In vivo efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria in Central Ethiopia
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Date
2011
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Malaria Journal,
Abstract
Background: In vivo efficacy assessments of the first-line treatments for Plasmodium falciparum malaria are
essential for ensuring effective case management. In Ethiopia, artemether-lumefantrine (AL) has been the first-line
treatment for uncomplicated P. falciparum malaria since 2004.
Methods: Between October and November 2009, we conducted a 42-day, single arm, open label study of AL for P.
falciparum in individuals >6 months of age at two sites in Oromia State, Ethiopia. Eligible patients who had
documented P. falciparum mono-infection were enrolled and followed according to the standard 2009 World
Health Organization in vivo drug efficacy monitoring protocol. The primary and secondary endpoints were PCR
uncorrected and corrected cure rates, as measured by adequate clinical and parasitological response on days 28
and 42, respectively.
Results: Of 4426 patients tested, 120 with confirmed falciparum malaria were enrolled and treated with AL. Followup
was completed for 112 patients at day 28 and 104 patients at day 42. There was one late parasitological failure,
which was classified as undetermined after genotyping. Uncorrected cure rates at both day 28 and 42 for the per
protocol analysis were 99.1% (95% CI 95.1-100.0); corrected cure rates at both day 28 and 42 were 100.0%.
Uncorrected cure rates at day 28 and 42 for the intention to treat analysis were 93.3% (95% CI 87.2-97.1) and 86.6%
(95% CI 79.1-92.1), respectively, while the corrected cure rates at day 28 and 42 were 94.1% (95% CI 88.2-97.6) and
87.3% (95% CI 79.9-92.7), respectively. Using survival analysis, the unadjusted cure rate was 99.1% and 100.0%
adjusted by genotyping for day 28 and 42, respectively. Eight P. falciparum patients (6.7%) presented with
Plasmodium vivax infection during follow-up and were excluded from the per protocol analysis. Only one patient
had persistent parasitaemia at day 3. No serious adverse events were reported, with cough and nausea/vomiting
being the most common adverse events.
Conclusions: AL remains a highly effective and well-tolerated treatment for uncomplicated falciparum malaria in
the study setting after several years of universal access to AL. A high rate of parasitaemia with P. vivax possibly
from relapse or new infection was observed.
Trial Registration: NCT01052584
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Citation
Hwang, J., Alemayehu, B. H., Nettey, H., Melaku, Z., Tekleyohannes, S. G., Teshi, T., . . . Filler, S. (2011). In vivo efficacy of artemether-lumefantrine against uncomplicated plasmodium falciparum malaria in central Ethiopia. Malaria Journal, 10.