Role of Monoclonal Antibodies in RSV Prevention

EP: 1.Overview of RSV in Infants and Children

EP: 2.Barriers Inhibiting Optimal Pediatric RSV Treatment

EP: 3.Long-Term Impact of Childhood RSV

EP: 4.Current Standards of Care in RSV Treatment for Children

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EP: 5.Role of Monoclonal Antibodies in RSV Prevention

EP: 6.Prophylactic Use of Monoclonal Antibodies for RSV in Infants

EP: 7.Financial Impact Associated With RSV

EP: 8.Implications and Considerations Related to Reimbursement of mAbs

Adam C. Welch, PharmD, MBA, FAPhA: Let’s shift now and talk about those monoclonal antibodies, because I think this is really something that’s kind of a new space for the CDC [Centers for Disease Control and Prevention] in particular. The Advisory Committee on Immunization Practices, ACIP, has given recommendations for the use of vaccines in this country for a very long time. But now they’re talking about antibodies, and they’re talking about that in preventing RSV infection similar to what vaccines do. So, [Debra Boyer, MD, MHPE], can you explain a little bit more about the monoclonal antibodies that are available for the prevention of RSV in children?

Debra Boyer, MD, MHPE:So, this is a really fascinating topic to talk about, and I think a topic that has evolved since I’ve been in pediatrics. So palivizumabis the one that’s available right now, and it’s a humanized monoclonal antibody that is short lasting. So it really requires monthly IM [intramuscular] injections. So that requires infants to come in on a monthly basis and get their injections. It has been shown in multiple studies to decrease RSV disease in high-risk children. It is expensive. I won’t quote the price myself. Dr Chen can help us think about that more too. But it’s not a cheap therapy to give. It decreases disease. As I mentioned, it decreased hospitalizations in these high-risk infants. But it’s interesting because the effectiveness really varies depending on the outcome that you look for. So I’ve seen effectiveness ranging from 45% to 82%, and that depends on the outcome that you look at. So are you looking at hospitalizations? Are you looking at what children just had to get medical attention? Right. Maybe go to their PCP [primary care provider] or a good urgent care center vs who was admitted vs who ended up in the ICU [intensive care unit] vs, unfortunately, mortality statistics. So, the latest data I saw [showed] about a 55% decrease in hospitalizations. So that is important when you look at the cost of those hospitalizations, as well, and the morbidity and mortality involved. So, it is effective, it’s expensive, and it’s a factor in terms of [adverse] effects. I would add it’s pretty minimal. It’s really looking at the standard vaccine, [adverse] effects, soreness, fever, rash, irritability, but in general, it’s not associated with significant [adverse] effects.

Adam C. Welch, PharmD, MBA, FAPhA: Well, thank you for that information. And I think it’s also important to realize that this is a very rapidly evolving disease, as far as a treatment standpoint. So just in July 2023, the FDA [Food and Drug Administration], for example, just approved [its] seventh mAB [monoclonal antibody] as another option, and it’s for the prevention of RSV [and] lower respiratory tract disease in neonates and infants who are born during or entering that first RSV season. Then they also added an indication in children up to [age] 24 months who are continuing to be vulnerable to that severe RSV disease in the second season. [Which gets you thinking,] Well, when is the RSV season? We talked about respiratory infections, and we [are] familiar with cold and flu season. When does RSV typically happen?

Debra Boyer, MD, MHPE: That’s an interesting question because we thought we knew the answer to that. And that’s not necessarily true anymore. But we used to say November through March, October…. But again, it all depends on where you are and your climates. So in certain climates that shifts. But in general, in the United States we tend to think around that time frame. However, post COVID[-19], that has really shifted. And we saw tremendous surges in RSV in the summer and early fall this past year, to the point that most pediatric institutions were overwhelmed, just as adult institutions were with children at its peak. So there’s the typical season, and that’s kind of what we’re seeing now. And I assume it’ll go back over the next couple of years to what we expected. But I think we have to keep our close eye on that.

Adam C. Welch, PharmD, MBA, FAPhA: And when you mentioned COVID-19, is that the impact of the hand washing, the distancing from the Purell, the hand sanitizer that’s everywhere, that people are just more aware of what it takes to transmit infection? And has that sort of shifted the RSV, those types of habits?

Debra Boyer, MD, MHPE: Well, I think it’s that children were in bubbles and were not getting viruses for a year to 2 years, not sharing things in daycare, and not sharing things at school. So they were very naive due to the infection. And there’s also some question about whether COVID[-19] has altered immune systems to some extent, and there is some literature on whether having had COVID[-19] has affected your immune response to other infections. So I think there are a lot of things out there that need to be better understood. But to me…it’s a combination of those things that causes this shift in the seasons and a surge in viral illnesses. And it’s not just RSV. I think we saw surges in many different viral illnesses as well.

Transcript edited for clarity.