Elsevier

Ophthalmology

Volume 107, Issue 8, 1 August 2000, Pages 1507-1511
Ophthalmology

Comparison of the efficacy and safety of valaciclovir and acyclovir for the treatment of herpes zoster ophthalmicus1☆,

https://doi.org/10.1016/S0161-6420(00)00222-0Get rights and content

Abstract

Objective

To compare the efficacy and safety of valaciclovir and acyclovir in immunocompetent patients with herpes zoster ophthalmicus.

Design

A multicenter, randomized, double-masked study.

Participants

One hundred ten immunocompetent patients with herpes zoster ophthalmicus diagnosed within 72 hours of skin eruption were treated; 56 were 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 daily. Patients in the acyclovir group received one 800-mg tablet of acyclovir five times daily and one tablet of placebo three times daily for 7 days.

Main outcome measures

Main outcome measures included the frequency, severity, and duration of ocular complications, patient reports of zoster-associated pain, and the outcome of skin lesions. Tolerance was also assessed on the incidence and types of adverse effects and changes in laboratory parameters. The analysis was mainly descriptive and performed on an intent-to-treat basis.

Results

Ocular complications of herpes zoster ophthalmicus were similar in the valaciclovir and acyclovir treatment groups. The main complications were conjunctivitis (54% and 52%, respectively), superficial keratitis (39% and 48%, respectively for punctate keratitis; 11% in each group for dendritic keratitis), stromal keratitis (13% in each group), and uveitis (13% and 17%, respectively). The long-term outcomes of these ocular complications were favorable and similar in both treatment groups. Pain duration and severity and outcome of skin lesions were similar between groups. Most patients reported prodromal pain. After 1 month, 25% of patients in the valaciclovir group and 31% in the acyclovir group still reported pain. The percentage of patients experiencing postherpetic neuralgia decreased during follow-up. The tolerance to acyclovir and valaciclovir was comparable and considered good. 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 zoster ophthalmicus, including conjunctivitis, superficial and stromal keratitis, and pain. Tolerability of the two drugs is similar, but the dosing schedule of valaciclovir is simpler.

Section snippets

Patients and methods

Immunocompetent patients 18 years of age or more with herpes zoster ophthalmicus diagnosed within 72 hours of skin eruption were eligible for this multicenter, randomized, double-masked study. The study was conducted in five study centers in France. Patients with other preexisting ocular disorders, renal failure (creatinine clearance <30 ml/min), immune dysfunction or disease necessitating cytotoxic or immunosuppressive treatment, liver failure, or intolerance or hypersensitivity to acyclovir

Results

One hundred ten immunocompetent patients were treated from July 1, 1994, through October 16, 1995 (n = 56 in the valaciclovir group; n = 54 in the acyclovir group). All patients were included in the intent-to-treat analysis. Fourteen patients withdrew (n = 4 valaciclovir group; n = 10 acyclovir group) as a result of disseminated zoster leading to hospital admission (n = 1), consent withdrawal (n = 5), kidney disorder (n = 5), a change in diagnosis (n = 1), loss to follow-up (n = 1), and a

Discussion

Several studies have demonstrated that valaciclovir is an effective treatment for herpes zoster.15, 16 In one comparative study of valaciclovir and acyclovir, in which a subset of 51 ophthalmic herpes zoster patients were analyzed, more than 90% of all patients had resolution of the ocular involvement within 5 weeks.15

In our study, valaciclovir 1000 mg three times daily helped reduce the incidence of the ocular complications of herpes zoster ophthalmicus to a similar degree as acyclovir 800 mg

Acknowledgements

For the French Zophtaval Working Group: JP Adenis, A Bron, D Rigal, I Riss-Tapiero, X Caradec, M Mouillon, JA Gastaud, M Montard, G Renard, C Kisterman, JL Arne, P Le Hoang.

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☆

Supported by Glaxo Wellcome, France.

1

Received April 29, 1999. Accepted April 3, 2000.

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Copyright © 2000 American Academy of Ophthalmology, Inc. Published by Elsevier Inc. All rights reserved.