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_2
Snippet: Despite RSV disease burden in HCT recipients and other high-risk adults, options for RSV prophylaxis or treatment in adults are limited. Aerosolized ribavirin is not indicated for RSV treatment in adults and is associated with concerns regarding difficulty of administration, adverse effects, and high cost [8, 9] . Although some centers report using aerosolized or oral ribavirin to treat RSV LRTI in adult HCT recipients, efficacy has not been demo.....
Document: Despite RSV disease burden in HCT recipients and other high-risk adults, options for RSV prophylaxis or treatment in adults are limited. Aerosolized ribavirin is not indicated for RSV treatment in adults and is associated with concerns regarding difficulty of administration, adverse effects, and high cost [8, 9] . Although some centers report using aerosolized or oral ribavirin to treat RSV LRTI in adult HCT recipients, efficacy has not been demonstrated in a randomized controlled clinical trial [10, 11] . Palivizumab is used for prevention of severe RSV disease in high-risk children ≤24 months of age but is not effective as treatment for established infection in children or adult HCT recipients [12] [13] [14] . Thus, there is an unmet need for specific treatment for adults at risk for severe RSV infection.
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