Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients

Åsberg, Anders; Humar, Atul; Rollag, Halvor; Jardine, Alan G.; Mouas, H.; Pescovitz, Mark D.; Sgarabotto, Dino; Tuncer, Murat; Noronha, Irene L.; Hartmann, Anders

doi:10.1111/j.1600-6143.2007.01910.x

Cited by 378 publications

(316 citation statements)

References 25 publications

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“…In a multicenter noninferiority trial, 321 solid organ (including li ver) trans plant recipients with nonsevere CMV disease were ran domized to valganciclovir (900 mg twice daily) or IV gan ciclovir (5 mg/kg twice daily) for a fixed 21d course, fol lowed by valganciclovir (900 mg once daily) maintenance treatment for 4 wk. The proportion of patients with viral eradication at 21 and 49 d were comparable in the IV gan ciclovir and valganciclovir groups (Figure 3) [79] . The overall time to viral eradication was 21 d with valganciclovir and 19 d with IV ganciclovir.…”

Section: Treatment Of CMV Disease After Liver Transplantationmentioning

confidence: 93%

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Current concepts on cytomegalovirus infection after liver transplantation

Lee

Razonable

2010

WJH

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Cytomegalovirus (CMV) is the most common viral pathogen that negatively impacts on the outcome of liver transplantation. CMV cause febrile illness often accompanied by bone marrow suppression, and in some cases, invades tissues including the transplanted allograft. In addition, CMV has been significantly asso ciated with an increased predisposition to allograft rejection, accelerated hepatitis C recurrence, and other opportunistic infections, as well as reduced overall pa tient and allograft survival. To negate the adverse effects of CMV on outcome, its prevention, whether through antiviral prophylaxis or preemptive therapy, is regarded as an essential component to the medical management of liver transplant patients. Two recent guidelines have suggested that antiviral prophylaxis or preemptive therapy are similarly effective in preventing CMV disease in modest-risk CMV-seropositive liver trans plant recipients, while antiviral prophylaxis is the preferred strategy over preemptive therapy for the preven tion of CMV disease in high-risk recipients [CMV-seronegative recipients of liver allografts from CMV-seropositive donors (D+/R-)]. However, antiviral prophylaxis has only delayed the onset of CMV disease in many CMV D+/R-liver transplant recipients, and at least in one study, such occurrence of late-onset primary CMV disease was significantly associated with increased mortality after liver transplantation. Therefore, optimized strategies for prevention are needed, and aggressive treatment of CMV infection and disease should be pursued. The standard treatment of CMV disease consists of intravenous ganciclovir or oral valganciclovir, and if feasible, one should also reduce the degree of immunosuppression. In one recent controlled clinical trial, val ganciclovir was found to be as effective and safe as intravenous ganciclovir for the treatment of mild to mo derate CMV disease in solid organ (including liver) tran splant recipients. In this article, the authors review the current state and the future perspectives of prevention and treatment of CMV disease after liver transplantation.

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Section: Treatment Of CMV Disease After Liver Transplantationmentioning

confidence: 93%

“…The first line treatment of CMV disease after li ver trans plantation is IV ganciclovir or valganciclovir [62,71,79] . In con trast, oral ganciclovir should not be used for the treatment of CMV disease because of its poor bioavailability [20] .…”

Section: Treatment Of CMV Disease After Liver Transplantationmentioning

confidence: 99%

Current concepts on cytomegalovirus infection after liver transplantation

Lee

Razonable

2010

WJH

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“…Absence of CMV replication was defined as two consecutive CMV-negative QNATs. Intravenous (IV) ganciclovir (5 mg/kg twice daily) or oral valganciclovir (900 mg twice daily) was given for curative treatment and was always followed by oral valganciclovir (900 mg/day), as described previously (20). The anti-CMV treatment was discontinued once absence of CMV replication was obtained.…”

Section: Study Design and Patientsmentioning

confidence: 99%

Easier Control of Late-Onset Cytomegalovirus Disease Following Universal Prophylaxis Through an Early Antiviral Immune Response in Donor-Positive, Recipient-Negative Kidney Transplants

Kaminski

Couzi

Garrigue³

et al. 2016

American Journal of Transplantation

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Universal prophylaxis for cytomegalovirus (CMV) prevention is viable but, compared with a preemptive strategy, leads to higher incidence of late-onset disease (LOD) associated with poor patient and graft survival. The purpose of this study was to compare LOD with early onset disease (EOD), with a focus on the highest risk kidney transplant recipients (KTRs): CMV seronegative recipients transplanted from seropositive donors (D+RÀ). Since CMV control depends on both antiviral treatment and specific immune response, we also compared Vd2-negative (Vd2 neg ) cd T cell expansion involved in CMV infection resolution. EOD was defined as occurring <3 mo and LOD as occurring >3 mo after transplantation. Depending on the period, universal prophylaxis or preemptive treatment was used. Overall, 168 D+RÀ KTRs were included between 2003 and 2011. LOD was associated with a lower peak DNAemia (p = 0.04), fewer recurrences (odds ratio 0.16; 95% confidence interval 0.05-0.55; p = 0.01) and shorter anti-CMV curative treatment (40 vs. 60 days, p < 0.0001). As a corollary, we found that Vd2 neg cd T cell expansion was faster in LOD than in EOD (31 vs. 168 days after the beginning of CMV disease, p < 0.0001). In D+RÀ KTRs, universal prophylaxis is associated with more LOD, which had better infection management and a faster immune response. These results support the use of universal prophylaxis over a preemptive strategy and reappraise outcomes of LOD.

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“…Valganciclovir has an oral bioavailability of 70%, compared to 7% for ganciclovir [10]. A study by Asberg, et al compared the efficacy of oral valganciclovir to intravenous ganciclovir in 321 solid organ transplant recipients with tissue-invasive CMV disease [11]. Patients were randomized to receive 21 days of either 900 mg oral valganciclovir twice daily or 5 mg/kg intravenous ganciclovir twice daily, followed by 49 days of valganci- This case highlights the importance of CMV chemoprophylaxis in heavily immunosuppressed patients.…”

Section: Discussionmentioning

confidence: 99%

A Case of Cytomegalovirus-Induced Arthritis after Lymphocyte-Depleting Therapy for Kidney Allograft Rejection

Fuquay¹,

Cooper²

2012

OJNeph

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Cytomegalovirus viremia and tissue-invasive disease are common after kidney transplantation. Chemoprophylaxis has made substantial improvement in this clinical problem. Here we report a 29-year-old woman who had kidney allograft rejection and received lymphocyte-depleting therapy. She presented with a new oligo-arthritis that led to 2 successive arthrocenteses. The etiology of the inflammation could not be determined initially. On the second arthrocentesis, a synovial fluid cytomegalovirus polymerase chain reaction test was positive. The patient responded to treatment with valganciclovir, had negative follow-up serum cytomegalovirus polymerase chain reaction tests, and experienced resolution of her joint inflammation. We review briefly the data for cytomegalovirus chemoprophylaxis, preemptive screening, and treatment recommendations.

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Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients

Cited by 378 publications

References 25 publications

Current concepts on cytomegalovirus infection after liver transplantation

Current concepts on cytomegalovirus infection after liver transplantation

Easier Control of Late-Onset Cytomegalovirus Disease Following Universal Prophylaxis Through an Early Antiviral Immune Response in Donor-Positive, Recipient-Negative Kidney Transplants

A Case of Cytomegalovirus-Induced Arthritis after Lymphocyte-Depleting Therapy for Kidney Allograft Rejection

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