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Discontinuation of Anticytomegalovirus Therapy in Patients With HIV Infection and Cytomegalovirus Retinitis
Scott M. Whitcup, MD;
Eric Fortin, MD;
Anne S. Lindblad, PhD;
Paul Griffiths, MD;
Julia A. Metcalf, BA;
Michael R. Robinson, MD;
Jody Manischewitz, MS;
Barbara Baird, RN;
Cheryl Perry, RN;
I. Michael Kidd, PhD;
Tamara Vrabec, MD;
Richard T. Davey, Jr, MD;
Judith Falloon, MD;
Robert E. Walker, MD;
Joseph A. Kovacs, MD;
H. Clifford Lane, MD;
Robert B. Nussenblatt, MD;
Janine Smith, MD;
Henry Masur, MD;
Michael A. Polis, MD
JAMA. 1999;282:1633-1637.
Context Persons with cytomegalovirus (CMV) retinitis and acquired immunodeficiency 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 antiretroviral therapy (HAART) and who had stable CMV retinitis could safely discontinue anti-CMV therapy without reactivation of their retinitis or increase in human immunodeficiency virus (HIV) viral load.
Design Prospective nonrandomized interventional trial performed from July 1997 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 109/L and being treated with systemic anti-CMV medications and HAART.
Interventions Discontinuation of specific anti-CMV therapy.
Main Outcome Measures Reactivation of CMV retinitis, development of extraocular CMV infection, detection of CMV in blood and urine, HIV burden, immunologic function, quality of life, morbidity, and mortality.
Results Twelve (89.7%) of 14 patients had evidence of immune recovery uveitis 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 patients but did not predict reactivation of CMV disease. Worsening immune recovery uveitis was associated with a substantial (>3 lines) vision loss in 3 patients.
Conclusions Maintenance anti-CMV medications were safely stopped in those patients who had stable CMV retinitis and elevated CD4+ cell counts and who were taking HAART. The study demonstrates that immune recovery following potent antiretroviral therapy is effective in controlling a major opportunistic infection, even in patients with a history of severe immunosuppression.
Author Affiliations: The Clinical Branch (Drs Whitcup and Smith and Ms Perry) and Laboratory of Immunology (Drs Fortin, Robinson, and Nussenblatt), National Eye Institute; Laboratory of Immunoregulation, The National Institute of Allergy and Infectious Diseases (Ms Metcalf and Drs Davey, Falloon, Walker, Lane, and Polis); and The Critical Care Medicine Department, Clinical Center, (Ms Baird and Drs Kovacs, and Masur), National Institutes of Health, Bethesda, Md; The EMMES Corporation, Potomac, Md (Dr Lindblad); Laboratory of Virology/Retrovirology, CBER, Food and Drug Administration, Rockville, Md (Ms Manischewitz); Departments of Virology, The Royal Free Hospital School of Medicine, London, England (Drs Griffiths and Kidd); and the Department of Ophthalmology, Wills Eye Hospital, Philadelphia, Pa (Dr Vrabec).
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