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

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

Nine patients (3 presatovir, 6 placebo) prematurely discontinued study treatment, and 4 patients discontinued study participation before day 28 (1 presatovir, 3 placebo) ( Figure 1 ). Twenty-seven (90.0%) of 30 patients in the presatovir group and 23/29 (79.3%) patients in the placebo group completed treatment to day 17 ( Figure 1 ). Figure 2A -B shows median absolute RSV viral load and change from baseline at each study visit. Despite adequate plasma concentrations (Supplemental results and Supplemental Table 3 ), presatovir treatment did not significantly reduce time-weighted average change in log 10 RSV viral load from day 1 to day 9 (−1.12 [1.226] log 10 copies/mL versus −1.09 [1.028] log 10 copies/ mL; treatment difference, −0.02 log 10 copies/mL; 95% CI, −.62, .57; P = .94) compared with placebo ( Table 2) .