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Previous Volume 333:615-620 September 7, 1995 Number 10 Next

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ABSTRACT

Background Cytomegalovirus retinitis, a sight-threatening infection associated with the acquired immunodeficiency syndrome (AIDS), currently requires lifelong intravenous treatment. An effective oral treatment would be an important advance.

Methods We compared oral with intravenous ganciclovir in an open-label, randomized study in patients with AIDS and newly diagnosed, stable cytomegalovirus retinitis (the disease was stabilized by three weeks of treatment with intravenous ganciclovir). Sixty subjects were randomly assigned to maintenance therapy with intravenous ganciclovir at a dose of 5 mg per kilogram of body weight daily, and 63 to maintenance therapy with oral ganciclovir at a dose of 3000 mg daily. The subjects were followed for up to 20 weeks, with photography of the fundi conducted every other week. The photographs were evaluated at the completion of the study by an experienced grader who was unaware of the subjects' treatment assignments.

Results Efficacy could be evaluated in 117 subjects; photographs were ungradable for 2 of the 117. On the basis of the masked assessment of photographs from 115 subjects, the mean time to the progression of retinitis was 62 days in those given intravenous ganciclovir and 57 days in those given oral ganciclovir (P = 0.63; relative risk [oral vs. intravenous], 1.08; 95 percent confidence interval for the difference in means, -22 to +12 days). On the basis of funduscopy by ophthalmologists who were aware of the subjects' treatment assignments, the mean time to progression was 96 days in subjects given intravenous ganciclovir and 68 days in subjects given oral ganciclovir (P = 0.03; relative risk [oral vs. intravenous], 1.68; 95 percent confidence interval for the difference in means, -45 to -11 days). Survival, changes in visual acuity, the incidence of viral shedding, and the incidence of adverse gastrointestinal events were similar in the two groups. Neutropenia, anemia, intravenous-catheter–related adverse events, and sepsis were more common in the group given intravenous ganciclovir.

Conclusions Oral ganciclovir is safe and effective as maintenance therapy for cytomegalovirus retinitis and is more convenient for patients to take than intravenous ganciclovir.

Source Information

From the University of California, San Francisco–Mt. Zion Medical Center, San Francisco (W.L.D., J.P.L.); Beth Israel Hospital, Boston (D.I., C.C.); Davies Medical Center, San Francisco (S.E.F.); the University of California, San Diego (S.A.S.); Rush Medical College, Chicago (C.A.B.); New York University Medical Center, New York (D.N.F.); the University of Wisconsin, Madison (L.H.); and Syntex Development Research, Palo Alto, Calif. (M.J.S., A.S., W.B.).

Address reprint requests to Dr. Drew at UCSF/Mt. Zion Medical Center, P.O. Box 7921, San Francisco, CA 94120.

Full Text of this Article

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Oral Ganciclovir for Cytomegalovirus Retinitis
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N Engl J Med 1996; 334:55-56, Jan 4, 1996. Correspondence

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