A CONTROLLED TRIAL OF ORAL ACYCLOVIR FOR IRIDOCYCLITIS CAUSED BY HERPES-SIMPLEX VIRUS

Objective: To assess the benefit of adding oral acyclovir to a regimen of topical prednisolone phosphate and trifluridine for the treatment of iridocyclitis caused by herpes simplex virus (HSV). Methods: Patien ts with HSV iridocyclitis were enrolled in a multicenter controlled cl inical trial supported by the National Eye Institute, Bethesda, Md, an d randomly assigned to receive a 10-week course of either oral acyclov ir, 400 mg, 5 times daily, or oral placebo in conjunction with regimen s of topical trifluridine and a topical corticosteroid. Follow-up exam inations were performed weekly during the 10-week treatment period, ev ery 2 weeks for an additional 6 weeks, and at 26 weeks after enrollmen t in the trial. Treatment failure was defined as a persistence or wors ening of ocular inflammation, withdrawal of medication because of toxi city, or a request by the patient to withdraw from the trial for any r eason. The trial was stopped because of slow recruitment after only 50 of the originally planned 104 patients were enrolled in more than 4 y ears. Results: A treatment failure occurred in 11 (50%) of the 22 pati ents in the acyclovir-treated group and in 19 (68%) of the 28 patients in the placebo group. Compared with the placebo group, the adjusted r ate ratio for a treatment failure in the acyclovir-treated group durin g the 10-week treatment period was 0.43 (90% confidence interval, 0.18 -1.02; P=.06, 1-tailed) and during the 16-week follow-up period (10-we ek treatment period plus 6-week observation period) was 0.60 (90% conf idence interval, 0.29-1.25; P=.13, 1-tailed in a proportional hazards model). The treatment effect seemed slightly greater when only the pat ients with a persistence or worsening of ocular HSV disease were consi dered as treatment failures tie, excludes terminations because of toxi c effects of the drug and patients who requested to withdraw from the trial). By life-table analysis, similar results were obtained; the pos sible benefit of acyclovir became apparent after the first 3 weeks of follow-up. Conclusion: While the number of patients recruited in this trial was too small To achieve statistically conclusive results, the t rend in the results suggests a benefit of oral acyclovir in the treatm ent of HSV iridocyclitis in patients receiving topical corticosteroids and trifluridine prophylaxis.