New treatment procedures for drug-resistant TB to replace painful injections
The new regimens included combinations of newer drugs such as bedaquiline and delamanid, along with repurposed drugs like clofazimine and linezolid.
Three new procedures for effectively and safely treating drug-resistant tuberculosis (TB) have been unveiled, following a major multinational clinical trial.
The new treatments are designed to streamline the treatment process, reduce side effects, and replace the painful daily injections currently used for treatment.
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The trial, which was led by researchers from Harvard Medical School and other members of the “End TB” project, was conducted with the goal of expanding treatment options for people suffering from rifampin-resistant tuberculosis.
The research, published on January 30 in the New England Journal of Medicine, aims to offer doctors more methods to tailor treatments for patients and to provide alternatives that are safer and less toxic.
“Tuberculosis that is resistant to rifampin, a key drug for treatment of tuberculosis, is a major global health threat,” reads the study.
According to the World Health Organisation (WHO), 410,000 people become sick with rifampin-resistant tuberculosis annually, but only 40 per cent of cases are diagnosed and treated, with just 65 per cent of those treated successfully.
The new regimens included combinations of newer drugs such as bedaquiline and delamanid, along with repurposed drugs like clofazimine and linezolid.
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Results showed that three of these combinations were effective for between 85 and 90 per cent of patients, compared to an 81 per cent success rate in the control group, which received the longer treatment regimen that also included the newly discovered medicines.
“Regimens were devised on the basis of expert opinion and pooled analyses of observational studies because no evidence was available from contemporary randomised, controlled clinical trials,” the study notes, highlighting the historical reliance on suboptimal treatments that included two injected drugs — aminoglycosides or polypeptides — which had substantial toxic effects.
The study further states that poor outcomes in the past were largely due to these lengthy 18-to-24-month regimens.
However, a second phase of the trial, conducted in 2016 and 2017, found that shorter, all-oral regimens lasting between six and nine months could safely treat rifampin-resistant TB in adults and adolescents.
“The results of this trial support the non-inferior efficacy of three all-oral shortened regimens for the treatment of rifampin-resistant tuberculosis. The results of the ‘end TB’ trial improve prospects for effective, simple, all-oral treatment for adults and children with this disease,” reads the study, offering hope for a significant advancement in the treatment of drug-resistant TB.
The research, which was launched in 2017 and concluded in October 2021, enrolled 754 participants from seven countries – Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa.
The study population included children as well as people infected with HIV or hepatitis C, which are both common in populations with high rates of TB.
Participants were randomly assigned to receive either the usual four-month standard treatment or one of five combinations of newer oral drugs, which would be administered over nine months.
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