Herpetic eye disease study : a controlled trial of oral acyclovir for herpes simplex stromal keratitis

• Published in: Ophthalmology (Rochester, Minn.) Vol. 101; no. 12; pp. 1871 - 1882
• Main Authors: BARRON, B. A, GEE, L, LAIBSON, P. R, STULTING, R. D, ASBELL, P. A, HAUCK, W. W, KURINIJ, N, DAWSON, C. R, JONES, D. B, WILHELMUS, K. R, KAUFMAN, H. E, SUGAR, J, HYNDIUK, R. A
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 01.12.1994
• Subjects: Acyclovir - administration & dosage; Acyclovir - adverse effects; Acyclovir - therapeutic use; Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Keratitis, Herpetic - drug therapy; Keratitis, Herpetic - physiopathology; Male; Medical sciences; Middle Aged; Patient Compliance; Pharmacology. Drug treatments; Prednisolone - administration & dosage; Prednisolone - therapeutic use; Prospective Studies; Regression Analysis; Treatment Outcome; Trifluridine - administration & dosage; Trifluridine - therapeutic use; United States; Visual Acuity; United States; Human; Corticosteroid; Drug combination; Cornea; Acyclic nucleoside; Purine nucleoside; Herpesviridae; Treatment efficiency; Alphaherpesvirinae; Oral administration; Herpes; Keratopathy; Infection; Virus; Eye disease; Chemotherapy; Ophthalmic preparation; Treatment; Viral disease; Antiviral; Ulcer; Herpesvirus hominis; Fluorine Organic compounds; Pyrimidine nucleoside
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/S0161-6420(13)31155-5

To evaluate the efficacy of oral acyclovir in treating stromal keratitis caused by herpes simplex virus (HSV) in patients receiving concomitant topical corticosteroids and trifluridine. The authors performed a randomized, double-masked, placebo-controlled, multicenter trial in 104 patients with HSV stromal keratitis without accompanying HSV epithelial keratitis. Sample size was chosen so that a 5%, one-tailed test would have an 80% chance of detecting a doubling of the median time to treatment failure. Patients were randomized to receive a 10-week course of either oral acyclovir (400 mg 5 times daily, n = 51) or placebo (n = 53). All patients also received a standard regimen of topical prednisolone phosphate and trifluridine. Ophthalmologic examinations were performed weekly during the 10-week treatment period, every 2 weeks for an additional 6 weeks, and at 6 months after entry into the trial. The median time to treatment failure (defined as worsening or no improvement of stromal keratitis or an adverse event) was 84 days (95% confidence interval, 69-93 days) for the acyclovir group and 62 days (95% confidence interval, 57-90 days) for the placebo group. By 16 weeks, 38 patients (75%) in the acyclovir group and 39 patients (74%) in the placebo group had failed treatment. Also by that time, the keratitis had resolved with trial medications, and there was no subsequent worsening in nine patients (18%) in the acyclovir group and ten (19%) in the placebo group. None of these results were significantly different between the two groups. However, visual acuity improved over 6 months in significantly more patients in the acyclovir group than in the placebo group. There was no statistically or clinically significant beneficial effect of oral acyclovir in treating HSV stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine with regard to time to treatment failure, proportion of patients who failed treatment, proportion of patients whose keratitis resolved, time to resolution, or 6-month best-corrected visual acuity. Visual acuity improved over 6 months in more patients in the acyclovir group than in the placebo group.