that more children will be at risk for severe RSV infection.
The AAP recommends palivizumab for only a very small number of infants because the evidence shows that the benefit is so limited.
Palivizumab does not prevent RSV. It has been shown to only modestly reduce how often children have to stay in a hospital for bronchiolitis treatment. It has not been shown to lower death rates. It has minimal effect on reactive airways disease and asthma.
RSV spreads easily from person to person. Children are most likely to catch it during the RSV season. This usually lasts from November to April.
Here are some things you can do to protect your baby from RSV:
- Breastfeed your baby. Breast milk provides antibodies, which help fight infection.
- Wash your hands with warm water and soap before picking up and holding your baby.
- Cough or sneeze into your elbow or upper arm.
- Wash objects that are touched a lot, such as toys. Use a disinfectant wipe or a cloth with soap and hot water. (A disinfectant is a cleaner that kills germs.)
- Do not smoke around your baby. Secondhand smoke increases the risk of a serious RSV infection.
- Try to steer clear of anyone who seems to have a cold.
- Keep your baby away from crowded areas, such as shopping malls and elevators. RSV spreads more easily when there are lots of people around.
- Avoid large-group child care during RSV season.
What Can I Expect Looking to the Future?
The AAP still believes that palivizumab is helpful for babies at greatest risk from RSV infection. Experts will keep studying, analyzing and reviewing the data on palivizumab and RSV. As new studies are published, guidelines might change again.
An RSV vaccine would provide even better protection. Researchers are working on making a safe and effective vaccine against RSV.