Efficacy and Safety of Aciclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial

July 2014 | Volume 13 | Issue 7 | Original Article | 791 | Copyright © 2014

Thomas Bieber MD,a Olivier Chosidow MD PhD,b Neil Bodsworth MD,c Stephen Tyring MD,d
Jana Hercogova MD,e Mark Bloch MD,f Matthew Davis MD,g Michael Lewis MD,h
David Boutolleau MD,i Pierre Attali MD MSc,j and the LIP Study Group

aDepartment of Dermatology and Allergy, University of Bonn, Bonn, Germany
bDepartment of Dermatology, Hospital Henri Mondor, Creteil, France
cTaylor Square Private Clinic, Darlinghurst, Australia
dDepartment of Dermatology, University of Texas Health Science Center, Houston, TX
eDermatovenereology Department, Bulovka Hospital, Prague, Czech Republic
fHoldsworth House Medical Practice, Darlinghurst, Australia
gRochester Clinical Research, Rochester, NY
hSchool of Dentistry, College of Biomedical and Life Sciences, Cardiff, UK
iVirology Department, Hospital Pitie-Salpetriere, Paris, France
jBioAlliance Pharma, Paris, France

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.

J Drugs Dermatol. 2014;13(7):791-798.

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INTRODUCTION

Herpes simplex virus (HSV) is the most widely spread virus in the herpes virus family. About one billion people worldwide have been infected with herpes viruses. Orofacial herpes most commonly results from primary infection with HSV-1 during childhood.1,2 Approximately 20% to 40% of people have experienced orofacial herpes at some time. In the United States, approximately 130 million individuals over the age of 12 are infected with HSV-13,4 and the prevalence is more than 70% in those aged > 80 years in Europe.5-7

HSV-1 is a mucocutaneous virus that remains latent in the trigeminal ganglion and in the oral mucosa. In patients harbouring HSV-1, reactivation is frequent, usually asymptomatic, and sometimes leads to classical labial lesions.8,9 HSV-1 replicates in the basal layer of mucosa before the onset of signs and/or symptoms, with maximum replication within the first 8 hours following the onset of prodromal symptoms. It is detected in oral mucosa, in saliva, and in herpes lesions.10,11 The amount of virus is highest during lesion development and diminishes as the herpes lesion matures.10,11

Nucleoside analogues aciclovir and its prodrug valaciclovir remain the reference treatment for recurrent herpes infection. After cellular intake and conversion to aciclovir triphosphate by cellular enzymes, aciclovir selectively inhibits HSV viral DNA replication.12 Its half-life inside the infected cell is short, about 1 hour.13 Aciclovir concentrations are over the 50% inhibitory concentration (IC50: 22.5 ng/ml); however they are low, delayed,

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