Journal Logo

Clinical Studies

FAMCICLOVIR FOR OPHTHALMIC ZOSTER: A RANDOMIZED ACICLOVIR CONTROLLED STUDY

Rapuano, Christopher J. MD

Author Information
  • Free

Tyring S, Engst R, Corriveau C, Palestine A, et al. Famciclovir for ophthalmic zoster: a randomized aciclovir controlled study. Br J Ophthalmol 2001;85:576–581.

Original study reprint requests: Alan G. Palestine, 1145 19th Street, NW, Suite 900, Washington, DC 20036.

Research Objective

To compare the efficacy and safety of famciclovir with aciclovir for the treatment of ophthalmic zoster.

Study Design

A randomized, double-masked, prospective controlled study.

Location

Multicentered worldwide in 87 centers.

Funding Source

SmithKline Beecham Pharmaceuticals, Collegeville, PA, and Harlow, UK.

Relevant Methodology

Four hundred fifty-four patients with ophthalmic zoster of trigeminal nerve (V1) comprised the intent-to-treat population. Oral famciclovir 500 mg three times daily or oral aciclovir 800 mg five times daily for 7 days were the treatment arms. Assessments included day 0 (screening), days 3 and 7 (during treatment), days 10, 14, 21, 28, and monthly thereafter, up to 6 months (follow-up). Proportion of patients who experienced ocular manifestations, severe manifestations, and nonsevere manifestations.

Outcome Measures

Loss of visual acuity.

Results

The percentage of patients who experienced one or more ocular manifestations was similar for famciclovir (142/245, 58.0%) and aciclovir (114/196, 58.2%) recipients, with no significant difference between groups (OR 0.99; 95% CI 0.68, 1.45). The percentage of patients who experienced severe and nonsevere manifestations was similar between groups, with no significant difference. The prevalence of individual ocular manifestations was comparable between groups. There was no significant difference between groups for visual acuity loss.

Conclusions

Famciclovir 500 mg three times daily was well tolerated and demonstrated efficacy similar to aciclovir 800 mg five times daily.

Comment

Famciclovir has been shown previously to be effective in treating uncomplicated herpes zoster infections, both in placebo-controlled and aciclovir-controlled trials. Additionally, aciclovir has been shown to be effective in treating herpes zoster ophthalmicus (HZO). This study was designed to compare oral famciclovir 500 mg 3 × day with oral aciclovir 800 mg 5 × day for 7 days in the treatment of HZO. It is a well-designed, multicenter, randomized, and double-masked trial with 454 patients treated. (Note: my group at Wills was one of the treatment centers.) Demographic characteristics and ocular manifestations at baseline were comparable between the two groups.

Ocular manifestations, both severe (including anterior uveitis, keratitis, and glaucoma) and nonsevere (including punctate epithelial keratitis, conjunctivitis, and subepithelial infiltrates) were almost identical between the two groups, both during the treatment period and for up to 6 months of follow-up. Adverse experiences, most commonly nausea (10%), headache (5%) and vomiting (5%), were similar for the two medications.

Certainly, if a patient with HZO is seen within 72 hours of first developing the rash, an oral antiviral medication should be started immediately and continued for 7 days. Famciclovir is as effective as aciclovir and is only used three times daily, compared with five times daily for aciclovir. However, in the United States, aciclovir is available as a generic medication (Wills/Jefferson pharmacy cost to patient for 7 days = $22.30), whereas famciclovir is not (Wills/Jefferson pharmacy cost to patient for 7 days = $113.96). If cost is not an issue, the three times daily dosing of famciclovir is more convenient. However, if cost is a factor, aciclovir has a distinct advantage.

© 2002 Lippincott Williams & Wilkins, Inc.