A global clinical trial for a new gonorrhoea treatment has shown promising results. The trial found that the oral antibiotic drug, zoliflodacin, is effective in treating gonorrhoea, a common bacterial sexually transmitted infection (STI) that spreads through unprotected vaginal, oral, or anal sex.
“This is an exciting result. It certainly places the spotlight on the much-needed field of STIs; and the need for new diagnostics, therapies and preventive interventions to reduce the burden of STIs in our community,” says Professor Sinead Delany-Moretlwe the director of research at the Reproductive Health and HIV Institute at the University of the Witwatersrand (Wits RHI).
Delany-Moretlwe was the lead scientist in the South African arm of the trial. South Africa was one of five countries involved. There were a total of 930 participants with uncomplicated gonorrhoea including women, people living with HIV, and adolescents. Most of the participants were in South Africa. This is the largest clinical trial ever done for new gonorrhoea treatment. The findings of the clinical trial are expected to be published in a peer-reviewed journal next year.
She says South Africa has a high burden of patients with gonorrhoea. In 2017 more than two-million people were reportedly diagnosed with the condition. In 2020 an estimated 82 million people around the world were diagnosed with gonorrhoea.
Delany-Moretlwe says that the oral pill has the potential to simplify gonorrhoea treatment as it is a single oral dose.
“Zoliflodacin can be given as a single dose oral therapy and so is simpler to administer than the current therapy. From a treatment perspective this is helpful as it ensures same day directly observed therapy ensuring treatment completion,” explains Delany-Moretlwe.
“The current treatment for gonorrhoea includes an injectable antibiotic that requires preparation and administration by a healthcare provider,” she explains. “But with the oral antibiotic people who may be needle phobic or concerned about injection site pain won’t be deterred from seeking gonorrhoea therapy.”
According to Delany-Moretlwe, gonorrhoea treatment in South Africa is provided syndromically. Patients with STIs are given a combination of drugs that can treat multiple pathogens that cause the same set of symptoms.
Delany-Moretlwe says the disease is particularly difficult to treat in women because of the challenge of diagnosing asymptomatic infections.
“If a woman does not have symptoms or does not recognise her symptoms and doesn’t seek care, she will not be treated. Ideally we need to shift to laboratory-based diagnosis of common sexually transmitted infections,” she says.
Dr Leandri Liebenberg, a medical officer at AIDS Healthcare Foundation, says the diagnosis of gonorrhoea in South Africa is extremely challenging due to tests being used. These require patients or clinicians to take vaginal, penile, or rectal swabs. The swabs are then sent to a laboratory with the capacity to do the required test.
“Some of the challenges I have come across are the lack of knowledge from clinicians regarding the need for testing/referral and the long turnaround time for results, leading to patients not returning for the review of results,” says Liebenberg.
Liebenberg says that it is concerning. If left untreated, gonorrhoea can facilitate HIV transmission and acquisition. It can also cause other complications such as pelvic inflammatory disease in women.
“Pelvic inflammatory disease can cause chronic pelvic pain and infertility due to structural damage of the fallopian tubes and internal abscess formation. While epididymitis is a long-term health risk for men with untreated gonorrhoea,” explains Liebenberg.
“We look forward to the next steps in the process regarding the pathway to licensure and access for those in greatest need,” says Delany-Moretlwe.
Delany-Moretlwe is hopeful that the participation of South Africans in the zoliflodacin trial will help to speed up the registration of the oral gonorrhoea treatment in the country.
“The benefits of zoliflodacin to South Africa is that when the data are submitted to SAHPRA for review and approval, the fact that we have data on South Africa has the potential to facilitate approval which can then speed up the process to ensure access,” says Delany-Moretlwe. –Health-e News.