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Comparison of Artemether-Lumefantrine with Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria in Eastern Nepal

Because available data suggest that resistance of Plasmodium falciparum to sulfadoxine-pyrimethamine (SP) is increasing in Nepal, an open-label, parallel-group efficacy/safety study was conducted in 99 Nepalese patients with uncomplicated falciparum malaria randomized 2:1 to artemetherlumefantrine (AL) or SP. Efficacy was assessed from clinical and microscopic evidence of treatment failure. Four SP-treated patients (12.1%; 95% CI, 4.0–29.1%) redeveloped parasitemia during the 28-day follow-up versus 0% (95% CI, 0–6.9%) in the AL group (P = 0.011), a difference that was confirmed by polymerase chain reaction (PCR) analysis of parasite DNA. PCR detected an additional six patients (two SP and four AL) with sub-microscopic gametocytemia or breakthrough parasitemia between Days 14 and 28, suggesting that AL efficacy was lower than estimated by microscopy. Dhfr and dhps mutations were not associated with outcome. AL is more effective than SP for uncomplicated malaria in Nepal, but regular monitoring of its efficacy should be carried out if this combination therapy is introduced.

Received October 5, 2006. Accepted for publication May 16, 2007.

Acknowledgments: The authors thank Ken Ilett (University of Western Australia) for sulfadoxine and pyrimethamine assays, Tiek Ying Lau (Malaria Research Centre, University Malaysia Sarawak) for molecular assays, and John Quinley (USAID, Nepal), Shambu Nath Jha (John Snow International, Nepal), and Dr. Banerjee (Ministry of Health and Population, Nepal) for advice and support. We are also grateful to the people of Jhapa District; the Staff of Mechi Zonal Hospital, Jhapa District; the Epidemiology and Disease Control Division, the Eastern Regional Health Directorate, and the Eastern Regional Health Directorate District Public Health Office (Jhapa) of the Nepal Government, Ministry of Health and Population, Department of Health Services, Kathmandu, Nepal.

Financial support: This study was supported by the Global Health Bureau of the United States Agency for International Development (USAID) under the terms of Contract GHS-I–03–03–00028–00 with RTI International.

Disclaimer: The authors have no conflict of interest.

^* Address correspondence to Timothy M. E. Davis, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959, Australia. E-mail: tdavis{at}cyllene.uwa.edu.au

Authors’ addresses: Suman Thapa, Sukraraj Tropical and Infectious Disease Hospital, Teku, Kathmandu, Nepal. Judith Hollander, Research Triangle Institute International, Kathmandu, Nepal. Mary Linehan, Research Triangle Institute International, One Metro Center, 701 13th Street, NW, Suite 750, Washington, DC 20005–3967, Telephone: 202–728–2080, Fax: 202–728–2095. Janet Cox-Singh, University Malaysia Sarawak, Malaria Research Centre, Faculty of Medicine and Health Sciences, Jalan Tun Ahmad Zaidi Adruce, 93150 Kuching, Sarawak, Malaysia, Telephone: 60–82–292256. Mahendra B. Bista, Nepal Government, Ministry of Health and Population, Department of Health Services, Epidemiology and Disease Control Division, Kathmandu, Nepal. Garib D. Thakur, Nepal Government, Ministry of Health and Population, Department Of Health Services, Epidemiology and Disease Control Division, Kathmandu, Nepal. Wendy A. Davis, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959, Australia, Telephone: 618–9431–3641, Fax 618–9431–2977. Timothy M. E. Davis, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959, Australia, Telephone: 618–9431–3229, Fax: 618–9431–2977.

Reprint requests: T. M. E. Davis, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959, Australia. E-mail: tdavis{at}cyllene.uwa.edu.au.