Efficacy and safety of aciclovir mucoadhesive buccal tablet in immunocompetent patients with labial herpes (LIP Trial): a double-blind, placebo-controlled, self-initiated trial.

BACKGROUND: Single-day, high-dose systemic antiviral drugs are effective in the treatment of labial herpes (herpes labialis [HL]). Aciclovir Lauriad(R) mucoadhesive buccal tablet (ABT) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in the oral cavity, supporting its evaluation as a single low dose in HL. METHODS: In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up period (intention-to-treat population). RESULTS: With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe. CONCLUSION: A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence.