Efficacy of artemether-lumefantrine and artesunate-amodiaquine as first line therapy of uncomplicated malaria in Burkina Faso, 11 years after policy change

Zongo, Issaka; Compaoré, Yves Daniel; Nikièma, Frédéric; Zongo, Moussa; Barry, Nouhoun; Somé, Fabrice A.; Kaboré, Naomie; Ouédraogo, Jean Bosco

doi:10.11604/pamj.2020.35.68.20849

Cited by 10 publications

(16 citation statements)

References 28 publications

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“…The risk of treatment failure among children receiving AL was 64% and 76% higher, in terms of PCR-uncorrected and PCR-corrected failures, respectively, compared with children receiving ASAQ. These findings compare well with other studies that have shown that parasite recurrence and recrudescence are commoner among patients receiving AL compared with those receiving ASAQ [ 26 , 32 ].…”

Section: Discussionsupporting

confidence: 90%

Trends and predictive factors for treatment failure following artemisinin-based combination therapy among children with uncomplicated malaria in Ghana: 2005–2018

et al. 2021

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Background Since the introduction of artemisinin-based combination therapy (ACT) in Ghana in 2005 there has been a surveillance system by the National Malaria Control Programme (NMCP) and the University of Ghana Noguchi Memorial Institute for Medical Research (UG-NMIMR) to monitor the therapeutic efficacy of ACTs for the treatment of uncomplicated malaria in the country. We report trends and determinants of failure following treatment of Ghanaian children with artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) combinations. Methods Per protocol analyses as well as cumulative incidence of day 28 treatment failure from Kaplan Meier survival analyses were used to describe trends of failure over the surveillance period of 2005–2018. Univariable and multivariable cox regression analyses were used to assess the determinants of treatment failure over the period. Results Day 28 PCR-corrected failure, following treatment with ASAQ, significantly increased from 0.0% in 2005 to 2.0% (95% CI: 1.1–3.6) in 2015 (p = 0.013) but significantly decreased to 0.4% (95% CI: 0.1–1.6) in 2018 (p = 0.039). Failure, following treatment with AL, decreased from 4.5% (95% CI: 2.0–9.4) in 2010 to 2.7% (95% CI: 1.4–5.1) in 2018, though not statistically significant (p = 0.426). Risk of treatment failure, from multivariable cox regression analyses, was significantly lower among children receiving ASAQ compared with those receiving AL (HR = 0.24; 95% CI: 0.11–0.53; p < 0.001); lower among children with no parasitaemia on day 3 compared with those with parasitaemia on day 3 (HR = 0.02; 95% CI: 0.01–0.13; p < 0.001); and higher among children who received ASAQ and had axillary temperature ≥ 37.5 °C on day 1 compared with those with axillary temperature < 37.5 °C (HR = 3.96; 95% CI: 1.61–9.75; p = 0.003). Conclusions Treatment failures for both ASAQ and AL have remained less than 5% (below WHO’s threshold of 10%) in Ghana since 2005. Predictors of treatment failure that need to be considered in the management of uncomplicated malaria in the country should include type of ACT, day 3 parasitaemia, and day 1 axillary temperature of patients being treated.

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Section: Discussionsupporting

confidence: 90%

Trends and predictive factors for treatment failure following artemisinin-based combination therapy among children with uncomplicated malaria in Ghana: 2005–2018

et al. 2021

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“…there was a positive progression towards ACPR from day 14 to day 28 with DHPP, suggesting that more treatment failures occurred during day 14 and day 21 for ASAQ compared to DHPP [10]. Progression to success was similar between ASAQ and artemether-lumefantrine (AMLM), in agreement with other studies conducted in Africa [23][24][25][26][27]. The apparent superiority of DHPP was assessed in a larger patient population and is in agreement with pharmacokinetic profiles of amodiaquine and lumefantrine, which have shorter elimination half-lives than piperaquine [28].…”

