A new drug-resistant tuberculosis ( DR-TB) treatment regimen will be available to pregnant women and children as early as next year. 

This follows the results of the BEAT Tuberculosis study which evaluated the effectiveness and safety of a new and shorter treatment regimen for DR-TB of four to five drugs over a six month period.  

Speaking to Health-e News Professor Norbert Ndjeka, chief director TB Control and Management of the National Department of Health says this study is groundbreaking, partly because it’s the world’s first clinical trial for DR-TB  that included children and pregnant women.

Ndjeka explains the strides the country has made in DR-TB treatment over the years.  

“In 2018 we made a breakthrough by providing a nine month oral treatment and we were excited to remove the injectable which was too painful for patients. Last year we introduced a regimen which consisted of four medicines for six months,” he says. 

“This new regimen will complement the one we introduced last year which was only meant for adults. We are very excited about the inclusion of pregnant women and children,” he says. 

It is estimated that 280 000 people in South Africa had TB, including 11 000 with DR-TB,  in 2022. TB is also the second leading cause of death in the country, claiming 54 000 lives.  

New regimen safe and effective 

Dr Francesca Conradie, the principal investigator who led the study says the primary aim was to evaluate the effectiveness and safety of a novel shortened treatment regimen for DR-TBdrug-resistant TB compared with the established standard of care. 

“BEAT Tuberculosis was a study to investigate more treatment options for drug-resistant TB. Currently the national TB programme’s guidelines advise the use of four drugs which are Bedaquiline, Pretomanid, Linezolid and Levofloxacin. While this is very effective, it cannot be given to children and pregnant women,” Conradie tells Health-e News. 

She says while the BEAT study has looked at Bedaquiline, Delamanid, Linezolid, Levofloxacin and Clofazimine. 

“This showed that it was safe and effective in all population groups including children and pregnant women. We also included people living with HIV and those who were undernourished so the new regimen  has increased treatment options,” she says.

The study began in 2019  with over 400 participants enrolled across study sites in Eastern Cape and KwaZulu-Natal.

“We now have a treatment alternative for everyone. This will help to treat everyone with TB and to end the TB epidemic,” Conradie says.

According to Ndjeka , the new treatment means that the department will save money. 

“The duration of treatment is shorter and this decreases the likelihood of losing TB patients to treatment. A lot of patients stop treatment as it gets costly for them to travel to facilities. If they stop treatment for two months or more they are considered a loss to follow up. When they come back for treatment they have to start from a scratch,” he says. 

Global recognition

Ndjeka says the data from the clinical trials was given to the World Health Organisation (WHO) who ruled that this regimen will be recommended for the whole world.

“This move excited us as the intention was to inform local guidelines. We never expected that it would also impact international guidelines,” he says. 

He says the researchers have until the end of the year to put systems in place so that the treatment is available next year.

“The pharmaceutical must know about it and start to work on the regimen. We are positive about this as the medicines are registered. It’s a matter of making sure that they are available in hospitals,” he says. – Health-e News