1HP vs. 3HP for Latent Tuberculosis
Trial question
Is one-month daily rifapentine plus isoniazid superior to three-month weekly rifapentine plus isoniazid in non-HIV patients with latent tuberculosis infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 490
490 patients (249 female, 241 male).
Inclusion criteria: non-HIV patients aged ≥ 13 years with latent tuberculosis.
Key exclusion criteria: suspected active tuberculosis; concurrently using medications with severe drug-drug interactions or allergic to study medications; life expectancy < 3 years; HIV infection; pregnancy.
Interventions
N=251 1HP (daily rifapentine plus isoniazid for 28 days).
N=239 3HP (12 doses of weekly rifapentine plus isoniazid).
Primary outcome
Systemic drug reactions
12.7%
10.9%
12.7 %
9.5 %
6.3 %
3.2 %
0.0 %
1HP
3HP
No significant
difference ↔
No significant difference in systemic drug reactions (12.7% vs. 10.9%; RR 1.17, 95% CI -2.32 to 4.66).
Secondary outcomes
Significant decrease in flu-like syndrome (40.6% vs. 96.2%; RR 0.42, 95% CI 0.17 to 0.67).
Significant decrease in flu-like syndrome without cutaneous symptoms (12.5% vs. 80.8%; RR 0.15, 95% CI 0.06 to 0.24).
Significant increase in pure urticaria (59.4% vs. 3.8%; RR 15.63, 95% CI 6.36 to 24.9).
Safety outcomes
No significant difference in adverse drug reaction and hepatotoxicity.
Conclusion
In non-HIV patients aged ≥ 13 years with latent tuberculosis, 1HP was not superior to 3HP with respect to systemic drug reactions.
Reference
Hung-Ling Huang, Men-Rui Lee, Chih-Hsin Lee et al. 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.
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