Uncomplicated gonococcal infections—urogenital and rectal types, in particular—can be successfully treated with oral zoliflodacin, results of a recent study showed.1
The new antibiotic, which inhibits DNA biosynthesis, was developed in response to antibiotic-resistant Neisseria gonorrhoeae.
To examine the effect of zoliflodacin among patients with uncomplicated gonorrhea, the researchers enrolled 179 participants (167 men and 12 women) in a multicenter, phase 2 trial from November 2014 through December 2015.
To be eligible for the trial, the participants had to have shown signs or symptoms of uncomplicated urogenital gonorrhea or untreated urogenital gonorrhea. Or, they had to have had sexual contact in the preceding 14 days with a person who had gonorrhea.
The participants were randomly assigned to receive either a single oral dose of zoliflodacin, 2 g or 3 g, or a single intramuscular dose of ceftriaxone, 500 mg, in a ratio of approximately 70:70:40.
To measure the antibiotic’s efficacy, the participants returned within 6±2 days after treatment, followed by a safety visit 31±2 days after treatment.
Of the 141 participants who were ultimately evaluated, 55 of the 57 participants who receivedzoliflodacin, 2 g; 54 of the 56 participants who received zoliflodacin, 3 g; and all 28 of the participants who received ceftriaxone had a microbiologic cure at urogenital sites.
Rectal infections were cured in all of the 5, 7, and 3 participants who received zoliflodacin, 2 g; zoliflodacin, 3 g; and ceftriaxone, respectively.
The efficacy in treatment of pharyngeal infections was less so.
Pharyngeal infections were cured in 4 of 8 participants, 9 of 11 participants, and all 4 participants in the groups that received zoliflodacin, 2 g; zoliflodacin, 3 g; and ceftriaxone, respectively.
Across all groups, there were 21 adverse events—mostly gastrointestinal-related—believed to be connected to zoliflodacin.
“The rate of reported gonorrhea cases in the United States has increased 75 percent since the historic low in 2009, and antibiotic resistance has considerably reduced the number of treatment options for this disease,” said the National Institute of Allergy and Infectious Diseases director, Anthony S Fauci, MD. “These encouraging research findings suggest that zoliflodacin has the potential to be a useful and easy-to-administer oral antibiotic for treating gonorrhea.”2
1. Taylor SN, Marrazzo J, Batteiger BE, et al. Single-dose zoliflodacin (ETX0914) for treatment of urogenital gonorrhea. N Engl J Med. 2018;379:1835-1845. doi:10.1056/NEJMoa1706988.
2. Novel antibiotic shows promise in treatment of uncomplicated gonorrhea. [press release]. Bethesda, MD: National Institute of Allergy and Infectious Diseases; November 7, 2018. https://www.nih.gov/news-events/news-releases/novel-antibiotic-shows-promise-treatment- uncomplicated-gonorrhea. Accessed November 8, 2018.