article · American Journal of Tropical Medicine and Hygiene
Routine assessment of artemisinin-based combination therapies (ACTs) is vital to detect emerging antimalarial drug resistance. Clinical efficacy and molecular resistance markers were examined across five sites in the Democratic Republic of the Congo. Children aged 6 to 59 months with confirmed uncomplicated Plasmodium falciparum malaria received artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ), or dihydroartemisinin-piperaquine (DP). Polymerase chain reaction-corrected efficacy ranged from 86% to 98% for AL, 91% to 100% for ASAQ, and 84% to 100% for DP. No known resistance-associated pfk13 mutations appeared, though specific pfmdr1 and pfcrt genotypes correlated with treatment outcomes. In one monitoring location near the Angolan border, two therapies exhibited efficacy below the 90% threshold established by the World Health Organisation to consider updating first-line treatment guidelines.
Malaria remains a major public health threat, especially for young children. Tracking the performance of standard treatments ensures healthcare systems detect failing medications early. Identifying geographic areas where efficacy drops below global benchmark levels provides public health authorities with essential data to review and adjust first-line clinical guidelines before widespread resistance develops.
The findings primarily inform national malaria control programmes, global health agencies, and diagnostic laboratories tracking drug resistance. The research represents clinical surveillance rather than a commercial product, meaning it does not indicate a direct commercialisation pathway. However, the genetic marker associations could support diagnostics developers seeking to refine molecular resistance testing panels used in clinical and surveillance settings.
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Routine assessment of the efficacy of artemisinin-based combination therapies (ACTs) is critical for the early detection of antimalarial resistance. We evaluated the efficacy of ACTs recommended for treatment of uncomplicated malaria in five sites in Democratic Republic of the Congo (DRC): artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ), and dihydroartemisinin-piperaquine (DP). Children aged 6-59 months with confirmed Plasmodium falciparum malaria were treated with one of the three ACTs and monitored. The primary endpoints were uncorrected and polymerase chain reaction (PCR)-corrected 28-day (AL and ASAQ) or 42-day (DP) cumulative efficacy. Molecular markers of resistance were investigated. Across the sites, uncorrected efficacy estimates ranged from 63% to 88% for AL, 73% to 100% for ASAQ, and 56% to 91% for DP. PCR-corrected efficacy estimates ranged from 86% to 98% for AL, 91% to 100% for ASAQ, and 84% to 100% for DP. No pfk13 mutations previously found to be associated with ACT resistance were observed. Statistically significant associations were found between certain pfmdr1 and pfcrt genotypes and treatment outcome. There is evidence of efficacy below the 90% cutoff recommended by WHO to consider a change in first-line treatment recommendations of two ACTs in one site not far from a monitoring site in Angola that has shown similar reduced efficacy for AL. Confirmation of these findings in future therapeutic efficacy monitoring in DRC is warranted.
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DOI: 10.4269/ajtmh.21-0214
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