Short-course regimens of rifapentine plus isoniazid to treat latent tuberculosis infection in older Chinese patients: a randomised controlled study

Latent tuberculosis infection (LTBI) management is now a critical component of the End TB Strategy. In this randomised controlled trial (ChiCTR-IOR-15007202), two short-course regimens with rifapentine plus isoniazid, the 3-month once-weekly regimen and the 2-month twice-weekly regimen, were initially designed to be evaluated for 50–70 years aged rural residents with LTBI in China. Due to the fast-growing occurrence of adverse effects, the treatments were early terminated after 8 weeks for once-weekly regimen and after 6 weeks for twice-weekly regimen, respectively. In the modified intention-to-treat analysis on the completed doses, cumulative rate of active disease during 2 years follow-up was 1.21% (14/1155) in the untreated controls, 0.78% (10/1284) in the group of 8-week once-weekly regimen, and 0.46% (6/1299) in the group of 6-week twice-weekly regimen. The risk of active disease was decreased with adjusted hazard ratio of 0.63 (95% CI, 0.27–1.43) and 0.41 (95% CI, 0.15–1.09) for the treatments, respectively. No significant difference was found in the occurrence of hepatotoxicity, 1.02% (13/1279) versus 1.17% (15/1279) (p=0.704). The short regimens tested must be used with caution among elderly because of the high rates of adverse effects. Further work is necessary to test the ultra-short regimens in younger people with LTBI.