Scientists have identified three new safe and effective treatment for drug resistant tuberculosis (TB), following a multi-national clinical trial conducted by researchers at Harvard Medical School and other partners in the “End TB” project.
The study, published on January 30 in the New England Journal of Medicine, aimed to expand treatment options, improve patient care and minimize side effects.
The new regimens are designed to replace daily injections with oral medications, making treatment less toxic and more accessible. Researchers noted that current treatment options for rifampin-resistant TB—a strain resistant to a key first-line antibiotic—have been inadequate due to poor effectiveness and low-quality evidence. These new therapies offer a promising alternative for patients worldwide.
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A multinational research study on drug-resistant tuberculosis (TB) was conducted between 2017 and October 2021, enrolling 754 participants from Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru and South Africa. The study aimed to evaluate new treatment regimens to improve effectiveness and reduce side effects.
The study population included children and individuals with HIV or hepatitis C, both prevalent in regions with high TB rates. Participants were randomly assigned to either the standard four-month treatment or one of five new nine-month oral drug combinations.
The new regimens consisted of newer drugs, bedaquiline and delamanid, alongside repurposed medications, clofazimine and linezolid. According to World Health Organization (WHO) recommendations, three of the five combinations demonstrated success rates of at least 85 per cent, compared to 81 per cent in the control group.
The study indicates that poor treatment outcomes in the past were due to “suboptimal 18-to-24-month regimens” that included aminoglycosides or polypeptides administered through injections, often causing significant toxic effects.
It further notes that previous treatment regimens were developed based on expert opinion and pooled analyses of observational studies, as no contemporary randomized controlled clinical trials were available to guide treatment decisions.
In 2016 and 2017, the EndTB (Evaluating Newly Approved Drugs for Multidrug-Resistant Tuberculosis) project launched the second phase of its trial. The goal was to identify shorter, all-oral treatment regimens lasting between six and nine months to safely and effectively treat rifampin-resistant TB in adults and adolescents.
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