A controlled trial of oral acyclovir for iridocyclitis caused by herpes simplex virus. The Herpetic Eye Disease Study Group
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: Patients with
HSV iridocyclitis were enrolled in a multicenter controlled clinical trial
supported by the National Eye Institute, Bethesda, Md, and randomly
assigned to receive a 10-week course of either oral acyclovir, 400 mg, 5
times daily, or oral placebo in conjunction with regimens of topical
trifluridine and a topical corticosteroid. Follow-up examinations were
performed weekly during the 10-week treatment period, every 2 weeks for an
additional 6 weeks, and at 26 weeks after enrollment in the trial.
Treatment failure was defined as a persistence or worsening of ocular
inflammation, withdrawal of medication because of toxicity, or a request by
the patient to withdraw from the trial for any reason. The trial was
stopped because of slow recruitment after only 50 of the originally planned
104 patients were enrolled in more than 4 years. RESULTS: A treatment
failure occurred in 11 (50%) of the 22 patients in the acyclovir-treated
group and in 19 (68%) of the 28 patients in the placebo group. Compared
with the placebo group, the adjusted rate ratio for a treatment failure in
the acyclovir-treated group during 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-week treatment period plus 6-week observation
period) was 0.60 (90% confidence interval, 0.29-1.25; P = .13, 1-tailed in
a proportional hazards model). The treatment effect seemed slightly greater
when only the patients with a persistence or worsening of ocular HSV
disease were considered as treatment failures (ie, excludes terminations
because of toxic effects of the drug and patients who requested to withdraw
from the trial). By life-table analysis, similar results were obtained; the
possible 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 trend in the
results suggests a benefit of oral acyclovir in the treatment of HSV
iridocyclitis in patients receiving topical corticosteroids and
trifluridine prophylaxis.
