Efficacy of artemether-lumefantrine therapy for the treatment of uncomplicated Plasmodium falciparum malaria in Southwestern Ethiopia.
BACKGROUND
The development and spread of chloroquine-resistant Plasmodium falciparum threatens the health of millions of people and poses a major challenge to the control of malaria. Monitoring drug efficacy in 2-year intervals is an important tool for establishing rational anti-malarial drug policies. This study addresses the therapeutic efficacy of artemether-lumefantrine (AL) for the treatment of Plasmodium falciparum in southwestern Ethiopia.


METHODS
A 28-day in vivo therapeutic efficacy study was conducted from September to December, 2011, in southwestern Ethiopia. Participants were selected for the study if they were older than 6 months, weighed more than 5 kg, symptomatic, and had microscopically confirmed, uncomplicated P. falciparum. All 93 eligible patients were treated with AL and followed for 28 days. For each patient, recurrence of parasitaemia, the clinical condition, and the presence of gametoytes were assessed on each visit during the follow-up period. PCR was conducted to differentiate re-infection from recrudescence.


RESULTS
Seventy-four (83.1 %) of the study subjects cleared fever by day 1, but five (5.6 %) had fever at day 2. All study subjects cleared fever by day 3. Seventy-nine (88.8 %) of the study subjects cleared the parasite by day 1, seven (7.9 %) were blood-smear positive by day 1, and three (3.4 %) were positive by day 2. In five patients (5.6 %), parasitaemia reappeared during the 28-day follow-up period. From these five, one (1.1 %) was a late clinical failure, and four (4.5 %) were a late parasitological failure. On the day of recurrent parasitaemia, the level of chloroquine/desethylchloroquine (CQ-DCQ) was above the minimum effective concentration (>100 ng/ml) in one patient. There were 84 (94.4 %) adequate clinical and parasitological responses. The 28-day, PCR-uncorrected (unadjusted by genotyping) cure rate was 84 (94.4 %), whereas the 28-day, PCR-corrected cure rate was 87 (97.8 %). Of the three re-infections, two (2.2 %) were due to P. falciparum and one (1.1 %) was due to P. vivax. From 89 study subjects, 12 (13.5 %) carried P. falciparum gametocytes at day 0, whereas the 28-day gametocyte carriage rate was 2 (2.2 %).


CONCLUSIONS
Years after the introduction of AL in Ethiopia, the finding of this study is that AL has been highly effective in the treatment of uncomplicated P. falciparum malaria and reducing gametocyte carriage in southwestern Ethiopia.
College of Health Siences, Jimma University, Jimma, Ethiopia. se.kebede@gmail.com.|Armauer Hansen Research Institute, Addis Ababa, Ethiopia. se.kebede@gmail.com.
Seleshi Kebede
SK
Mekonnen
Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia. gtmedhin@yahoo.com.
Girmay
G
Medhin
Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia. nega_berhe@yahoo.com.|Ethiopia and Centre for Imported and Tropical Diseases, Oslo University Hospital-Ulleval, Oslo, Norway. nega_berhe@yahoo.com.
Nega
N
Berhe
Department of Bioinformatics and Genomics, University of North Carolina at Charlotte, Charlotte, NC, USA. ronaldmclouse@gmail.com.
Ronald M
RM
Clouse
Armauer Hansen Research Institute, Addis Ababa, Ethiopia. aseffaa@gmail.com.
Abraham
A
Aseffa
D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008853:Microscopy; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes