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Firas El Chaer, Dimpy P Shah, Roy F Chemaly
Cytomegalovirus (CMV) infection is a significant complication in hematopoietic cell transplantation (HCT) recipients. Four antiviral drugs are used for preventing or treating CMV: ganciclovir, valganciclovir, foscarnet, and cidofovir. With prolonged and repeated use of these drugs, CMV can become resistant to standard therapy, resulting in increased morbidity and mortality, especially in HCT recipients. Antiviral drug resistance should be suspected when CMV viremia (DNAemia or antigenemia) fails to improve or continue to increase after 2 weeks of appropriately dosed and delivered antiviral therapy...
October 19, 2016: Blood
Nahid Shahabadi, Mehdi Pourfoulad, Neda Hosseinpour Moghadam
DNA-binding properties of an antiviral drug, valganciclovir (valcyte) was studied by using emission, absorption, circular dichroism, viscosity, differential pulse voltammetry, fluorescence techniques, and computational studies. The drug bound to calf thymus DNA (ct-DNA) in a groove-binding mode. The calculated binding constant of UV-vis, Ka, is comparable to groove-binding drugs. Competitive fluorimetric studies with Hoechst 33258 showed that valcyte could displace the DNA-bound Hoechst 33258. The drug could not displace intercalated methylene blue from DNA double helix...
October 19, 2016: Nucleosides, Nucleotides & Nucleic Acids
G Varela-Fascinetto, C Benchimol, R Reyes-Acevedo, M Genevray, D Bradley, J Ives, H T Silva
This multicenter, open-label study evaluated the tolerability of extended prophylaxis with valganciclovir in pediatric kidney transplant recipients at risk of CMV disease. Fifty-six patients aged 4 months to 16 years received once-daily valganciclovir oral solution and/or tablets, dosed by BSA and renal function, for up to 200 days. The most common AEs on treatment were upper respiratory tract infection (33.9%), urinary tract infection (33.9%), diarrhea (32.1%), leukopenia (25.0%), neutropenia (23.2%), and headache (21...
October 17, 2016: Pediatric Transplantation
Bernadette M Cameron, Sean E Kennedy, William D Rawlinson, Fiona E Mackie
This study evaluated the efficacy of prophylactic ValGCV in preventing CMV and EBV infections in a single-center pediatric kidney transplant population (2008-2014). Therapy duration was determined according to donor/recipient serostatus. EBV monitoring was performed using monthly plasma PCR for 18 months post-transplant and for CMV, monthly for 6 months after prophylaxis cessation. Data were collected on 35 children, median age 10.6 years. There were 15 (42.9%) and 11 (31.4%) recipients seronegative for CMV or EBV, respectively, who received a kidney from a seropositive donor...
October 4, 2016: Pediatric Transplantation
William J Muller
Viral infections in the fetus or newborn often involve the central nervous system (CNS) and can lead to significant morbidity and mortality. Substantial progress has been made in identifying interventions decreasing adverse neurodevelopmental outcomes in this population. This review highlights progress in treatment of important viruses affecting the CNS in these susceptible hosts, focusing on herpes simplex (HSV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), and enteroviruses. The observation that high-dose acyclovir improves mortality in neonatal HSV disease culminated decades of antiviral research for this disease...
September 27, 2016: Pediatric Research
Ester Fernández López, Elsie Chan
PURPOSE: There is currently limited information regarding the outcomes of endothelial keratoplasty in eyes with cytomegalovirus (CMV) endotheliitis. We report the results of Descemet stripping automated endothelial keratoplasty (DSAEK) for endothelial failure secondary to CMV. METHODS: This is a retrospective review of 4 eyes of 4 patients with CMV endotheliitis and DSAEK. CMV was confirmed in each case by a positive aqueous tap on qualitative polymerase chain reaction...
September 21, 2016: Cornea
Ben Kerr Winter, Anand Odedra, Steve Green
BACKGROUND: Medical tourism, where patients travel abroad intentionally to access medical treatment, is a growing trend. Some of these patients travel to undergo organ transplantation. This study aims to quantify the number of UK patients who undergo liver transplantation abroad, assessing their motivations and management. METHODS: Questionnaires were sent to all seven UK liver transplant units enquiring about liver patients receiving transplant abroad. Included were questions on destination, motivation, and pre and post-transplant care...
