A phase 3 clinical trial, SHINE (Shorter Treatment for Minimal Tuberculosis in Children), has found that a shortened four-month regimen of rifampicin, isoniazid, pyrazinamide plus or minus ethambutol in children with smear-negative and non-severe tuberculosis (TB) was not inferior to the standard six-month treatment, when there are no adverse events.
According to health officials, a four-month long treatment regimen of drugs works as effectively as a six-month one for children with mild cases of TB.
Dr Aarti Kinikar, professor at BJ Medical College, head of the paediatrics department at Sassoon General Hospital and principal investigator of the Phase 3 SHINE trial in Pune, told The Indian Express that the trial’s findings have the potential to change current treatment guidelines for children with drug-susceptible TB.
Overall, the trial had 1,250 participants across seven sites — two in India (one at BJMC and another at the National Institute for Research in Tuberculosis, Chennai) and five in South Africa. The Johns Hopkins University-BJMC (Clinical Research Site) collaboration enrolled 86 participants in the open-labelled, randomised trial, which commenced in 2017 and ended in February this year.
The findings were first presented at the 51st Union Conference on Lung Health held virtually in October this year. The World Health Organization (WHO) and US-based Centers for Disease Control and Prevention (CDC) had also announced promising findings from two TB trials, to which the JHU-BJMC partnership in Pune had contributed, according to Dr Murlidhar Tambe, dean of BJ Medical College and Sassoon General Hospital.
It is estimated that 1.2 million children across the world develop TB every year, of which 2,30,000 die — most of them without having accessed adequate care and treatment. Dr Kinikar said that a majority of these children with TB have lesser severe forms of the disease. Long treatment regimens can result in high costs to families and health services, along with risks of drug interactions in children living with HIV and issues regarding adherence to treatment, as per WHO representatives.
Shorter and effective — yet safe — treatment regimens for children with both drug-susceptible and drug-resistant TB make for a key intervention to achieve the WHO’s ‘End TB’ strategy targets. According to researchers, the findings from the SHINE trial have the potential to update current guidelines for the treatment of drug-susceptible TB in children.
Dr Vidya Mave, research director of the BJMC-Johns Hopkins Clinical Trial Unit and one of the co-principal investigators of the trial, said that India assumes the world’s largest burden of TB. The treatment is prolonged and difficult, particularly for children. “The team is proud to have contributed to findings that shorten the length of treatment,” Mave added.
Four-month course of daily TB treatment Is as effective as six-month course for adults
In another important finding, the CDC announced the results of a Phase 3 trial that found that a daily regimen of high-dose rifapentine with moxifloxacin administered over four months is as effective as the current six-month standard of care for affected adults. With no difference in adverse events, the shortened treatment is just as safe.
The study enrolled more than 2,500 participants from clinical sites in 13 countries, including the BJGMC-JHU-India Clinical Research Site in Pune, where 61 participants were enrolled. The study represents the largest drug-susceptible TB treatment trial ever conducted by the CDC. Dr Sanjay Gaikwad and others from the BJGMC have contributed to the landmark international effort.
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