Breakthrough research highlights safer MDR-TB treatment for children

LAHORE : Breakthrough research presented at The Union World Conference on Lung Health has provided critical insights into the safety, tolerability, and adherence profiles of key treatments used in WHO-recommended regimens for multidrug-resistant TB (MDR-TB).

Results from TB-CHAMP, a phase 3 double-blind, multi-site randomised trial conducted in South Africa by University College London (UCL), UK, and Stellenbosch University, South Africa, assessed Levofloxacin as a preventative treatment for MDR-TB in children and adolescents aged 0-17 years.

The study revealed that among the 155 (17%) children who prematurely discontinued treatment, 70 did so for clinical reasons, while 85 stopped for non-clinical reasons. Of the 818 children provided with information on treatment adherence and who did not stop prematurely for clinical reasons, 61 (7%) exhibited poor adherence.

While adherence to Levofloxacin was found to be generally good, researchers emphasised the need for strategies to improve adherence, including enhanced counseling and support for caregivers.

Researchers from UCL and Stellenbosch University also presented pooled data from TB-CHAMP and VQUIN, an independent phase 3 trial conducted primarily in adults in Vietnam. The combined analysis showed no evidence of serious safety concerns with Levofloxacin as a preventative treatment for MDR-TB. However, researchers noted that low-grade adverse events (AEs) affected treatment tolerability, particularly among adults, leading to treatment discontinuation.

Additionally, Stellenbosch University researchers shared findings from CATALYST, a multi-country pharmacokinetic, safety, and acceptability trial focusing on child-friendly formulations of clofazimine (CFZ) and moxifloxacin (MFX). The study also assessed combination regimens of CFZ, MFX, and bedaquiline (BDQ), key components of WHO-recommended regimens for rifampicin-resistant TB (RR-TB).

The study found that children on combinations of MFX, CFZ, and BDQ experienced higher mean QTcF (a measure of the ‘resting’ phase of a heartbeat on an electrocardiogram [ECG]), necessitating additional clinical visits and drug switching. Researchers recommended avoiding this combination when alternatives are available and emphasized the need for careful ECG monitoring. Speaking from Bali, Dr. Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), said:

“Multidrug resistance in TB represents a severe threat, both to those living with the disease and to global health. Treatment regimens that prioritise safety and adherence are paramount in addressing this threat.”

She said: “The new research presented at the Union Conference this week marks crucial progress in improving treatment regimens, especially for children.”