PURPOSE: Valganciclovir (VGCV) is increasingly being used for extended durations of prophylaxis, therapy, or suppression. Neutropenia is a recognized side effect, and this study sought to define the incidence, time-dependence, and risk factors for neutropenia in VGCV-treated patients.
METHODS: 119 lung recipients at one center from 2002-4 were studied. CMV prophylaxis since mid-2002 was VGCV for 6 mos. Also in 2002, a PTLD prevention program included reduction of immunosuppression and VGCV for + EBV DNA levels. Data was collected on neutropenia, duration of VGCV, renal function, concomitant medications, and clinical outcomes. (Pts in a multicenter VGCV study were excluded from analysis.) VGCV-associated neutropenia was defined as neutropenia (ANC < 1000 or WBC < 2000) occurring while on VGCV therapy.
RESULTS: Of 119 pts studied, 73 (61%) received VGCV and 34/73 of these (47%) had neutropenia. Neutropenia also developed in 6/46 patients not on VGCV (13%, p=0.0002). Most were on other agents which can cause leukopenia (AZA 10, MMF 5, TMP-SMX 22, sirolimus 3). VGCV-neutropenia occurred at a median of 5 mos post transplant (mean 7 mos, range 3-22 mos) after treatment with VGCV for a median of 4 mos (mean 5 mos, range 1-22 mos). Neither age nor gender were significantly different between VGCV-neutropenic and non-neutropenic pts. Mean renal function (MDRD) was 63 ml/min in VGCV-neutropenia pts and 74.9 in VGCV-pts without neutropenia (p=NS). When neutropenia occurred, VGCV was discontinued in 11 pts and decreased in 4; an immunosuppressive drug was discontinued in 9 and decreased in 5. G-CSF was required in 5 (19%). 6/34 pts (15%) were admitted with fever.
CONCLUSION: Neutropenia is common in lung transplant pts receiving longer courses of VGCV (47%), occurring at a median of 4 mos of VGCV therapy. 18% required admission.
CLINICAL IMPLICATIONS: The risks and benefits of longer courses of VGCV must be carefully weighed, and close monitoring of the CBC and dose adjustment for changing renal function are crucial.
DISCLOSURE: Andrew Githaiga, None.