Results from a groundbreaking South African study have influenced World Health Organization policy on the treatment of TB, and put the Global South centre stage for driving improved treatment for all.
Results from a groundbreaking South African study have influenced World Health Organization policy on the treatment of TB, and put the Global South centre stage for driving improved treatment for all.
In a joint statement, the national Health department, Wits Health Consortium, Clinical HIV Research Unit and The United States Agency for International Development (USAID) said the initiative, BEAT Tuberculosis, has become the world`s first initiative in the fight against drug-resistant tuberculosis (DR-TB) for all population groups, influencing the World Health Organization policy on treating TB internationally.
The BEAT Tuberculosis clinical study was conducted at the Clinical HIV Research Unit (CHRU) Isango Lethemba TB Research Unit in the Eastern Cape and KwaZulu-Natal over the past six years.
The study was born from a South African need to find better treatment options for DR-TB.
“The main intention was to inform local guidelines but international guidelines have also been changed,” the statement read.
“The BEAT Tuberculosis study represents a groundbreaking approach in the fight against tuberculosis, particularly with its inclusive research methodology.
By incorporating pregnant women and children into the clinical trials, the study has expanded the understanding of TB treatment's efficacy and safety across broader demographics.
“The study's success in demonstrating safety and effectiveness of the new short oral regimen in these key populations marks a pivotal step towards a more comprehensive and equitable healthcare strategy for tuberculosis management,” said Dr Francesca Conradie, principal investigator who led the study.
The primary aim was to evaluate the effectiveness and safety of a novel shortened treatment regimen for DR-TB compared with the established standard of care. The standard treatment comprised a seven-drug regimen administered over a minimum of nine months.
This was compared with a stream-lined regimen of four to five medications, including newer agents like bedaquiline and delamanid, administered over only six months.
A second objective of the BEAT Tuberculosis study aimed to enhance research capacity for DR-TB, within the Eastern Cape and KwaZulu-Natal, by fostering community engagement and providing training to healthcare personnel in clinical research methodologies for TB treatment.
“This collaborative effort received crucial support from the National and Provincial Departments of Health that provided essential medication and laboratory infrastructure for safety and efficacy assessments,” added Conradie.
The study began in 2019 and despite the formidable challenges posed by Covid-19, over 400 participants were enrolled across study sites in the Eastern Cape and KwaZulu-Natal.
Professor Norbert Ndjeka, Chief Director TB Control and Management at the national Health department said: “In South Africa in 2022, an estimated 280 000 people developed TB, and 54 000 died from the disease.
“With this concerning observation in mind, we acknowledge the BEAT Tuberculosis project as an exemplary and concerted effort to advance TB treatment and research capabilities, poised to bring about transformative changes in RR-TB management worldwide.
“While the study was originally intended to inform local treatment guidelines, the results are now set to benefit patients everywhere.”
USAID Southern Africa Mission Director Leslie Marbury said in partnership with South Africa's National Health department, USAID has improved Tuberculosis patient care worldwide.
“We celebrate the 400 participants who made this trial possible and brought the world closer to ending Tuberculosis.
“We also thank all BEAT Tuberculosis stakeholders for their dedication and commitment to this globally recognized study.”
Cape Times
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