Efficacy of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for Treatment of Uncomplicated Malaria in Children in Zaire and Uíge Provinces, Angola

DOI: 10.1128/AAC.04181-14

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FIG 1
PCR-uncorrected and PCR-corrected survival functions for time until failure from a 2013 therapeutic efficacy study of AL in Zaire and Uíge Provinces, Angola. DP data are not shown as efficacy was uniformly high.

TABLE 1

Characteristics of patients at enrollment in therapeutic efficacy studies in Zaire and Uíge Provinces, Angola, in 2013

TABLE 2

Sample size by study arm in therapeutic efficacy studies in Zaire and Uíge Provinces, Angola, in 2013

TABLE 3

Response to treatment in therapeutic efficacy studies in Zaire and Uíge Provinces, Angola, in 2013

Parameter	Result in study arm
	AL		DP
	Zaire (n = 79)	Uíge (n = 78)	Zaire (n = 80)	Uíge (n = 83)
ACPR, n (%)	61 (77)	72 (92)	79 (99)	83 (100)
Treatment failure, n (%)	18 (23)	6 (7.7)	1 (1.2)	0 (0)
Early	1 (1.3)	0 (0)	0 (0)	0 (0)
Late	17 (22)	6 (7.7)	1 (1.2)	0 (0)
Day 14	1 (1.3)	0 (0)	0 (0)	0 (0)
Day 21	10 (13)	3 (3.8)	0 (0)	0 (0)
Day 28	6 (7.6)	3 (3.8)	1 (1.2)	0 (0)
Reinfections	10 (13)	4 (5.1)	1 (1.2)	0 (0)
Recrudescence	7 (8.9)	2 (2.6)	0 (0)	0 (0)
Day 3 clearance, % (95% CI)	100 (96–100)	97.6 (92–100)	100 (96–100)	100 (96–100)
Cumulative success rate on day 28, % (95% CI)
PCR uncorrected	77.4 (69–87)	92.3 (87–98)	98.8 (96–100)	100^a
PCR corrected	89.6 (83–97)	97.4 (94–100)	100^a	100^a
Proportion of ACPR on day 28, % (95% CI)
PCR uncorrected	77.2 (66–86)	92.3 (84–97)	98.8 (93–100)	100 (96–100)
PCR corrected	88.4 (78–95)	97.3 (91–100)	100 (95–100)	100 (96–100)

↵a Confidence intervals were not calculated for the Kaplan-Meier estimator when the rate was 100%.

TABLE 4

Molecular characteristics of 25 observed treatment failures during therapeutic efficacy studies in Zaire and Uíge Provinces, Angola, in 2013

Patient ID no.	Treatment arm^a	Classification^b	MOI^c	Resistance marker(s) on day 0 and day of failure^d
				pfmdr1^e		SNP^f		K13
				CN	Haplotype	Chr 10	Chr 13	K13
B313^g	AL-Z	ETF	2	1	NYD	wt	wt	wt
A111	AL-U	RECR	1	1	NFD	wt	wt	wt
A145	AL-U	RECR	1	1	NYD	wt	wt	wt
B314	AL-Z	RECR	1	1	NYD	wt	wt	wt
B384	AL-Z	RECR	1	1	NYD	wt	wt	wt
B385	AL-Z	RECR	2	1	NFD	wt	wt	wt
B399	AL-Z	RECR	2	1	NFD	wt	wt	wt
B404	AL-Z	RECR	2	1	NFD	wt	wt	wt
B416	AL-Z	RECR	2	1	NYD	wt	wt	wt
B422	AL-Z	RECR	2/1	1	NYD+NFD/NYD	wt	wt	wt
A114	AL-U	REIN	1	1	NYD	wt	wt	wt
A115	AL-U	REIN	2/1	1	YFD/YYD	wt	wt	wt
A144	AL-U	REIN	4/1	1	NYD	wt	wt	wt
A171	AL-U	REIN	1/2	1	YYD/NFD	wt	wt	wt
B304	AL-Z	REIN	1	1	NFD	wt	wt	wt
B312	AL-Z	REIN	1	1	NYD	wt	wt	wt
B371	AL-Z	REIN	2	1	NFD	wt	wt	wt
B375	AL-Z	REIN	1/2	1	NFD/YYD	wt	wt	wt
B386	AL-Z	REIN	1	1	YYY/NYD	wt	wt	wt
B387	AL-Z	REIN	1	1	NFY/NYD	wt	wt	wt
B398	AL-Z	REIN	1	1	NYD	wt	wt	wt
B402	AL-Z	REIN	2/1	1	YYY/NYD	wt	wt	wt
B421	AL-Z	REIN	1/2	1	NYD/NFD	wt	wt	wt
B423	AL-Z	REIN	1/2	1	NFD/NYD	wt	wt	wt
C560	DP-Z	REIN	1	1	YYD	wt	wt	wt

↵a AL, artemether-lumefantrine; DP, dihydroartemisinin-piperaquine; Z, Zaire; U, Uíge.
↵b ETF, early treatment failure; RECR, recrudescence; REIN, reinfection.
↵c Multiplicities of infection (MOI) either are the same for day 0 and the day of failure or are reported as day 0 MOI/day of failure MOI.
↵d Resistance markers either are the same for day 0 and the day of failure or are reported as day 0/day of failure. wt, wild type.
↵e “CN” represents the P. falciparum multidrug resistance gene 1 copy number, and “haplotype” represents the haplotype constructed from mutations N86Y, Y184F, and D1246Y.
↵f Shown are the chromosome 10 (Chr 10) SNP at position 688956 and Chr 13 SNP at position 1718319 associated with artemisinin resistance.
↵g Molecular data for early treatment failure are available for day 0 only.