Risk of SDRs Under 3HP and 1HP Regimen for LTBI

Summary

Successful implement of preventive therapy for subjects with latent tuberculosis infection (LTBI) is the critical step for elimination of tuberculosis (TB). The major obstacle of traditional preventive therapy is the unacceptable long treatment duration, taking isoniazid 5mg/kg daily for a total of 9 months (9H), thus seriously compromising its acceptability. With the introduction of 12-doses weekly high-dose (15 mg/kg) rifapentine plus isoniazid (3HP regimen), the completion rate of 3HP has be shown to be much higher than 9H. However, 4.9% to 9.1% of LTBI cases who received 3HP failed to complete treatment because of side effects. Systemic drug reactions (SDRs), even hypotension and shock, under 3HP treatment are higher than 9H treatment. A recent study in HIV patients demonstrated that a new short-term regimen, consisting of isoniazid 5mg/kg plus rifapentine 10mg/kg daily for one month (1HP), has a similar risk of adverse reactions as 3HP. Clinical study with head-to-head comparison between 3HP and 1HP, however, remains lacking. The prospective multicenter study is conducted to investigate whether risk of SDRs under 1HP is lower than that under 3HP. Hypothesis: 1HP has a lower incidence rate of SDRs than 3HP Objectives: 1. To compare the risk of SDRs in 1HP treatment and in 3HP treatment 2. To explore side effect profile of 1HP Methods: This multicenter randomized control trial will compare the risk of SDRs under conventional 3HP regimen (Arm 1: 3HP), and a new regimen consisting of daily rifapentine (10 mg/kg) plus isoniazid (5 mg/kg) for 1 month (Arm 2: 1HP).

Timeline

Start

2019-09-24

Primary completion

2023-10-08

Completion

2023-12-15

Publications

• Huang HL, Lee MR, Lee CH, Cheng MH, Lu PL, Sheu CC, Wang JY, Chong IW, Yang JM. One-month daily and three-month weekly rifapentine plus isoniazid are comparable in completion rate and safety for latent tuberculosis infection in non-HIV Population: a randomized controlled trial. Clin Microbiol Infect. 2024 Nov;30(11):1410-1417. doi: 10.1016/j.cmi.2024.06.024. Epub 2024 Jul 10.

Drugs

Indications