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One-Month Tuberculosis Preventive Therapy Regimen Proves Effective and Safe for Latent Infection

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One-Month TB Treatment Proves Safe and Effective for Non-HIV Patients

A study published in PLOS Medicine has demonstrated that a one-month treatment regimen (1HP) for latent tuberculosis (TB) infection is safe and effective for patients without HIV.

This finding suggests a new option for clinicians and public health programs in preventing active TB disease.

Background on Tuberculosis

Tuberculosis remains a significant global health concern. An estimated one-quarter of the world's population carries a latent infection. In 2024, the World Health Organization reported over 10 million active TB cases and 1.2 million deaths, solidifying TB's position as a leading cause of death from infectious disease.

Current Treatment Regimens

Current treatments for latent TB infection aim to prevent its progression to active disease:

  • 3HP: This involves a three-month, weekly regimen, totaling 12 doses, of isoniazid and rifapentine.
  • 1HP: A one-month, daily regimen consisting of 30 doses of isoniazid and rifapentine. This regimen was previously recommended for individuals with TB and HIV, as well as for those over 13 who had been in contact with infected individuals.

Historically, Tuberculosis Preventive Therapy (TPT) typically required 6-9 months of isoniazid alone. These longer courses often presented challenges with toxicity and treatment completion rates.

The Ultra Curto Clinical Trial

The Ultra Curto randomized clinical trial aimed to assess the safety and efficacy of the 1HP regimen specifically for latent TB patients who do not have HIV. The study was led by Richard Chaisson, M.D., director of the Johns Hopkins University Center for Tuberculosis Research.

Study Design and Participants

Researchers from Johns Hopkins Medicine collaborated with organizations in Brazil to conduct the trial. They enrolled 500 adolescents and adults across two Brazilian cities. All participants in the study tested positive for latent TB infection but were negative for HIV.

Participants were randomized into two distinct treatment groups:

  • 1HP group: Comprising 249 participants.
  • 3HP group: Comprising 251 participants.

The median age of the participants across both groups was 39 years.

Key Outcomes and Results

The Ultra Curto trial meticulously evaluated several critical factors: treatment completion rates, the incidence of side effects, discontinuation due to adverse effects, and ultimately, the prevention of latent TB progressing to active disease.

  • Treatment Completion: The 1HP group achieved an 89.6% completion rate, which was notably higher than the 84.1% completion rate observed in the 3HP group.
  • Adverse Effects: Adverse safety effects or treatment discontinuation due to side effects were reported in 16.1% of 1HP recipients and 10.4% of 3HP recipients.

Importantly, the adverse events experienced by the 1HP group were generally considered minor and did not prevent the vast majority of patients from completing the full one-month course.

  • Treatment Success: Both the 1HP and 3HP regimens demonstrated high rates of positive treatment outcomes, effectively preventing the progression of latent TB to active disease.

Implications for TB Prevention

The compelling findings from the Ultra Curto trial indicate that the one-month 1HP regimen is a viable and effective option for treating latent TB infection in non-HIV patients.

This breakthrough provides an additional, shorter preventive therapy choice for clinicians and public health programs worldwide. Such a streamlined regimen holds the potential to significantly improve patient adherence and bolster global efforts to control tuberculosis.

The study received federal funding from the National Institutes of Health's National Institute of Allergies and Infectious Diseases.