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).