Results from Exciting New Clinical Trial Show Promise for Gonorrhea
Findings continue to underscore the need for increased public health investment
Stephanie S. Arnold Pang
National Coalition of STD Directors
Washington, D.C. – Yesterday, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) announced that two new antibiotic regimens using existing drugs – injectable gentamicin in combination with oral azithromycin, and oral gemifloxacin in combination with oral azithromycin – successfully treated gonorrhea infections in a clinical trial. While the results of this trail are a positive step forward in responding to the growing antibiotic resistance of gonorrhea, the National Coalition of STD Directors (NCSD) underscores that this success is not the silver bullet in responding to the possibility of drug-resistant gonorrhea; additional investments in public health infrastructure are still desperately needed.
This is the first clinical trial to evaluate these drugs as combination therapy for gonorrhea. Many participants, however, reported negative side effects, mostly nausea and diarrhea, which underscores the continued need for additional and more tolerable options for gonorrhea treatment. It should be noted that the release of these findings do not change the CDC’s gonorrhea treatment guidelines. The only recommended first-line treatment regimen for gonorrhea is still injectable ceftriaxone, in combination with one of two other oral antibiotics, either azithromycin or doxycycline.
“The success of this Phase IV trial shows promise in fighting a very serious and impending epidemic—untreatable gonorrhea. NCSD congratulates the CDC and NIH on the success of this Phase IV trial,” stated William Smith, Executive Director of the National Coalition of STD Directors. “NCSD continues to be concerned, however, about public health’s ability to respond to growing gonorrhea resistance. What these results have not changed is this: the current public health infrastructure has been continually strained and is currently unable to prepare as necessary for the arrival of untreatable gonorrhea. We continue to need a coordinated effort for public health to be prepared for an untreatable gonorrhea epidemic,” continued Smith.
Earlier this year, NCSD released an Emergency Funding Request for Multi-Drug Resistant Gonorrhea to ensure those on the front-line of public health have the resources they need to respond to the likelihood of drug-resistant gonorrhea. Investments made now can help us better understand where resistant gonorrhea will likely strike and allow us to respond when it does to minimize its effect. Additional funding like what is included in this request is desperately needed to ensure that when untreatable gonorrhea occurs in America, we will be prepared to respond.
“In addition, while the results of the trials are promising, we must remember these are existing antibiotics and gonorrhea has shown a remarkable ability to develop resistance quickly to all of our existing families of antibiotics. So while these treatments may buy us some additional time, we need investments in the creation of new antibiotics immediately,” stated Smith.
NCSD supported the passage of the Generating Antibiotic Incentives Now (GAIN) Act, which passed as part of Food and Drug Administration (FDA) legislation in 2012. The GAIN Act creates incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections, which could help address the growing resistance of gonorrhea to antimicrobials. To be eligible for these incentives, a drug must be used to treat diseases caused by antibiotic- or antifungal-resistant pathogens (including new or emerging pathogens), or be part of a “qualifying pathogens” list maintained by the FDA. In December of 2012, NCSD’s Executive Director William Smith testified in front of an FDA panel to encourage to addition of Neisseria gonorrhoeae, the bacterium that causes gonorrhea, to this pathogen list.
NCSD also stands with Dr. Anthony S. Fauci, the Director of NIH’s National Institute of Allergy and Infectious Diseases, agreeing that a point-of-care drug susceptibility test would be helpful to providers to ensure which treatment regimen will be most effective for their patient. We look forward to working with our diagnostic partners in developing more specific diagnostic tools to ensure patients and providers know how best to treat each case gonorrhea at the time of diagnosis.
The findings of this study will be presented this week by CDC’s Robert Kirkcaldy, M.D., at the 20th Meeting of the International Society for Sexually Transmitted Diseases Research (ISSTDR) in Vienna, Austria.
The National Coalition of STD Directors (NCSD) is a partnership of public health professionals dedicated to promoting sexual health through the prevention of STDs. NCSD provides dynamic leadership that strengthens STD Programs by advocating for effective policies, strategies,
and sufficient resources by increasing awareness of the medical and social impacts of STDs.
For more information, visit www.NCSDDC.org.