Respiratory Syncytial Virus Prophylaxis Research Articles

Monoclonal antibody therapies in respiratory syncytial virus prophylaxis-An umbrella review.

The aim was to gather an overview of the evidence of monoclonal antibody therapies in respiratory syncytial virus (RSV) prophylaxis in children. For this umbrella review of previous meta-analyses, we searched PubMed, Scopus, and Web of Science databases in August 2023. We included systematic reviews with meta-analyses of randomized controlled trials. One author extracted the data, and another author validated the data. We extracted all analyses focusing on clinical outcomes and comparing prophylaxis to placebo. Risk of bias in systematic reviews (ROBIS) tool was used to analyze the risk of bias in the included reviews. AMSTAR-2 was used to evaluate the quality of the included reviews. After screening of 323 abstracts and 22 full reports, a total of seven systematic reviews with meta-analyses were included. The risk of bias was rated to be low in four and high in three of these. Three reviews were of moderate quality, one low, and three very low quality according to AMSTAR-2 classification. Six of the meta-analyses were direct comparisons, and one was a network meta-analysis. Five of the reviews focused on palivizumab, one in nirsevimab, and one included all monoclonal antibodies. Six reviews focused on preterm neonates and consisted of 42 comparisons to placebo of which 21 showed efficacy, and 21 had no evidence of a difference. The positive effect was seen in all reviews against RSV infection and RSV hospitalization in palivizumab and nirsevimab groups compared to placebo. None of the mortality comparisons showed efficacy. One meta-analysis focused on cystic fibrosis patients and had eight comparisons, but it was underpowered to detect any results. The overall evidence from previous meta-analyses shows that monoclonal antibodies are effective in preventing RSV infections and RSV hospitalizations in preterm infants. However, no effect on mortality was seen in these studies. Evidence certainty has been ranked mainly from low to moderate.

Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol

ABSTRACT Nirsevimab has been recently licensed for universal RSV prophylaxis in infants. NIRSE-GAL is a three-year population-based study initiated in Galicia in September 2023. It aims to evaluate nirsevimab effectiveness against RSV-related hospitalizations lower respiratory tract infections (LRTI), severe RSV, all-cause LRTI, and all-cause hospitalization. NIRSE-GAL also aims to estimate nirsevimab impact on primary healthcare use in the short and mid-term, children’s wheezing and asthma, and medical prescriptions for RSV. The immunization campaigns will be scheduled based on the expected start week for the RSV season and will last the whole season. Immunization will be offered to: i) infants born during the campaign (seasonal), ii) infants < 6 months at the start of the campaign (catch-up), and iii) infants with high-risk factors, aged 6–24 months at the start of the campaign (high-risk). The follow-up period will start: i) the immunization date for all immunized infants, ii) the start of the campaign, for the non-immunized catch-up or high-risk groups, or iii) the birthdate for the non-immunized seasonal group. Infants will be followed up until outcome occurrence, death, or end of study. Nirsevimab effectiveness will be estimated using Poisson and Cox regression models. Sensitivity and stratified analyses will be undertaken. The number of averted cases and the number needed to immunize will be estimated. Immunization failure and nirsevimab safety will be monitored. NIRSE-GAL was approved by the ethics committee of Galicia (CEIC 2023–377) and registered in ClinicalTrials.gov (ID: NCT06180993). Findings will be mainly shared via peer-reviewed publications and scientific conferences.

Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young Children.

Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab's role in clinical practice and highlighting continuing questions. A literature search of PubMed was conducted utilizing the phrases "nirsevimab" and "medi8897." Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized. Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics. Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%). Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations. Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.

Updates on respiratory syncytial virus prophylaxis: the past, present and future.

