MUMBAI: A shorter regimen for children with drug-sensitive tuberculosis will be included in the World Health Organization’s consolidated treatment guidelines to be released soon. The guidelines are based on the University College London-led SHINE (Shorter Treatment for Minimal Tuberculosis in Children) trial that found a shortened regimen of 4 months was not inferior to the conventional 6-month course.

While the complete paper on the SHINE trial is yet to be published, the researchers presented their findings in the 51st virtual Union World Conference on Lung Health in 2020.

The SHINE trial covers 1204 children under 16 years including 127 children living with HIV at five sites- South Africa, Uganda, Zambia and India. The two trial sites in India included the National Institute for Research in Tuberculosis, Chennai and BJ Government Medical College, Pune. The trial compared 4 versus 6 months of treatment with anti-TB medicines such as rifampicin, isoniazid, pyrazinamide plus or minus ethambutol in children with smear-negative, non-severe TB. All participants were followed for 18 months after enrolment to monitor the success of the treatment. Minimal TB was defined as non-severe lung or lymph gland TB, where the TB bacteria cannot easily be found in the sputum through smear microscopy (smear negative).

“About 50% to 60% of paediatric patients have the non-severe form of TB, yet they get 6-month-long treatment courses, and sometimes even beyond 6 months,” Dr Aarti Kinikar, the principal investigator at the Pune site told HT. Kinikar is a professor at BJ Medical College and head of the paediatrics department at Sassoon General Hospital.

“India has a huge problem of non-compliance of TB treatment, which is often triggered by the longer treatment duration. A shorter regimen will definitely improve compliance,” said Kinikar adding that a shortened regimen also reduces the exposure of medicines and their side effects on the liver, eyes and hearing. In addition to the side effects, children also miss out on school making it challenging for them to cope, and the caregivers also struggle to continue with the treatment schedule.

While the findings of the SHINE trial have been approved by WHO, it will depend on India’s Central TB Division to adopt them for implementation in the country. Till now, pediatric TB treatment regimens are largely based on adult clinical trials, even as children are more likely to have minimal TB.

In August 2021, WHO’s guidelines development group reviewed the evidence from the SHINE trial and recommended that children and adolescents with non-severe, presumed drug-susceptible TB should be put on a 4-month regimen rather than the standard 6-month regimen. The important considerations to determine the eligibility of patients for the short treatment course will be described in the full consolidated guidelines to be released this month.

“Children are often presenting with mild disease. If they are diagnosed on time, they can now be treated with a shorter course,” lead investigator at the Zambian trial site, Dr Chishala Chabala was quoted in a media release. “The SHINE results are an opportunity to improve treatment of children with TB,” said Chabala.

Mumbai-based pulmonologist Dr Salil Bendre who practices at the Nanavati Hospital said a long duration of treatment also increases the out-of-pocket expenditure, which becomes challenging for many families. “A shorter regimen will definitely improve treatment compliance,” he said.