Scott M. Palmer, MD, MHS; Ajit P. Limaye, MD; Missy Banks, BS; Dianne Gallup, MS; Jeffrey Chapman, MD; E. Clinton Lawrence, MD; Jordan Dunitz, MD; Aaron Milstone, MD; John Reynolds, MD; Gordon L. Yung, MD; Kevin M. Chan, MD; Robert Aris, MD; Edward Garrity, MD; Vincent Valentine, MD; Jonathan McCall, BA; Shein-Chung Chow, PhD; Robert Duane Davis, MD; Robin Avery, MD
Palmer SM, Limaye AP, Banks M, Gallup D, Chapman J, Lawrence EC, et al. Extended Valganciclovir Prophylaxis to Prevent Cytomegalovirus After Lung Transplantation: A Randomized, Controlled Trial. Ann Intern Med. 2010;152:761-769. doi: 10.7326/0003-4819-152-12-201006150-00003
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Published: Ann Intern Med. 2010;152(12):761-769.
Cytomegalovirus (CMV) is the most prevalent opportunistic infection after lung transplantation. Current strategies do not prevent CMV in most at-risk patients.
To determine whether extending prophylaxis with oral valganciclovir from the standard 3 months to 12 months after lung transplantation is efficacious.
Randomized, clinical trial. Patients were randomly assigned by a central automated system to treatment or placebo. Patients and investigators were blinded to treatment status. (ClinicalTrials.gov registration number: NCT00227370)
Multicenter trial involving 11 U.S. lung transplant centers.
136 lung transplant recipients who completed 3 months of valganciclovir prophylaxis.
9 additional months of oral valganciclovir (n = 70) or placebo (n = 66).
The primary end point was freedom from CMV disease (syndrome or tissue-invasive) on an intention-to-treat basis 300 days after randomization. Secondary end points were CMV disease severity, CMV infection, acute rejection, opportunistic infections, ganciclovir resistance, and safety.
CMV disease occurred in 32% of the short-course group versus 4% of the extended-course group (P < 0.001). Significant reductions were observed with CMV infection (64% vs. 10%; P < 0.001) and disease severity (110 000 vs. 3200 copies/mL, P = 0.009) with extended treatment. Rates of acute rejection, opportunistic infections, adverse events, CMV UL97 ganciclovir-resistance mutations, and laboratory abnormalities were similar between groups. During the 6 months after study completion, a low incidence of CMV disease was observed in both groups.
Longer-term effects of extended prophylaxis were not assessed.
In adult lung transplant recipients who have received 3 months of valganciclovir, extending prophylaxis by an additional 9 months significantly reduces CMV infection, disease, and disease severity without increased ganciclovir resistance or toxicity. A beneficial effect with regard to prevention of CMV disease seems to extend at least through 18 months after transplantation.
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Hematology/Oncology, Infectious Disease, Prevention/Screening, Pulmonary/Critical Care.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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