Human respiratory syncytial virus (RSV) causes acute respiratory infection in individuals of all age groups. It is the most common pathogen identified in infants and young children with acute lower respiratory infection. Although most infants and young children experience mild, cold-like symptoms, some infants develop severe lower respiratory tract disease such as pneumonia and bronchiolitis that may result in an emergency department visit or hospitalization. In the United States, hospitalization rates have risen during the last decades, and while premature infants with chronic lung disease and congenital heart disease are at increased risk for severe presentations, the majority of hospitalizations occur in previously healthy infants. Until recently, RSV prophylaxis was only available for former preterm infants and those with certain underlying medical conditions. The need for preventive interventions against RSV is crucial. This paper will provide a review of the vaccine development, the spectrum of RSV prophylaxis, current challenges associated with the cost, insurance coverage and equitable distribution of targeted therapies.

Efficacy and Safety of Palivizumab as a Prophylaxis for Respiratory Syncytial Virus (RSV) Disease: An Updated Systemic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to summarize the current evidence regarding the efficacy and safety of palivizumab as a prophylaxis for respiratory syncytial virus (RSV) disease. We searched MEDLINE via PubMed, Scopus, Cochrane, Web of Science, Embase, and Science Direct from inception till November 2023. Studies that assessed the efficacy and safety of palivizumab in infants aged between 28 days and three months of age were included. We analyzed the data using Review Manager 5.4 software, with results pooled across studies and expressed as risk ratios (RR) with 95% confidence intervals (CI). A total of 10 studies were included. The effect estimates favored palivizumab over placebo regarding the hospitalization for RSV infection (RR=0.51, 95% CI: 0.40 to 0.65; P<0.00001) and ICU admission (RR=0.49, 95% CI: 0.30 to 0.81; P=0.005). On the other hand, the effect estimate showed no significant difference between palivizumab and placebo regarding all-cause mortality (RR=0.69, 95% CI: 0.42 to 1.15; P=0.16), lower respiratory tract infection (RR=0.42, 95% CI: 0.11 to 1.69; P=0.22), and need for mechanical ventilation (RR=0.75, 95% CI: 0.34 to 1.67; P=0.48). Palivizumab can be considered a prophylaxisfor RSV disease in young children as it is safe, well-tolerated, and effective in reducing RSV hospitalizations. However, further research through high-quality randomized controlled trials is required to determine its efficacy as a therapeutic agent for established RSV infections.

Early lessons from the implementation of universal respiratory syncytial virus prophylaxis in infants with long-acting monoclonal antibodies, Galicia, Spain, September and October 2023.

A monoclonal antibody for universal respiratory syncytial virus prophylaxis in infants has recently been licensed. We share our experiences of integrating nirsevimab into the regional immunisation programme in Galicia, Spain. After a 3-week hospital-based immunisation campaign with flexible individualised appointments and educational activities, nirsevimab uptake was 97.5% in the high-risk group, 81.4% in the catch-up group and 92.6% in infants born during the campaign. This successful implementation strategy can serve as a model and may inform other countries' programmatic deliberations.

Effect of Palivizumab Prophylaxis on Respiratory Syncytial Virus Infection in Very Preterm Infants in the First Year of Life in The Netherlands.

Respiratory Syncytial Virus (RSV) poses a severe threat to infants, particularly preterm infants. Palivizumab, the standard preventive prophylaxis, is primarily utilized in high-risk newborns due to its cost. This study assessed palivizumab's effectiveness in preventing RSV infections in predominantly very preterm infants during their first year of life. Serum samples from a prospective multicentre cohort study in the Netherlands were analyzed to assess RSV infection rates by measuring IgG levels against three RSV proteins: nucleoprotein, pre-fusion, and post-fusion protein. Infants were stratified based on gestational age (GA), distinguishing very preterm (≤32 weeks GA) from moderate/late preterm (>32 to ≤36 weeks GA). In very preterm infants, palivizumab prophylaxis significantly reduced infection rates (18.9% vs. 48.3% in the prophylaxis vs. non-prophylaxis group. Accounting for GA, sex, birth season, and birth weight, the prophylaxis group showed significantly lower infection odds. In infants with >32 to ≤36 weeks GA, the non-prophylaxis group (55.4%) showed infection rates similar to the non-prophylaxis ≤32-week GA group, despite higher maternal antibody levels in the moderate/late preterm infants. In conclusion, palivizumab prophylaxis significantly reduces RSV infection rates in very premature infants. Future research should explore clinical implications and reasons for non-compliance, and compare palivizumab with emerging prophylactics like nirsevimab aiming to optimize RSV prophylaxis and improve preterm infant outcomes.

