To prevent tuberculosis (TB) in children with latent tuberculosis infection (which is not active but can become active), combination treatment with the medications rifapentine and isoniazid was as effective as longer treatment with only isoniazid, according to a study published online by JAMA Pediatrics.
Children account for a substantial portion of the global burden of active and latent tuberculosis. Treating latent tuberculosis infection (LTBI) in children is beneficial because it can prevent TB from developing and limits transmission of Mycobacterium tuberculosis, according to background information in the study.
M. Elsa Villarino, M.D., M.P.H., of the U.S. Centers for Disease Control and Prevention (CDC), Atlanta, and coauthors compared the safety and effectiveness of combination therapy with rifapentine and isoniazid to treatment only with isoniazid. The randomized clinical trial compared 12, once-weekly doses of the combination drugs given with supervision by a healthcare professional with nine months of daily isoniazid treatment without supervision by a health care professional in children (ages 2 to 17 years) with latent tuberculosis infection from 29 study sites in the United States, Canada, Brazil, China and Spain. Of the 1,058 children enrolled, 905 were eligible for the evaluation of treatment effectiveness (471 in the combination-therapy group and 434 in the isoniazid-only group.
The cumulative proportion of children in whom TB was diagnosed was zero of 471 in the combination-therapy group vs. 3 of 434 in the isoniazid-only group, according to the study results. Neither group had any treatment-attributed hepatotoxicity (liver damage), serious adverse events or deaths.
"We found that combination therapy with rifapentine and isoniazid was well tolerated and safe in children aged 2 to 17 years who were treated for LTBI," the study concludes.
(JAMA Pediatr. Published online January 12, 2015. doi:10.1001/jamapediatrics.2014.3158. Available pre-embargo to the media at http://media.
Editor's Note: Authors made conflict of interest disclosures. Sanofi provided the rifapentine for this study and has donated more than $2.5 million to the CDC Foundation to supplement available U.S. federal funding for rifapentine research. Please see article for additional information, including other authors, author contributions and affiliations, etc.
Editorial: 12-Dose Drug Regimen Also Option for TB Prevention in Kids
In a related editorial, Ben J. Marais, Ph.D., of the Children's Hospital at Westmead, Sydney, Australia, writes: "Confirmation that isoniazid and rifapentine combination therapy is safe and of equivalent efficacy to isoniazid monotherapy in children aged 2 to 17 years is an important and long-awaited finding."
"Given the strength of the evidence and the urgent need to implement effective tuberculosis prevention strategies in high-burden settings as well as the move toward tuberculosis elimination in nonendemic areas, it is hoped that isoniazid and rifapentine combination therapy soon becomes the standard of care for HIV-uninfected individuals in most settings. Unfortunately, rifapentine is not widely available outside the United States," the author concludes.
(JAMA Pediatr. Published online January 12, 2015. doi:10.1001/jamapediatrics.2014.3157. Available pre-embargo to the media at http://media.
Editor's Note: Please see article for additional information, including other authors, author contributions and affiliations, etc.
Media Advisory: To contact corresponding author Ruth N. Moro, M.D., M.P.H., call the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention news media line at 404-639-8895 or email NCHHSTPMediaTeam@cdc.gov. To contact editorial author Ben J. Marais, Ph.D., email firstname.lastname@example.org