Guideline for CMV Prophylaxis and Treatment in Lung Transplant Recipients

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1 Guideline for CMV Prophylaxis and Treatment in Lung Transplant Recipients Indications: Post-Lung Transplant Patients Procedure: The lung is a major site for Cytomegalovirus (CMV) latency and recurrence. All donors and transplant candidates will be screened for CMV status prior to transplant. The transplant provider will order appropriate medication and monitoring parameters. Pre-Transplant Serologic Status and Risk for CMV Disease High Risk Donor (+) / Recipient (-) Intermediate Risk Donor (+) / Recipient (+) Donor (-) / Recipient (+) Low Risk Donor (-) / Recipient (-) I. CMV Prophylaxis A. Initiated for all high and intermediate risk lung transplant recipients Ganciclovir 5 mg/kg IV BID High Risk Intermediate Risk Induction^^^ Maintenance *** Induction^^^ Maintenance *** Cytomegalovirus Immune Globulin (Cytogam ) Within 72 hours: 150 mg/kg Weeks 2, 4, 6, 8: 100 mg/kg Weeks 12, 16: 50 mg/kg Valganciclovir (Valcyte ) 900 mg PO BID x 14 days followed by Valganciclovir (Valcyte ) 900 mg PO Daily x 12 months Ganciclovir 5 mg/kg IV BID Valganciclovir (Valcyte ) 900 mg PO BID x 14 days followed by Valganciclovir (Valcyte ) 900 mg PO Daily x 12 months Low Risk ### Maintenance && Acyclovir 400 mg Oral BID x 12 months Induction None & ^^^ Administer ganciclovir IV therapy until patient no longer NPO and able to tolerate PO meds. If renally impaired, dose ganciclovir appropriately *** Begin valgancilovir once patient can swallow pills/suspension. If renally impaired, dose valganciclovir appropriately ### Ensure leuko-depleted/cmv(-) blood products for recipient &&& For prevention of HSV and VZV reactivation ONLY; does not cover CMV

2 B. If unable to acquire or tolerate valganciclovir (i.e. adverse effects, costs, insurance, etc.), consider the following options: 1. Preemptive therapy in addition to the following: a. Acyclovir 400 mg PO BID x 6-12 months OR b. Valacyclovir 2 grams PO QID x 6-12 months 2. If valganciclovir is discontinued due to leucopenia, then check CMV antigenemia weekly. If patients ANC < 1000, check CMV PCR instead. II. CMV Treatment A. Initiate treatment if CMV Rapid Antigen (pp65 antigenemia) is positive. Acquire CMV DNA by PCR (quantitative) as soon as possible and continue to treat for asymptomatic or symptomatic patients. B. Asymptomatic patient CMV Viral Load (DNA PCR) < 1000 copies/ml > 1000 copies/ml Treatment *** None or Valganciclovir 900 mg PO BID Secondary Prophylaxis ^^^ None Valganciclovir 900 mg PO Daily ### CMV PCR weekly until 3 consecutive (-) results CBC and BMP weekly in *** Duration: minimum of 14 days based on clinical symptoms and virologic clearance (two consecutive negative samples). Initial treatment with IV ganciclovir for severe or life- threatening disease, high viral load, or questionable GI absorption ^^^ Duration: 1-3 months, beginning 1 week after negative CMV PCR ### If recurrence of PCR > 1000 within 3 months of previous treatment, then continue valganciclovir 900 mg PO Daily for life C. Symptomatic patient and/or Tissue-Invasive Disease CMV Viral Load (DNA PCR) > 250 copies/ml Treatment *** D (+) / R (-) Cytogam IV (100 mg/kg) ### Secondary Prophylaxis ^^^ Valganciclovir 900 mg PO Daily CMV PCR every 72 hours until negative CBC and BMP weekly while in treatment phase *** Duration: minimum of 14 days based on clinical symptoms and virologic clearance ^^^ Duration: 1-3 months, beginning when clinical symptoms improve ### Days 1, 4, and 7. For critically ill patients, administer additional doses on Days 14 and 21.

