Comparison of the efficacy and safety of valaciclovir and acyclovir for the treatment of herpes zoster ophthalmicus

Objective: To compare the efficacy and safety of valaciclovir and acyclovir in immunocompetent patients with herpes tester ophthalmicus. Design: A multicenter, randomized, double-masked study. Participants: One hundred ten immunocompetent patients with herpes tester o phthalmicus diagnosed within 72 hours of skin eruption were treated; 56 wer e allocated to the valaciclovir group and 54 to the acyclovir group. Methods: Patients randomized to the valaciclovir group received two 500-mg tablets of valaciclovir three times daily and one tablet of placebo twice d aily. Patients in the acyclovir group received one 800-mg tablet of acyclov ir five times daily and one tablet of placebo three times daily for 7 days. Main Outcome Measures: Main outcome measures included the frequency, severi ty, and duration of ocular complications, patient reports of tester-associa ted pain, and the outcome of skin lesions. Tolerance was also assessed on t he incidence and types of adverse effects and changes in laboratory paramet ers. The analysis was mainly descriptive and performed on an intent-to-trea t basis. Results: Ocular complications of herpes tester ophthalmicus were similar in the valaciclovir and acyclovir treatment groups. The main complications we re conjunctivitis (54% and 52%, respectively), superficial keratitis (39% a nd 48%, respectively for punctate keratitis; 11% in each group for dendriti c keratitis), stromal keratitis (13% in each group), and uveitis (13% and 1 7%, respectively). The long-term outcomes of these ocular complications wer e favorable and similar in both treatment groups. Pain duration and severit y and outcome of skin lesions were similar between groups. Most patients re ported prodromal pain. After 1 month, 25% of patients in the valaciclovir g roup and 31% in the acyclovir group still reported pain. The percentage of patients experiencing postherpetic neuralgia decreased during follow-up. Th e tolerance to acyclovir and valaciclovir was comparable and considered goo d. The most frequent adverse events were vomiting and edema of the eyelids or face (3%-5%). Three serious adverse events not linked to the study drugs occurred. Conclusions: Valaciclovir is as effective as acyclovir in preventing ocular complications of herpes tester ophthalmicus, including conjunctivitis, sup erficial and stromal keratitis, and pain. Tolerability of the two drugs is similar, but the dosing schedule of valaciclovir is simpler. Ophthalmology 2000;107:1507-1511 (C) 2000 by the American Academy of Ophthalmology.