Study revolutionises global TB treatment

Source: Francesca Conradie.

While TB remains a threat to global public health and - the second leading cause of death in South Africa, the Beat Tuberculosis clinical study 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.

As all stakeholders celebrate a breakthrough in eradicating TB, Beat Tuberculosis is a local research study, in collaboration with the National Department of Health, funded by the United States Agency for International Development (USAid) and executed by the University of the Witwatersand.

The results from the study have influenced the World Health Organization policy on the treatment of TB, and at the same time put the Global South centre stage for driving improved treatment for all.

Inclusive TB research

“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,” says Francesca Conradie, the principal investigator who led this 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 streamlined 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,” adds Conradie.

Transformative TB initiative

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.

Norbert Ndjeka, chief director TB Control and management of the National Department of Health adds, “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.”

The United States Agency for International Development (USAid) is a key funding partner for the Beat Tuberculosis initiative. USAid Southern Africa mission director, Leslie Marbury, highlights, "In partnership with South Africa's National Department of Health, USAid has improved tuberculosis patientcare 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, including the National Department of Health, the Eastern Cape and KwaZulu-Natal Health Departments, and local medical facilities, for their dedication and commitment to this globally recognised study.”

TB symptoms

The most common symptoms of TB are a cough that lasts more than two weeks, weight loss, drenching night sweats and a fever. If you have any of these, go to your local clinic. You will be asked to produce sputum or phlegm which will be tested for TB. If the test is positive, the correct treatment will be started.