An Adaptive Randomized Trial of an Intermittent Dosing Schedule of Aerosolized Ribavirin in Patients With Cancer and Respiratory Syncytial Virus Infection

Abstract

A continuous dosing schedule of aerosolized ribavirin has been used for respiratory syncytial virus (RSV) upper respiratory tract infection and lower respiratory tract infection (LRTI) but is associated with high cost and inconvenient administration. We conducted an adaptive randomized trial to evaluate the effectiveness of an intermittent dosing schedule of ribavirin versus that of a continuous dosing schedule of ribavirin in preventing RSV LRTIs in 50 hematopoietic stem cell transplant recipients or patients with hematologic malignancies. LRTI occurred in 3 patients (9%) receiving the intermittent schedule and in 4 (22%) receiving the continuous schedule, with a 0.889 posterior probability. Because the intermittent schedule is easy to administer and has a higher efficacy than the continuous schedule, we recommend the intermittent schedule for patients who are at risk for RSV LRTI. Clinical Trials Registration. NCT00500578.

Characterization of Ribavirin Aerosol With Small Particle Aerosol Generator and Vibrating Mesh Micropump Aerosol Technologies

“…[4][5][6][7] High-dose, short-duration aerosolized ribavirin therapy (60 mg/mL), administered for 2 h 3 times/d has been shown to be well-tolerated by patients while achieving the same ribavirin blood and secretion levels as the previously recommended 20 h of continuous therapy. 8 The shorter intermittent-duration administration of aerosol has become the standard inhalation schedule because it has been proven to be equally effective as the continuous delivery while reducing environmental contamination.…”

Compassionate use experience with high‐titer respiratory syncytical virus (RSV) immunoglobulin in RSV‐infected immunocompromised persons

“…This drug has been used off-label in oral, intravenous, and inhaled formulations in immunocompromised patients with RSV, despite questionable efficacy. 10,11 A second option for treatment of RSV infection is immunoglobulin, generally combined with ribavirin. 8,12,13 Presently, two immunoglobulin products are available, including the monoclonal antibody palivizumab (Synagis ® , MedImmune, Gaithersburg, MD, USA), approved for prophylaxis in high-risk infants, and pooled human intravenous immunoglobulin (IVIG).…”

Respiratory Syncytial Virus Disease: Prevention and Treatment

“…It is administered either continuously or intermittently using a small particle aerosol generator via face mask in a scavenging tent to prevent environmental contamination. A standard dose is 20 mg/mL (6 g reconstituted with 300 mL of sterile water) administered for 12-18 h/day for 3-7 days, although it is frequently administered in a highdose, short duration protocol as 60 mg/mL (6 g reconstituted with 100 mL of sterile water) given for 2 h every 8 h, for a total of 6 h daily (Chemaly et al 2012). Aerosolized ribavirin is frequently administered for longer periods of time in patients with severe lower respiratory tract disease.…”