Preventive treatment

Currently there is no adequate treatment for the virus. There is a preventive treatment called abbosynagis that is given every month during the winter months (November-March) AbboSynagis is a monoclonal antibody that was successfully developed to help prevent an infectious disease1.

It is given as an indication to prevent serious diseases in the lower respiratory tract caused by Respiratory Syncytial Virus (RSV) in children who are at high risk of 3RSV disease.

AbboSynagis has been found to be effective and safe in neonates with Bronchopulmonary Dysplasia (BPD), neonates with a history of preterm birth (at or before 35 weeks) and in children with hemodynamically significant Congenital Heart Disease (CHD).

AbboSynagis has been shown to be effective in reducing hospitalization rates due to RSV in premature infants and in infants with 1, 2CHD.

References

1. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102:531-537.

2. Feltes T, Cabalka A, Meissner C, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003;143:532-540.

3. Abbosynagis (Palivizumab). Full prescribing information

Lowered in several hospitalizations
The efficacy of the vaccine has been studied very extensively among all subpopulations of preterm infants worldwide, starting with the registry study from 1998 and throughout the last decade.
In the IMPACT STUDY registration study that tested the effectiveness of the vaccine in reducing hospitalizations due to RSV, 80% showed a decrease among this age group.

After the drug was registered, efficacy data was accumulated on wider and more diverse populations and an even more significant decrease in hospitalization rates was demonstrated among the thousands of premature babies who received the treatment compared to the control group.

A meta-analysis published by Simoes et.al of 13 prospective and retrospective studies demonstrated a drastic decrease in hospitalization rates among all preterm subpopulations, with the most drastic decrease observed among the 32-35 age group.

The clinical experience in Israel

In Israel, as in the Western world, hospitalizations for respiratory reasons are the main cause of hospitalization among newborns up to one year of age. In Israel, the number of hospitalizations caused by RSV is estimated at about 4,100 hospitalizations (Prof. Somech, 2008).

It can also be seen from the data of the infectious diseases unit in Soroka that infections in the lower respiratory tract are the main reason for visits to the emergency room, both among the Jews and among the Bedouins.

The effectiveness of the treatment in Israel was studied at the Shaare Zedek Hospital, which has a birth rate of about 12,000 births per year and the Soroka Medical Center, which is the leader in the number of births in Israel (about 16,000 births per year).
At Shaare Zedek Medical Center, a review was performed on the data of premature infants up to week 29 who received vaccination during 5 consecutive years 2002-2007 (5 consecutive winters) and it was found that out of 159 premature infants, no one was hospitalized with a diagnosis of RSV during 5 consecutive seasons. It can be seen that the average duration of hospitalization was 4.96 days among the non-vaccinated population.

At the Soroka Medical Center, headed by Prof. Asher Tal, director of the 2nd Pediatric Department, the effectiveness of the vaccine in reducing the average length of hospitalization for those hospitalized due to RSV from 94 premature infants to week 29 was investigated against a control group (premature infants who did not get vaccinated at all or received less than 3 vaccinations), between the years 2001- 2007.
The average length of hospitalization decreased in 46% from 9.4 days on average among the control group to 5.1 among the children who received Singis.

Importance of giving 5 vaccines

All studies including the registration study tested the effectiveness of the treatment regimen of 5 monthly treatments during the entire RSV season.
Hand and his associates showed in a study published in 2008 in Pediatr Infect Dis that among premature infants who missed 1 out of 5 vaccines, an increased rate of hospitalizations for only RSV and unplanned doctor visits was observed.

Administering consecutive monthly treatments throughout the season allows reaching serum levels of over 40 micrograms per milliliter, while inconsistent administration at a monthly level during the season does not allow reaching this desired level, resulting in an increase in hospitalizations.