To prevent tuberculosis in children with dormant infection, combination treatment with rifapentine and isoniazid was as effective as longer treatment with only isoniazid, results of a study published in JAMA Pediatrics indicate.
Nearly one million pediatric patients develop tuberculosis (TB) each year, noted Ben J. Marais, PhD, of the Children’s Hospital at Westmead in Sydney, Australia, in an accompanying editorial.
“Tuberculosis case loads are highly concentrated in areas affected by poverty and social disruption, but all countries are affected owing to increased international travel, population migration, and refugee resettlement.”
To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid versus nine months of isoniazid treatment for latent tuberculosis infection in children, M. Elsa Villarino, MD, MPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, and colleagues conducted a randomized, open-label clinical trial.
From December 2010 through September 2013, patients aged two to 17 years who were eligible for latent TB infection treatment were assigned to two groups. Patients enrolled in the combination-therapy group (n=471) were assigned 12 once-weekly doses of the combination drugs, administered with supervision by a health-care professional, for three months. The control group (n=434) was assigned to receive 270 daily doses of isoniazid without provider supervision for nine months.
Rates of treatment discontinuation because of adverse events, toxicity grades 1 to 4, and deaths from any cause were compared. TB disease diagnosed within 33 months of enrollment was the main end point for testing effectiveness.
In the combination-therapy group, 88.1% of the participants completed treatment compared with 80.9% of participants assigned to the isoniazid-only group (P=0.003). None of the 471 participants in the combination-therapy group developed TB, compared with three participants (cumulative rate, 0.75%) in the isoniazid-only group.
“Given the strength of the evidence and the urgent need to implement effective TB prevention strategies in high-burden settings as well as the move towards TB elimination in nonendemic areas, it is hoped that rifapentine and isoniazid combination therapy soon becomes the standard care for HIV-uninfected individuals in most settings,” said editorial author Marais.