Phase 3 trial shows efficacy of new antibiotic against gonorrhoea

This study demonstrates, with solid data, that zoliflodacin—a new oral antibiotic—may become an effective alternative in the face of growing resistance in the treatment of gonorrhoea. The WHO and the CDC [Centres for Disease Control and Prevention, in the US] consider resistant gonorrhoea a priority threat due to levels of resistance to ceftriaxone—our first-line drug—of up to 30% in Southeast Asia.

In our setting, where ceftriaxone remains effective, I see zoliflodacin as a second-line option, especially in situations where the usual treatment is not effective.

This is a randomised clinical trial with a very large sample of patients, which shows that a dose of a new oral antibiotic (zoliflodacin) is as effective as the standard treatment (ceftriaxone + azithromycin) for treating uncomplicated urogenital gonorrhoea in men and women. The study is particularly important because it offers an alternative to ceftriaxone, which is virtually the only therapeutic option available for treating gonorrhoea.

Gonococcus, the causative agent of gonorrhoea, has become resistant to various antibiotics to which it was previously sensitive. In fact, there are areas of the world (some regions in China, for example) with high rates of resistance to ceftriaxone, and there is concern that resistance to this excellent antibiotic will spread to parts of the world where it is now merely anecdotal (Europe is included in this group). The fear that resistance to ceftriaxone will become widespread has made the treatment of resistant gonorrhoea a priority in the search for alternative treatments.

The finding that this new antibiotic, zoliflodacin, is as active as ceftriaxone (in the study it is combined with azithromycin) for the treatment of gonorrhoea is a major breakthrough and a relief. This is the main conclusion of the study: it is effective and well tolerated. It has the advantage of being an oral antibiotic (ceftriaxone is intramuscular) and is administered in a single dose (like ceftriaxone). It is true that as long as resistance to ceftriaxone is not a problem in our environment, there is no reason to use the new antibiotic. The development of resistance to a new antibiotic is the main problem to be addressed, and it would be a pity if this antibiotic were to become useless due to the development of resistance and we were unable to use it in cases where we really had no other alternatives.

The study is therefore encouraging. We have a new antibiotic that is useful for the treatment of gonorrhoea, including gonorrhoea that is resistant to all antibiotics. Given that we currently have ceftriaxone, which is highly effective, very well tolerated and inexpensive, and that the resistance rate is still anecdotal, the new antibiotic should not be used widely until we have a better understanding of the risk of resistance and other aspects related to clinical practice.