Ganciclovir (see Antiviral Drugs) is approved for both induction and maintenance Treatment of retinitis caused by acquired or recurrent CMV Infection in immunocompromised patients, including HIV-infected adults, and for prevention of CMV Infection in transplant recipients. Ganciclovir also is used to treat CMV Infections of other sites (esophagus, colon, lungs) and for preemptive Treatment of immunosuppressed adults with CMV antigenemia or viremia. Limited data in children suggest that safety and efficacy are similar to those in adults. Oral ganciclovir no longer is available in the United States, but oral valganciclovir is available in tablet form.
Limited data in neonates with symptomatic congenital CMV disease involving the central nervous system (CNS) suggest possible benefit of 6 weeks of parenteral ganciclovir therapy (6 mg/kg/dose administered intravenously every 12 hours) for protecting against hearing deterioration and potentially in decreasing developmental impairment at 1 to 2 years of age. Therapy is not recommended routinely in this population because of possible toxicities and adverse events associated with prolonged intravenous therapy in young infants with a medication that causes neutropenia in a significant proportion of recipients. If parenteral ganciclovir is used in the management of these patients, its use should be limited to patients with symptomatic congenital CMV disease involving the central nervous system who are able to start Treatment within the first month of life. Experts differ in opinion as to whether patients with isolated hearing loss should be classified as symptomatic with CNS involvement; however, patients with such limited involvement are not the group in which therapeutic benefit has been documented. A liquid formulation of valganciclovir is not available commercially, and extemporaneously compounded preparations have not been evaluated sufficiently to ensure the stability and pharmacokinetics of such formulations. A research grade of pharmaceutically produced valganciclovir is being evaluated in clinical trials conducted by the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.
Preterm infants with perinatally acquired CMV Infection can have symptomatic, end-organ disease (eg, pneumonitis, hepatitis, thrombocytopenia). Antiviral Treatment has not been studied in this population. If such patients are treated with parenteral ganciclovir, a reasonable approach is to treat for 2 weeks and then reassess responsiveness to therapy. If clinical data suggest benefit of Treatment, an additional 1 to 2 weeks of parenteral ganciclovir can be considered if symptoms and signs have not been resolved.
In stem cell transplant recipients, the combination of Immune Globulin Intravenous (or CMV Immune Globulin Intravenous) and ganciclovir administered intravenously has been reported to be synergistic in Treatment of CMV pneumonia. Valganciclovir and foscarnet also have been approved for Treatment and maintenance of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) (see Antiviral Drugs). Foscarnet is more toxic but may be advantageous for some patients with HIV infection, including people with disease caused by ganciclovir-resistant virus or people who are unable to tolerate ganciclovir. Cidofovir is efficacious for maintenance therapy of CMV retinitis in adults with AIDS and CMV retinitis, but cidofovir has not been studied in children and is nephrotoxic.
As in all human hosts, CMV establishes lifelong latency and, as such, is not eliminated from the body with antiviral Treatment of CMV disease. Until immune reconstitution is achieved with highly active antiretroviral therapy (HAART), chronic suppressive therapy should be administered to HIV-infected patients with a history of CMV end-organ disease (eg, retinitis, colitis, pneumonitis) to prevent recurrence. Recognizing limitations of the pediatric data but drawing on the growing experience in adult patients, discontinuing prophylaxis may be considered for pediatric patients 1 to 6 years of age who are receiving HAART therapy and have a sustained (eg, greater than 6 months) increase in CD4+ T-lymphocyte count to greater than 500 cells/mm3 or CD4+ T-lymphocyte percentage to greater than 15%, and for children older than 6 years of age, an increase in CD4+ T-lymphocyte count to greater than 100 cells/mm3 or CD4+ T-lymphocyte percentage to greater than 15%. Such decisions should be made in close consultation with an ophthalmologist and should take into account such factors as magnitude and duration of CD4+ T-lymphocyte increase, anatomic location of the retinal lesion, vision in the contralateral eye, and the feasibility of regular ophthalmologic monitoring. All patients who have had anti-CMV maintenance therapy discontinued should continue to undergo regular ophthalmologic monitoring at least 3 to 6 month intervals for early detection of CMV relapse as well as for immune reconstitution uveitis.
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