Efficacy of valganciclovir and ganciclovir for cytomegalovirus disease in solid organ transplants: A meta-analysis

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Abstract

Background:

Cytomegalovirus (CMV), a problematic virus in solid organ transplant recipients (SOTR) such as liver, can worsen overall mortality and transplant outcome, so its prevention and treatment is a key of success in such patients. This study is aimed to compare the efficacy of ganciclovir (GCV) and valganciclovir (VGC) for prevention and treatment of infection with CMV.

Materials and Methods:

After sensitive and systematic search in PubMed, EMBASE, Cochrane and other available databases, both prospective and retrospective studies on effect of VGC and GCV in prevention and treatment of CMV disease among SOTR, which had our study criteria, were included. The pooled risk estimates were calculated using random-effects models.

Results:

Among 1324 title, 19 studies were included. In 11 prophylactic studies (2368 patients), the pooled risk of CMV disease (VGC relative to GCV) was 1.16, 95% confidence interval (CI): 0.91-1.49 and in studies of liver transplant recipients, 1.53, 95% CI: 0.86-2.70. Rate of viremia eradication in VGC to GCV was 1.05, 95% CI: 0.97-1.13. In 3 treatment studies (422 patients), rate of successful treatment in VGC to GCV was 0.98, 95% CI: 0.91-1.06 and viremia eradication 0.95, CI 95% 0.77-1.16. All these values did not show statistically significantly differences between GCV and VGC.

Conclusion:

It can be concluded that VGC as an alternative to GCV can be used with equal efficacy in prevention and treatment of CMV disease in SOTR.

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Most cited references 82

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Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients.

C V Paya, Emily Blumberg, Atul Humar … (2004)

We compared the efficacy and safety of valganciclovir with those of oral ganciclovir in preventing cytomegalovirus (CMV) disease in high-risk seronegative solid organ transplant (SOT) recipients of organs from seropositive donors (D+/R-). In this randomised, prospective, double-blind, double-dummy study, 364 CMV D+/R- patients received valganciclovir 900 mg once daily or oral ganciclovir 1000 mg three times a day (tid) within 10 days of transplant and continued through 100 days. CMV disease, plasma viremia, acute graft rejection, graft loss and safety were analyzed up to 6 and 12 months post-transplant. Endpoint committee-defined CMV disease developed in 12.1% and 15.2% of valganciclovir and ganciclovir patients, respectively, by 6 months, though with a difference in the relative efficacy of valganciclovir and ganciclovir between organs (i.e. an organ type-treatment interaction). By 12 months, respective incidences were 17.2% and 18.4%, and the incidence of investigator-treated CMV disease events was comparable in the valganciclovir (30.5%) and ganciclovir (28.0%) arms. CMV viremia during prophylaxis was significantly lower with valganciclovir (2.9% vs. 10.4%; p=0.001), but was comparable by 12 months (48.5% valganciclovir vs 48.8% ganciclovir). Time-to-onset of CMV disease and to viremia were delayed with valganciclovir; rates of acute allograft rejection were generally lower with valganciclovir. Except for a higher incidence of neutropenia with valganciclovir (8.2%, vs 3.2% ganciclovir) the safety profile was similar for both drugs. Overall, once-daily oral valganciclovir was as clinically effective and well-tolerated as oral ganciclovir tid for CMV prevention in high-risk SOT recipients.

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International consensus guidelines on the management of cytomegalovirus in solid organ transplantation.

Anders Åsberg, A. Caliendo, Upton Allen … (2010)

Cytomegalovirus (CMV) remains one of the most common infections after solid organ transplantation, resulting in significant morbidity, graft loss, and occasional mortality. Management of CMV varies considerably among transplant centers. A panel of experts on CMV and solid organ transplant was convened by The Infectious Diseases Section of The Transplantation Society to develop evidence and expert opinion-based consensus guidelines on CMV management including diagnostics, immunology, prevention, treatment, drug resistance, and pediatric issues.

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Risk factors, clinical characteristics, and outcome of Nocardia infection in organ transplant recipients: a matched case-control study.

Anton Peleg, K. Shutt, Z Qureshi … (2007)

Risk factors for Nocardia infection in organ transplant recipients have not been formally assessed in the current era of transplantation. We performed a matched case-control study (1:2 ratio) between January 1995 and December 2005. Control subjects were matched for transplant type and timing. Univariate matched odds ratios were determined and conditional logistic regression was performed to identify independent risk factors. Clinical and microbiological characteristics of all case patients were reviewed. Among 5126 organ transplant recipients, 35 (0.6%) were identified as having cases of Nocardia infection. The highest frequency was among recipients of lung transplants (18 [3.5%] of 521 patients), followed by recipients of heart (10 [2.5%] of 392), intestinal (2 [1.3%] of 155), kidney (3 [0.2%] of 1717), and liver (2 [0.1%] of 1840) transplants. In a comparison of case patients with 70 matched control subjects, receipt of high-dose steroids (odds ratio, 27; 95% confidence interval, 3.2-235; P=.003) and cytomegalovirus disease (odds ratio, 6.9; 95% confidence interval, 1.02-46; P=.047) in the preceding 6 months and a high median calcineurin inhibitor level in the preceding 30 days (odds ratio, 5.8; 95% confidence interval, 1.5-22; P=.012) were found to be independent risk factors for Nocardia infection. The majority of case patients (27 [77%] of 35) had pulmonary disease only. Seven transplant recipients (20%) had disseminated disease. Nocardia nova was the most common species (found in 17 [49%] of the patients), followed by Nocardia farcinica (9 [28%]), Nocardia asteroides (8 [23%]), and Nocardia brasiliensis (1 [3%]). Of the 35 case patients, 24 (69%) were receiving trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis. Thirty-one case patients (89%) experienced cure of their Nocardia infection. Receipt of high-dose steroids, history of cytomegalovirus disease, and high levels of calcineurin inhibitors are independent risk factors for Nocardia infection in organ transplant recipients. Our study provides insights into the epidemiology of Nocardia infection in the current era, a period in which immunosuppressive and prophylactic regimens have greatly evolved.

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Author and article information

Journal

Journal ID (nlm-ta): J Res Med Sci

Journal ID (iso-abbrev): J Res Med Sci

Journal ID (publisher-id): JRMS

Title: Journal of Research in Medical Sciences : The Official Journal of Isfahan University of Medical Sciences

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 1735-1995

ISSN (Electronic): 1735-7136

Publication date (Print): December 2014

Volume: 19

Issue: 12

Pages: 1185-1192

Affiliations

[1]Kermanshah Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

[1 ]Research Center for Environmental Determinants of Health (RCEDH), Kermanshah University of Medical Sciences, Kermanshah, Iran

Author notes

Address for correspondence: Dr. Farid Najafi, School of Population Health, Kermanshah University of Medical Sciences, Kermanshah, Iran. E-mail: farid_n32@ 123456yahoo.com ; fnajafi@ 123456kums.ac.ir

Article

Publisher ID: JRMS-19-1185

PMC ID: 4333528

PubMed ID: 25709661

SO-VID: 6d65e7be-44b9-40bd-942a-d1e2b8c1faf9

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Efficacy of valganciclovir and ganciclovir for cytomegalovirus disease in solid organ transplants: A meta-analysis

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Most cited references 82

Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients.

International consensus guidelines on the management of cytomegalovirus in solid organ transplantation.

Risk factors, clinical characteristics, and outcome of Nocardia infection in organ transplant recipients: a matched case-control study.

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