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Table 5 Incidence of post-randomisation grade 3 and 4 adverse events in the 106 HIV-1-infected children randomised in the ANRS 12206 MONOD study according to arm (Abidjan and Ouagadougou, February 2013–April 2015)

From: Efavirenz-based simplification after successful early lopinavir-boosted-ritonavir-based therapy in HIV-infected children in Burkina Faso and Côte d’Ivoire: the MONOD ANRS 12206 non-inferiority randomised trial

Outcomes Total N = 106 Arm 1: AZT/ABC + 3TC + LPV/r (twice daily) N = 54 Arm 2: ABC + 3TC + EFV (once daily) N = 52 p value
SAE
 Hospitalisations and clinical SAE 6 (5.7) 2d (3.7) 4e (7.7) 0.43
 Grade 3 or 4 adverse eventsa 1 (0.9) 0 (0.0) 1 (1.9) 0.90
 Toxicity causing ART modificationb 3 (2.8) 1 (1.9) 2 (3.8) 0.61
 Sleeping disorders declared by caregivers 9 (8.5) 4 (7.4) 5 (9.6) 0.74
Specific biological adverse eventsc
 Anaemia, grade 3 and 4 3 (2.8) 1 (1.9) 2 (3.8) 0.61
 Neutropenia, grade 3 and 4 10 (9.4) 9 (16.7) 1 (1.9) 0.02
 Thrombopenia, grade 3 and 4 1 (0.9) 1 (1.9) 0 (0.0) 1.00
 Hyperglycaemia, grade 3 and 4 0 (0.0) 0 (0.0) 0 (0.0) -
 Hypercholesterolemia, grade 3 0 (0.0) 0 (0.0) 0 (0.0) -
 Hypertriglyceridemia, grade 3 and 4 0 (0.0) 0 (0.0) 0 (0.0) -
 Hypercreatininaemia, grade 3 and 4 0 (0.0) 0 (0.0) 0 (0.0) -
 Hypertransaminasaemia AST or ALT, grade 3 and 4 2 (1.9) 1 (1.9) 1 (1.9) 1.00
 Hyperbilirubinaemia, grade 3 and 4 5 (4.7) 3 (5.6) 2 (3.9) 1.00
 Hyperamylasaemia, grade 3 and 4 2 (1.9) 0 (0.0) 2 (3.9) 0.24
 Hyperlipasaemia, grade 3 and 4 0 (0.0) 0 (0.0) 0 (0.0) -
  1. Data are presented as n (%)
  2. AZT Zidovudine, 3TC Lamivudine, LPV/r Lopinavir-boosted ritonavir, ABC Abacavir, EFV Efavirenz, SAE Serious adverse events, ART Antiretroviral therapy, AST Aspartate transaminase, ALT Alanine transaminase
  3. aHepatitis due to a cytotoxic treatment administrated by a healer
  4. bOne toxicity substitution in a child randomised to LPV/r was from AZT to ABC for neutropenia. Two toxicity substitutions in children randomised to EFV to LPV arm: one for sleeping disorders persisting 10 months after randomisation and one for hypertransaminasaemia due to a cytotoxic treatment administrated by a healer
  5. cNo other biological SAE including glycaemia, cholesterolaemia, triglyceridaemia, creatininaemia, lipaseamia
  6. d2 gastroenteritis
  7. e1 gastroenteritis, 1 pneumonia, 1 upper respiratory infection with malaria, 1 malaria