Despite global efforts, tuberculosis (TB) remains a challenge. It causes an estimated 1.3 million deaths and afflicts millions of individuals globally. World Tuberculosis Day reminds us that TB requires international cooperation and collaboration to control, spread and treat TB effectively. Effective treatment of TB prevents transmission, which is key to controlling the disease.
Leeds Teaching Hospitals NHS Trust (LTHT) is actively participating in several studies on TB. The TB-DILI study is a trial to evaluate the optimal treatment regimen for patients who experience Drug-Induced Liver Injury (DILI).
Drug-induced liver injury (DILI) is a common serious side effect of Anti-Tuberculosis Treatment (ATT). Often, it is mild and resolves spontaneously upon stopping the drug, but rarely, it can be fatal.
53 – 57% of DILI episodes occur during the first 2 weeks of treatment, and 75 – 88% within the first 8 weeks.
Currently, there is a different practice as to what is the safest and best treatment to give after someone has had a DILI.
The TB DILI Study, is a multi-site trial, aiming to recruit 350 participants by December 2026, and focuses on Active and Latent TB. Potentially eligible patients will generally be identified either during routine outpatient clinics/consultations, community clinics and mobile clinics, or hospital in-patients.
Active TB patients with DILI episodes may join and be randomly assigned 3 or 4-drug TB treatment after confirmation of liver damage related to TB treatment. Participants sign a consent form, undergo confirmation within 5 days, and complete short health questionnaires. Randomization ensures fair comparisons in recovery. Regular care continues, and the study team monitors for 12 months, occasionally contacting participants about their health.
For Latent TB, data on drug-induced liver injury and recurrence are collected.
This study seeks to find the best approach to recommencing treatment for patients whose treatment was halted due to drug-induced liver injury. Additionally, the study aims to identify the most cost-effective re-introduction strategy for the NHS.
At LTHT, we have recruited one patient to both parts of the study. Our involvement underscores commitment to driving advancements that positively impact patient care in infectious disease.
The outcomes of the TB-DILI study have the potential to reshape treatment guidelines for TB patients in the UK and globally. By providing evidence-based recommendations on the optimal drug regimen, the study can influence clinical practice, reduce the incidence of DILI, and improve patient outcomes.
Dr Fiona McGill, Consultant in Infection and Principal Investigator for the TB DILI study, said, “This study is a pragmatic study that aims to answer a simple question that all TB doctors face every week. It is important for patient outcomes to ensure we know what treatment is safe and efficacious in those who have had adverse events.”
For more information about the study and how to participate, please visit here.