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J Infect Dis. 2018 Jul 24;218(5):748-756. doi: 10.1093/infdis/jiy227.

Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study.

Author information

Janssen Research & Development, Beerse, Belgium.
Children's Foundation Research Institute, Le Bonheur Children's Hospital, Memphis.
Department of Pediatrics, University of Tennessee School of Medicine, Memphis.
Department of Microbiology, Immunology, and Biochemistry, University of Tennessee School of Medicine, Memphis.
hVIVO Services Limited, Queen Mary Bioenterprises Innovation Centre, London, United Kingdom.



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.

Clinical trials registration: NCT02387606; EudraCT number: 2014-005041-41.

[Indexed for MEDLINE]

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