New data indicate that the drug WC2031 was noninferior
to Vibramycin for the treatment of uncomplicated urogenital chlamydia.
WC2031 (Warner Chilcott) is a delayed-released
doxycycline hyclate treatment administered once daily. The CDC currently
recommends that azithromycin or doxycycline be used to treat uncomplicated
chlamydia, but recent studies have raised concerns about the efficacy of
azithromycin for this purpose. Researchers compared WC2031 with doxycycline
hyclate capsules (Vibramycin, Pfizer).
“With the recent concerns about the efficacy of
azithromycin for genital chlamydial infection treatment, it is important to
continue to investigate new antimicrobial regimens for chlamydia
treatment,” study researcher William Geisler, MD, associate
professor at the University of Alabama, Birmingham, told Infectious Disease
The study was a randomized, double blind, double-dummy,
active-controlled multicenter trial. Patients with uncomplicated urogenital
chlamydia were randomly assigned to a 200-mg tablet of WC2031 once daily for 7
days or 100 mg twice daily of Vibramycin for 7 days. The participants included
men or nonpregnant women aged 19 to 45 years. They were enrolled from April to
There were 495 patients enrolled, of whom 247 were
assigned to WC2031 and 248 were assigned to Vibramycin. The microbial cure rate
for WC2031 was 95.5% compared with 95.2% for Vibramycin. There were no
significant differences in cure rates between arms, but in both arms, the cure
rate was higher among men. The clinical cure rate for WC2031 was 84.8% compared
with 76% for Vibramycin.
There were 99 adverse events in the WC2031 group and 132
in the Vibramycin group. The types of adverse events were similar and included
nausea, vomiting, headache, diarrhea, abdominal pain, bacterial vaginosis and
“If WC2031 receives FDA approval for chlamydia
treatment, it would be the first available once-daily formulation of
doxycycline for chlamydia treatment with potential for improved treatment
adherence and tolerability over twice-daily doxycycline formulations,”
Geisler WM. Clin Infect Dis. 2012;55:82-88.
Dr. Geisler received research funding and has served as a
consultant for Warner Chilcott. Other researchers reported financial
relationships with ActivBiotics, Becton Dickinson Diagnostics, Cempra
Pharmaceuticals, Cepheid, Gen-Probe, GlaxoSmithKline, Merck, Pfizer, Roche
Molecular and Siemens Diagnostics.