Rifapentine dosing for drug-susceptible tuberculosis: stage 1 of a seamless phase 2/3 randomized clinical trial
Abstract
OBJECTIVES
To evaluate the safety and efficacy across rifapentine doses ranging from 10 to 20 mg/kg for pulmonary drug-susceptible tuberculosis population.
METHODS
The stage 1 of this seamless phase 2/3 randomized controlled trial recruited enrolled adults with drug-susceptible tuberculosis at 16 sites in China between 1 February 2023 and 29 September 2024 (NCT05401071). Participants were randomly divided (1:1:1:1) to receive one of three 4-month regimens containing rifapentine 10, 15, or 20 mg/kg daily plus isoniazid, moxifloxacin, and pyrazinamide, or a standard 6-month regimen consisting of isoniazid, rifampicin, pyrazinamide, and ethambutol. In the stage 1, the primary endpoint was the incidence of permanent regimen discontinuation for safety reasons by week 8. Key secondary endpoints included culture conversion before week 8, adverse events during treatment, and favourable outcomes at the end of treatment.
RESULTS
A total of 400 participants underwent randomization in stage 1. The incidences of primary endpoint were 9.3% (9/97), 8.9% (9/101), and 14.6% (14/96) in the rifapentine 10, 15, and 20 mg/kg groups, and 3.0% (3/99) in the control group, respectively. Culture conversion before week 8 occurred in 73.8% (45/61), 84.8% (56/66), and 87.9% (51/58) of participants in the rifapentine 10, 15, and 20 mg/kg groups, and 78.0% (46/59) in the control group. Favourable outcomes at the end of treatment were similar across the groups: 81.4% (79/97) in the control group, 80.9% in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 400 participants or records.
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