Author Interviews, Infections, Leukemia, MD Anderson, Transplantation / 20.05.2018 Interview with: Roy F. Chemaly, MD, MPH F.A.C.P., F.I.D.S.A. Department of Infectious Diseases Infection Control and Employee Health Division of Internal Medicine MD Anderson Center What is the background for this study? What are the main findings? Response: CytomegalovirusCMV infection is a common cause of morbidity and mortality in allo-HCT recipients. Evidence suggests that CMV infection has not only an enormous clinical burden, but a substantial economic burden as well. We conducted this study at MD Anderson to determine the economic and clinical burden of preemptive therapy (PET) for CMV infection. Between 2012 and 2015, 100 consecutive patients hospitalized at our institution for allo-HCT who experienced reactivation of CMV and were treated pre-emptively, were enrolled. The majority of patients were men (55%), who had underlying leukemia (73%), and underwent matched unrelated donor transplant (59%). At the time of hospitalization, most patients had acute GvHD (62%), and were on steroids (58%) within 30 days of CMV reactivation which occurred at a median of 32 days post-HCT (2 -174). A total of 192 episodes of PET occurred in the 100 allo-HCT recipients within 1 year post-HCT. PET consisted of ganciclovir (41%), foscarnet (40%), and valganciclovir (38%). IVIG was also used as adjunct therapy in 20% of episodes. Progression to Cytomegalovirus disease occurred in 4 patients (4%) and mainly affected the GI tract. Mean length of stay for patients treated with ganciclovir or foscarnet was 32 days (2-141) and 41 days (1-177), respectively. The average direct cost per patient admitted for PET was $126,038 ($7,866-$641,841) and the mean cost of CMV antiviral drug per hospitalization was $6,096 for IVIG, $2,410 for foscarnet, $836 for ganciclovir, and $780 for valganciclovir. Serious side effects from PET were observed in 35% of patients on ganciclovir and 12% of patients on foscarnet. Total direct cost per encounter was significantly higher in patients who had serious side effects from foscarnet. All-cause mortality was 59% at 1 year post-transplant. (more…)
Author Interviews, Brigham & Women's - Harvard, Infections, Leukemia, Merck, Transplantation / 12.12.2017 Interview with: Francisco M. Marty, M.D Associate Professor, Harvard Medical School Dana–Farber Cancer Institute and Brigham and Women’s Hospital What is the background for this study? What are the main findings? Response: Cytomegalovirus (CMV) is the most common infection in patients who undergo allogeneic hematopoietic-cell transplantation (bone marrow transplantation with cells from donors different than the patient). Up until now, we had no antiviral agent that could be used for prophylaxis (prevention) of CMV post-transplant because of the side effects of drugs available to date (ganciclovir, valganciclovir, foscarnet, cidofovir). This trial confirmed that letermovir was highly effective in preventing CMV infection when used in the first 100 days after allogeneic HCT, was associated with minimal side effects of concern and was also associated with lower all-cause mortality by Week 24 post-HCT. (more…)
Author Interviews, Cost of Health Care, Infections, Merck, Stem Cells, Transplantation / 12.10.2017 Interview with: Dr. Jonathan Schelfhout, PhD Director, Outcomes Research Merck & Co. Inc. North Wales, PA What is the background for this study? What are the main findings? Response: The cost of hematopoietic stem cell transplantation has received increased attention after it was identified as a top 10 contributor to increasing healthcare costs in an AHRQ 2016 report. Many recent studies have explored the cost of HSCT but additional research is needed on the costly complications that can follow the transplant procedure. This research is particularly relevant for inpatient decision makers, as most transplant centers receive one bundled payment for the transplant and the treatment of any complications over the first 100 days. (more…)
