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

Abstract

BACKGROUND:

Single-day, high-dose systemic antiviral drugs are effective in the treatment of labial herpes (herpes labialis [HL]). Aciclovir Lauriad® 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.

• Authors: Thomas Bieber, Olivier Chosidow, Neil Bodsworth, Stephen Tyring, Jana Hercogova, Mark Bloch, Matthew Davis, Michael Lewis, David Boutolleau, Pierre Attali, LIP Study Group
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 13 Issue 7 Pg. 791-8 (Jul 2014) ISSN: 1545-9616 [Print] United States
• PMID: 25007361 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Tablets
• Acyclovir

Topics

• Acyclovir (administration & dosage, adverse effects, therapeutic use)
• Adhesiveness
• Administration, Buccal
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
• Chronic Disease
• Double-Blind Method
• Drug Delivery Systems
• Female
• Follow-Up Studies
• Herpes Labialis (drug therapy)
• Humans
• Male
• Middle Aged
• Recurrence
• Tablets
• Treatment Outcome
• Young Adult