Researchers at the World Conference on Lung Health in Bali, Indonesia, presented findings from the endTB-Q trial, indicating a shorter, tailored treatment regimen is effective for many patients with multi-drug-resistant tuberculosis (MDR-TB). The trial sought a simpler, less toxic option for fluoroquinolone-resistant MDR-TB, which is typically treated with lengthy 18-month regimens.
The endTB-Q clinical trial involved 323 patients from multiple countries, including India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam. Researchers tested a combination of four TB drugs: bedaquiline, clofazimine, delamanid, and linezolid (BCDL). The treatment was administered for six months, with a possible extension to nine months based on the patient's response.
Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial, stated, "Our trial innovated in several important ways...we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria."
The results showed that approximately 87% of patients were cured with the BCDL regimen, compared to 89% in the control arm that received the current WHO-recommended treatment. However, researchers noted that the 87% who improved generally had less severe TB. For those with severe TB, a nine-month BCDL regimen was insufficient, and longer treatments remain necessary.
Guglielmetti added, "Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic."
Bedaquiline Safe for Children
Another study presented at the conference addressed the use of bedaquiline in children with drug-resistant TB. The IMPAACT P1108 trial, funded by the NIH and involving experts from Stellenbosch University in South Africa, found that bedaquiline has a high degree of safety and tolerance in infants, children, and adolescents.
Simon Schaaf, a researcher involved in the trial, said, "The P1108 trial has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind."
Children account for approximately 12% of all TB cases globally, or 1.3 million cases annually. Despite bedaquiline being authorized for use since 2012, trials for its use in children were lacking until recently.
Additional Findings
Other research shared at the conference included findings from Indonesia, where mobile chest X-ray screening proved effective in identifying active TB cases, particularly in individuals without classic symptoms. In Vietnam, researchers emphasized the importance of active case finding in ethnic minorities and remote communities, also utilizing mobile X-ray units.
In the Philippines, person-centered active case finding was found to improve healthcare access for vulnerable populations by integrating TB screening into a poverty alleviation program.
Dr. Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), stated, "Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied...The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB."
