Discontinuation of anticytomegalovirus therapy in patients with HIV infection and cytomegalovirus retinitis

Context Persons with cytomegalovirus (CMV) retinitis and acquired immunodef iciency syndrome (AIDS) have required lifelong anti-CMV therapy to prevent the progression of retinal disease and subsequent loss of vision. Objective To determine whether patients who were taking highly active antir etroviral therapy (HAART) and who had stable CMV retinitis could safely dis continue anti-CMV therapy without reactivation of their retinitis or increa se in human immunodeficiency virus (HIV) viral load. Design Prospective nonrandomized interventional trial performed from July 1 997 to August 1999. Setting Clinical Center of the National Institutes of Health, Bethesda, Md. Patients Fourteen patients with stable CMV retinitis and HIV infection and CD4(+) cell counts higher than 0.15 x 10(9)/L and being treated with system ic anti-CMV medications and HAART. Interventions Discontinuation of specific anti-CMV therapy. Main Outcome Measures Reactivation of CMV retinitis, development of extraoc ular CMV infection, detection of CMV in blood and urine, HIV burden, immuno logic function; quality of life, morbidity, and mortality. Results Twelve (89.7%) of 14 patients had evidence of immune recovery uveit is before anti-CMV drugs were discontinued. No patient had reactivation of CMV retinitis or development of extraocular CMV disease during mean follow- up of 16.4 months (range, 8.3-22.0 months) without anti-CMV therapy. Human immunodeficiency viral load remained stable following cessation of anti-CMV medications, Blood and urine assays for CMV were briefly positive in 9 pat ients but did not predict reactivation of CMV disease. Worsening immune rec overy uveitis was associated with a substantial (>3 lines) vision loss in 3 patients. Conclusions Maintenance anti-CMV medications were safely stopped in those p atients who had stable CMV retinitis and elevated CD4(+) cell counts and wh o were taking HAART, The study demonstrates that immune recovery following potent antiretroviral therapy is effective in controlling a major opportuni stic infection, even in patients with a history of severe immunosuppression .