CDC updates STI treatment guidelines for first time since 2015
Treating Gonorrhea May Become Easier Due To New Antibiotic - PhillyVoice
A new treatment for gonorrhea shows promise, which is welcome news with global rates of the sexually transmitted infection on the rise and antibiotic resistance becoming more prevalent.
The oral antibiotic gepotidacin, used to treat urinary tract infections, was as effective as current treatments for uncomplicated gonorrhea and powerful against strains of the bacteria that are resistant to other antibiotics, a study published Monday in the Lancet showed.
MORE: One-third of Americans report excessive sleepiness — and the issue deserves greater attention, experts sayA novel treatment for the sexually transmitted disease is significant, because only one reliable treatment still exists, and President Donald Trump's administration has shut down the federal lab that monitors STI rates.
Gonorrhea is a sexually transmitted bacterial infection that spreads through semen and vaginal fluid. People also can become infected with gonorrhea through oral and anal sex and can pass it to infants during childbirth. It is the second most common STI caused by a bacteria in the United States, behind chlamydia, according to the Cleveland Clinic. It causes about 1 million new infections a year, primarily in young men.
Gonorrhea rates reached a historic low in the United States in 2009 and then steadily increased through 2021. Reported cases have dipped in recent years, with a 9.2% decrease from 2021 to 2022 and a 7.7% decrease between 2022 and 2023, according to the most recent statistics available from the Centers for Disease Control and Prevention.
But the STI has been increasing among young men, with 550.5 cases per 100,000 men ages 15 to 24 in 2022 compared to 523.5 cases per 100,000 men in that age group in 2017, according to the Department of Health and Human Services.
Additionally, a 2024 report from the World Health Organization found that cases of antibiotic-resistant gonorrhea are rising. Nine countries reported elevated levels of gonorrhea strains that were resistant to ceftriaxone, the last line treatment for gonorrhea.
"Widespread resistance" of gonorrhea means that "there is the risk that soon gonorrhea will be impossible to treat in the absence of new drugs or strategies to curb the burden of disease," according to an editorial published in the Lancet alongside the new research.
The study involved 622 people, comparing the effectiveness of the new antibiotic to the standard treatment — an injection of the antibiotic ceftriaxone. New antibiotic treatment with gepotidacin may be more effective against resistant gonorrhea and may also improve compliance among people wary of injections, the researchers said.
But the study had limitations because it involved mostly white men and primarily looked at urogenital gonorrhea, a type of the infection that infects the genital tract. People also can get gonorrhea in the throat through oral sex and in the rectum through anal sex.
Gonorrhea can lead to serious health issues, including infertility in men and women, pelvic inflammatory disease in women and, more rarely, septic arthritis, characterized by warm, red, swollen and painful joints. But often people who have gonorrhea have no symptoms.
Signs of gonorrhea in men include painful urination, pain or swelling in one testicle and a pus-like discharge from the penis. Women may experience increased vaginal discharge, painful urination, vaginal bleeding in between periods and abdominal or pelvic pain, according to the Mayo Clinic.
Gonorrhea also can cause anal itching, discharge and some bleeding from the rectum, as well as straining during bowel movements. Gonorrhea sometimes affects the eyes, causing pain, sensitivity to light and discharge. Swollen lymph nodes and a sore throat may accompany gonorrhea that affects the throat.
Gepotidacin Gets Priority Review For Uncomplicated Urogenital Gonorrhea
Gepotidacin Gets Priority Review for Uncomplicated Urogenital Gonorrhea - Infectious Disease AdvisorThe Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (NDA) for gepotidacin in the treatment of uncomplicated urogenital gonorrhea in patients aged 12 years and older weighing at least 45kg.
Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by blocking 2 different type II topoisomerase enzymes. It is currently approved under the brand name Bluejepa for the treatment of uncomplicated urinary tract infections in female patients.
The NDA for the gonorrhea indication is supported by data from the EAGLE-1 study (ClinicalTrials.Gov Identifier: NCT04010539), which compared the safety and efficacy of oral gepotidacin to intramuscular (IM) ceftriaxone plus oral azithromycin in adolescent and adult patients (N=628) with uncomplicated urogenital infection caused by Neisseria gonorrhoeae.
Study participants were randomly assigned to receive 2 oral doses of gepotidacin 3000mg or IM ceftriaxone 500mg plus oral azithromycin 1000mg. The primary endpoint was microbiological success, defined as culture-confirmed elimination of N. Gonorrhoeae from the urogenital site at the test-of-cure visit (day 4 to 8).
Findings showed the trial met its primary endpoint demonstrating the noninferiority of gepotidacin to standard of care gonorrhea treatment. Microbiological success was reported in 92.6% (95% CI, 88.0-95.8) of patients treated with gepotidacin and 91.2% (95% CI, 86.4-94.7) of those who received ceftriaxone plus azithromycin.
No bacterial persistence of N. Gonorrhoeae at the urogenital site was observed in either treatment arm. Gastrointestinal side effects were the most commonly reported adverse events with gepotidacin.
The FDA has assigned a Prescription Drug User Fee Act goal date of December 11, 2025 to make a decision on the application. If approved, gepotidacin would provide a new oral option for gonorrhea, a sexually transmitted infection that has been recognized as an urgent public health threat by the US Centers for Disease Control and Prevention.
This article originally appeared on MPR
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Oral Antibiotic Shows Promise To Cure Uncomplicated Gonorrhea
An investigational oral antibiotic called zoliflodacin was well-tolerated and successfully cured most cases of uncomplicated gonorrhea when tested in a Phase 2 multicenter clinical trial, according to findings published today in the New England Journal of Medicine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, sponsored the clinical study.
Gonorrhea is a common sexually transmitted disease (STD) that affects both men and women, particularly young people ages 15 to 24 years. Gonorrhea is the second most commonly reported notifiable disease in the United States. In 2017, more than 550,000 cases of gonorrhea were reported in the United States. If untreated, gonorrhea infection can lead to pelvic inflammatory disease, ectopic pregnancy, infertility, and an increased risk of HIV infection. Pregnant women can pass the infection to their babies, who can become blind or develop life-threatening infections as a result.
Gonorrhea is caused by the bacterium Nesseria gonorrhoeae, which has progressively developed resistance to each of the antimicrobials used to treat it. As a result, in 2015, the U.S. Centers for Disease Control and Prevention revised gonorrhea treatment guidelines to recommend dual therapy with injectable ceftriaxone and oral azithromycin to reduce the emergence of resistance to ceftriaxone.
Zoliflodacin (formerly known as ETX0914 and AZD0914), developed by Entasis Therapeutics based in Waltham, Mass., represents a new type of oral antibiotic that inhibits DNA synthesis in a different way than currently approved antibiotics.
"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 NIAID Director Anthony S. Fauci, M.D. "These encouraging research findings published today suggest that zoliflodacin has the potential to be a useful and easy-to-administer oral antibiotic for treating gonorrhea."
The study took place from November 2014 through December 2015 and was led by Stephanie N. Taylor, M.D., of Louisiana State University Health Sciences Center in New Orleans. Study investigators recruited patients from sexual health clinics there and in Seattle; Indianapolis, Indiana; Birmingham, Alabama; and Durham, N.C. The trial enrolled 179 participants (167 men and12 non-pregnant women) ages 18 to 55 years with either symptoms of uncomplicated urogenital gonorrhea, untreated urogenital gonorrhea or sexual contact with someone with gonorrhea within 14 days before enrollment. Participants were randomly selected to receive either a single 2 or 3-gram dose of oral zoliflodacin or a 500-milligram (mg) dose of injectable ceftriaxone. Among the 117 per-protocol participants who were evaluated six days after treatment, 98 percent (48 of 49 participants) of those who received the 2-gram zoliflodacin dose, 100 percent (47 of 47 participants) of those who received the 3-gram dose, and all (21 of 21) of the participants in the ceftriaxone group were considered cured of their urogenital gonorrhea based on culture results.
Zoliflodacin cured all rectal gonorrheal infections (4 of 4 participants who received the 2-gram dose and 6 of 6 participants who received the 3-gram dose) as did ceftriaxone (3 of 3 participants). However, the investigational drug did not fare as well in treating patients with gonorrhea infections of the throat (pharyngeal): 67 percent of volunteers who received the 2- gram dose (4 of 6 participants) and 78 percent of those who received the 3-gram dose (7 of 9 participants) were cured. All of the participants (4 of 4) in the ceftriaxone group achieved a cure.
The investigational antibiotic was well tolerated with transient gastrointestinal upset the most commonly reported adverse effect. Microbiological evaluation of post-treatment clinical isolates did not demonstrate resistance to zoliflodacin.
In March 2018, NIAID completed a study to evaluate zoliflodacin's pharmacokinetics, safety and tolerability as a single oral dose to serve as a bridge from the Phase 2 clinical trial formulation to the final formulation for Phase 3 testing. Results from that study have not yet been made public. Additionally, in September 2018 NIAID launched a Phase 1 study to evaluate the investigational drug's cardiac effects, a standard safety test for new drugs such as this.
Zoliflodacin has been awarded fast track status by the U.S. Food and Drug Administration for development as oral treatment for gonococcal infections. It is expected to begin Phase 3 testing in the Netherlands, South Africa, Thailand and the United States next year.
Source: https://www.Niaid.Nih.Gov/news-events/novel-antibiotic-shows-promise-treatment-uncomplicated-gonorrhea
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