Valganciclovir as CMV reactivation prophylaxis in patients receiving alemtuzumab for marrow failure syndromes

Abstract

as CMV reactivation prophylaxis in patients receiving alemtuzumab for marrow failure syndromes.

Alemtuzumab is safe and effective as immunosuppressive treatment for aplastic anaemia and single‐lineage marrow failure: a pilot study and a survey from the EBMT WPSAA

“…No CMV disease, Epstein–Barr virus‐related disease or lymphoproliferative disorders were observed. A sensitive polymerase chain reaction method confirmed negative CMV viraemia in all patients receiving prophylactic valganciclovir (Risitano et al , 2009); four patients developed asymptomatic CMV reactivation after the discontinuation of anti‐viral prophylaxis, but viraemia (just above the detection limit) promptly disappeared with pre‐emptive valganciclovir. Finally, one patient with pre‐treatment occult HBV infection developed HBV reactivation (positive for Hepatitis B surface antigen and HBV viremia) without laboratory signs of hepatitis; lamivudine therapy was started and was effective in viral clearing.…”

“…Low dose (1 mg/kg) oral cyclosporine A commenced from day 7, and then adjusted according to blood level (targeting 100–200 ng/ml using a monoclonal assay) at the time of immune reconstitution. An intensive anti‐infectious prophylaxis was used (Table I, Risitano et al , 2009), which included anti‐cytomegalovirus (CMV) prophylaxis by oral vanganciclovir and weekly monitoring of CMV viraemia, anti‐Pneumocystis Jirovecii prophylaxis by oral trimethoprim‐sulphametoxazole, anti‐bacterial and anti‐fungal prophylaxis in case of severe neutropenia (<0·5 × 10 9 /l), and prophylactic lamivudine in patients with possible occult hepatitis B virus (HBV).…”

Alternative immunosuppression in patients failing immunosuppression with ATG who are not transplant candidates: Campath (Alemtuzumab)

“…42 When all the 28 patients enrolled in the study were considered (13 AA, 13 pure red cell aplasia (PRCA) and 2 pure white cell aplasia (PWCA), see below), after a cumulative observation of 978 patient-months infectious events were infrequent, and mostly included viral reactivation: 1 Varicella zoster with shingles, 4 herpes simplex and 4 subclinical CMV reactivation (as assessed by a sensitive PCR method, in patients who have discontinued the prophylactic ganciclovir), all resolving quickly after anti-viral treatment (either acyclovir or preemptive valganciclovir). 41 No CMV disease, EBV-related disease or lymphoproliferative disorder was observed. To note, a subclinical (no increase of liver enzymes) seroconversion of HBV with DNAemia was seen in a patient with occult HBV infection (HBsAg À /HBcAb IgG þ ), with prompt viral clearing after lamivudine treatment (three subsequent patients with possible occult HBV infection received prophylactic lamivudine, without subsequent HBV viral reactivation).…”

“…A strict antiinfectious policy was observed in all patients, which included broad anti-bacterial and anti-fungal agents (ciprofloxacin and itraconazole, respectively) in case of severe neutropenia (o500/mL), specific anti-CMV prophylaxis (valganciclovir 450 mg orally bi-daily for 3 months, followed by CMV DNAemia monitoring and pre-emptive treatment) and pneumocystis prophylaxis (cotrimoxazole bi-daily thrice a week). 41 We enrolled 13 AA patients, of whom 9 had no previous IST; all the patients completed the treatment without any relevant adverse event, usually in an outpatient regimen (the treatment itself did not require hospitalization in any case). The most frequent adverse events were mild infusion reactions (local rubor, chills and fever), usually selflimiting or easily managed by paracetamol.…”