Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

Summary

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

Timeline

Start

2015-12-31

Primary completion

2017-02-20

Completion

2017-09-27

Outcome

Missed primary endpoint

paper Presatovir did not significantly improve the primary endpoint in the FAS (treatment difference [95% CI], 0.10 [-0.43, 0.63] log10 copies/ml; p = 0.72) PMID 36964084 ↗

paper or the shorter symptom-duration subgroup (-0.12 [-0.94, 0.69] log10 copies/ml; p = 0.76). PMID 36964084 ↗

Publications

• Gottlieb J, Torres F, Haddad T, Dhillon G, Dilling DF, Knoop C, Rampolla R, Walia R, Ahya V, Kessler R, Budev M, Neurohr C, Glanville AR, Jordan R, Porter D, McKevitt M, German P, Guo Y, Chien JW, Watkins TR, Zamora MR. A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant. J Heart Lung Transplant. 2023 Jul;42(7):908-916. doi: 10.1016/j.healun.2023.01.013. Epub 2023 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Presatovir	Small molecule	100 mg	Oral

Indications