Efficacy of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Mozambique, 2022

Jul 14, 2025Malaria journal

Effectiveness of four malaria treatments for uncomplicated Plasmodium falciparum infection in Mozambique in 2022

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Abstract

100% efficacy was observed for artemether-lumefantrine (AL) and artesunate-amodiaquine (AS-AQ) at multiple sites in Mozambique.

In total, 828 participants were enrolled across four treatment groups: AL, AS-AQ, dihydroartemisinin-piperaquine (DP), and artesunate-pyronaridine (AS-PY).
Day 28 corrected efficacy for AL was above 97%, while AS-AQ also achieved 100% efficacy at specific sites.
For DP, the corrected efficacy on day 42 was 100% in one location and 97.75% in another.
All treatments demonstrated efficacy above the 90% WHO-recommended threshold for effective malaria treatment.
Adverse events were reported in less than 2% of participants, indicating good tolerance for all drugs tested.

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BACKGROUND: Artemether-lumefantrine (AL) and artesunate-amodiaquine (AS-AQ) are the first-line treatments against malaria in Mozambique. Dihydroartemisinin-piperaquine (DP) has been used in-country for mass drug administration campaigns, and artesunate-pyronaridine (AS-PY) is considered an alternative drug to delay AL resistance in the country. To assess whether AL and AS-AQ remain efficacious and to confirm that DP and AS-PY are potential alternatives for uncomplicated malaria treatment, an in vivo therapeutic efficacy study was conducted in Mozambique at five sentinel sites.

METHODS: This study was conducted in the districts of Montepuez (AL), Dondo (AL and AS-AQ), Mopeia (AL and AS-PY), Moatize (AL and AS-AQ), and Massinga (AL and DP) following the 2009 World Health Organization (WHO)-recommended protocol. Patients aged 6 months to 11 years with uncomplicated Plasmodium falciparum malaria (1000-200,000 parasites/µl) were enrolled, followed, and assessed for 28 days (AL and AS-AQ) or 42 days (DP and AS-PY). Genotyping for msp1/msp2/poly-α markers and match counting via the WHO/Medicines for Malaria Venture (MMV) 3/3 algorithm were used to differentiate recrudescences from new infections. The primary outcome was polymerase chain reaction corrected efficacy for each drug.

RESULTS: In total, 828 participants were enrolled in the four study arms: AL (462), AS-AQ (183), DP (91), and AS-PY (92). Among the recruited participants, 10.2% (85/828) were lost to follow-up or withdrew, and 60 had recurrent malaria infections, 55 of which were considered new infections and five recrudescences. Day 28 corrected AL efficacy was 100% (95% CI 94.3-100) in Massinga, 100% in Dondo, 100% (95% CI 95.5-100) in Moatize, 97.63% (95% CI 94.4-100) in Mopeia, and 98.68% (95% CI 96.2-100) in Montepuez. Day 28 corrected AS-AQ efficacy was 100% in Dondo and 100% (95% CI 95.4-100) in Moatize. For DP, the corrected efficacy on day 42 was 100% (95% CI 94.1-100) in Massinga, and that on day 42 was 97.75% (95% CI 94.7-100) in Mopeia. All drugs were well tolerated, with adverse events reported in less than 2% of the participants.

CONCLUSION: AL and AS-AQ remain effective, as their efficacy remained above the 90% WHO-recommended cut-off. DP and AS-PY also showed therapeutic efficacy above the WHO-acceptable cut-off and could be used as first-line treatments when needed. All four artemisinin-based combinations were well tolerated, with minimal safety concerns.

TRIAL REGISTRATION: Clinicaltrials.gov: NCT05343312.

Key numbers

100%

AL Efficacy Day 28

Efficacy measured at multiple sites including Massinga, Dondo, and Moatize.

100%

AS-AQ Efficacy Day 28

Efficacy confirmed in Dondo and Moatize.

100%

DP Efficacy Day 42

Efficacy assessed in Massinga.

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Efficacy of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Mozambique, 2022

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