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• W2802452703 abstract "Respiratory syncytial virus (RSV) disease has no effective treatment. JNJ-53718678 is a fusion inhibitor with selective activity against RSV. After confirmation of RSV infection or 5 days after inoculation with RSV, participants (n = 69) were randomized to JNJ-53718678 75 mg (n = 15), 200 mg (n = 17), 500 mg (n = 18), or placebo (n = 17) orally once daily for 7 days. Antiviral effects were evaluated by assessing RSV RNA viral load (VL) area under the curve (AUC) from baseline (before the first dose) until discharge, time-to-peak VL, duration of viral shedding, clinical symptoms, and quantity of nasal secretions. Mean VL AUC was lower for individuals treated with different doses of JNJ-53718678 versus placebo (203.8–253.8 vs 432.8 log10 PFUe.hour/mL). Also, mean peak VL, time to peak VL, duration of viral shedding, mean overall symptom score, and nasal secretion weight were lower in each JNJ-53718678–treated group versus placebo. No clear exposure–response relationship was observed. Three participants discontinued due to treatment-emergent adverse events of grade 2 and 1 electrocardiogram change (JNJ-53718678 75 mg and 200 mg, respectively) and grade 2 urticaria (placebo). JNJ-53718678 at all 3 doses substantially reduced VL and clinical disease severity, thus establishing clinical proof of concept and the compound’s potential as a novel RSV treatment. ClinicalTrials.gov: NCT02387606; EudraCT number: 2014-005041-41." @default.
• W2802452703 created "2018-05-17" @default.
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• W2802452703 date "2018-04-19" @default.
• W2802452703 modified "2023-10-01" @default.
• W2802452703 title "Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study" @default.
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• W2802452703 doi "https://doi.org/10.1093/infdis/jiy227" @default.
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