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Treatment of Acute Uncomplicated Falciparum Malaria with Artemether-Lumefantrine in Non-immune Populations: A Safety, Efficacy, and Pharmacokinetic Study

The efficacy and safety of artemether-lumefantrine for the treatment of malaria in nonimmune populations are not well defined. In this study, 165 nonimmune patients from Europe and non-malarious areas of Colombia with acute, uncomplicated falciparum malaria or mixed infection including P. falciparum were treated with the six-dose regimen of artemether-lumefantrine. The parasitologic cure rate at 28 days was 96.0% for the per protocol population (119/124 patients). Median times to parasite clearance and fever clearance were 41.5 and 36.8 hours, respectively. No patient had gametocytes after Day 7. Treatment was well tolerated; most adverse events were mild to moderate and seemed to be related to malaria. There were few serious adverse events, none of which were considered to be drug-related. No significant effects on ECG or laboratory parameters were observed. In conclusion, the six-dose regimen of artemether-lumefantrine was effective and well tolerated in the treatment of acute uncomplicated falciparum malaria in nonimmune patients.

Received January 8, 2007. Accepted for publication July 15, 2007.

Acknowledgments: The authors thank the other investigators, namely A. Stich, Medical Mission Hospital, Wurzburg, Germany; D. Malvy, University Hospital, Bordeaux, France; T. Debord, Hôpital Bégin, St-Mandé, France; F. Castelli, Institute of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy; H.J. Furrer, Inselspital, Bern, Switzerland; B. Marchou, Hôpital Purpan, Toulouse, France; D. Overbosch, Havenziekenhuis and Institute for Tropical Diseases, Rotterdam, The Netherlands; and the late K. Markwalder, University Hospital, Zurich, Switzerland. In addition, we thank all the staff involved in the collaborating centers and the patients who participated. We also thank H. Reinhart, Novartis Switzerland, and M.-N. Bizot and L. Masson, Novartis Pharma SAS, Rueil-Malmaison, France, for expert technical assistance in analyzing lumefantrine and desbutyl-lumefantrine in plasma samples; M. Wilkie, Novartis Pharmaceuticals Corporation, East Hanover, NJ, for participating in the conduct of the study; M. Wibberg and T. Widmayer, Datamap GmbH, Freiburg, Germany, for conducting the analyses; and P. D. Hunt, Novartis Horsham Research Centre, Horsham, UK, for assistance with the manuscript.

Financial support: This study was supported by Novartis Pharma AG, Basel, Switzerland.

Disclosure: Some of the authors wish to disclose that they are employees of Novartis Pharma or have received grants or honoraria from Novartis. This statement is made in the interest of full disclosure and not because the authors consider this a conflict of interest.

^* Address correspondence to Christoph Hatz, Swiss Tropical Institute, Socinstrasse 57, 4002 Basel, Switzerland. E-mail: christoph.hatz{at}unibas.ch

Authors’ addresses: Christoph Hatz, Swiss Tropical Institute, Socinstrasse 57, 4002 Basel, Switzerland, Telephone: 41–0–61–2848255, Fax: 41–0–61–2718654. Jaime Soto, FADER/Cibic, Calle 60 A No. 5, 54 Suite 201, Bogota, Colombia, Telephone: 57–0–1–3482171, Fax: 57–0–1–3476093. Hans Dieter Nothdurft, Abteilung für Infektions- und Tropenmedizin der Universität München, Leopoldstrasse 5, D-80802 München, Germany, Telephone: 49–0–89–21803830, Fax: 49–0–89–336038. Thomas Zoller, Universitätsklinikum Charité, Medizinische Klinik mit Schwerpunkt Infektiologie, Campus Virchow-Klinikum, Augustenburger Platz 1, D-13353 Berlin, Germany, Telephone: 49–0–30–450653806, Fax: 49–0–30 450553906. Thomas Weitzel, Tropeninstitut Berlin, Spandauer Damm 130, 14050 Berlin, Germany, Telephone: 49–0–30–30116816, Fax: 49–0–30–30116888. Louis Loutan, Unité de Médecine des Voyages et des Migrations, Hopitaux Universitaires de Genève, Rue Micheli-du-Crest 24, 12011 Genève 14, Switzerland, Telephone: 41–0–22–3729615, Fax: 41–0–22–3729626. Francois Bricaire, Department of Tropical and Infectious Diseases, Pavillon Laveran, Groupe Hospitalier Pitié-Salpêtrière, 47 Bd de l ’ Hôpital, 75651 Paris Cedex 13, France, Telephone: 33–0–1–42160111, Fax: 33–0–1–42160165. Frederick Gay, Department of Tropical and Infectious Diseases, Pavillon Laveran, Groupe Hospitalier Pitié-Salpêtrière, 47 Bd de l’Hôpital, 75651 Paris Cedex 13, France, Telephone: 33–0–1–42160148, Fax: 33–0–1–42160165. Gerd-Dieter Burchard, Bernhard-Nocht-Institut für Tropenmedizin, Klinische Abteilung, Bernhard-Nocht-Strasse 74, D-20359 Hamburg, Germany, Telephone: 49–0–40–42818390, Fax: 49–0–40–42818394. Kim Andriano, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936–1080, Telephone: 862–778–8608, Fax: 973–781–3922. Gilbert Lefèvre, Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland, Telephone: 41–61–3246114, Fax: 41–61–3248940. Patricia Ibarra de Palacios, Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland, Telephone: 41–61–32–47540, Fax: 41–61–32–46537. Blaise Genton, Policlinique Médicale Universitaire, Rue du Bugnon 44, 1011 Lausanne, Switzerland, Telephone: 41–0–21–3144859, Fax: 41–0–21–3144857.

Reprint requests: Christoph Hatz, Swiss Tropical Institute, Socinstrasse 57, 4002 Basel, Switzerland. E-mail: christoph.hatz{at}unibas.ch.