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Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes.

Publication ,  Journal Article
Sacks, SL; Varner, TL; Davies, KS; Rekart, ML; Stiver, HG; DeLong, ER; Sellers, PW
Published in: J Infect Dis
April 1990

To explore further topical antiviral therapy for recurrent genital herpes, 188 culture-proven patients were randomized to receive treatment with topical interferon-alpha in high-dose (10(6) IU/g with 1% nonoxynol-9 in 3.5% methylcellulose) or low-dose (10(3) IU/g with 0.1% nonoxynol-9 in 3.5% methylcellulose) treatments or placebo (3.5% methylcellulose, alone), applied three times daily for 5 days. Of these, 105 experienced prodromal symptoms within the study period and applied the medication, of whom 99 could be evaluated for efficacy. Patients were followed with daily clinical assessments and cultures until reepithelialization. The median time to negative virus culture in high-dose recipients was 2.5 days compared with 3.9 days for placebo recipients (P = .023), and a significant dose response was observed (P = .016). Antiviral effects were more prominent in men than women. High-dose recipients also had reduced median duration of symptoms to 2.7 days from 3.7 days for placebo recipients (P = .03), with a significant dose-response relationship (P = .047). Effects on duration of symptoms were more prominent in women. Times to complete reepithelialization in those who applied the drug during the prodromal phase were 5.8 days for high-dose recipients compared with 6.5 days for placebo recipients (P = .053). A multivariate ranked linear model analysis of four efficacy variables (crusting, healing, virus shedding, symptom duration) also favored the high-dose gel (P = .015). High-dose topical interferon-alpha preparation is effective for patients with recurrent genital herpes. Applied early in the course of a recurrent episode, this treatment is safe and may provide a topical alternative to other types of therapy in the future.

Duke Scholars

Published In

J Infect Dis

DOI

ISSN

0022-1899

Publication Date

April 1990

Volume

161

Issue

4

Start / End Page

692 / 698

Location

United States

Related Subject Headings

  • Sex Factors
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Polyethylene Glycols
  • Nonoxynol
  • Middle Aged
  • Microbiology
  • Male
  • Interferon Type I
  • Humans
 

Citation

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Sacks, S. L., Varner, T. L., Davies, K. S., Rekart, M. L., Stiver, H. G., DeLong, E. R., & Sellers, P. W. (1990). Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes. J Infect Dis, 161(4), 692–698. https://doi.org/10.1093/infdis/161.4.692
Sacks, S. L., T. L. Varner, K. S. Davies, M. L. Rekart, H. G. Stiver, E. R. DeLong, and P. W. Sellers. “Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes.J Infect Dis 161, no. 4 (April 1990): 692–98. https://doi.org/10.1093/infdis/161.4.692.
Sacks, S. L., et al. “Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes.J Infect Dis, vol. 161, no. 4, Apr. 1990, pp. 692–98. Pubmed, doi:10.1093/infdis/161.4.692.
Journal cover image

Published In

J Infect Dis

DOI

ISSN

0022-1899

Publication Date

April 1990

Volume

161

Issue

4

Start / End Page

692 / 698

Location

United States

Related Subject Headings

  • Sex Factors
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Polyethylene Glycols
  • Nonoxynol
  • Middle Aged
  • Microbiology
  • Male
  • Interferon Type I
  • Humans