3rd Conference on Retroviruses and Opportunistic Infections Washington, DC - January 28-February 1, 1996

Conf Retroviruses Opportunistic Infect 1996 Jan 28-Feb 1; 3rd:54 (abstract no. 9)

Wolitz R, Friedberg D, Spector SA, Wong R, Stempien MJ
Kaiser Permanente, San Francisco, CA.

Concern has been expressed that oral ganciclovir (GCV) prophylaxis may alter the initial presentation or treatment outcome of patients who develop cytomegalovirus (CMV) retinitis during or following prophylaxis. A randomized placebo (PLA)-controlled study of the efficacy and safety of 3 grams oral GCV daily for prevention of CMV disease in people infected with HIV was recently completed. For the cohort of patients who developed retinitis, data on presentation was gathered at time of diagnosis. Retinitis treatment outcome was assessed through review of medical records.

RESULTS: Of 725 randomized patients, 111 developed CMV retinitis based on an intent-to-treat analysis. Kaplan-Meier estimates of 18-month retinitis rates were 18% (GCV) and 39% (PLA), a 49% overall risk reduction (p < 0.001). At diagnosis, GCV and PLA patients were balanced with regard to age, sex, ethnic origin, Karnofsky score, and CD4 count (GCV, mean CD4 11 µL; PLA, mean CD4 13 µL). At diagnosis, there was a greater frequency of sight-threatening (Zone 1) retinitis among PLA patients (GCV, 16%, 9/55; PLA, 39%, 20/51, p<0.01), and the frequency of bilateral Zone 1 retinitis was also greater among PLA patients (GCV, 2%, 1/54; PLA, 8%., 4/51). Peripheral (Zones 2 and 3) involvement was similar between groups. Bilateral retinitis was present at diagnosis in 20% (12/59) of GCV and 25% (13/52) of PLA patients. Ganciclovir was the initial retinitis therapy for 94% (98/104) of subjects who developed retinitis. Treatment outcome data show no significant difference for time to retinitis progression or lack of response (relative risk GCV:PLA= 0.82).

CONCLUSION: Oral ganciclovir prophylaxis significantly decreases the risk of developing CMV retinitis, in particular, sight-threatening (Zone 1) retinitis.

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Copyright © 1996 - Foundation for Retrovirology and Human Health . Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health.