3 D. Ganciclovir Resistance (2 weeks of treatment with increasing/unchanged viral load) 1. Send for CMV genotypic resistance testing (mutations in UL97 and UL54) 2. Consult Infectious Disease service 3. Empiric Treatment: Treatment ^^^ Secondary Prophylaxis Severe CMV Disease *** add / switch to Foscarnet 60 mg/kg IV Q 8 Hours Valganciclovir 900 mg PO Daily x 1-3 months Non-Severe CMV Disease Ganciclovir 10 mg/kg IV Q 12 Hours or Foscarnet 60 mg/kg IV Q 8 Hours Valganciclovir 900 mg PO Daily x 1-3 months CBC and BMP weekly while in CBC and BMP weekly while in *** Consider dose reduction of immunosuppressive therapy in patients with severe CMV disease, nonresponsive disease, high viral loads, and/or leucopenia. Consider Cytogam as an adjunct to antiviral therapy. ^^^ Continue therapy until symptoms improve, then start secondary prophylaxis. Adjust dosing of medications based upon renal function. 4. Definitive Treatment a. Guided by results of genotypic testing References: 1. Zamora MR, Davis RD, Colm L. Management of cytomegalovirus infection in lung transplant recipients: evidence-based recommendations. Transplantation. 2005;80: Kotton CN, Kumar D, Caliendo AM, et al. International consensus guidelines on the management of cytomegalovirus in solid organ transplanatation. Transplanation. 2011; 89: Razonable RR. Humar A, et al. Cytomegalovirus in solid organ transplantation. American Journal of Transplantation. 2013; 13: Snydman DR, Limaye AP, Potena L, et al. Update and review: state-of-the-art management of cytomegalovirus infection and disease following thoracic organ transplantation. Transplantations Proceedings. 2011; 43:S Mitsani D, Nguyen MH, Kwak EJ, et al. Cytomegalovirus disease among donor-posititve / recipient-negative lung transplant recipients in the era of valganciclovir prophylaxis. Journal of Heart Lung Transplant. 2010; 29: Copeland AF, Davis WA, Snyder LD, et al. Long term efficacy and safety of 12-months of valganciclovir prophylaxis compared with 3 months after lung transplantation: a singlecenter, long-term, follow-up analysis from a randomized, controlled cytomegalovirus prevention trial. 2011; 30: Bonaros N, Mayer B, Schachner T, et al. CMV-hyperimmune globulin for preventing cytomegalovirus infection and disease in solid organ transplant recipients: a meta-analysis. Clin Transplant. 2008; 22:89-97.

4 8. Kruger RM, Paranjothi S, Storch GA, et al. Impact of prophylaxis with cytogam alone on the incidence of CMV viremia in CMV-seropositive lung transplant recipients. Journal of Heart Lung Transplant. 2003; 22: Zamora MR, Nicolls MR, Hodge TN, et al. Following universal prophylaxis with intravenous ganciclovir and cytomegalovirus immune globulin, valganciclovir is safe and effective for prevention of CMV infection following lung transplantation. American Journal of Transplantation. 2004; 4: Asberg A, Humar A, Rollag H, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. American Journal of Transplant. 2007; Dosing of Antiviral Mediations for Renal Impairment Ganciclovir (Cytovene ) - IV Creatinine Clearance (mg/kg/dose) Dosing Interval (hours) (mg/kg/dose) Dosing Interval (hours) to to to < times weekly post-hd times weekly post-hd Valganciclovir (Valcyte ) Creatinine Clearance mg po twice daily 900 mg po daily po twice daily 450 mg po daily mg po once daily 450 mg po every other day mg every other day 450 twice weekly < 10 (on hemodialysis) not not Acyclovir (Zovirax ) Creatinine Clearance Normal Dose Regimen Adjusted Dose Regimen > mg po twice daily 400 mg po twice daily 0 to 10 (post-hd) 400 mg po twice daily 200 mg po twice daily

5 Foscarnet (Foscavir ) CrCl (ml/min/kg) (equivalent to 180 mg/kg/day) > mg/kg Q 8H > 1.0 to mg/kg Q 8H > 0.8 to 1.0 > 0.6 to 0.8 > 0.5 to to 0.5 < mg/kg Q 60 mg/kg Q 90 mg/kg Q 70 mg/kg Q 80 mg/kg Q 60 mg/kg Q (equivalent to 90 or 120 mg/kg/day) 90 mg/kg Q 120 mg/kg Q 70 mg/kg Q 90 mg/kg Q 65 mg/kg Q 80 mg/kg Q 105 mg/kg Q 60 mg/kg Q 80 mg/kg Q 65 mg/kg Q Compliance, Policy & Regulatory Committee Approval 11/21/2013 Reinaldo Rampolla, M.D. Medical Director, Lung Transplantation 12/5/2013 George E. Loss, Jr., Ph.D., M.D. Chief, Multi-Organ Transplant Institute 12/11/2013

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