Author Interviews, Merck, Pharmacology / 13.06.2017 Interview with: Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A Professor, Department of Infectious Diseases, Director, Infection Control and Employee Health, Division of Internal Medicine Director of the clinical virology research program,Department of infectious diseases Infection control and employee health The University of Texas MD Anderson Would you briefly explain the significance of CMV infections? What is the background for this study? Response: Cytomegalovirus (CMV) is one of the most important causes of infectious complications following organ transplantation and is a significant cause of illness and death in patients who have undergone allogeneic hematopoietic cell transplantation (allo-HCT). For more than 20 years, we have been managing this infection and trying to develop effective strategies to control it, but to no one’s satisfaction; CMV infection is still associated with significant morbidity and mortality in this high-risk population. Most transplant centers have adopted preemptive antiviral therapy as the strategy of choice for HCT patients.1 While anti-CMV drugs have decreased the incidence of CMV diseases, their use for prophylaxis has not been associated with improved outcomes.1 Demographic and transplant trends heighten the need for new anti-CMV agents. In the U.S, 83% of people aged 60 and older are CMV seropositive. These older patients received 8% of all hematopoietic-cell transplants in 2000-2006, a figure that jumped to 22% in 2007-2013. As Baby Boomers age, many more allogeneic transplant patients will be CMV seropositive. Therefore, prophylactic antiviral compounds that could effectively control viral replication, and restrict some pathologic processes of CMV diseases, could potentially lessen the complications associated with CMV infection and possibly reduce all-cause mortality. (more…)
Author Interviews, OBGYNE / 01.12.2016 Interview with: Dr. Kenji Tanimura M.D., Ph.D. Assistant professor Division of Obstetrics and Gynecology Graduate School of Medicine and Hideto Yamada M.D., Ph.D. Professor and Chairman Department of Obstetrics and Gynecology Kobe University Graduate School of Medicine What is the background for this study? Response: Congenital cytomegalovirus (CMV) infection can cause long-term neurological sequelae, such as hearing difficulties and mental retardations, in affected children. Some investigators reported that early diagnosis and antiviral therapy can improve neurological outcomes in symptomatic congenital infected infants. However, universal screening of newborns for congenital CMV infection is not yet available. Therefore, the development of non-invasive methods for prenatal detection of mothers and newborns at high risk for congenital CMV infection has been desired. We aimed to determine maternal clinical, laboratory, and ultrasound findings that effectively predict the occurrence of congenital CMV infection in high-risk pregnant women, who were positive for CMV IgM. We performed maternal blood screening for CMV IgG and IgM, and 300 IgM-positive pregnant women, including 22 with congenital CMV infection, received series of examinations. We evaluated maternal clinical and laboratory findings, including serum CMV IgM and IgG, IgG avidity index, antigenemia testing, and CMV-DNA PCR for the maternal serum, urine, and uterine cervical secretion, and prenatal ultrasound findings. (more…)
Author Interviews, Infections, Transplantation / 28.09.2015 Interview with: Dr. Wilfried Gwinner Div. of Nephrology and Hypertension University of Hanover Medical School HannoverDr. Wilfried Gwinner Div. of Nephrology and Hypertension University of Hanover Medical School Hannover and Dr. Uta Erdbruegger Div. Nephrology and Hypertension Division University of Virginia, Charlottesville Dr. Uta Erdbruegger Div. Nephrology and Hypertension Division University of Virginia, Charlottesville   Medical Research: What is the background for this study? What are the main findings? Dr. Erdbruegger: Controversy exists whether CMV infections or viremia after kidney transplantation affect patient and graft survival. We aimed to explore the role of CMV in a retrospective study on almost 600 patients followed at our transplant center over a period of up to 10 years post-transplant. The analysis included protocol biopsy findings and causes for graft failure and death. We observed reduced patient and graft survival in patients with CMV as reported in some of the previous studies. However, we found that patients with CMV had an inferior kidney function and significant chronic allograft changes in the biopsies very early after transplantation – even before the CMV infection. Also, CMV infection was not specifically related to a progression of chronic changes. On the other hand, we confirmed well-established factors like inferior graft function early on, delayed graft function, and higher donor and recipient age as important for patient and graft survival. In none of these analyses, CMV was a significant factor. In summary, this suggests that CMV is rather an epiphenomenon. Alternatively, we might have missed a possible small effect of CMV in our statistics. In any case, our results do not support a significant role of CMV in patient and graft outcomes. (more…)