Direct long-acting antibodies: updating the language of RSV prevention to reflect the evolution of mAbs.

The language of medicine is constantly evolving, typically to better describe a new understanding of disease, adjust to changing social sensibilities, or simply to reflect a new drug class or category. We address the need for an updated language around monoclonal antibodies, or "mAbs" - a widely used medical term, but one which is now too general to accurately reflect the range of mAb pharmaceuticals, their effects, and the intended patients. The question of "what should we call a monoclonal antibody immunisation against respiratory syncytial virus (RSV) to ensure accurate understanding of the product?" was the basis for a virtual advisory panel in May 2022. The panel was convened by Sanofi with the intention of reviewing appropriate language in terminology in the context of mAb-based prophylaxis for RSV. The panel comprised several global experts on RSV and vaccination, a trained linguist specialising in doctor-patient interactions and medical language, and several experts in marketing and communications. We suggest the term "Direct Long-acting Antibody" (DLA) for a specific sub-class of mAbs for use in prevention of RSV disease in infants. This terminology should differentiate from other mAbs, which are generally not used as therapies in infants. This change will more accurately convey the specific mode of action of a mAb in infants, and how it could impact the prevention of communicable diseases: this class of mAbs is not an active treatment, but rather will offer direct and rapid protection lasting at least 5 months.

EE182 Costs and Health Impact of Wastewater Surveillance to Guide Respiratory Syncytial Virus Prophylaxis in Canada, Compared to Clinical Surveillance

EE182 Costs and Health Impact of Wastewater Surveillance to Guide Respiratory Syncytial Virus Prophylaxis in Canada, Compared to Clinical Surveillance

The rapidly changing landscape of respiratory syncytial virus prophylaxis.

The introduction of nirsevimab (a respiratory syncytial virus [RSV] monoclonal antibody that can protect for minimum 5 months with a single dose) and RSV maternal vaccines to protect young infants has the potential to dramatically decrease RSV hospitalizations in Canada. However, there remain many unanswered questions before optimal use of these products can be assured.

1943. RSV Prophylaxis for 29-34 Gestational Preemies. Are Current Guidelines Justified? Lessons from an Israeli Multicenter Off-seasonal Study

Abstract Background Respiratory syncytial virus (RSV) prophylaxis provided during the winter to infants born at 29–34-week gestational age (wGA) is controversial. We utilized the unprecedented opportunity of high load off-season RSV admissions with no prophylaxis given during the summer of 2021, to assess the impact of withholding palivizumab on the relative burden of hospitalized 29-34 wGA infants. Methods This was a national multi-center observational retrospective study in 11 medical centers in Israel. We included infants under 1 year-old, who were hospitalized with RSV between November 2017 and August 2021. Demographics and clinical data were extracted from the medical records. We categorized our cohort into a seasonal admissions group (November- March) when palivizumab was indicated, and an off-season admissions group (April-October) when palivizumab was not indicated. The primary outcome was the proportion of 29-34 wGA hospitalizations in each group. Secondary outcomes included clinical severity parameters. Results We included 4,340 children in our study; 57% were males, 61% were Jewish, and the median age at admission was 2.9 months (IQR 1.4-6.4). A total of 3,296 infants were admitted during the RSV season, and 1,044 were admitted off-season. The proportion of 29-34 wGA preemies was significantly higher in the off-season admissions group compared to the in season patients (7% vs 2.1%, p&amp;lt; 0.001). We found a significantly higher prevalence of Jewish (77% vs 57%, p=0.001) and higher socioeconomic status (55% vs 45%, p&amp;lt; 0.001) children in the group admitted off-season compared to those in season. Logistic regression analysis revealed that the relative-odds of 29-34 wGA preemies to be hospitalized off-season was 2.67 (95% CI: 1.8-3.9, p&amp;lt; 0.001) fold higher than in season, independent of ethnicity, socioeconomic-status, gender, age, or institution. Clinical severity parameters did not differ significantly between the groups. Flow chart of study participants The proportion of 29-34 wGA preterm infants out of total admissions categorized into seasonal and out of season RSV infections Clinical severity in the subgroup of 29-34 wGA preterm infants Conclusion Our results reveal a significant higher proportion of 29-34 wGA preemies among the children hospitalized during off-season periods, when RSV immunoprophylaxis was not indicated. These findings may support the current broad Israeli policy of administration. Disclosures All Authors: No reported disclosures

