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

Patient demographics and baseline characteristics were generally balanced between study groups (Table 1) . Overall, the majority of patients (50/59; 84.7%) underwent allogeneic HCT and had chronic or acute GVHD (34/59, 57.6%). At start of study treatment, 53 (89.8%) patients were hospitalized for a median of 3 days (range, 0-133 days). Twenty-one (35.6%) patients required >2 L/min of oxygen supplementation, and 23 (39.0%) patients were prescribed ribavirin (any formulation). RSV LRTI was confirmed from induced sputum in 41 (69.5%) patients and by bronchoalveolar lavage in 18 (30.5%) patients. Median time from onset of RSV infection symptoms to start of study treatment was 5 days (range, 1-26 days). Infection was due to RSV A in 29 (49.2%) patients and RSV B in 28 (47.5%) patients; 2 (3.4%) patients (1 presatovir, 1 placebo) had missing day 1 RSV viral load data and were excluded from the efficacy population (N = 57). Median intranasal RSV viral load on day 1 was 6.36 log 10 copies/mL (range, 2.5-8.23 log 10 copies/mL).