September 14, 2016: Travel Medicine and Infectious Disease
S Heldenbrand, C Li, R P Cross, K A DePiero, T B Dick, K Ferguson, M Kim, E Newkirk, J M Park, J Sudaria-Kerr, E M Tichy, K R Ueda, R Weng, J Wisniewski, S Gabardi
BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs. 900 mg/day for 3-months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between 01/2008 and 10/2011...
September 17, 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
William D Rawlinson, Stuart T Hamilton, Wendy J van Zuylen
PURPOSE OF REVIEW: The purpose of review is to assess the recent studies of therapy of pregnant women and neonates, aimed at preventing the consequences of congenital cytomegalovirus (CMV) infection. RECENT FINDINGS: A recent randomized controlled trial of treatment of CMV during pregnancy with hyperimmune globulin did not show significant efficacy in prevention of foetal infection and morbidity, although there was a trend towards improvement with treatment. Trials of antiviral therapy of the mother during pregnancy have involved small numbers only, confounded by ethical and practical difficulties, and further studies are needed to demonstrate whether or not antivirals are useful and well tolerated in this setting...
September 7, 2016: Current Opinion in Infectious Diseases
R Gonçalves, C Valente, E Ferreira, J E Serra, J Saraiva da Cunha
Cytomegalovirus is a double stranded DNA virus that can be present in nearly all organs and body fluids. The primary infection is usually asymptomatic in the immunocompetent host and it is common among adolescents and young adults. The symptomatic form appears, in the majority of cases, as a mononucleosis syndrome with full recovery without specific treatment. We report a case of a 25 years old woman who presented with hepatitis due to CMV infection and history of omalizumab administration one month earlier...
2016: IDCases
Denise Bradley, Sebastian Moreira, Vishak Subramoney, Clifford Chin, Jane Ives, Ka Wang
BACKGROUND: Valganciclovir (VGCV) effectively prevents cytomegalovirus disease in adult and pediatric solid organ transplant (SOT) recipients. A dosing algorithm for VGCV for pediatric patients, based on body surface area and renal function, provides a personalized dose using age-appropriate formulations. The suitability of this dosing algorithm has not been assessed specifically in infants and neonates 4 months of age and younger receiving a SOT. METHODS: This multicenter prospective study evaluated the pharmacokinetics (PK) and safety of VGCV oral solution in 17 heart transplant recipients 4 months of age and younger who received two doses of VGCV on consecutive days using the pediatric dosing algorithm...
August 30, 2016: Pediatric Infectious Disease Journal
S A Fayek, E Beshears, R Lieber, N Alvey, A Sauer, J Poirier, E F Hollinger, O K Olaitan, S Jensik, J Geyston, M M Brokhof, A C Hodowanec, M Hertl, D M Simon
BACKGROUND: Cytomegalovirus (CMV)-seronegative kidney transplant (KTx) recipients of organs from CMV-seropositive donors (D+/R-) are at increased risk for CMV infection. Despite valganciclovir (VGCV) prophylaxis (900 mg daily for 200 days), late-onset CMV (LO-CMV) occurs at excessive rates. VGCV-associated cost and toxicities remain problematic. METHODS: We retrospectively evaluated 50 D+/R- adult KTx recipients from August 2008 to August 2014 who received low-dose VGCV (450 mg daily) prophylaxis for an extended duration...
July 2016: Transplantation Proceedings
M A AlDabbagh, M R Gitman, D Kumar, A Humar, C Rotstein, S Husain
The role of antiviral prophylaxis for the prevention of posttransplant lymphoproliferative disease (PTLD) remains controversial for solid organ transplantation (SOT) recipients who are seronegative for Epstein-Barr virus (EBV) but who received organs from seropositive donors. We performed a systematic review and meta-analysis to address this issue. Two independent assessors extracted data from studies after determining patient eligibility and completing quality assessments. Overall, 31 studies were identified and included in the quantitative synthesis...
August 22, 2016: American Journal of Transplantation
K Jorga, C Chavanne, N Frey, T Lave, V Lukacova, N Parrott, R Peck, B Reigner
Population pharmacokinetic (PopPK) and physiologically-based pharmacokinetic (PBPK) models are frequently used to support pediatric drug development. Both methods have strengths and limitations and we used them complementarily to support the regulatory approval of a dosing algorithm for valganciclovir in children <4 months. An existing pediatric PBPK model was extended to neonates and showed that potential physiological differences compared to older children are minor. The PopPK model was used to simulate ganciclovir exposures in children with population typical combinations of body size and renal function and to assess the effectiveness of an alternative dosing algorithm suggested by FDA...