Respiratory Syncytial Virus Prophylaxis With Palivizumab Is Not Associated With Improved Lung Function in Infants of Very Low Birth Weight at Early School Age

BackgroundPrematurity and infection with respiratory syncytial virus (RSV) are major risk factors for impaired lung function beyond the neonatal period. Research QuestionTo examine the long-term effects of palivizumab immunoprophylaxis in the first year of life on lung function and frequency of bronchitis episodes in 5 to 6-year-old preterm infants. Study Design and MethodsPreterm infants with a birth weight below 1500 grams (Very low birth weight infants, VLBWI) were enrolled in a German Neonatal Network (GNN) cohort study between 2009 and 2016. Children were examined by a single follow-up team at 5 to 6 years of age. VLBWI who received at least five doses of palivizumab were compared with children who never received palivizumab. Analyses were stratified by bronchopulmonary dysplasia (BPD) and gestational age. We analysed forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and the risk for respiratory tract infections at the age of 5 to 6 years via univariate analyses and linear and logistic regression models. ResultsOut of N = 1986 VLBWI with follow-up at 5-6 years, N = 951 (48%) received immunoprophylaxis with palivizumab. Children with BPD (N = 1019) had a much lower FEV1 than children without BPD (median FEV1 z-score -1.51 vs. -1.09; p< 0.001). However, FEV1 in children with BPD was not altered by palivizumab (median FEV1 z-score in 698 children with BPD and palivizumab: -1.57; IQR -0.75 to -2.43 vs. 320 children with BPD without palivizumab: -1.37; IQR -0.69 to -2.25; p= 0.1). As for FEV1, we did not find any protective effects of palivizumab for other endpoints or in other risk groups. InterpretationPalivizumab immunoprophylaxis in VLBWI is not associated with improved lung function or lower rates of respiratory tract infections in early school-age infants.

Summer 2023 ACIP Update: RSV Prevention and Updated Recommendations on Other Vaccines.

The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention (CDC), normally meets three times per year to develop US vaccine recommendations. The ACIP met June 21-23, 2023, to discuss respiratory syncytial virus (RSV) vaccines, influenza vaccines, pneumococcal vaccines, meningococcal vaccines, and COVID-19 vaccines. The ACIP also held a special meeting on August 3, 2023 to discuss RSV prophylaxis in infants. This update summarizes the proceedings of these meetings that are most relevant to the pediatric population. Major updates for pediatric clinicians include a new recommendation for the monoclonal antibody nirsevimab for prevention of RSV disease in all infants, recommendations regarding use of 20-valent pneumococcal conjugate vaccine (PCV20), and discussion of potential forthcoming changes to meningococcal and COVID-19 vaccination recommendations.

Seasonal Prevalence of Respiratory Pathogens Among Children in the United Arab Emirates: A Multicenter Cross-Sectional Study in the Pre-COVID-19 Era.

