Journal Article

A Randomized, Controlled Study of a Simple, Once-Daily Regimen of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated, Multidrug-Resistant Falciparum Malaria

Elizabeth A. Ashley, Rose McGready, Robert Hutagalung, Lucy Phaiphun, Thra Slight, Stephane Proux, Kyaw Lay Thwai, Marion Barends, Sornchai Looareesuwan, Nicholas J. White and François Nosten

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 41, issue 4, pages 425-432
Published in print August 2005 | ISSN: 1058-4838
Published online August 2005 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/432011
A Randomized, Controlled Study of a Simple, Once-Daily Regimen of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated, Multidrug-Resistant Falciparum Malaria

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Background. Dihydroartemisinin-piperaquine (DP) is a fixed-combination antimalarial drug increasingly deployed in Southeast Asia. The current regimen involves 4 doses given over 3 days. Simplification of the dose regimen should facilitate treatment adherence and thereby increase effectiveness.

Methods. In a randomized, controlled, 3-arm trial conducted along the northwestern border of Thailand, the standard 4-dose course of DP (DP4) was compared to an equivalent dose given as a once-daily regimen (DP3) and to the standard treatment of mefloquine-artesunate (MAS3).

Results. A total of 499 patients were included in the study. Times to fever and parasite clearance were similar in all groups. The PCR genotyping-adjusted cure rates at day 63 after treatment initiation were 95.7% (95% confidence interval [95% CI], 92.2%–98.9%) for MAS3, 100% for DP4, and 99.4% (95% CI, 98.1%–100%) for DP3. The DP4 and DP3 cure rates were significantly higher than that for MAS3 (P = .008 and P = .03, respectively). All regimens were well tolerated. There were 3 deaths (1 in the MAS3 group and 2 in the DP3 group), all of which were considered to be unrelated to treatment. Rates of other adverse events were comparable between the groups, except for diarrhea, which was more common in the DP4 group (P = .05 vs. the MAS3 group).

Conclusions. A once-daily, 3-dose regimen of DP is a highly efficacious treatment for multidrug-resistant falciparum malaria. This simple, safe, and relatively inexpensive fixed combination could become the treatment of choice for falciparum malaria.

Journal Article.  3962 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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