Treatment for children with nonsevere TB can be shortened to 4 months
Treatment for children with nonsevere tuberculosis can be safely shortened from 6 to 4 months, according to the results of a study published this week in The New England Journal of Medicine.
Researchers conducted a randomized, controlled trial (SHINE) that sought to examine whether children with drug-susceptible, nonsevere, smear-negative TB could be effectively treated with a shorter course of therapy.
“It is estimated that nearly one-quarter of children with TB die, but the vast majority — 90% —die because they are not diagnosed and started on treatment,” co-author Diana M. Gibb, MD, a professor of epidemiology and pediatrician at the University College London, said in a press release. “A shorter treatment for children with nonsevere TB allows savings of on average $17 per child, which can be used to improve the screening coverage and find the missing children with TB.”
The CDC recently recommended a 4-month regimen to treat patients aged 12 years or older with drug-susceptible pulmonary TB, a decision based on clinical trial results that showed the regimen — rifapentine, moxifloxacin, isoniazid and pyrazinamide — was noninferior to the standard 6-month regimen.
“Challenges remain in terms of the availability of child-friendly formulations of rifapentine and moxifloxacin, data on doses in children, and cost,” Gibb and colleagues wrote in the new study. “However, our results show that a new regimen with new drugs is not necessary for the shortening of treatment in the majority of children with drug-susceptible tuberculosis, since such treatment shortening can be accomplished with the affordable, child-friendly, fixed-dose combinations that are already available.”
Although children are more likely to contract minimal TB, until now, treatment regimens have been based on the results of trials in adults and often required 6 months of a combination of daily medicines, the researchers said.
“People think that a child with TB must be very sick — that’s not true,” co-author Anna Turkova, MD, a pediatrician at St. Mary’s Hospital in London, said in the release. “It is known that two-thirds of children who fall ill with TB every year have nonsevere TB and therefore could be treated with shorter treatment.”
The researchers randomly assigned 1,204 children aged 2 months to 16 years to receive either 4 or 6 months of a WHO-recommended first-line treatment for TB. The median age of the children was 3.5 years and 11% had HIV.
“The primary efficacy outcome was unfavorable status” by 72 weeks — a combination of treatment failure, loss to follow-up during treatment, or death, the researchers explained. In all, 3% of participants in each group experienced a primary-outcome event, well within the noninferiority margin of six percentage points.
“Children are often presenting with mild disease,” Chishala Chabala BSc, MBChB, MMed, MSc, an investigator at the University Teaching Hospital in Lusaka, Zambia, said in the release. “If they are diagnosed on time, they can now be treated with a shorter course. The SHINE results are an opportunity to improve treatment of children with TB.”
Treatment length reduced for children with tuberculosis. https://www.ucl.ac.uk/news/2022/mar/treatment-length-reduced-children-tuberculosis. Published March 10, 2022. Accessed March 10, 2022.