ADVERSE EVENTS AND AUTOPSY FINDINGS AFTER INTRAVITREOUS CIDOFOVIR (HPMPC) THERAPY IN PATIENTS WITH ACQUIRED-IMMUNE-DEFICIENCY-SYNDROME (AIDS)

Objective: The purpose of the study is to evaluate the adverse events and autopsy findings in a series of consecutive 20-mu g intravitreous cidofovir injections at a single institution. Design: The study design was a nonrandomized, consecutive case series. Participants: Seventy-s ix patients with acquired immune deficiency syndrome with cytomegalovi rus retinitis were studied prospectively. Sixty-three patients had 1 m onth's follow-up or longer, and this comprised the study group. In add ition, histopathologic findings from 18 eyes of 9 patients were studie d at autopsy. Intervention: A total of 296 injections of 20 mu g cidof ovir were given in 115 eyes. Sixty-three patients who had 246 injectio ns in 93 eyes had 1 month's follow-up or longer for the evaluation of adverse events. Main Outcome Measures: Postinjection chronic hypotony associated with permanent visual loss, transient hypotony, iritis, and its long-term sequela (posterior synechia and cataract, retinal detac hment, extraocular cytomegalovirus involvement) were the outcomes of i nterest in this study. Additionally, light and electron microscopic st udies of human eyes were performed. Results: The most severe adverse e vent was postinjection chronic hypotony. This phenomenon was associate d with permanent visual loss. This was observed in 1% of the injection s and 3% of the eyes of the patients (95% confidence interval, 0%-6%). Transient hypotony associated with mild-to-moderate visual loss devel oped in 14%, but vision recovered to baseline levels in these eyes sub sequently. Analysis showed that transient hypotony in the injected eye could predict postinjection chronic hypotony in the fellow eye (two-t ailed Fisher's exact test, P = 0.02). The incidence of iritis was 32%; posterior synechia and cataract were the long-term sequela of the iri tis and developed in 19% and 11% of the eyes, respectively. The incide nce of retinal detachment was lower (6%). Histopathologic evaluation o f the eyes showed mild-to-moderate atrophy of the nonpigmented epithel ium of the ciliary body and no other evidence of intraocular toxicity. Conclusions: The most serious adverse event was postinjection chronic hypotony, which occurred in 3% of eyes. Episodes of transient hypoton y appear to indicate that the fellow eye was predisposed to chronic hy potony. Therefore, it may be prudent to give intravitreous injections at least 2 weeks apart in the fellow eye to evaluate the clinical resp onse of the injected eye.