Standardized consensus definitions for resistant and refractory cytomegalovirus (CMV) infections and diseases in transplant recipients were developed by the CMV Resistance Working Group of the CMV ...Drug Development Forum and are intended to be used in clinical trials.
Abstract
Despite advances in preventive strategies, cytomegalovirus (CMV) infection remains a major complication in solid organ and hematopoietic cell transplant recipients. CMV infection may fail to respond to commercially available antiviral therapies, with or without demonstrating genotypic mutation(s) known to be associated with resistance to these therapies. This lack of response has been termed “resistant/refractory CMV” and is a key focus of clinical trials of some investigational antiviral agents. To provide consistent criteria for future clinical trials and outcomes research, the CMV Resistance Working Group of the CMV Drug Development Forum (consisting of scientists, clinicians, regulatory officials, and industry representatives from the United States, Canada, and Europe) has undertaken establishing standardized consensus definitions of “resistant” and “refractory” CMV. These definitions have emerged from the Working Group’s review of the available virologic and clinical literature and will be subject to reassessment and modification based on results of future studies.
Meyer and Avery comment on the implications of a study by Hostetler et al. (page 2864), in which screening of a large group of lung transplant candidates revealed that some lacked humoral immunity to ...measles, mumps, and varicella, especially younger patients and those with cystic fibrosis.
Summary Background Multiple reconstructive procedures are common for the reconstruction of complex facial deformities of skin, soft tissues, bony structures, and functional subunits, such as the ...nose, lips, and eyelids. However, the results have been unsatisfactory. An innovative approach entailing a single surgical procedure of face allograft transplantation is a viable alternative and gives improved results. Methods On Dec 9, 2008, a 45-year-old woman with a history of severe midface trauma underwent near-total face transplantation in which 80% of her face was replaced with a tailored composite tissue allograft. We addressed issues of immunosuppressive therapy, psychological and ethical outcomes, and re-integration of the patient into society. Findings After the operation, the patient did well physically and psychologically, and tolerated immunosuppression without any major complication. Routine biopsy on day 47 after transplantation showed rejection of graft mucosa; however, a single bolus of corticosteroids reversed rejection. During the first 3 weeks after transplantation, the patient accepted her new face; 6 months after surgery, the functional outcome has been excellent. In contrast to her status before transplantation, the patient can now breathe through her nose, smell, taste, speak intelligibly, eat solid foods, and drink from a cup. Interpretation We show the feasibility of reconstruction of severely disfigured patients in a single surgical procedure using composite face allotransplantation. Therefore, this should be taken in consideration as an early option for severely disfigured patients. Funding None.
PDF
