There is evidence that palivizumab prophylaxis is effective in reducing the frequency of hospitalisations due to RSV infection, i.e. in reducing the incidence of serious lower respiratory tract RSV disease in children with chronic lung disease, congenital heart disease or those born preterm.Results from economic evaluations of palivizumab prophylaxis are inconsistent, implying that economic findings must be interpreted with caution. ICER values varied considerably across studies, from highly cost-effective to not cost-effective. The availability of low-cost palivizumab would reduce its inequitable distribution, so that RSV prophylaxis would be available to the poorest countries where children are at greatest risk.

Background Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing acute respiratory infections, resulting in about 3.4 million hospitalisations annually in children under five. Palivizumab is the only product approved for prevention of serious RSV disease, as motavizumab is no longer being developed for this condition. The efficacy and safety of palivizumab has been evaluated in randomized controlled trials (RCTs) and a large number of economic evaluations (EEs) have tested its cost‐effectiveness. Objectives To assess the effectiveness and safety of palivizumab prophylaxis in reducing the risk of complications (hospitalization due to RSV infection) in high‐risk infants and children. To assess the cost‐effectiveness (or cost‐utility) of palivizumab prophylaxis in infants and children in different risk groups. Search methods We searched CENTRAL (2012, Issue 7), MEDLINE (1996 to July week 4, 2012), EMBASE (1996 to August 2012), CINAHL (1996 to August 2012) and LILACS (1996 to August 2012) for RCTs. We searched the NHS Economic Evaluations Database (NHS EED 2012, Issue 4), Health Economics Evaluations Database (HEED, 9 August 2012), Paediatric Economic Database Evaluations (PEDE, 1980 to 2009), MEDLINE (1996 to July week 4, 2012) and EMBASE (1996 to August 2012) for EEs. Selection criteria We included RCTs comparing palivizumab prophylaxis with a placebo or another type of prophylaxis in preventing serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. We included cost‐effectiveness analyses and cost‐utility analyses comparing palivizumab prophylaxis with no prophylaxis. Data collection and analysis Two review authors independently assessed risk of bias for the included studies and extracted data for both the RCTs and EEs. We calculated risk ratios (RRs) and their associated 95% confidence intervals (CIs) for dichotomous outcomes and for adverse events (AEs). For continuous outcomes, we provided a narrative summary of results due to missing data on standard deviations. We performed fixed‐effect meta‐analyses for the estimation of pooled effects whenever there was no indication of heterogeneity between included RCTs. We summarised the results reported in included EEs, such as incremental costs, incremental effectiveness, and incremental cost‐effectiveness and/or cost‐utility ratios (ICERs), and we calculated ICER present values in 2011 Euros for all studies. Main results Of the seven available RCTs, three compared palivizumab with a placebo in a total of 2831 patients, and four compared palivizumab with motavizumab in a total of 8265 patients. All RCTs were sponsored by the drug manufacturing company. The overall quality of RCTs was good, but most of the outcomes assessed relied on data from only two studies. Palivizumab prophylaxis was associated with a statistically significant reduction in RSV hospitalisations (RR 0.49, 95% CI 0.37 to 0.64) and a statistically non‐significant reduction in all‐cause mortality (RR 0.69, 95% CI 0.42 to 1.15) ...

Background Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing acute respiratory infections, resulting in about 3.4 million hospitalisations annually in children under five. Palivizumab is the only product approved for prevention of serious RSV disease, as motavizumab is no longer being developed for this condition. The efficacy and safety of palivizumab has been evaluated in randomized controlled trials (RCTs) and a large number of economic evaluations (EEs) have tested its cost‐effectiveness. Objectives To assess the effectiveness and safety of palivizumab prophylaxis in reducing the risk of complications (hospitalization due to RSV infection) in high‐risk infants and children. To assess the cost‐effectiveness (or cost‐utility) of palivizumab prophylaxis in infants and children in different risk groups. Search methods We searched CENTRAL (2012, Issue 7), MEDLINE (1996 to July week 4, 2012), EMBASE (1996 to August 2012), CINAHL (1996 to August 2012) and LILACS (1996 to August 2012) for RCTs. We searched the NHS Economic Evaluations Database (NHS EED 2012, Issue 4), Health Economics Evaluations Database (HEED, 9 August 2012), Paediatric Economic Database Evaluations (PEDE, 1980 to 2009), MEDLINE (1996 to July week 4, 2012) and EMBASE (1996 to August 2012) for EEs. Selection criteria We included RCTs comparing palivizumab prophylaxis with a placebo or another type of prophylaxis in preventing serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. We included cost‐effectiveness analyses and cost‐utility analyses comparing palivizumab prophylaxis with no prophylaxis. Data collection and analysis Two review authors independently assessed risk of bias for the included studies and extracted data for both the RCTs and EEs. We calculated risk ratios (RRs) and their associated 95% confidence intervals (CIs) for dichotomous outcomes and for adverse events (AEs). For continuous outcomes, we provided a narrative summary of results due to missing data on standard deviations. We performed fixed‐effect meta‐analyses for the estimation of pooled effects whenever there was no indication of heterogeneity between included RCTs. We summarised the results reported in included EEs, such as incremental costs, incremental effectiveness, and incremental cost‐effectiveness and/or cost‐utility ratios (ICERs), and we calculated ICER present values in 2011 Euros for all studies. Main results Of the seven available RCTs, three compared palivizumab with a placebo in a total of 2831 patients, and four compared palivizumab with motavizumab in a total of 8265 patients. All RCTs were sponsored by the drug manufacturing company. The overall quality of RCTs was good, but most of the outcomes assessed relied on data from only two studies. Palivizumab prophylaxis was associated with a statistically significant reduction in RSV hospitalisations (RR 0.49, 95% CI 0.37 to 0.64) and a statistically non‐significant reduction in all‐cause mortality (RR 0.69, 95% CI 0.42 to 1.15) ...

Cochrane Review: Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B. Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database of Systematic Reviews 2013, Issue 4.

AimTo evaluate the administration of antipyretics to children with upper respiratory tract infections (URTI) by their parents or guardians without consultation with physicians, and compare epidemiological and clinical characteristics of patients who received antipyretics and of untreated patients.MethodsA prospective observational study was performed in three pediatric clinics in Zagreb, Croatia, from March to June 2002. A total of 171 children aged from 2 to 14 years with symptoms and signs of URTI lasting more than 2 days and fever above 38°C lasting more than 2 days were included in the study. Data were collected on the usage of antipyretics, patients’ demographic and epidemiological characteristics, and clinical signs and symptoms.ResultsAntipyretics, predominantly paracetamol, were used in 29.8% of patients. Their usage was less frequent in children attending day-care centers (49% of treated and 70% of untreated children, P = 0.014) and in children with reiterated URTIs (33.3% of treated and 55.8% of untreated children, P = 0.008). However, it was more frequent in children with recent URTIs in the family (33.3% of treated and 7.5% of untreated children, P < 0.001). Overall, most clinical signs and symptoms of URTI were notably less pronounced in patients treated with antipyretics.ConclusionsAntipyretics use correlated with less pronounced clinical signs and symptoms of infection, which indicates their anti-inflammatory activity, but also with negative effects such as lethargy. It is necessary to educate parents on the positive and negative aspects of antipyretics use and on the optimal choice of an antipyretic drug.