Journal Article

Efficacy and Safety of Oral Pleconaril for Treatment of Colds Due to Picornaviruses in Adults: Results of 2 Double-Blind, Randomized, Placebo-Controlled Trials

Frederick G. Hayden, Darrell T. Herrington, Teresa L. Coats, Kenneth Kim, Ellen C. Cooper, Stephen A. Villano, Siyu Liu, Spencer Hudson, Daniel C. Pevear, Marc Collett and Mark McKinlay

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue 12, pages 1523-1532
Published in print June 2003 | ISSN: 1058-4838
Published online June 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/375069
Efficacy and Safety of Oral Pleconaril for Treatment of Colds Due to Picornaviruses in Adults: Results of 2 Double-Blind, Randomized, Placebo-Controlled Trials

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The novel capsid-binding antiviral pleconaril inhibits in vitro replication of most rhinoviruses and enteroviruses. Oral pleconaril treatment was studied in 2 parallel randomized, double-blind, placebo-controlled trials. Among 1363 picornavirus-infected participants (65%) in the studies combined, the median time to alleviation of illness was 1 day shorter for pleconaril recipients than for placebo recipients (P > .001). Cold symptom scores and frequency of picornavirus cultured from nasal mucus specimens were lower among pleconaril recipients by day 2 of treatment. No treatment effects were seen in those without picornavirus infection. Pleconaril was associated with a higher incidence of nausea (6% vs. 4%) and diarrhea (9% vs. 7%) and with small increases in mean serum cholesterol levels and platelet counts, compared with baseline measurements. A subsequent 6-week prophylaxis study found that pleconaril induces cytochrome P-450 3A enzymes, which metabolize a variety of drugs, including ethinyl estradiol. Early pleconaril treatment was well tolerated and significantly reduced the duration and severity of colds due to picornaviruses in adults.

Journal Article.  5834 words.  Illustrated.

Subjects: infectious diseases ; immunology ; public health and epidemiology ; microbiology

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