Phase I study of intravenous ribavirin treatment of respiratory syncytial virus pneumonia after marrow transplantation

Antimicrob Agents Chemother. 1996 Nov;40(11):2555-7. doi: 10.1128/AAC.40.11.2555.

Abstract

Respiratory syncytial virus (RSV) pneumonia in marrow transplant recipients is associated with significant mortality. Ribavirin is a nucleoside analog with activity against RSV and in its aerosolized formulation is the only drug approved for treatment of RSV pneumonia in the United States. The clinical use of aerosolized ribavirin has been limited by caregivers' concerns about drug exposure and potential teratogenic effects. Since there is lack of proven efficacy and safety of the aerosolized ribavirin in this setting, we performed a phase I study of intravenous ribavirin treatment. Between November 1993 and May 1994, 10 patients with clinically significant RSV pneumonia at the Fred Hutchinson Cancer Research Center were enrolled. Only 2 of the 10 survived (20%; 95% CI, 3-56). Two of the 10 patients developed acute hemolysis that necessitated discontinuation of the medication. In conclusion, treatment of marrow transplant recipients with RSV pneumonia with intravenous ribavirin did not improve mortality compared with historical controls treated with the aerosolized drug.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Bone Marrow Transplantation / physiology*
  • Female
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Postoperative Complications / drug therapy*
  • Postoperative Complications / virology
  • Respiratory Syncytial Virus Infections / drug therapy*
  • Respiratory Syncytial Virus Infections / virology
  • Ribavirin / administration & dosage
  • Ribavirin / therapeutic use*

Substances

  • Antiviral Agents
  • Ribavirin