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Randomized controlled trial of isoniazid to prevent primary TB infection in Kenyan HIV-exposed uninfected infants published in Clinical Infectious Diseases

Mother and infant pair at a health facility in Kenya. Paul J. Brown Photography.

Children born to mothers living with HIV are at an increased risk of tuberculosis (TB) infection, and young infants are particularly vulnerable to rapidly progressing to TB disease. Isoniazid preventative therapy (IPT) is used routinely to prevent TB after known TB exposure, but recent data suggest most transmission (70-90%) to young children occurs outside the household without identified exposure. Whether IPT can be used to prevent TB initial infection is unknown.

In a new publication in Clinical Infectious Diseases, Assistant Professor Dr. Sylvia LaCourse (Medicine – Allergy & Infectious Diseases and Global Health) and co-investigators for the infant TB Infection Prevention Study (iTIPS) investigated whether IPT is effective in preventing primary TB infection in HIV-exposed infants in Kenya.  This project is led Principal Investigator Dr. Grace John-Stewart (Professor, Global Health, Epidemiology, Medicine – Allergy & Infectious Diseases, Pediatrics) and Site Principal Investigator Dr. John Kinuthia (Affiliate Associate Professor, Global Health; Head of Research and Programs, Kenyatta National Hospital), who both contributed to the publication.  Between August 2016 and June 2018, investigators conducted a randomized controlled trial with 300 infants in Kenya between 6-10 weeks of age. Half of the infants received a dose of medication every day for 12 months, while the other half did not receive the medication. At the end of 12 months, infants were tested for TB infection using either a blood test or skin test.

Though more research is required, the results displayed a trend of lower infection rates among infants who received isoniazid for 12 months compared to infants who did not. The results aligned with previous pediatric TB prevention research, demonstrating that isoniazid was safe to use and did not cause adverse health effects.  Ongoing research can help determine how best to use this intervention that leads to fewer TB infections in children born to mothers living with HIV.

Click here to read the abstract and here to read the full publication.  iTIPS is funded by the Thrasher Research Fund and conducted in collaboration with the University of Washington, Emory University, and University of Nairobi/Kenyatta National Hospital.