Systematic Review of the Efficacy and Safety of RSV-Specific Monoclonal Antibodies and Antivirals in Development

Andrea T K Sevendal; Siobhan Hurley; Adam W Bartlett; William Rawlinson; Gregory J Walker

doi:10.1002/rmv.2576

Systematic Review of the Efficacy and Safety of RSV-Specific Monoclonal Antibodies and Antivirals in Development

Rev Med Virol. 2024 Sep;34(5):e2576. doi: 10.1002/rmv.2576.

Authors

Andrea T K Sevendal¹, Siobhan Hurley¹, Adam W Bartlett^{2

3}, William Rawlinson^{1

4}, Gregory J Walker^{1

4}

Affiliations

¹ Virology Research Laboratory, Serology and Virology Division (SAViD), NSW Health Pathology, Prince of Wales Hospital, Sydney, Australia.
² Department of Immunology and Infectious Diseases, Sydney Children's Hospital Network, Sydney, Australia.
³ Kirby Institute, University of New South Wales, Sydney, Australia.
⁴ School of Biomedical Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.

PMID: 39209729
DOI: 10.1002/rmv.2576

Abstract

Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely-publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR-searched Nov 29th, 2023) to identify studies on all RSV-specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab-YTE, nirsevimab, ALX-0171, suptavumab, clesrovimab) and 12 AV therapies (ALN-RSV01, RSV604, presatovir, MDT-637, lumicitabine, IFN-α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP-938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV-specific AV availability is less advanced, although EDP-938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development. TRIAL REGISTRATION: PROSPERO registration: CRD42022376633.

Keywords: RSV; antiviral; monoclonal antibody; respiratory syncytial virus; systematic review; therapeutics.

Publication types

Systematic Review

MeSH terms

Antibodies, Monoclonal* / administration & dosage
Antibodies, Monoclonal* / adverse effects
Antibodies, Monoclonal* / immunology
Antibodies, Viral / administration & dosage
Antibodies, Viral / adverse effects
Antibodies, Viral / immunology
Antiviral Agents* / administration & dosage
Antiviral Agents* / adverse effects
Antiviral Agents* / immunology
Clinical Trials as Topic
Humans
Respiratory Syncytial Virus Infections* / drug therapy
Respiratory Syncytial Virus Infections* / immunology
Respiratory Syncytial Virus Infections* / prevention & control
Respiratory Syncytial Virus, Human* / drug effects
Respiratory Syncytial Virus, Human* / immunology
Treatment Outcome

Substances

Antibodies, Monoclonal
Antibodies, Viral
Antiviral Agents