palivizumab
Regulatory sources consulted
Approved indications
- Prevention of serious RSV lower respiratory tract disease in high-risk children: infants born at ≤35 weeks and ≤6 months at season start; bronchopulmonary dysplasia treated in the previous 6 months and age ≤24 months; or hemodynamically significant congenital heart disease and age ≤24 months.
Contraindications
Absolute
- Previous significant hypersensitivity reaction to palivizumab.
Clinical warnings
- It may cause anaphylaxis and other severe hypersensitivity reactions; have immediate treatment available and do not re-expose after a severe reaction. — DailyMed, set_id 3a0096c7-8139-44cd-bba4-520ab05c2cb2
- Major warning · Use cautiously in thrombocytopenia or coagulation disorders because of the intramuscular route. — DailyMed, set_id 3a0096c7-8139-44cd-bba4-520ab05c2cb2
- Major warning · It is prophylaxis, not treatment of RSV infection. It may interfere with immunologic RSV detection tests. — DailyMed, set_id 3a0096c7-8139-44cd-bba4-520ab05c2cb2
Adverse events
Common (≥1%)
Fever and rash
Rare but serious
Anaphylaxis and severe hypersensitivity reaction
Recent literature (PubMed)
Bronchiolitis is the most common lower respiratory tract infection in young children. Respiratory syncytial virus (RSV) is the most common viral cause of bronchiolitis. RSV is spread through respiratory droplets, and the number of cases varies with season. For most patients, standard precautions (e.g., hand hygiene, surface cleaning, avoiding contact with sick individuals) are recommended. However, prophylaxis with palivizumab may be considered for infants at high risk. Initial symptoms occur after an incubation period of four to six days and include rhinorrhea, congestion, sneezing, and fever. Signs of lower respiratory tract involvement may follow and include cough, tachypnea, retractions, difficulty feeding, and accessory muscle use. Diagnosis is typically clinical; routine use of radiography or viral testing is not recommended. Treatment of RSV bronchiolitis is mainly supportive. Oxygen saturation should be maintained above 90%. Hydration and nutrition should be maintained by nasogastric or intravenous routes, if needed. Therapies such as bronchodilators, epinephrine, nebulized hypertonic saline, corticosteroids, antibiotics, and chest physiotherapy are not recommended. Although most episodes of RSV bronchiolitis are self-limited, some children have an increased risk of asthma later in life.
Data describing respiratory syncytial virus (RSV) neutralizing antibody (nAb) levels for nirsevimab, a recently approved, extended half-life, anti-RSV fusion protein (F protein) monoclonal antibody, relative to the previous standard of care, palivizumab, have not been reported. MEDLEY was a randomized, palivizumab-controlled, phase 2/3 study of nirsevimab during 2 RSV seasons (season 1 and 2) in infants born preterm (≤35 weeks' gestational age; dosed season 1 only) or with congenital heart disease or chronic lung disease of prematurity (dosed seasons 1 and 2). Participants were randomly assigned to receive a single dose of nirsevimab followed by 4 monthly placebo doses, or 5 once-monthly doses of palivizumab. Anti-RSV F protein serology (ie, levels of prefusion [pre-F]/postfusion [post-F] conformation antibodies), nirsevimab and palivizumab concentrations, and RSV nAbs were measured in participant serum collected at baseline (pre-dose) and days 31, 151, and 361. Serologic data were similar in seasons 1 and 2. Nirsevimab predominately conferred pre-F antibodies, whereas palivizumab conferred pre-F and post-F antibodies. Nirsevimab and palivizumab serum concentrations highly correlated with nAb levels in both seasons. In season 1, nAb levels in nirsevimab recipients were highest in day 31 samples and gradually declined but remained 17-fold above baseline at day 361. nAb levels in palivizumab recipients increased incrementally with monthly doses to day 151. nAb levels followed similar patterns in season 2. nAb levels were ∼10-fold higher with nirsevimab compared with palivizumab across both seasons. Nirsevimab prophylaxis confers ∼10-fold higher and more sustained RSV nAb levels relative to palivizumab.
