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Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial
Chishala Chabala1,2,3, Eric Wobudeya4, Marieke M van der Zalm5
1Department of Paediatrics, School of Medicine, University of Zambia, Lusaka, Zambia.
Insights
Children living with HIV (CWH) treated for nonsevere tuberculosis (TB) had similar outcomes with 4 or 6 months of treatment. However, CWH experienced higher mortality and hospitalization rates compared to children without HIV.
Area of Science:
- Pediatric infectious diseases
- HIV/AIDS research
- Tuberculosis treatment
Background:
- Children living with human immunodeficiency virus (HIV) face elevated risks for tuberculosis (TB) and poorer health outcomes, even with antiretroviral therapy (ART).
- The SHINE trial investigated treatment outcomes for children with nonsevere TB, comparing outcomes between those with and without HIV.
Purpose of the Study:
- To evaluate the outcomes of children living with HIV (CWH) and children without HIV who were treated for nonsevere tuberculosis (TB) within the SHINE trial.
- To compare the efficacy of 4 versus 6 months of TB treatment duration in CWH.
Main Methods:
- The SHINE trial was a randomized study involving children under 16 with smear-negative, nonsevere TB.
- Participants were randomized to receive either 4 or 6 months of TB treatment and followed for 72 weeks.
- Outcomes assessed included TB relapse/recurrence, mortality, hospitalizations, adverse events, and HIV virological suppression.
Main Results:
- Children living with HIV (CWH) were more likely to be underweight and anemic compared to children without HIV.
- CWH experienced higher rates of hospitalization (adjusted odds ratio, 2.4) and mortality (adjusted hazard ratio, 2.6).
- HIV status, young age (<3 years), malnutrition, and low hemoglobin (<7 g/dL) independently predicted mortality in CWH.
Conclusions:
- Treatment duration of 4 or 6 months did not significantly impact TB treatment outcomes for children living with HIV (CWH).
- Regardless of TB treatment duration, CWH exhibited increased rates of mortality and hospitalization compared to children without HIV.
- Clinical Trial Registration: ISRCTN63579542.
Background:
Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial.
Methods:
SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH.
Results:
Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P = .07) but more underweight (weight-for-age z score, -2.3; (3.3, -0.8 versus -1.0; -1.8, -0.2; P < .01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P < .01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241-1134), and CD4% was 16% (10-26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3-4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42).
Conclusions:
We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration. ISRCTN63579542.
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