Treatment of tuberculosis (TB) infection effectively prevents its progression and cures it. Persons aged 12 and older can safely and effectively take rifapentine and isoniazid for three months to treat latent tuberculosis infection. Published data for children is limited. Data on the 3-month weekly rifapentine plus isoniazid (3 HP) in children in India are currently unavailable.
Objective: To compare the treatment completion rates and incidence rates of adverse drug reactions among childrens with TB undergoing the 9H and 3HP regimens.
Methods: This was a prospective, open-label, multicentre randomised trial involving children with newly diagnosed TB. 263 participants were randomised into two groups to have 131 patients in the 3HP group and 132 to the 9H group. Primary endpoint was completion of the 270-day treatment within 12 months. Adverse drug reaction were analysed in both the groups.
Results: Comparing the 9H group with the 3HP group, those who dropped out of the 9H group stopped participating more often. Reason for dropping out was consent withdrawal. Incidence of hepatotoxicity was lower in the 3HP group than in the 9H group. However, grade 2 and 3 ADR were more in the 3HP group.
Conclusion: An increased completion rate was seen with the 3HP regimen compared with the 9H regimen, as well as better tolerance to adverse effects.