Respiratory syncytial virus (RSV) causes a significant burden of acute respiratory illness across all ages, particularly for infants and older adults. Infants, especially those born prematurely or with underlying health conditions, face a high risk of severe RSV-related lower respiratory tract infections (LRTIs). Globally, RSV contributes to millions of LRTI cases annually, with a disproportionate burden in low- and middle-income countries (LMICs). The RSV virion outer capsule contains glycoproteins G and F which are essential for viral entry into respiratory epithelial cells and represent key targets for therapeutics development. The F-glycoprotein has several highly conserved antigenic sites that have proven useful targets for the development of monoclonal antibodies (mAbs) against RSV. Historically, prevention in infants was limited to the mAb palivizumab, which, despite its efficacy, was costly and inaccessible in many regions. Recent advancements include nirsevimab, a long-acting mAb that has shown substantial efficacy in reducing medically attended RSV-related disease in infants, in phase III clinical trials, early regional and national real-world data. In addition, three new vaccines have been approved: two protein subunit vaccines and a messenger RNA vaccine. The vaccines are all licenced for use in older adults, with one also approved as a maternal vaccine. Promising candidates in development include the mAb clesrovimab, which has an extended half-life and high levels in the nasal epithelial lining and high safety and efficacy profiles in late-stage trials. There are also a wide range of vaccine candidates currently in late-stage clinical trials. These developments signify a major advancement in RSV prevention strategies, offering improved protection for high-risk populations. With the ongoing rollout of the recently licenced vaccines and mAbs internationally, the landscape of RSV care is rapidly changing. We also must ensure these advances reach those in L
With an increasing global incidence in children younger than the age of five, respiratory syncytial virus (RSV) is one of the most common viral respiratory infections worldwide. Despite the increasing number of cases among infants and young children, RSV can infect any age group; however, some individuals are more high risk than others. Premature infants, young children, elderly, and immunocompromised individuals are the most likely to suffer a more severe presentation of RSV in comparison to healthy adults. RSV is transmitted through respiratory droplets via direct contact with an infected individual or with contaminated surfaces. The viral genome of RSV consists of 11 proteins. Out of these 11, two proteins allow for the attachment of the virus to the respiratory epithelial cells and fusion with host cells. Upon fusion, the viral material transfers to the host cell, where viral replication occurs. It is important to acknowledge that an individual is considered infectious and can transmit the virus even before the symptomatic presentation of RSV begins. As long as the individual is shedding the virus, he or she is considered infectious. The length of viral shedding also differs depending on the severity of the infection, who is infected, and the underlying immune status of an individual. Currently, there is no definitive treatment for RSV; however, supportive therapy is considered the mainstay treatment. Some pharmaceutical treatments such as ribavirin have been FDA-approved; however, the administration is typically limited to children and infants. Palivizumab is also administered as an immune prophylaxis; however, both therapies are constantly at the end of a cost-effective debate due to their extensively expensive nature and questionable adverse effect profiles. Supportive therapy includes hydration, supplemental oxygen, and mechanical ventilation in hospitalized cases; however, most RSV cases can be treated as outpatient cases. Prevention techniques such as hand
Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing respiratory tract infection in infants, the elderly and people with poor immune function, which causes a huge disease burden worldwide every year. It has been more than 60 years since RSV was discovered, and the palivizumab monoclonal antibody, the only approved specific treatment, is limited to use for passive immunoprophylaxis in high-risk infants; no other intervention has been approved to date. However, in the past decade, substantial progress has been made in characterizing the structure and function of RSV components, their interactions with host surface molecules, and the host innate and adaptive immune response to infection. In addition, basic and important findings have also piqued widespread interest among researchers and pharmaceutical companies searching for effective interventions for RSV infection. A large number of promising monoclonal antibodies and inhibitors have been screened, and new vaccine candidates have been designed for clinical evaluation. In this review, we first briefly introduce the structural composition, host cell surface receptors and life cycle of RSV virions. Then, we discuss the latest findings related to the pathogenesis of RSV. We also focus on the latest clinical progress in the prevention and treatment of RSV infection through the development of monoclonal antibodies, vaccines and small-molecule inhibitors. Finally, we look forward to the prospects and challenges of future RSV research and clinical intervention.