August 17, 2016: Clinical Pharmacology and Therapeutics
C Hutterer, S Hamilton, M Steingruber, I Zeitträger, H Bahsi, N Thuma, Z Naing, Z Örfi, L Örfi, E Socher, H Sticht, W Rawlinson, S Chou, V J Haupt, M Marschall
HCMV is a member of the family Herpesviridae and represents a worldwide distributed pathogen with seropositivity rates in the adult population ranging between 40% and 90%. Notably, HCMV infection is a serious, sometimes life-threatening medical problem for newborns and immunosuppressed individuals, including transplant recipients and patients under antitumoral chemotherapy. Current standard therapy with valganciclovir has the disadvantage of inducing drug-resistant virus mutants and toxicity-related side effects...
October 2016: Antiviral Research
Kirsten Lindner, Christoph Anthoni, Susanne Beckebaum, Norbert Senninger, Jens Peter Hölzen, Heiner Wolters
OBJECTIVES: Cytomegalovirus infections cause the most frequent infection after solid-organ transplant. While Cytomegalovirus prophylaxis is established in high-risk patients (donor+/ recipient-), data on Cytomegalovirus prophylaxis in other serostatus constellation are rare. The aim of this study was to evaluate the influence of Cytomegalovirus treatment strategy after a liver transplant (preemptive therapy vs general prophylaxis) in the largest group of patients: Cytomegalovirus seropositive donor and recipient...
August 2016: Experimental and Clinical Transplantation
Robin K Avery, Ravit Arav-Boger, Kieren A Marr, Edward Kraus, Shmuel Shoham, Laura Lees, Brandon Trollinger, Pali Shah, Rich Ambinder, Dionysios Neofytos, Darin Ostrander, Michael Forman, Alexandra Valsamakis
BACKGROUND: Antiviral-resistant or refractory cytomegalovirus (CMV) infection is challenging, and salvage therapies, foscarnet, and cidofovir, have significant toxicities. Several investigational anti-CMV agents are under development, but more information is needed on outcomes of current treatments to facilitate clinical trial design for new drugs. METHODS: Records of solid organ transplant (SOT) and hematopoietic cell transplant (HCT) recipients at a single center over a 10-year period were reviewed retrospectively to characterize those who had received foscarnet treatment for ganciclovir-resistant or refractory CMV infection...
October 2016: Transplantation
D Morita, K Hirabayashi, Y Katsuyama, H Morokawa, M Motobayashi, T Kurata, T Shigemura, M Tanaka, Y Inaba, K Koike, Y Nakazawa
We describe successful treatment of 3 cases of human herpesvirus 6 (HHV-6) encephalitis/myelitis following cord blood transplantation (CBT). Ganciclovir (GCV) (10 mg/kg/day) reduced HHV-6 load to undetectable levels in cerebrospinal fluid (CSF). Early dose reduction in the presence of HHV-6 detectable in CSF resulted in an increased HHV-6 load. GCV was capably shifted to valganciclovir (VGCV) with an almost equivalent concentration. GCV/VGCV may be effective for HHV-6 encephalitis/myelitis after CBT, although HHV-6 load in CSF should be monitored...
October 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
V Lukacova, P Goelzer, M Reddy, G Greig, B Reigner, N Parrott
A physiologically based pharmacokinetic (PBPK) model has been developed for ganciclovir and its prodrug valganciclovir. Initial bottom-up modeling based on physicochemical drug properties and measured in vitro inputs was verified in preclinical animal species, and then, a clinical model was verified in a stepwise fashion with pharmacokinetic data in adult, children, and neonatal patients. The final model incorporated conversion of valganciclovir to ganciclovir through esterases and permeability-limited tissue distribution of both drugs with active transport processes added in gut, liver, and kidney...
July 22, 2016: AAPS Journal
Chethan Puttarajappa, Manoj Bhattarai, Girish Mour, Chengli Shen, Puneet Sood, Rajil Mehta, Nirav Shah, Amit D Tevar, Abhinav Humar, Christine Wu, Sundaram Hariharan
BACKGROUND: The burden of cytomegalovirus infection in CMV high-risk (donor positive to recipient negative) kidney transplant recipients getting thymoglobulin induction and six months of valganciclovir is not well characterized. Additionally, the role of post-prophylaxis surveillance remains unclear. METHODS: One-year observational study of forty-eight high-risk CMV kidney transplant recipients transplanted under thymoglobulin between January 2013 and July 2014...
September 2016: Clinical Transplantation
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