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GANCICLOVIR PREVENTS CMV DISEASE IN AIDS.

Cytomegalovirus infections, particularly CMV retinitis, are common and extremely debilitating in late- stage AIDS. The new oral formulation of ganciclovir prompted this Roche-sponsored study of its efficacy in CMV prophylaxis.

In a prospective, randomized, blinded format, 725 persons with severe HIV-related immunosuppression received either oral ganciclovir (1000 mg three times daily) or placebo for a median one-year follow-up. Screening ophthalmologic exams were performed at two-month intervals, whether visual symptoms were present or not.

The incidence of end-organ CMV disease was almost halved in the group receiving ganciclovir (14 vs. 26 percent); retinitis diagnosed by characteristic fundoscopic appearance accounted for the vast majority of these infections. Ganciclovir had few serious toxic effects other than bone- marrow suppression: 14 percent of recipients required erythropoietin, and 24 percent required granulocyte colony- stimulating factor during treatment (compared with 6 and 9 percent of the placebo group, respectively). Despite ganciclovir's prophylactic efficacy against CMV disease, it did not affect overall survival.

Comment: Oral ganciclovir is clearly effective in preventing CMV retinitis in a vulnerable population. However, important quality-of-life issues remain: namely, the drug's efficacy in preventing symptomatic disease and prolonging healthy survival. A positive impact on these variables might justify ganciclovir's significant expense and toxicity as a long-term prophylactic agent.

— A Zuger

Published in Journal Watch General Medicine June 25, 1996

Citation(s):

Spector SA et al. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. N Engl J Med 1996 Jun 6 334 1491-1497.

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