Response-oriented preemptive therapy against cytomegalovirus disease with low-dose ganciclovir: a prospective evaluation.

Abstract

BACKGROUND:

Preemptive therapy against cytomegalovirus (CMV) disease has succeeded in reducing the incidence of CMV disease, but the toxicity of ganciclovir remains problematic.

METHODS:

We prospectively evaluated the efficacy and toxicity of a preemptive protocol with ganciclovir at a reduced initial dose in 40 patients who achieved engraftment after allogeneic hematopoietic stem cell transplantation.

RESULTS:

Twenty-three (58%) patients had high-risk features, including transplant from an HLA-mismatched or unrelated donor, or associated acute graft-versus-host disease. CMV antigenemia assay was performed weekly, and ganciclovir was started in a risk-adapted manner, in which the initial dose of ganciclovir was fixed at 5 mg/kg/d and then adjusted based on the results of a weekly CMV antigenemia assay. In this protocol, 23 (58%) patients demonstrated positive antigenemia, and 19 (48%) received a preemptive administration of ganciclovir. Only one patient had CMV disease in the gastrointestinal system, which was successfully treated with a regular therapeutic dose of ganciclovir. Consequently, the total dose of ganciclovir was significantly less than that in a previous protocol using the conventional double dose (5 mg/kg twice daily) of ganciclovir (134 mg/kg vs. 190 mg/kg on average, P=0.046). There were no significant toxicities attributed to ganciclovir, except for neutropenia <0.5 x 109/L, which developed in three patients for 3, 4, and 14 days, respectively, with granulocyte colony-stimulating factor support.

CONCLUSION:

Preemptive therapy with a low initial dose of ganciclovir appeared to be effective even in high-risk patients. Further randomized controlled trial is warranted.

• Authors: Yoshinobu Kanda, Shin Mineishi, Takeshi Saito, Akiko Saito, Mutsuko Ohnishi, Hironari Niiya, Aki Chizuka, Kunihisa Nakai, Toshio Takeuchi, Hiroshi Matsubara, Atsushi Makimoto, Ryuji Tanosaki, Hideo Kunitoh, Kensei Tobinai, Yoichi Takaue
• Journal: Transplantation (Transplantation) Vol. 73 Issue 4 Pg. 568-72 (Feb 27 2002) ISSN: 0041-1337 [Print] United States
• PMID: 11889432 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Antigens, Viral
• Antiviral Agents
• Ganciclovir

Topics

• Adult
• Aged
• Antigens, Viral (blood)
• Antiviral Agents (therapeutic use)
• Cytomegalovirus Infections (epidemiology, prevention & control)
• Female
• Ganciclovir (therapeutic use)
• Hematopoietic Stem Cell Transplantation
• Humans
• Male
• Middle Aged
• Postoperative Complications (prevention & control)
• Prospective Studies
• Transplantation, Homologous