Oral acyclovir for herpes simplex virus eye disease: effect on prevention of epithelial keratitis and stromal keratitis. Herpetic Eye Disease Study Group.

OBJECTIVES: To investigate the effect of oral acyclovir therapy for recurrences of herpes simplex virus (HSV) epithelial keratitis and stromal keratitis and to determine if certain patients derive differential benefit.
DESIGN: This randomized, double-masked clinical trial enrolled 703 immunocompetent patients with prior HSV eye disease within the preceding year; assigned 357 patients to receive oral acyclovir, 800 mg/d, and 346 to receive placebo; and followed up patients during a 12-month treatment period for the development of HSV eye disease.
RESULTS: The cumulative probability of a recurrence of any type of ocular HSV disease during the 1-year treatment period was 19% in the acyclovir group compared with 32% in the placebo group. Sixteen patients in the acyclovir group and 30 in the placebo group had more than 1 recurrence. A benefit was seen for preventing both epithelial keratitis (rate ratio, 0.62; 95% confidence interval, 0.39-0.97) and stromal keratitis (rate ratio, 0. 57; 95% confidence interval, 0.36-0.89). Although a relative benefit of treatment on preventing any type of recurrence was present in most subgroups, the magnitude of absolute benefit was greatest among patients with the highest number of prior episodes of ocular HSV disease. The benefit in preventing stromal keratitis was seen solely among patients with a history of stromal keratitis.
CONCLUSIONS: Long-term suppressive oral acyclovir therapy reduces the rate of recurrent HSV epithelial keratitis and stromal keratitis. Acyclovir's benefit is greatest for patients who have experienced prior HSV stromal keratitis. Arch Ophthalmol. 2000;118:1030-1036

RCT Entities:   Population Interventions Outcomes