title: Efficacy and safety of oral pleconaril for treatment of colds due to picornaviruses in adults: results of 2 double-blind, randomized, placebo-controlled trials.
abstract: 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.
authors.affiliation: Department of Internal Medicine, University of Virginia, Charlottesville, USA. FGH@virginia.edu
authors.forename: Frederick G
authors.initials: FG
authors.lastname: Hayden
authors.forename: Darrell T
authors.initials: DT
authors.lastname: Herrington
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Coats
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kim
authors.forename: Ellen C
authors.initials: EC
authors.lastname: Cooper
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Villano
authors.forename: Siyu
authors.initials: S
authors.lastname: Liu
authors.forename: Spencer
authors.initials: S
authors.lastname: Hudson
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Pevear
authors.forename: Marc
authors.initials: M
authors.lastname: Collett
authors.forename: Mark
authors.initials: M
authors.lastname: McKinlay
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003139:Common Cold / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010069:Oxadiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D010080:Oxazoles; D010849:Picornaviridae / Q000187:drug effects; D010850:Picornaviridae Infections / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D010069:Oxadiazoles; D010080:Oxazoles; C115201:pleconaril