July 19, 2012
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Once-daily doxycycline noninferior to twice-daily capsule for chlamydia

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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 News.

William Geisler

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 October 2010.

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 vulvovaginal candidiasis.

“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 said.

References:

Geisler WM. Clin Infect Dis. 2012;55:82-88.

Disclosures:

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.