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

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)

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)	2^d (3.7)	4^e (7.7)	0.43
Grade 3 or 4 adverse events^a	1 (0.9)	0 (0.0)	1 (1.9)	0.90
Toxicity causing ART modification^b	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 events^c
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)	-

Data are presented as n (%)
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
^aHepatitis due to a cytotoxic treatment administrated by a healer
^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
^cNo other biological SAE including glycaemia, cholesterolaemia, triglyceridaemia, creatininaemia, lipaseamia
^d2 gastroenteritis
^e1 gastroenteritis, 1 pneumonia, 1 upper respiratory infection with malaria, 1 malaria

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