Abstract
BackgroundThe efficacy of artemisinin-based combination therapy (ACT) has been established. The objective of the present study was to compare the efficacy and safety in the Central African Republic (CAR) of three commercially available artemisinin-based combinations, artemether + lumefantrine (AL), artesunate + sulphamethoxypyrazine–pyrimethamine (AS-SMP) and artesunate + amodiaquine (AS-AQ), with those of sulphadoxine–pyrimethamine + amodiaquine (SP-AQ), which was the first-line reference treatment in the country from 2004, until it was replaced by ACT in 2006 in accordance with changes in international recommendations based on resistance identified in other regions.MethodsChildren aged six to 59 months with uncomplicated Plasmodium falciparum malaria were recruited in Bangui, the capital of the CAR. The 251 patients selected were randomly assigned to receive AL (n = 60), AS-SMP (n = 58), AS-AQ (n = 68) or SP-AQ (n = 65) and were followed up for 28 days. Clinical outcome was classified according to the standard 2003 World Health Organization protocol.ResultsAt day 28, the cure rates in a per-protocol analysis were 92% (48/52) with AL, 93% (50/54) with AS-SMP, 93% (55/59) with AS-AQ and 100% (57/57) with SP-AQ, with no statistically significant difference between the four treatments. Defervescence was significantly faster with AS-AQ than with AL (p <0.035). Fatigue was reported significantly more frequently by patients receiving AQ than by those treated with AS-SMP or AL (p = 0.006). All the other adverse events reported were mild, and no significant difference was noted by treatment.ConclusionThe three artemisinin-bsed combinations show similar, satisfactory results, comparable to that with SP-AQ. This evaluation is the first conducted in CAR since the official introduction of ACT. It should guide the National Malaria Control Programme in choosing the appropriate ACT for treatment of uncomplicated P. falciparum malaria in the future.
Highlights
The efficacy of artemisinin-based combination therapy (ACT) has been established
The objective of the present study was to assess the efficacy and the safety of three artemisinin-based combinations artemether + lumefantrine (AL), artesunate (AS) + sulphamethoxypyrazinepyrimethamine (SMP) (AS + SMP is not a combination recommended by World Health Organization (WHO) but is available on Central African markets and is widely used) and AS + AQ in the Central African Republic (CAR) and to compare their efficacy with that of the SP + AQ combination that was previously used as first-line treatment in the country
The day-28 polymerase chain reaction (PCR)-uncorrected cure rates in the per-protocol analysis showed no significant difference in efficacy (p = 0.077): 91% (79–97%), 86% (74–94%), 93% (84–98%) and 98% (91–100%) for the AL, artesunate + sulphamethoxypyrazine–pyrimethamine (AS-SMP), artesunate + amodiaquine (AS-AQ) and sulphadoxine–pyrimethamine + amodiaquine (SP-AQ) groups, respectively
Summary
The efficacy of artemisinin-based combination therapy (ACT) has been established. The objective of the present study was to compare the efficacy and safety in the Central African Republic (CAR) of three commercially available artemisinin-based combinations, artemether + lumefantrine (AL), artesunate + sulphamethoxypyrazine–pyrimethamine (AS-SMP) and artesunate + amodiaquine (AS-AQ), with those of sulphadoxine–pyrimethamine + amodiaquine (SP-AQ), which was the first-line reference treatment in the country from 2004, until it was replaced by ACT in 2006 in accordance with changes in international recommendations based on resistance identified in other regions. Medical doctors and nurses lacked confidence in the efficacy of ACT, as some patients returned with positive thick smears more than 72 hours after treatment with artemether + lumefantrine (AL); they continued to prescribe anti-malarial drugs that were not recommended (personal observation). These treatment failures may have been due to lack of communication or non-respect of the recommendation that this drug be taken during a fatty meal to ensure good bioavailability of artemether [18,19]
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