Background Viral respiratory infections in children pose a significant burden on healthcare facilities globally. In the United Arab Emirates (UAE) these account for 15% of all healthcare encounters among children. However, the seasonal prevalence and molecular epidemiology of respiratory viral infections in the UAE remains unknown. We sought to determine trends in seasonal viral prevalence in order to monitor disease activity and optimize the timing of Respiratory Syncytial Virus (RSV) prophylaxis among high-risk infants in the UAE. Methods This cross-sectional multicenter study included children 0-18 years of age who presented to a large private healthcare group in Dubai, UAE, and had upper respiratory samples collected for multiplex polymerase chain reaction (mPCR) testing between January 1st and December 31st, 2019. Sociodemographic, clinical, and molecular data were examined for children who tested positive for any pathogen on the mPCR panel. Results A total of three thousand and ninety-eight infants and children had mPCR assays performed during the study period, of which 2427 (78.3%) were positive for any respiratory pathogen. The median age of our sample population was 39 months and 56.8% were male. Emergency room was the most common site (34.7%) of sample collection and the vast majority of children presented with fever (85.3%). Rhinovirus/enterovirus was the most prevalent viral infection (45%) throughout the year and peaked in September, followed by Influenza (20.2%), and RSV (17.1%). RSV season, defined as an infection prevalence of >10%, occurred from August to December with a peak in October. Adenovirus (15.6%) infections peaked in June and accounted for 43% of hospitalizations in our study (p<0.05). Viral co-infections with RSV and rhinovirus/enterovirus were most common and observed in 19.9 % of children. Conclusion Rhinovirus/enterovirus is the most prevalent viral pathogen throughout the calendar year among the pediatric population in the UAE. RSV season begins earlier than reported in other countries regionally, hence RSV prophylaxis should be initiated in August to optimize protection among high-risk infants.

Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29–34 6/7 weeks' gestation in the United States

Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born ≥29 0/7 weeks' gestational age (GA) without additional risk factors. A novel drug candidate, nirsevimab, has been developed for this population. We analyzed the cost-effectiveness of palivizumab/nirsevimab vs. no prophylaxis in this population. A hybrid-Markov model predicted the RSV clinical course in the first year of life and sequelae in the subsequent four years for preterm infants from the healthcare and societal perspectives. Model parameters were derived from the literature. We calculated costs and quality-adjusted life-years (QALYs) to produce an incremental cost-effectiveness ratio (ICER) evaluated at a willingness-to-pay threshold of $150,000/QALY. Sensitivity analyses assessed model robustness. A threshold analysis examined nirsevimab pricing uncertainty. Compared to no prophylaxis, palivizumab costs $9572 and $9584 more from the healthcare and societal perspectives, respectively, with 0.0019 QALYs gained per patient over five years, resulting in ICERs >$5 million per QALY from each perspective. Results were robust to parameter uncertainties; probabilistic sensitivity analysis revealed that no prophylaxis had a 100% probability of being cost-effective. The threshold analysis suggested that nirsevimab is not cost-effective when compared to no prophylaxis if the price exceeds $1962 from a societal perspective. Palivizumab is dominated by no prophylaxis for preterm infants 29 0/7-34 6/7 weeks' GA with no additional risk factors. Relevant stakeholders should consider alternatives to palivizumab for this population that are both effective and economical.

