Selected article for: "antiviral treatment and clinical trial"
Author: Marty, Francisco M; Chemaly, Roy F; Mullane, Kathleen M; Lee, Dong-Gun; Hirsch, Hans H; Small, Catherine B; Bergeron, Anne; Shoham, Shmuel; Ljungman, Per; Waghmare, Alpana; Blanchard, Elodie; Kim, Yae-Jean; McKevitt, Matt; Porter, Danielle P; Jordan, Robert; Guo, Ying; German, Polina; Boeckh, Michael; Watkins, Timothy R; Chien, Jason W; Dadwal, Sanjeet S
Title: A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
  • Document date: 2019_12_3
    • ID: sl45z4i0_31
    Snippet: This is the first placebo-controlled clinical trial, to our knowledge, evaluating treatment of RSV LRTI with a new antiviral agent in HCT recipients. Presatovir had a favorable safety profile and was well tolerated but did not decrease timeweighted average change in nasal RSV viral load from day 1 to day 9, number of days with supplemental oxygen use, or frequency of respiratory failure or mortality relative to placebo. In contrast, presatovir tr.....
    Document: This is the first placebo-controlled clinical trial, to our knowledge, evaluating treatment of RSV LRTI with a new antiviral agent in HCT recipients. Presatovir had a favorable safety profile and was well tolerated but did not decrease timeweighted average change in nasal RSV viral load from day 1 to day 9, number of days with supplemental oxygen use, or frequency of respiratory failure or mortality relative to placebo. In contrast, presatovir treatment significantly reduced viral load, clinical signs, and symptoms of experimental RSV infection in healthy volunteers treated upon detection of RSV replication [16] . Potential explanations for this discrepancy have important implications for design of clinical trials evaluating antiviral treatments for RSV infection in HCT recipients and other patient populations.

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