Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial

Copeland, Catherine; Davis, William A.; Snyder, Laurie D.; Banks, Missy; Avery, Robin K.; Davis, Robert D.; Palmer, Scott M.

doi:10.1016/j.healun.2011.02.017

Cited by 61 publications

(28 citation statements)

References 15 publications

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“…Third, the rates of CMV infection and ganciclovir resistance among CMV-infected patients were 28% and 9.4%, respectively, despite receipt of valganciclovir prophylaxis for a median of 7 months (range, 4 to 21 months). The rate of CMV infection was higher than in a recent multicenter study of extended valganciclovir prophylaxis (17,18). Taken together, the data demonstrate that ganciclovir-resistant CMV infections remained a major cause of morbidity and mortality.…”

Section: Discussionmentioning

confidence: 57%

“…Interestingly, UL97 mutations were detected in 2.9% of lung transplant recipients randomized to the extended valganciclovir arm of the multicenter study (17), which was virtually identical to the 2.6% rate among our lung transplant recipients. Ganciclovir resistance was not reported in a follow-up study of a subset of patients from the earlier trial, who were from a single center (18). Nevertheless, our data showcase that concerns over the potential for ganciclovir resistance with extended valganciclovir prophylaxis are legitimate (2,17,20).…”

Section: Discussionmentioning

confidence: 62%

“…Valganciclovir, an oral prodrug that achieves ganciclovir concentrations comparable to those of intravenous (i.v.) ganciclovir (11), is at least as effective and safe in reducing CMV infections after lung transplantation (8,(12)(13)(14)(15)(16)(17)(18). Controversy persists, however, over the recommended duration of valganciclovir prophylaxis.…”

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confidence: 99%

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Ganciclovir-Resistant Cytomegalovirus Infections among Lung Transplant Recipients Are Associated with Poor Outcomes despite Treatment with Foscarnet-Containing Regimens

Minces

Nguyen

Mitsani

et al. 2014

Antimicrob Agents Chemother

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Ganciclovir-resistant cytomegalovirus (CMV) infections are reported infrequently among lung transplant recipients receiving extended valganciclovir prophylaxis. We performed a single-center, retrospective review of ganciclovir-resistant CMV infections in a program that employed valganciclovir prophylaxis for >6 months after lung transplant. CMV infections were diagnosed in 28% (170/607) of patients. UL97 mutations were detected in 9.4% ( The median whole-blood CMV load was 4.13 log 10 copies/cm 3 (range, 2.54 to 5.53), and 93% (14/15) of patients had low-moderate immune responses (Cylex Immunoknow). Antiviral therapy was successful, failed, or eradicated viremia followed by relapse in 12% (2/16), 31% (5/16), and 56% (9/16) of patients, respectively. Eighty-seven percent (14/16) of patients were treated with foscarnet-containing regimens; toxicity developed in 78% (11/14) of these. Median viral load half-life and time to viremia eradication among foscarnet-treated patients were 2.6 and 23 days, respectively, and did not correlate with protection from relapse. Sixty-nine percent (11/16) of patients developed CMV pneumonitis, and 25% (4/16) died of it. Serum viral load was independently associated with death among foscarnet-treated patients (P ‫؍‬ 0.04). In conclusion, ganciclovir-resistant CMV infections remained a major cause of morbidity and mortality following lung transplantation. Foscarnet-based regimens often eradicated viremia rapidly but were ineffective in the long term and limited by toxicity.

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Section: Discussionmentioning

confidence: 57%

Section: Discussionmentioning

confidence: 62%

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Ganciclovir-Resistant Cytomegalovirus Infections among Lung Transplant Recipients Are Associated with Poor Outcomes despite Treatment with Foscarnet-Containing Regimens

Minces

Nguyen

Mitsani

et al. 2014

Antimicrob Agents Chemother

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“…However, the association was small, and not adjusted for potential risk factors for CMV disease such as donor and recipient CMV serostatus 31 , type, timing and dose of immunosuppressive therapy 28, 29, 32 , or CMV prevention practices 14, 15 . It is possible that native lung infections such as bacterial pneumonia and fungal infections result in increased inflammation 33, 34 , thereby leading to transactivation of latent CMV in the transplanted lung and subsequent CMV disease 26, 27 .…”

Section: Discussionmentioning

confidence: 96%

“…An international consensus committee convened in 2010 recommended at least 6 months of anti-CMV prophylaxis for CMV-seronegative lung transplant recipients that received lungs from CMV-seropositive donors (D+/R-) and 3 to 6 months of anti-CMV prophylaxis for CMV seropositive recipients (R+) 13 . A randomized controlled trial that demonstrated the superiority of 12 months over 3 months of valganciclovir prophylaxis in preventing CMV disease among D+/R- and R+ lung transplant recipients 14, 15 supports even longer treatment.…”

Section: Introductionmentioning

confidence: 98%

Incidence, Risk Factors and Outcomes of Delayed-onset Cytomegalovirus Disease in a Large Retrospective Cohort of Lung Transplant Recipients

et al. 2015

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Background Cytomegalovirus (CMV) replication and disease commonly occur in lung transplant recipients after stopping anti-CMV prophylaxis. The epidemiology of CMV disease is not well-studied given difficulties in assembling representative study populations with prolonged follow-up. We hypothesized that delayed-onset CMV disease (> 100 days post-transplant) occurs more commonly than early-onset CMV disease in lung transplant recipients, and is associated with an increased risk of death. Methods We assembled a large cohort of lung transplant recipients using 2004 to 2010 ICD-9-CM billing data from 3 Agency for Healthcare Research and Quality (AHRQ) State Inpatient Databases (SID), and identified demographics, comorbidities, CMV disease coded during hospital readmission and inpatient death. We used Cox proportional hazard multivariate analyses to assess for an independent association between delayed-onset CMV disease and death. Results In the cohort of 1,528 lung transplant recipients from 12 transplant centers, delayed-onset CMV disease occurred in 13.7% (n=210) and early-onset CMV disease occurred in 3.3% (n=51). Delayed-onset CMV pneumonitis was associated with inpatient death > 100 days post-transplant (aHR 1.6, 95% CI 1.1-2.5), after adjusting for transplant failure/rejection (aHR 2.5, 95% CI 1.5-4.1), bacterial pneumonia (aHR 2.8, 95% CI 2.0-3.9), viral pneumonia (aHR 1.5, 95% CI 1.1-2.1), fungal pneumonia (aHR 1.8, 95% CI 1.3-2.3), single lung transplant (aHR 1.3, 95% CI 1.0-1.7) and idiopathic pulmonary fibrosis (aHR 1.4, 95% CI 1.0-1.8). Conclusions Delayed-onset CMV disease occurred more commonly than early-onset CMV disease among lung transplant recipients. These results suggest that delayed-onset CMV pneumonitis was independently associated with an increased risk of death.

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Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

Vernooij,

Michael,

Ladhani

et al. 2024

Cochrane Database of Systematic Reviews

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Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial

Cited by 61 publications

References 15 publications

Ganciclovir-Resistant Cytomegalovirus Infections among Lung Transplant Recipients Are Associated with Poor Outcomes despite Treatment with Foscarnet-Containing Regimens

Ganciclovir-Resistant Cytomegalovirus Infections among Lung Transplant Recipients Are Associated with Poor Outcomes despite Treatment with Foscarnet-Containing Regimens

Incidence, Risk Factors and Outcomes of Delayed-onset Cytomegalovirus Disease in a Large Retrospective Cohort of Lung Transplant Recipients

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

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