The National Institutes of Health (NIH) has reported positive outcomes from a Phase III clinical trial (ACTG 5279) comparing a one-month antibiotic regimen to standard nine-month therapy in preventing active tuberculosis (TB) in HIV patients.
Results indicated that the safety and efficacy of the short-term regimen of rifapentine and isoniazid were similar to that of the nine-month treatment with isoniazid alone.
This short course is intended to improve patient adherence and reduce risk of side-effects.
NIH’s National Institute of Allergy and Infectious Diseases (NIAID) funded the international trial that was carried out by the NIAID-funded AIDS Clinical Trials Group.
Director of NIAID Anthony Fauci said: “Globally, tuberculosis kills more people than any other infectious disease, and it is the leading cause of death for people living with HIV.
“These results have the potential to dramatically change clinical practice by offering people living with HIV who are at risk of developing active tuberculosis an additional, shorter-duration prevention option that is safe, effective and more convenient.”
The trial data is also expected to help further research on TB prevention in HIV-negative people who are at risk of developing TB.
For the study, a total of 3,000 HIV patients aged 13 years and above were enrolled across Botswana, Haiti, Brazil, Kenya, Peru, the US, South Africa, Malawi, Thailand, and Zimbabwe.
The subjects either had a high risk of TB or were diagnosed with latent infection, and about 50% of them were on antiretroviral therapy for their HIV.
According to the results, the one-month and nine-month regimens were both found to be safe but the adverse effects were less with the short-term combination therapy.
It was also observed that around 97% of subjects given with the short-course therapy completed the entire course, compared with 90% in the nine-month arm.