A Comparison of Different Valgancyclovir Formulations in the Universal 6-Month Prophylaxis Against CMV Infection in Renal Transplant Recipients: A Randomized Single-Centre Study
| Autor: | Vesna Furic-Cunko, Zeljko Kastelan, Zoran Zimak, Tvrtko Hudolin, Jason Kirincich, Nikolina Bašić-Jukić |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Time Factors Congenital cytomegalovirus infection Cytomegalovirus Renal function Antiviral Agents Gastroenterology 03 medical and health sciences Lymphocele 0302 clinical medicine Internal medicine medicine Humans Valganciclovir 030212 general & internal medicine Adverse effect Kidney transplantation Proteinuria business.industry General Medicine Middle Aged medicine.disease Kidney Transplantation Transplant Recipients Transplantation Treatment Outcome Cytomegalovirus Infections DNA Viral Female 030211 gastroenterology & hepatology medicine.symptom business Follow-Up Studies medicine.drug |
| Zdroj: | PRILOZI. 40:47-55 |
| ISSN: | 1857-8985 1857-9345 |
| DOI: | 10.2478/prilozi-2020-0004 |
| Popis: | Introduction: Cytomegalovirus (CMV) is the most common opportunistic infective pathogen in kidney transplant recipients. Valganciclovir (VAL) is commonly used for prophylaxis, especially in high-risk recipients. Generic VAL formulations have become available, but the data about their safety and efficacy are lacking. Methods: Consecutive de novo kidney transplant patients were randomized to generic VAL Valganciklovir Teva® (VT group)(24 patients) or Alvanocyte® (A group), Alvogen (19 patients) or to Valcyte® (V group), Roche (23 patients) in a 18-month open-label study. Universal prophylaxis was used for 6 months after the transplantation. CMV DNA levels were measured at 1,3,6,9,12 and 18 months after the transplantation. All positive measurements of CMV DNA were recorded. Results: Groups did not differ regarding the clinical characteristics or the risk for developing CMV infection in the post-transplant period. CMV replications were most common at 9 months after the transplantation with rates of 9% for the V, 13% for the VT and 26% for the A group (p=0.26). At 12 months, positive CMV DNA was recorded in 22%, 8% and 11 % of patients taking V, VT and A, respectively (p=0.37). Rates of biopsy-proven acute rejection, adverse events, and serious adverse events were similar for all formulations. Lymphocele occurred most commonly in the V group (35%) compared to 17% in VT and 17% in the A group (p=0.23). One patient from each of the A and VT groups developed CMV disease. Additionally, they were the only two patients with CMV DNA copies above 656 IU/ml. Glomerular filtration rates were similar in all groups at all time points, while proteinuria was significantly higher at 12 months in patients who received V 0.32 g/day (0.18 – 0.42), compared to patients on VT 0.2 (0.1 – 0.2), or A 0.2 (0.2 – 0.3), p=0.04. Conclusion: Valgancyclovir efficacy and safety in this limited data set is similar with early administration of V, VT and A after kidney transplantation. Additional studies aimed at elucidating the effectiveness of this treatment regimen in patients who are at high risk for developing CMV infection are necessary to draw further conclusions. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|