Inclusion of ethambutol in the intensive phase of treatment

For many years, ethambutol was not recommended for use in children aged under 5 years. The concern was that it might cause optic neuritis in children who were too young to report the early visual symptoms, which could lead to irreversible blindness. A review of pharmacokinetic and safety data on ethambutol in children concluded that the risk of ocular toxicity was negligible if recommended dosages were adhered to, especially considering the fact that the use of ethambutol is limited to the intensive phase of treatment (88, 89).

In the SHINE trial, ethambutol was included in the first 2 months of treatment, depending on the local policy in place at the recruitment site for both the 4-month regimen and the comparator 6-month regimen. All children living with HIV in the SHINE trial received ethambutol in the first 2 months of treatment (regardless of the regimen they received).

It is preferred that children living with HIV who receive the 4-month regimen receive ethambutol for the first 2 months of treatment, irrespective of the background prevalence of HIV. In addition, it is strongly recommended that ethambutol be added to the 4-month regimen for the first 2 months in settings with a high background prevalence of isoniazid resistance or HIV infection.

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