Short-Course TB Prevention Shows Promise in High-Risk Populations as Global Trials Advance
核心洞察
A new one-month tuberculosis (搜索) prevention treatment using rifapentine and isoniazid (1HP) is being tested in people with diabetes through the BALANCE trial, which has enrolled over 100 participants in Cape Town.
A clinical trial in Brazil demonstrated that both one-month daily and three-month weekly antibiotic regimens achieved high completion rates of 89.6% and 84.1% respectively in HIV (搜索)-negative individuals exposed to TB.
The shorter treatment courses could transform TB prevention globally by improving patient adherence and reducing the burden of traditional 6-9 month regimens that many patients fail to complete.
Two major clinical trials are demonstrating the potential of ultra-short tuberculosis (搜索) prevention regimens to transform global TB control, with promising results emerging from studies in high-risk populations including people with diabetes and those exposed to active TB disease.
BALANCE Trial Targets Diabetes Population
The Centre for Infectious Diseases Research in Africa (搜索)'s BALANCE trial has enrolled more than 100 participants at its Khayelitsha Site B Community Health Centre in Cape Town since beginning recruitment in July 2025. Led by Chief Investigator Prof. Molebogeng Rangaka, the multi-site, multi-country study is investigating whether a one-month tuberculosis (搜索) preventive treatment is safe and effective for people with diabetes who are at risk of developing TB disease.
The new one-month TB preventive treatment combines the antibiotics rifapentine and isoniazid, known as 1HP. This regimen has previously demonstrated efficacy in preventing TB disease in people living with HIV (搜索), with additional benefits including higher completion rates and fewer side effects compared to standard 6- or 9-month TB preventive treatments.
"We think this new shorter treatment may alter the balance of benefit against potential harms. If it works, this could result in a change in WHO policy in favour of providing 1HP TB preventive treatment to people living with diabetes," said Prof. Rangaka.
Currently, the World Health Organization does not recommend standard 6- or 9-month TB preventive treatment for people with diabetes who are not living with HIV (搜索) or recent contacts of people with active disease, as it remains unclear whether benefits would outweigh treatment risks. However, people with diabetes face an increased chance of developing TB disease and dying from TB.
The BALANCE trial represents the first study of 1HP in people with diabetes or people without HIV (搜索). Study collaborator Prof. Robert J Wilkinson explained the trial design: "People who choose to participate will be randomly assigned by computer to either a group that receives enhanced diabetes care plus 1HP, or a group that receives enhanced diabetes care alone. We will monitor who develops TB disease and who develops side effects from the treatments in each group."
The complete BALANCE trial will recruit 3,100 people older than 15 with diabetes across the Philippines and South Africa over five years. Philippine clinical research sites in Dasmariñas and Muntinlupa, managed by CareCT (搜索), are expected to begin recruitment in the first quarter of 2026.
Brazilian Study Confirms Safety Profile
Complementing the BALANCE trial findings, a clinical trial led by Richard Chaisson of Johns Hopkins School of Medicine (搜索) has provided robust safety and efficacy data for short-course TB prevention regimens. The study, published in PLOS Medicine, compared one-month daily treatment with three-month weekly treatment in 500 HIV (搜索)-negative individuals in Brazil who had been exposed to TB.
Participants were randomly assigned to receive isoniazid and rifapentine either daily for one month or weekly for three months. Both regimens demonstrated similarly high completion rates, with 89.6% completing the one-month course and 84.1% completing the three-month regimen. Adverse reactions were typically mild or moderate and occurred at comparable rates in both groups.
"Tuberculosis (搜索) preventive treatment regimens have now been shortened from 6-9 months of daily medication to 1 month of daily treatment or 12 once-weekly doses, a transformational advance. Our study shows that both of the ultra-short regimens are well-tolerated and have high rates of completion," the authors stated.
Global Impact Potential
The findings address a critical challenge in TB prevention: the length of traditional treatments that many patients fail to complete. Coauthor Betina Durovni emphasized the broader implications: "The high rates of treatment completion and excellent safety profile of the short-course regimens will help Brazil and other high-burden countries achieve TB control by facilitating widespread uptake of TB preventive treatment."
Marcelo Cordeiro-Santos, another study coauthor, highlighted the global significance: "Preventing TB with short courses of well-tolerated medicines ensures that millions more people around the world can be protected from the devastating consequences of TB disease."
The researchers noted that expanding preventive therapy access is essential for reducing TB infections globally, and these shorter regimens, combined with newer generic formulations that can be taken at home, could facilitate broader implementation of TB prevention programs.
As the authors concluded: "Prevention of tuberculosis (搜索) in people at the greatest risk is essential for global control of the disease, and shorter preventive treatment regimens will be instrumental in catalyzing uptake in high-burden countries."