Tuberculosis is one of the leading causes of mortality in patients with human immunodeficiency virus (HIV). Preventive therapies are used across the world, but their efficacy and outcomes are not well-implemented. However, recent studies suggest the combination of rifapentine and isoniazid can help prevent HIV-related tuberculosis. This study aims to investigate the effectiveness of rifapentine plus isoniazid in treating HIV-related tuberculosis.
This is a randomized, open-label, phase-3, non-inferiority trial that included a total of 3,000 HIV-infected patients living in areas of high tuberculosis prevalence. The participants were randomly assigned to a 1-month regimen of daily rifapentine plus isoniazid or with 9 months of isoniazid alone. The primary outcome was the diagnosis of tuberculosis or death from tuberculosis.
At the median follow-up of 3.3 years, 32 out of 1,488 patients (2%) in the 1-month combination group and 33 of 1,498 patients (2%) in the 9-month group were diagnosed with tuberculosis. The incidence rate of tuberculosis was 0.65 and 0.67 per 100 person-years, respectively. Serious adverse events occurred in 6% of 1-month group participants and 7% of 9-month participants.
The research concluded that the one-month regimen of rifapentine plus isoniazid was non-inferior to 9-month isoniazid alone treatment for preventing tuberculosis disease in HIV-infected patients.