Cost-Effectiveness of an RSVpreF Vaccine for Prevention of Respiratory Syncytial Virus Outcomes in Infants

&#x0D; From CADTH’s search of the economic literature, 4 economic studies were identified that assessed the cost-effectiveness of respiratory syncytial virus (RSV) immunization during pregnancy in high-income countries, including 1 study set in Nunavik, Quebec. Only 1 of these studies specifically considered the product of interest (RSVpreF), and only in a scenario analysis.&#x0D; In the 4 identified studies that evaluated the cost-effectiveness of RSV immunization during pregnancy, the outcomes predicted by the models focused on those related to infants. There is a lack of evidence on outcomes — thus cost-effectiveness — for the persons who are pregnant.&#x0D; The results from the 4 studies varied considerably. RSV immunization during pregnancy ranged from being more effective and associated with lower total costs (dominant) to more than $200,000 per quality-adjusted life-year gained when compared with no intervention. The results depended on the modelled region, efficacy, pricing, and severity of the RSV season.&#x0D; In 2 studies, year-round RSV immunization during pregnancy was not considered cost-effective compared with seasonal RSV prophylaxis with long-acting monoclonal antibodies (mAbs), such as nirsevimab, when the price per dose was the same as that of the long-acting mAb. RSV immunization during pregnancy was estimated to become cost-effective when its acquisition cost per dose was 2 to 5 times lower than that of the long-acting mAb.&#x0D;

Exploring the adoption of less restricted criteria for respiratory syncytial virus prophylaxis in late preterm infants: insights from a retrospective analysis

BackgroundPreterm infants born between 33 and 35 weeks of gestational age (wGA) have been considered a “major underserved population” and ineligible to receive palivizumab (PLV), the only drug authorized to date for respiratory syncytial virus (RSV) prophylaxis, by current international guidelines. In Italy, such a vulnerable population is currently eligible for prophylaxis, and, in our region, specific risk factors are taken into consideration (SINLazio score) to target prophylaxis for those at highest risk. Whether the adoption of less or more restrictive eligibility criteria for PLV prophylaxis would translate into differences in bronchiolitis and hospitalization incidence is not known.Materials and methodsA retrospective analysis was conducted in 296 moderate-to-late preterm infants (born between 33 and 35+6 weeks) who were being considered for prophylaxis in two epidemic seasons: 2018–2019 and 2019–2020. The study participants were categorized according to both the SINLazio score and the Blanken risk scoring tool (BRST), which was found to reliably predict RSV-associated hospitalization in preterm infants on the basis of three risk factor variables.ResultsBased on the SINLazio score, approximately 40% of infants (123/296) would meet the criteria to be eligible for PLV prophylaxis. In contrast, none of the analyzed infants would be considered eligible for RSV prophylaxis on the basis of the BRST. A total of 45 (15.2%) bronchiolitis diagnoses were recorded on average at 5 months of age in the overall population. Almost seven out of 10 (84/123) patients exhibiting ≥3 risk factors to be eligible for RSV prophylaxis according to SINLazio criteria would not be receiving PLV if they were categorized on the basis of the BRST. Bronchiolitis occurrence in patients with a SINLazio score ≥3 was approximately 2.2 times more likely than that in patients with a SINLazio score &amp;lt;3. PLV prophylaxis has been associated with a 91% lower risk of requiring a nasal cannula.ConclusionOur work further supports the need for targeting late preterm infants for RSV prophylaxis and calls for an appraisal of the current eligibility criteria for PLV treatment. Therefore, adopting less restrictive criteria may ensure a comprehensive prophylaxis of the eligible subjects, thus sparing them from avoidable short- and long-term consequences of RSV infection.

Monoclonal antibodies for prophylaxis and therapy of respiratory syncytial virus, SARS-CoV-2, human immunodeficiency virus, rabies and bacterial infections: an update from the World Association of Infectious Diseases and Immunological Disorders and the Italian Society of Antinfective Therapy.

