What is the recommended dose of valganciclovir (Valcyte) for the treatment of Cytomegalovirus (CMV) disease?

Valganciclovir Dosing for CMV Disease

For treatment of CMV disease in adults, valganciclovir 900 mg orally twice daily for 14-21 days (induction therapy) followed by 900 mg once daily for chronic maintenance therapy is the recommended regimen. 1, 2, 3

Induction Therapy Dosing

Standard Adult Dosing

• Valganciclovir 900 mg orally twice daily for 14-21 days is the established induction dose for CMV retinitis 1, 2
• This oral regimen provides ganciclovir exposure (AUC) comparable to intravenous ganciclovir 5 mg/kg twice daily 3, 4, 5
• The 900 mg twice daily dose was proven equally effective to IV ganciclovir in a randomized controlled trial of 160 AIDS patients with newly diagnosed CMV retinitis 3, 5

CMV Colitis or Esophagitis

• Initial IV ganciclovir 5 mg/kg twice daily for 3-5 days, followed by valganciclovir 900 mg twice daily for the remainder of a 2-3 week course is recommended 2
• Alternatively, if symptoms are not severe enough to interfere with oral absorption, valganciclovir 900 mg twice daily can be used from the start for 21-28 days 1

CNS Disease

• Combination therapy with ganciclovir 5 mg/kg IV every 12 hours PLUS foscarnet 60 mg/kg IV every 8 hours should be used until symptoms improve, followed by chronic suppressive therapy 1
• This dual approach is preferred for neurologic disease due to the severity and potential for irreversible damage 1

Maintenance (Chronic Suppressive) Therapy

• Valganciclovir 900 mg orally once daily is the standard maintenance dose after completing induction therapy 1, 2
• Maintenance therapy should continue for life unless immune reconstitution occurs (CD4+ count >100 cells/µL sustained for 3-6 months on antiretroviral therapy) 1

Special Populations

Pediatric Patients

• Limited data exists for pediatric dosing of valganciclovir 1, 2
• For children old enough to receive adult dosing, valganciclovir 900 mg once daily is preferred over oral ganciclovir for maintenance therapy 1
• For symptomatic congenital CMV infection with neurologic involvement, IV ganciclovir 6 mg/kg every 12 hours for 6 weeks is recommended rather than valganciclovir 1

Renal Transplant Recipients

• Valganciclovir 450 mg daily provides adequate systemic exposure for CMV prophylaxis in kidney transplant patients and is equipotent to 900 mg for prevention 6, 7
• However, for treatment of active CMV disease (not prophylaxis), the full 900 mg twice daily induction dose should be used 2

Hepatic Dysfunction

• Valganciclovir should not be used in patients with hepatic dysfunction, particularly liver transplant patients, due to higher rates of CMV disease compared with IV ganciclovir 2

Critical Dosing Considerations

Renal Dose Adjustment Required

• All doses must be adjusted for renal function 3, 8
• The FDA label provides specific dose reductions based on creatinine clearance 3

Food Administration

• Valganciclovir should be taken with food to maximize bioavailability (24-56% higher AUC with food) 4

Sequential Therapy Option

• A short course of IV ganciclovir 5 mg/kg twice daily for 5 days followed by valganciclovir 900 mg twice daily for 16 days achieved viral load eradication in 66.7% of solid organ transplant patients 8
• This approach may shorten hospital stay while maintaining efficacy 8

Monitoring Requirements

• Complete blood count monitoring is essential due to risk of myelosuppression (neutropenia, anemia, thrombocytopenia) 2
• Dose reduction or interruption may be necessary in up to 40% of patients due to hematologic toxicity 2
• Renal function should be monitored regularly as renal toxicity can occur 2
• For CMV retinitis, dilated indirect ophthalmoscopy should be performed at diagnosis, after induction completion, at 1 month, and monthly thereafter while on treatment 1

Common Pitfalls to Avoid

• Do not use the prophylaxis dose (450-900 mg once daily) for active CMV disease treatment—induction requires twice daily dosing 2, 6
• Do not delay antiretroviral therapy initiation in patients with CMV retinitis, gastrointestinal disease, or pneumonitis, as no evidence suggests worsening of disease 1
• Do not use valganciclovir for sight-threatening retinitis lesions without considering ganciclovir intraocular implant plus oral valganciclovir, which is superior for preventing relapse 1