Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

Summary

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

Timeline

Start

2015-01-31

Primary completion

2017-04-17

Completion

2017-04-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Presatovir vs Placebo; p = 0.94; Treatment difference -0.02 (95% CI -0.62 to 0.57) NCT02254421 ↗

paper presatovir treatment did not significantly reduce time-weighted average change in viral load PMID 31915807 ↗

Publications

• Marty FM, Chemaly RF, Mullane KM, Lee DG, Hirsch HH, Small CB, Bergeron A, Shoham S, Ljungman P, Waghmare A, Blanchard E, Kim YJ, McKevitt M, Porter DP, Jordan R, Guo Y, German P, Boeckh M, Watkins TR, Chien JW, Dadwal SS. 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 Infection of the Lower Respiratory Tract. Clin Infect Dis. 2020 Dec 31;71(11):2787-2795. doi: 10.1093/cid/ciz1167.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Presatovir	Small molecule	200 mg	Oral

Indications