Monoclonal antibodies (mABs) are safe and effective proteins produced in laboratory that may be used to target a single epitope of a highly conserved protein of a virus or a bacterial pathogen. For this purpose, the epitope is selected among those that play the major role as targets for prevention of infection or tissue damage. In this paper, characteristics of the most important mABs that have been licensed and used or are in advanced stages of development for use in prophylaxis and therapy of infectious diseases are discussed. We showed that a great number of mABs effective against virus or bacterial infections have been developed, although only in a small number of cases these are licensed for use in clinical practice and have reached the market. Although some examples of therapeutic efficacy have been shown, not unlike more traditional antiviral or antibacterial treatments, their efficacy is significantly greater in prophylaxis or early post-exposure treatment. Although in many cases the use of vaccines is more effective and cost-effective than that of mABs, for many infectious diseases no vaccines have yet been developed and licensed. Furthermore, in emergency situations, like in epidemics or pandemics, the availability of mABs can be an attractive adjunct to our armament to reduce the impact. Finally, the availability of mABs against bacteria can be an important alternative, when multidrug-resistant strains are involved.

Impact of using the International Risk Scoring Tool on the cost-utility of palivizumab for preventing severe respiratory syncytial virus infection in Canadian moderate-to-late preterm infants

Background and objectiveTo assess the cost-utility of palivizumab versus no prophylaxis in preventing severe respiratory syncytial virus (RSV) infection in Canadian moderate-to-late preterm (32–35 weeks’ gestational age) infants using an (i) International Risk Scoring Tool (IRST) and (ii) Canadian RST (CRST).MethodsA decision tree was developed to assess cost-utility. Infants assessed at moderate- and high-risk of RSV-related hospitalization (RSVH) by the IRST or CRST received palivizumab or no prophylaxis and then progressed to either (i) RSVH; (ii) emergency room/outpatient medically attended RSV-infection (MARI) or (iii) were uninfected/non-medically attended. Infants admitted to intensive care could incur mortality (0.43%). Respiratory morbidity was accounted in all uninfected surviving infants for 6 years or 18 years (RSVH/MARI). Palivizumab efficacy (72.2% RSVH reduction) and hospital outcomes were from the Canadian CARESS, PICNIC and RSV-Quebec studies. Palivizumab costs (50 mg: CAN$752; 100 mg: $1,505) were calculated from Canadian birth statistics combined with a growth algorithm. Healthcare/payer and societal costs (May 2022; 1.5% discounting) were included.ResultsCost per quality-adjusted life year (QALY) was $29,789 with the IRST (0.79 probability of being <$50,000) and $15,833 with the CRST (0.96 probability). The model was most sensitive to utility scores, long-term sequelae and palivizumab cost. Vial sharing improved the incremental cost-utility ratio (IRST: $22,319; CRST: $9,231).ConclusionsPalivizumab was highly cost-effective (vs no prophylaxis) in Canadian moderate-to-late preterm infants using either the IRST or CRST. The IRST has fewer risk factors than the CRST (3 vs 7, respectively), captures more potential RSVHs (85% vs 54%) and provides another option to guide cost-effective RSV prophylaxis in Canada.

Respiratory syncytial virus and its prophylaxis with palivizumab: exploring nurses' knowledge.

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections in children. Premature infants and infants with underlying health issues are at increased risk of developing severe RSV infection. Prophylactic treatment with palivizumab reduces their risk of hospitalisation. To measure nurses' knowledge of RSV and RSV prophylaxis and explore their perceived potential barriers to palivizumab administration to children in the acute hospital setting. A non-experimental, quantitative fixed study design was adopted. A 17-item online questionnaire was used to survey nurses caring for children under the age of 1 year in an acute children's teaching hospital. Questionnaires were completed by 144 nurses, giving a response rate of 53%. Respondents demonstrated an adequate knowledge of RSV and its prophylaxis but also some knowledge deficits, notably about the eligibility criteria for palivizumab. The most cited perceived potential barriers to palivizumab administration were uncertainty about which infants are eligible for it, forgetting to check whether a patient is due to receive a dose, parental refusal for treatment because their child is ill, and not knowing the contraindications of palivizumab. Front-line hospital staff have a crucial role in identifying infants eligible for prophylactic RSV treatment, in initiating prophylaxis in a timely manner, in avoiding missed or delayed palivizumab doses during infants' hospital stays, and in educating families about the importance of RSV prevention.