In a significant breakthrough, scientists have identified three safe and highly effective treatment regimens for drug-resistant tuberculosis (TB). The findings come from a multinational clinical trial led by researchers at Harvard Medical School, in collaboration with the “End TB” project and other global research institutions.
Published in the New England Journal of Medicine on January 30, the study aims to expand the range of treatment options available to patients with rifampin-resistant TB. The new approaches focus on reducing side effects, eliminating the need for painful injections, and offering more patient-friendly, oral medication alternatives.
For decades, TB treatment has been plagued by limited options, particularly for patients with resistance to rifampin, one of the first-line antibiotics used to combat the disease. Conventional treatments often involve toxic drug combinations and prolonged regimens that lead to severe side effects, making adherence difficult for many patients.
The newly discovered treatments promise not only improved effectiveness but also a shorter and more tolerable treatment period. Instead of enduring 18 to 24 months of treatment including injectable medications patients can now complete their therapy in as little as six to nine months using all-oral regimens.
Launched in 2017 and concluding in October 2021, the study enrolled 754 participants from diverse backgrounds in countries including Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa. The study group included children, as well as individuals co-infected with HIV or hepatitis C two conditions frequently found in populations with high TB prevalence.
Participants were divided into different groups, with some receiving the standard TB treatment while others were placed on one of five new oral drug combinations. These regimens featured both newly developed drugs (bedaquiline and delamanid) and repurposed medications (clofazimine and linezolid).
The results showed that three of the five new regimens achieved success rates of 85% to 90%, surpassing the 81% success rate of the standard treatment. This finding indicates that these new drug combinations could significantly improve patient outcomes while making TB treatment more manageable.
The control group, which received conventional long-term treatment, included recently discovered TB drugs but still relied on older regimens known for their side effects. In contrast, the new treatments eliminate the need for injectable drugs, which have historically been associated with severe toxicity.
Drug-resistant TB remains a major global health threat. According to the World Health Organization (WHO), approximately 410,000 people develop rifampin-resistant TB each year, yet only 40% of cases are diagnosed and treated. Of those who receive treatment, only 65% recover successfully, highlighting the urgent need for more effective treatment solutions.
Historically, many patients with rifampin-resistant TB were subjected to toxic drug combinations based on expert opinions and observational studies rather than rigorously controlled clinical trials. The new research changes this paradigm by providing evidence-based solutions that improve both effectiveness and patient experience.
The End TB project, which has been working to develop shorter, all-oral treatment options since 2016, has now paved the way for a new standard of care. The latest phase of research confirms that three newly identified regimens can provide safe, effective alternatives to outdated treatment approaches.
“The results of this trial support the non-inferior efficacy of three all-oral shortened regimens for the treatment of rifampin-resistant tuberculosis,” the researchers stated. “These findings improve prospects for effective, simple, all-oral treatment for adults and children with this disease.”
This breakthrough marks a significant step toward eliminating TB as a global health threat, offering new hope to millions of patients worldwide. With further implementation and accessibility, these improved treatment options could help turn the tide in the fight against drug-resistant TB.
