Type of publication:
Conference abstract
Author(s):
Hanfelt-Goade D.; Maimon N.; Nimer A.; Riviere F.; Catherinot E.; Ison M.; Jeong S.; Walsh E.; Falsey A.R.; Gafter-Gvili A.; Nama S.; Napora P.; Chowers M.; Bergeron A.; Zeltser D.; *Moudgil H.; Limaye A.P.; Couturaud F.; Nseir W.; McKevitt M.; Porter D.; Jordan R.; Guo Y.; German P.; Watkins T.R.; Gossage D.L.; Chien J.W.
Citation:
American Journal of Respiratory and Critical Care Medicine; May 2018; vol. 197
Abstract:
RATIONALE: Presatovir has been shown to significantly reduce nasal viral load and signs and symptoms of RSV infection in a healthy human challenge study. We evaluated the safety and efficacy of presatovir in hospitalized adults infected with RSV. METHODS: RSV infected subjects with <= 5 days of symptoms were randomized (1:1) to oral presatovir 200 mg or placebo once on Day 1, in addition to standard of care. Subjects were stratified by 4 categories: no chronic airways or lung disease, chronic obstructive pulmonary disease (COPD), asthma or other chronic airways or lung disease. The primary endpoint was the time weighted average change (TWAC) in nasal RSV viral load from baseline through Day 5. Secondary endpoints included mean TWAC in patient reported outcomes (Flu-PROTM), duration of hospital stay following study drug administration and rate of unplanned medical encounters related to a respiratory illness after initial hospital discharge through Day 28. RESULTS: From May 2014 to May 2017, 189 subjects from 78 centers were enrolled. Mean (SD) duration of symptoms prior to first dose of study drug was 3 (1.2) and 3 (1.1) days for the presatovir and placebo groups respectively. Despite maintaining mean plasma levels above 4-fold paEC95 for 5 days, presatovir treatment did not reduce the TWAC in viral load or the mean number of hospitalization free days (Table). The placebo group had a greater TWAC in Flu-PROTM score and a lower rate of unplanned medical encounters after initial hospital discharge than the presatovir group. The percentage of subjects with Treatment- Emergent Adverse Events (TEAE) and >= Grade 3 TEAEs (presatovir vs. placebo) were similar in both groups [65.2% vs. 67.0%] and [6.5% vs. 8.5%] respectively. The percentage of subjects with serious adverse events was also similar [8.7% vs 13.8%]. Two COPD subjects in the presatovir group died due to worsening COPD, one on day 5 during the study period and the other on day 36 after the study period. CONCLUSIONS: Presatovir did not significantly reduce viral load or improve clinical outcomes in hospitalized adults with RSV. (Table Presented) .