New TB regimen reduces treatment time by a third — clinical trial

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Lung health researchers have announced important developments in tuberculosis (TB) research at the Union World Conference. This includes promising data from a clinical trial demonstrating that treatment time for people living with TB can be reduced by a third. Typically, TB treatment currently lasts at least six months, but the study reported that participants were TB-free after a regimen of four months.

Susan Dorman of the Medical University of South Carolina presented the results from this randomised, controlled trial, which enrolled more than 2,500 participants from 13 countries. “This is the first clinical trial to identify a shorter regimen that works as well as the standard six-month regimen” said Dorman. “A shorter regimen will enable people with TB to be cured faster and may reduce treatment costs, improve quality of life and help more people successfully complete their treatment.”

This study gives the first estimate of the full-income losses due to TB mortality until 2050. It estimated cause-eliminated life expectancy in 165 countries, if TB deaths fell by 25 annually.

Sachin Silva of Harvard University presented the study and reported that failure to achieve the End TB targets by 2030 will have devastating economic impacts on countries with high prevalence of HIV and TB, especially in sub Saharan Africa.

The economic and human cost of not ending TB by the UN target of 2030 and instead the more likely date of 2045, will be to the order of some $3trn, with 5.7m avoidable TB deaths.

Silva noted that COVID-19 has certainly made 2045 the more likely scenario, suggesting even a brief shut down in TB programmes because of the pandemic is likely to have calamitous epidemiologic and economic consequences.

“There is a growing awareness that symptom-based screening doesn’t catch everyone, and our study was designed to find these missing cases”, said Rebecca Berhanu of Boston University, reporting on a study evaluating the effectiveness of TB screening based on risk-factor, rather than symptoms.

The Targeted Universal Testing for Tuberculosis cluster-randomised trial, included more than 22,000 participants in 60 primary health care facilities in South Africa. Six percent of people in the study were found to have TB, even without symptoms. “These results add to the mounting evidence that passive case detection, based on symptom-based screening alone, is not sufficient to identify all cases of TB.” said Berhanu.

While TB control programmes use symptom-based screening to identify individuals for further investigation, these results confirm that this approach does not find all patients with TB.

Other announcements included promising new insights on the birth outcomes of pregnant women exposed to isoniazid preventive therapy, the potential feasibility of using an adapted PPE mask attached with a gelatin membrane to collect sputum from children and a study by US researchers demonstrating the economic and human cost of not meeting the UN target of ending TB by 2030.

 

TB co-director at the New York-based advocacy organisation Treatment Action Group (TAG), Mike Frick, is quoted in Spotlight as saying that these results mark “the biggest jump or shift in TB care in decades”. “It kind of changes everything,” he said.

There are expected to be some cost-savings attached to a two-month cut in treatment length, but there is uncertainty on whether or not the amount of money spent on the actual drugs will come down, said Dorman, who also represents both bodies involved in the trial (the TBTC and NIAID/NIH). While the current six-month treatment is dirt-cheap, rifapentine and moxifloxacin are both comparatively expensive – although this may change over time.

“(The) important question about cost really includes two (main) ideas. Firstly, the cost of new medicines, for example rifapentine and moxifloxacin, as well as their supply,” said Dorman. She added that the “other part of the cost equation is how much can be saved in reducing the length of treatment” including funds “potentially saved by TB programmes and at the TB-provider level and time cost saved by participants on their own work and economic activities”.

“We receive the results with a lot of gratification and happiness. TB-affected communities have always wished for shorter, easier TB treatment with fewer side effects. We strongly believe this is a real breakthrough, as the new regimen will generate better treatment outcomes for TB patients. We are on the path to wipe out TB as a killer disease,” said TAG’s Dorothy Namutamba is quoted as saying.

“We call for national TB programmes, regulatory agencies, and international organisations to make this four-month regimen of existing drugs available as soon as possible – starting in the countries that hosted clinical trials sites that made this result possible,” said Frick.

“Considering that this was a publicly funded study, the results should be considered as a public good made available to all. We further encourage funders and researchers to fill remaining data gaps so that this new, shorter regimen can be used in children under 12, in pregnant women, and in people with co-morbidities not included in Study 31/A5349,” he said.

Frick explained that, even if the drugs ended up being affordable to low-and middle-income countries, there remain a number of bureaucratic processes to take place before the new regimen can actually get to patients.

“Following the presentation of the results, an application will be submitted to the World Health Organisation to evaluate the results to be considered to be included in its updated TB treatment guidelines. After this, governments will have to update national guidelines in response to that,” he said.

But many, including Dr Arne von Delft from South African advocacy organisation TB Proof, are still hopeful TB treatment can be shortened even further in future. He said in the Spotlight report that “four months is still a long time” and that moxifloxacin in particular “is far from safe”.

“But this is promising progress nevertheless,” he said.

 

Union World Conference material

 

Full Spotlight report

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