Back to Search
Start Over
Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2018 Jul 24; Vol. 218 (5), pp. 748-756. - Publication Year :
- 2018
-
Abstract
- Background: Respiratory syncytial virus (RSV) disease has no effective treatment. JNJ-53718678 is a fusion inhibitor with selective activity against RSV.<br />Methods: 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.<br />Results: 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).<br />Conclusions: 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.<br />Clinical Trials Registration: ClinicalTrials.gov: NCT02387606; EudraCT number: 2014-005041-41.
- Subjects :
- Administration, Oral
Adolescent
Adult
Antiviral Agents pharmacology
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions pathology
Female
Healthy Volunteers
Humans
Imidazolidines pharmacology
Indoles pharmacology
Male
Middle Aged
Placebos administration & dosage
Respiratory Syncytial Virus Infections pathology
Respiratory Syncytial Virus Infections prevention & control
Respiratory Syncytial Virus, Human isolation & purification
Treatment Outcome
Viral Load
Virus Shedding
Young Adult
Antiviral Agents administration & dosage
Imidazolidines administration & dosage
Indoles administration & dosage
Respiratory Syncytial Virus Infections drug therapy
Respiratory Syncytial Virus, Human drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 218
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 29684148
- Full Text :
- https://doi.org/10.1093/infdis/jiy227