تعليق5.4.1 Subgroups in which the regimen is recommended
Children with peripheral lymph node TB
Although the numbers of children with peripheral lymph node TB in the SHINE trial were small (N=19 in the 16-week arm and N=21 in the 24-week arm), there was no difference in the proportion of unfavourable outcomes between the two arms. The SHINE trial also found that 16 weeks of treatment was not inferior to 24 weeks of treatment in children with both peripheral lymph node disease and pulmonary disease (N=182 in the 16-week arm and N=171 in the 24-week arm). These results may provide reassurance for clinicians regarding a seemingly delayed clinical response to TB treatment, which is frequently seen in children with peripheral lymph node TB (where lymph nodes remain enlarged even after treatment).
CALHIV
CALHIV were eligible for enrolment in the SHINE trial; 65 (11%) CALHIV were enrolled in the 16-week arm and 62 (10%) in the 24-week arm, with 49% of CALHIV in the 16-week arm and 43% in the 24-week arm being on ART at the time of enrolment. Among CALHIV, 20% in both arms had a CD4 count of less than 200 cells/mm3 , and 51% of CALHIV in the 16-week arm and 63% in the 24-week arm were classified as “severe” according to the WHO immunological classification for established HIV infection (33). In this subgroup, the 16-week regimen was again not inferior to the 24-week regimen, although the 95% confidence interval (CI) for the difference from the control arm in the unfavourable rate was wide (risk difference –4.3, 95% CI: –14.9 to 6.2).
Clinicians may consider treating CALHIV with non-severe TB for 4 months, depending on the degree of immunosuppression, ART status and presence of other opportunistic infections (34). These children and adolescents will need to be monitored closely, especially at 4 months of treatment, and treatment will need to be extended to 6 months if there is insufficient progress.
5.4.2 Subgroups in which the regimen is not recommended
Children with severe acute malnutrition
No separate subgroup analysis could be conducted for children with severe acute malnutrition (SAM)14 in the SHINE trial owing to the low numbers (30 children with SAM in the 16-week arm and 33 in the 24-week arm). Because SAM is defined as a danger sign, even if children with SAM have a nonsevere form of TB, they should preferably receive 6 months of TB treatment.