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Isoniazid preventive therapy during infancy does not adversely affect growth among HIV-exposed uninfected children:
Ashenafi Shumey Cherkos1, Sylvia M LaCourse2,3,4, Daniel A Enquobahrie2
1Department of Population and Community Health, School of Public Health, University of North Texas Health Science Center, Fort Worth, Texas, United States of America.
Insights
Isoniazid preventive therapy (IPT) did not affect infant growth in the first two years. This study on HIV-exposed uninfected infants found no significant differences in weight-for-age or height-for-age z-scores between groups.
Area of Science:
- Pediatric infectious diseases
- Global child health
- Tuberculosis prevention
Background:
- Isoniazid preventive therapy (IPT) reduces tuberculosis (TB) risk.
- Long-term effects of IPT on infant growth are not well-established.
- This study evaluated IPT's impact on growth in HIV-exposed uninfected (HEU) infants without known TB exposure.
Purpose of the Study:
- To assess the impact of isoniazid preventive therapy (IPT) on infant growth.
- To compare growth trajectories (weight-for-age z-score [WAZ] and height-for-age z-score [HAZ]) in HIV-exposed uninfected infants receiving IPT versus a control group.
- To analyze growth outcomes up to 24 months of age.
Main Methods:
- A non-blinded randomized controlled trial (RCT) involving 298 HIV-exposed uninfected infants in Kenya.
- Infants received daily isoniazid for 12 months (IPT arm) or no intervention (control arm).
- Intent-to-treat linear mixed-effects models were used to compare WAZ and HAZ between groups through 24 months of age.
Main Results:
- No significant differences in WAZ or HAZ were observed between the IPT and control arms.
- Both groups experienced declines in WAZ and HAZ, with greater HAZ decline noted in male infants.
- Infants in the IPT arm showed a slightly higher monthly weight-for-height z-score (WHZ) increase by 24 months.
Conclusions:
- Isoniazid preventive therapy (IPT) administered to HIV-exposed uninfected infants does not significantly impact growth outcomes during the first two years of life.
- Growth trajectories for weight-for-age and height-for-age z-scores were similar between infants receiving IPT and those in the control group.
- Further research may explore potential subtle effects or long-term impacts beyond 24 months.
Background:
Isoniazid preventive therapy (IPT) decreases risk of tuberculosis (TB) disease; impact on long-term infant growth is unknown. In a recent randomized trial (RCT), we assessed IPT effects on infant growth without known TB exposure.
Methods:
The infant TB Infection Prevention Study (iTIPS) trial was a non-blinded RCT among HIV-exposed uninfected (HEU) infants in Kenya. Inclusion criteria included age 6-10 weeks, birthweight ≥2.5 kg, and gestation ≥37 weeks. Infants in the IPT arm received 10 mg/kg isoniazid daily for 12 months, while the control trial received no intervention; post-trial observational follow-up continued through 24 months of age. We used intent-to-treat linear mixed-effects models to compare growth rates (weight-for-age z-score [WAZ] and height-for-age z-score [HAZ]) between trial arms.
Results:
Among 298 infants, 150 were randomized to IPT, 47.6% were females, median birthweight was 3.4 kg (interquartile range [IQR] 3.0-3.7), and 98.3% were breastfed. During the 12-month intervention period and 12-month post-RCT follow-up, WAZ and HAZ declined significantly in all children, with more HAZ decline in male infants. There were no growth differences between trial arms, including in sex-stratified analyses. In longitudinal linear analysis, mean WAZ (β = 0.04 [95% CI:-0.14, 0.22]), HAZ (β = 0.14 [95% CI:-0.06, 0.34]), and WHZ [β = -0.07 [95% CI:-0.26, 0.11]) z-scores were similar between arms as were WAZ and HAZ growth trajectories. Infants randomized to IPT had higher monthly WHZ increase (β to 24 months 0.02 [95% CI:0.01, 0.04]) than the no-IPT arm.
Conclusion:
IPT administered to HEU infants did not significantly impact growth outcomes in the first two years of life.
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