Aug 21, 2014

Oral GS-5806 activity in a respiratory syncytial virus challenge study

The New England Journal of Medicine
John P DeVincenzoJason W Chien

Abstract

Respiratory syncytial virus (RSV) is a common cause of infant hospitalizations and is increasingly recognized as a cause of considerable morbidity and mortality. No accepted antiviral treatment exists. We conducted a double-blind, placebo-controlled study of GS-5806, an oral RSV-entry inhibitor, in healthy adults who received a clinical challenge strain of RSV intranasally. Participants were monitored for 12 days. At the time of a positive test for RSV infection or 5 days after inoculation, whichever occurred first, participants were randomly assigned to receive GS-5806 or placebo in one of seven sequential cohorts. Cohorts 1 to 4 received a first dose of 50 mg of GS-5806 and then 25 mg daily for the next 4 days, cohort 5 received a first dose of 50 mg and then 25 mg daily for the next 2 days, cohort 6 received one 100-mg dose, and cohort 7 received a first dose of 10 mg and then 5 mg daily for the next 4 days. Dose selection for cohorts 5, 6, and 7 occurred after an interim analysis of data for cohorts 1 to 4. The primary end point was the area under the curve (AUC) for the viral load, which was assessed after administration of the first dose through the 12th day after inoculation. Secondary end points were mucus weight and sy...Continue Reading

Mentioned in this Paper

Respiratory Syncytial Virus Infections
Area Under Curve
Pyrazoles
Viral Release from Host Cell
Acetaminophen
Morbidity Aspects
Viral Shedding
Citricum acidum, citric acid, homeopathic preparation
Influenza virus vaccine
Virus Titer

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