Impact of Respiratory Syncytial Virus

Bracht, Marianne; Basevitz, Debbie; Cranis, Marilyn; Paulley, Rose

doi:10.2165/11593140-000000000-00000

Cited by 15 publications

(3 citation statements)

References 73 publications

(62 reference statements)

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“…Six articles provided detailed information on specific symptoms, impacts, and experiences associated with RSV in adult patients [ 3 , 14 – 18 ]. Desktop research identified nine additional articles or websites [ 2 , 5 , 6 , 19 – 24 ]. Table 1 details all signs, symptoms, and impacts of RSV infection identified in the literature, including impact on daily activities and emotions contained in the Flu-iiQ.…”

Section: Resultsmentioning

confidence: 99%

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Romano

Finelli

Lewis

et al. 2023

Health Qual Life Outcomes

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Background Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure. Methods A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes. Results In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined. Conclusions The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.

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Section: Resultsmentioning

confidence: 99%

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Romano

Finelli

Lewis

et al. 2023

Health Qual Life Outcomes

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“…Treatment with JNJ-8678 administered for 7 days was well tolerated and, importantly, there were no new safety signals in this pediatric population compared with previous studies in healthy adults. Reported AEs were symptoms not uncommon in infants and typical of those which present during RSV infection [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study

Martinón-Torres

Rusch

Huntjens

et al. 2020

Clinical Infectious Diseases

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Abstract Background This phase 1b study evaluated the pharmacokinetics, safety, and antiviral effects of the respiratory syncytial virus (RSV)–specific fusion inhibitor JNJ-53718678 (JNJ-8678) in hospitalized RSV-infected patients aged > 1 to ≤24 months. Methods Patients categorized by age (cohort 1: ≥6 to ≤24 months; cohort 2: ≥3 to < 6 months; cohort 3: > 1 to < 3 months) were randomized to oral JNJ-8678 or placebo once daily for 7 days. Dose increases followed data review committee recommendations (cohort 1: 2/6/8/9 mg/kg; cohort 2: 1.5/4.5/6 mg/kg; cohort 3: 1/3/5 mg/kg). Cohort 1 included a 9 mg/kg dose, as target exposures were not reached at lower doses. Sparse pharmacokinetic samples were assessed using population pharmacokinetics modeling. Safety was assessed by adverse events (AEs), laboratory tests, and electrocardiograms. To assess antiviral effects, RSV RNA viral load from nasal swabs was quantified over time using reverse-transcription quantitative polymerase chain reaction. Results Patients received JNJ-8678 (n = 37) or placebo (n = 7). Pharmacokinetic parameters were similar at the highest doses for cohorts 1–3 (area under the plasma concentration–time curve from time of administration up to 24 hours postdosing at day 7: 35 840, 34 980, and 39 627 ng × hour/mL, respectively). Two grade 3 AEs were reported (both bronchiolitis; 1 JNJ-8678, 1 placebo), reported as serious AEs; all other AEs were grade 1 or 2. Two additional serious AEs were reported (rhinitis [JNJ-8678]; pneumonia [placebo]). No deaths, grade 4 AEs, or AEs leading to discontinuation were reported. Median RSV viral load change from baseline in JNJ-8678 vs placebo by day 3 was −1.98 vs −0.32 log10 copies/mL. Conclusions In RSV-infected infants, JNJ-8678 was well tolerated. Target exposures were reached and antiviral activity was observed. Clinical Trials Registration NCT02593851.

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“…In a severe viral infection, diarrhea could be caused by a direct enterocyte virus infection (such as RSV) [ 13 ] and/or sepsis-associated factors (cytokinemia, endotoxemia, and gut dysbiosis), as demonstrated in severe dengue infection [ 14 , 15 ]. As such, hypercytokinemia in sepsis induces the breakdown of intestinal tight junctions (TJs), allowing the translocation of PAMPs from the gut into blood circulation (gut translocation) [ 16 , 17 , 18 , 19 , 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

Neutrophil Extracellular Traps in Severe SARS-CoV-2 Infection: A Possible Impact of LPS and (1→3)-β-D-glucan in Blood from Gut Translocation

Saithong

Worasilchai

Saisorn

et al. 2022

Cells

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Due to limited data on the link between gut barrier defects (leaky gut) and neutrophil extracellular traps (NETs) in coronavirus disease 2019 (COVID-19), blood samples of COVID-19 cases—mild (upper respiratory tract symptoms without pneumonia; n = 27), moderate (pneumonia without hypoxia; n = 28), and severe (pneumonia with hypoxia; n = 20)—versus healthy control (n = 15) were evaluated, together with in vitro experiments. Accordingly, neutrophil counts, serum cytokines (IL-6 and IL-8), lipopolysaccharide (LPS), bacteria-free DNA, and NETs parameters (fluorescent-stained nuclear morphology, dsDNA, neutrophil elastase, histone–DNA complex, and myeloperoxidase–DNA complex) were found to differentiate COVID-19 severity, whereas serum (1→3)-β-D-glucan (BG) was different between the control and COVID-19 cases. Despite non-detectable bacteria-free DNA in the blood of healthy volunteers, using blood bacteriome analysis, proteobacterial DNA was similarly predominant in both control and COVID-19 cases (all severities). In parallel, only COVID-19 samples from moderate and severe cases, but not mild cases, were activated in vitro NETs, as determined by supernatant dsDNA, Peptidyl Arginine Deiminase 4, and nuclear morphology. With neutrophil experiments, LPS plus BG (LPS + BG) more prominently induced NETs, cytokines, NFκB, and reactive oxygen species, when compared with the activation by each molecule alone. In conclusion, pathogen molecules (LPS and BG) from gut translocation along with neutrophilia and cytokinemia in COVID-19-activated, NETs-induced hyperinflammation.

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Impact of Respiratory Syncytial Virus

Cited by 15 publications

References 73 publications

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study

Neutrophil Extracellular Traps in Severe SARS-CoV-2 Infection: A Possible Impact of LPS and (1→3)-β-D-glucan in Blood from Gut Translocation

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