By: Thoboloko Ntšonyane
MASERU – A ground has been gained in the treatment of multidrug-resistant tuberculosis (MDR-TB), with trial results recently published at Botšabelo Hospital, showcasing this recorded success.
The World Health Organisation (WHO) defines MDR-TB as,
“a form of TB disease caused by a strain of “M. tuberculosis complex that is resistant to rifampicin and isoniazid”
TB is one of the top leading causes of premature deaths worldwide and Lesotho is one of the most affected countries in the world.
The new treatment regime not only promises a shorter duration for patients but also offers a much more affordable option compared to previous treatments.
The Partners In Health (PIH) country’s Executive Director Dr Melino Ndayizigiye says the trial enrolled a diverse group of 754 patients drawn from seven countries including Lesotho, Georgia, India, Kazakhstan, Pakistan, Peru and South Africa.
PIH collaborates with other organisations and academic institutions to research new treatments for MDR-TB through a rigorous clinical trial that started in 2017.
Announcing the results, the MDR-TB Senior Medical Officer who also doubles as the Lesotho Site Principal Investigator for endTB trial, Dr Kunda Kwabisha Mikanda confirms that TB affects most poor people.
Dr Mikanda says the treatment of the MDR-TB was “too long” as it took between 18 to 24 months. “So the treatment was not effective and the patient had to swallow 14 000 pills throughout the treatment, which means for 24 months a patient had to take almost 20 pills per day. Not only that, a patient had to get infections for six months,” adding that this treatment was linked to many side effects.
Some of those side effects linked to the conventional MDR-TB treatment he said are kidney failure, psychosis, permanent deafness, and the patients were unable to carry on with their daily routines.
He said the cost of treating the disease was also expensive.
Dr Mikanda said the MDR-TB trial was initiated to find better, shorter, and less toxic drugs, which can help patients live without injections and with fewer side effects.
He continued to explain that the purpose of this trial was to develop effective regimens within nine months, with minimal side effects, to better manage MDR-TB.
The EndTB project, he indicated that its aim was to provide access to the new drugs to patients with MDR-TB and its clinical trials were randomised. Dr Mikanda said they tested a new nine-month oral regimen in line with the WHO ‘standard of care’ which was running in the country for 18 to 24 months.
“Now, among the patients who were included in the trial, almost all the patients included those who have HIV, diabetes, adolescents, and we manage to also maintain women who fell pregnant throughout the trial. During the trial we found out after analysis that the regimen among those clinical trials there was more efficient to treat MDR-TB,” he says.
The Lesotho Site Principal Investigator for endTB trial said “effective, shorter” among other ongoing regimens in the country. He said the trial evaluated five regimens. “We had an experimental arm, and one arm which was a control arm of WHO standard of care”.
The regimens Dr Mikanda said achieved favorable outcomes one with 99 %, 90% and 85% as they demonstrated “non-inferiority to standard of care”.
On the safety part, there were low modalities as compared to the previous ones, with had side effects of anemia, tingling and liver enzymes, “those are side effects we can manage through the proper monitoring” of the patient undergoing treatment.
The previous treatment regimen he says would cost around $5,000 about M92 600 per patient over 24 months. However, the new regimen is more affordable at $400 per, equivalent to M7 400 patients for nine months of treatment. Additionally, the new regimen requires patients to take seven to eight pills per day.
This advancement is expected to significantly improve patient outcomes and accessibility.
WHO reports that Lesotho has seen a 13% decrease in TB incidence over the past decade, now standing at 661 cases per 100,000 people. Despite this progress, the country still faces one of the highest TB incidences globally. Additionally, case-finding has improved from 32% in 2020 to 47% in 2023, but it must nearly double to meet national and global targets for ending TB by 2030.
“We have to be proud of what we have done in the endTB trial to find better, shorter, less toxic drugs to treat our patient. And what is exciting is we manage to include in our regimen patients with HIV, diabetes, mineworkers, people using drugs, so those medications are very effective even on those patients with comorbidities,” Dr Mikanda says.
According to the WHO, approximately 410,000 people worldwide (with a 95% uncertainty interval of 370,000–450,000) developed multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2022.
Although the treatment success rate for those diagnosed with MDR/RR-TB has been improving, WHO is concerned that it still remains worryingly low. Globally, the treatment success rate increased to 63% in 2020, up from 60% in 2019 and 50% in 2012.