WHO/HIV/2013.32 © World Health Organization 2013
GRADE table: What ARV regimen to start in children younger than 3 years old?
Author(s): Penazzato M.
Date: 2012-09-25
Question: Should treatment interruption be used in infants and young children living with HIV starting early ART?
Settings: Resource-limited settings Bibliography: Wamalwa 2012
Quality assessment No. of patients Effect
Quality Importance No. of
studies Design Risk of
bias Inconsistency Indirectness Imprecision Other considerations
Treatment
interruption Control Relative
(95% CI) Absolute
Serious adverse events (follow-up median 9.9 months1)
1 randomized
trials
serious2 no serious inconsistency3
serious4 serious5,6 none 1/21
(4.8%)
1/21 (4.8%)
RR 1 (1 to 1)
- ⊕ΟΟΟ
VERY LOW
CRITICAL
0.1%7 -
23%7 -
Weight-for-age z-score change (follow-up median 9.9 months;8 better indicated by lower values)
1 randomized
trials
serious2 no serious inconsistency
serious4 serious5 none 16 15 - median 0.13 lower
(0.31 lower to 0.05 higher)9
⊕ΟΟΟ VERY LOW
CRITICAL
Height-for-age z-score change (follow-up median 9.9 months;8 better indicated by lower values)
1 randomized
trials
serious2 no serious inconsistency3
serious4 serious5 none 16 15 - median 0.10 lower
(0.33 lower to 0.13 higher)10
⊕ΟΟΟ VERY LOW
CRITICAL
Weight for height z-score change (follow-up median 9.9 months;8 measured by: mean change; better indicated by lower values)
1 randomized
trials
serious2 no serious inconsistency
serious4 serious5 none 16 15 - median 0.11 lower (32
lower to 0.1 higher)11
⊕ΟΟΟ VERY LOW
CRITICAL
1 This is post-randomization follow up.
2 Unblinded by design, assessment of serious adverse effects may have biased the results. In addition, the trial was terminated early for rapid restart of treatment.
WHO/HIV/2013.32 © World Health Organization 2013
3 Only one trial assessed this specific question, providing a comparator with continuous ART.
4 Children were severely immunosuppressed at treatment initiation and therefore do not necessarily represent the entire population of infants and children starting early ART.
5 The sample size calculation did not account for early restart or unplanned interruption.
6 Very low level of events in both arms.
7 Based on 95% CI calculation from the control arm.
8 Total post-randomization follow-up, but outcome assessed at six months from randomization.
9t-test, P = 0.16.
10t-test, P = 0.4.
11t-test, P = 0.3.
