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WHO has integrated guidelines to enable shorter tuberculosis treatment courses for children | Latest News India
Mumbai: A shorter regimen for children with drug-sensitive tuberculosis will be included in the upcoming World Health Organization integrated treatment guidelines. The guidelines are based on the University of London-led SHINE (Short-term Treatment for Minimum Tuberculosis in Children) trials, which found that the 4-month shortened regimen was not inferior to the traditional 6-month course.
Although the full paper on the SHINE trial has not yet been published, researchers presented their findings at the 51st World Congress on Virtual Union on Lung Health in 2020.
The SHINE trial enrolls 1204 children under the age of 16 including 127 children living with HIV in five locations in South Africa, Uganda, Zambia and India. The two test sites in India included the National Tuberculosis Research Institute in Chennai and the BJ Government Medical College in Pune. The study compared 4-month and 6-month treatment with anti-tuberculosis drugs such as rifampicin, isoniazid, pyrazinamide plus or minus ethambutol in children with smear-negative and non-severe tuberculosis. All participants were followed for 18 months after enrollment to monitor the success of treatment. Minimal tuberculosis is defined as non-severe lung or lymphatic tuberculosis, and M. tuberculosis cannot be easily found in sputum by smear microscopy (smear negative).
“Approximately 50% to 60% of pediatric patients have non-severe tuberculosis, but they take a 6-month course of treatment, sometimes longer than 6 months,” said Pune Site Principal Investigator. Said Dr. Aarti Kinikar. HT. Kinikar is a professor at BJ Medical College and head of pediatrics at Sassoon General Hospital.
“India has a major problem of non-compliance with tuberculosis treatment, which is often caused by longer treatment periods. Shortening the regimen will definitely improve compliance,” Kinical said. He added that drug exposure and side effects on the liver, eyes and hearing are also reduced. In addition to the side effects, children are also unable to go to school, difficult to deal with, and caregivers struggle to keep up with their treatment schedules.
The results of the SHINE trial are approved by WHO, but it depends on whether India’s Central Tuberculosis Department adopts it for domestic implementation. To date, pediatric tuberculosis treatment regimens are primarily based on adult clinical trials, even though children are more likely to suffer from minimal tuberculosis.
In August 2021, the WHO Guidelines Development Group reviewed the evidence for the SHINE trial to provide children and adolescents with presumed non-severe tuberculosis with a 4-month regimen instead of the standard 6-month regimen. Was recommended. Key considerations for determining patient eligibility for a short-term treatment course are set out in the fully integrated guidelines released this month.
“Children often present with mild illness. If diagnosed on time, they can now be treated on shorter courses,” said Dr. Chishara Chabara, principal investigator at the Zambian clinical trial facility. Quoted in the media release. “The SHINE results are an opportunity to improve the treatment of children with tuberculosis,” said Chabara.
Dr. Salil Bendre, a Mumbai-based pulmonologist who practices at Nanabati Hospital, said longer treatment periods would increase out-of-pocket costs and make it difficult for many families. “Shorter regimens will definitely improve treatment compliance,” he said.
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