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Antimicrobial Agents and Chemotherapy, February 2008, p. 477-482, Vol. 52, No. 2
0066-4804/08/$08.00+0     doi:10.1128/AAC.01173-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Effect of Resiquimod 0.01% Gel on Lesion Healing and Viral Shedding When Applied to Genital Herpes Lesions

Kenneth H. Fife,^1* Tze-Chiang Meng,² Daron G. Ferris,³ and Ping Liu^2,

Division of Infectious Diseases, Department of Medicine, Indiana University School of Medicine, 435 EH, 545 Barnhill Drive, Indianapolis, Indiana 46202,¹ Department of Medical and Scientific Affairs, 3M Pharmaceuticals, 3M Center-275-2W-14, St. Paul, Minnesota 55144,² Department of Obstetrics and Gynecology, Medical College of Georgia, HH 105, 1120 15th Street, Augusta, Georgia 30912³

Received 5 September 2007/ Returned for modification 26 October 2007/ Accepted 12 November 2007

Resiquimod, a Toll-like receptor 7/8 agonist developed as a topical treatment to decrease recurrences of anogenital herpes, induces proinflammatory cytokines that may delay lesion healing. Adults with frequently recurring anogenital herpes were randomized within 24 h of onset of a recurrence to vehicle or resiquimod 0.01% gel two times per week for 3 weeks. Subjects underwent daily lesion assessments and sampling for herpes simplex virus DNA PCR for 21 days or until investigator-determined healing of lesion(s). Eighty-two subjects with a mean age of 39 ± 10.5 years and a median of seven recurrences per year were enrolled in the study. The qualifying recurrence was positive by PCR for herpes simplex virus in 68% of subjects. No difference was observed between the vehicle (39 subjects) and resiquimod (43 subjects) groups with respect to time to healing (median of 7.0 days versus median of 6.5 days, respectively; Cox proportional hazard model ratio of 1.229; 95% confidence interval, 0.778 to 1.942; P = 0.376). The distributions of maximum severity scores for any investigator-assessed local skin signs and for subject-assessed local symptoms were similar between treatment groups (P = 0.807 and P = 0.103, respectively). For subjects with at least one positive PCR result, no difference was observed for time to cessation of viral shedding (median of 7 days versus median of 5 days for vehicle and resiquimod groups, respectively; Cox proportional hazard model ratio of 1.471; 95% confidence interval, 0.786 to 2.754; P = 0.227). Application of resiquimod 0.01% two times per week for 3 weeks did not delay the healing of genital herpes lesions or reduce acute viral shedding.

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* Corresponding author. Mailing address: Indiana University School of Medicine, Emerson Hall 435, 545 Barnhill Drive, Indianapolis, IN 46202. Phone: (317) 274-8114. Fax: (317) 274-1587. E-mail: kfife{at}iupui.edu

Published ahead of print on 26 November 2007.

Present address: Department of Biostatistics, M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Unit 447, University of Texas, Houston, TX 77030.

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Antimicrobial Agents and Chemotherapy, February 2008, p. 477-482, Vol. 52, No. 2
0066-4804/08/$08.00+0     doi:10.1128/AAC.01173-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.