non-cephalosporin gonorrhea therapies

as perhaps a follow-up to the last blog on pelvic exams, there was a recent article in  Journal of Infectious Diseases looking at non-cephalosporin treatments for gonorrhea (see gonorrhea noncephalosporin rx JID 2104 in dropbox,or doi: 10.1093/cid/ciu521). this article is important because of the increasing resistance of gonorrhea to multiple agents over the past 50 years (eg, sulfa, penicillins, tetracyclines, cipro). at this time the only recommended treatment by the CDC is cephalosporins (eg, ceftriaxone, since there is too much resistance to cefixime), but there are reports of resistance to ceftriaxone, and it is unclear what to do if the patient has significant cephalosporin allergy. hence the importance of this study, where 401 patients (mean age 27, 35% MSM, and only 10% women, 60% black, 22% white, 9% HIV positive), from 5 sites across the US with uncomplicated GC aged 15-60 were randomly assigned to gentamicin 240 mg IM plus azithromycin 2 gm orally, or gemifloxacin (a 4th generation fluoroquinolone) 320mg orally plus azithromycin 2 gm orally. primary outcome was microbiological cure at 10-17 days after treatment. this study was supported by the CDC and NIH. results:



--202 patients receiving gentamicin/azithro: 100% cure, including 10 of 10 pharyngeal infections and 1 of 1 rectal infections
--199 patients receiving gemifloxacin/azithro: 99.5% cure, including 15 of 15 pharyngeal infections and 5 of 5 rectal infections​ (the one patient who failed therapy probably had a reinfection)
--GI adverse effects were common and pretty similar in both groups: 30+% with nausea, 5% with vomiting, 20% with diarrhea -- the vast majority being "mild". somewhat more GI toxicity in the gemifloxacin arm, though probably the GI toxicity is largely from the azithro



so, these may be important therapies in the future. azithro 2gm has good efficacy as monotherapy, but the concern is that gonorrhea develops resistance to macrolides pretty easily.  the above is clearly a preliminary study. there are concerns about the skew of the patients (eg, very few women), and how easily gonorrhea might develop resistance to these meds (though it is heartening that there was a 100% cure rate, and the likelihood of resistance is probably less with double therapy). but this seems pretty reasonable to me for patients either with cephalosporin resistance or intolerance

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