Section: Ordinal Outcome With Several Time-pointssupporting

confidence: 87%

Methodological approaches for analysing data from therapeutic efficacy studies

Youdom

Basco

2021

Malar J

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Several anti-malarial drugs have been evaluated in randomized clinical trials to treat acute uncomplicated Plasmodium falciparum malaria. The outcome of anti-malarial drug efficacy studies is classified into one of four possible outcomes defined by the World Health Organization: adequate clinical and parasitological response, late parasitological failure, late clinical failure, early treatment failure. These four ordered categories are ordinal data, which are reduced to either a binary outcome (i.e., treatment success and treatment failure) to calculate the proportions of treatment failure or to time-to-event outcome for Kaplan–Meier survival analysis. The arbitrary transition from 4-level ordered categories to 2-level type categories results in a loss of statistical power. In the opinion of the authors, this outcome can be considered as ordinal at a fixed endpoint or at longitudinal endpoints. Alternative statistical methods can be applied to 4-level ordinal categories of therapeutic response to optimize data exploitation. Furthermore, network meta-analysis is useful not only for direct comparison of drugs which were evaluated together in a randomized design, but also for indirect comparison of different artemisinin-based combinations across different clinical studies using a common drug comparator, with the aim to determine the ranking order of drug efficacy. Previous works conducted in Cameroonian children served as data source to illustrate the feasibility of these novel statistical approaches. Data analysis based on ordinal end-point may be helpful to gain further insight into anti-malarial drug efficacy.

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“…[3], 15 published articles with efficacy data for five recommended artemisinin-based combinations used alone or in combination with methylene blue or primaquine were identified and reviewed [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]. An overview of the data presented in the 15 articles can be found in Table 1.…”

Section: Current Evidence Of Act Efficacy In Burkina Fasomentioning

confidence: 99%

“…Sep–Dec 2012 [ 7 ] Single arm (28 days) 6–59 months (105) AL 86.7 PCR correction with msp2 only Decrease Re-infection classified as ACPR Increase Ouagadougou and Nanoro. 2012–2014 [ 8 ] Multicentre, multicounty, single arm (28 and 42 days) > 28 days and <5 kg (20) AL 100 day 28-100 day 42 a Re-infection classified as ACPR Increase Colsama and Sakary health centres, Bobo-Dioulasso Jun–Dec 2016 [ 9 ] RCT (28 days) > 6 months (281) AL vs ASAQ 85.2 vs 97.0 No PCR correction Decrease Nanoro health district Sep 2008-Jan 2010 [ 10 ] RCT (28 and 42 days) 6–59 months (340) AL vs ASAQ 89.8 vs 89.7 - day 28 66.7 vs 63.0 day 42 PCR correction with msp1 and msp2 Decrease Re-infection classified as ACPR Increase Unsupervised treatment Decease Nanoro health district Sep 2010-Oct 2012 [ 11 – 13 ] RCT (28 days) > 6 months (680) AL vs ASAQ 77.8 vs 84.1 PCR correction with msp1 and msp2 Decrease Re-infection classified as ACPR Increase Unsupervised treatment …”

Section: Current Evidence Of Act Efficacy In Burkina Fasomentioning

confidence: 99%

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Is there evidence of anti-malarial multidrug resistance in Burkina Faso?

Rasmussen

Ringwald

2021

Malar J

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Recently, Gansané and colleagues published an article on inadequate efficacy of two different forms of artemisinin-based combination therapy (ACT) in Burkina Faso. The development of Plasmodium falciparum resistance to different ACT partner drugs at levels that could affect the efficacy of two ACT would both be startling and a cause for great concern. In reviewing the available data collected since 2008 on ACT efficacy in Burkina Faso, the analysis shows that the reported efficacy of the tested ACT varies greatly. Most of the studies have considerable methodological deviations and challenges, especially in PCR correction done to distinguish between recrudescence and re-infection, and in the failure to omit re-infections in the calculation of efficacy rates. So far, there is no convincing evidence in the articles reviewed that multidrug resistance has emerged in Burkina Faso. However, the potential consequence of failing ACT means that the results published by Gansané et al. urgently need to be confirmed. Furthermore, articles reporting on efficacy data need to include an examination of the potential consequences of any methodological deviations.

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Efficacy of artemether-lumefantrine and artesunate-amodiaquine as first line therapy of uncomplicated malaria in Burkina Faso, 11 years after policy change

Cited by 10 publications

References 28 publications

Trends and predictive factors for treatment failure following artemisinin-based combination therapy among children with uncomplicated malaria in Ghana: 2005–2018

Trends and predictive factors for treatment failure following artemisinin-based combination therapy among children with uncomplicated malaria in Ghana: 2005–2018

Methodological approaches for analysing data from therapeutic efficacy studies

Is there evidence of anti-malarial multidrug resistance in Burkina Faso?

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