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Title: An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia
Authors: Neena Valecha
Aung Pyae Phyo
Mayfong Mayxay
Paul N. Newton
Srivicha Krudsood
Sommay Keomany
Maniphone Khanthavong
Tiengkham Pongvongsa
Ronnatrai Ruangveerayuth
Chirapong Uthaisil
David Ubben
Stephan Duparc
Antonella Bacchieri
Marco Corsi
Bappanad H.K. Rao
Prabash C. Bhattacharya
Nagesh Dubhashi
Susanta K. Ghosh
Vas Dev
Ashwani Kumar
Sasithon Pukittayakamee
National Institute of Malaria Research India
Shoklo Malaria Research Unit
Oxford University Tropical Medicine Research Collaboration
University of Health Sciences
Churchill Hospital
Mahidol University
Salavan Provincial Hospital
Centre of Malariology
Savannakhet Provincial Malaria Station
Mae Sod Hospital
Mae Ramat Hospital
International Center Cointrin
Sigma-Tau S.p.A.
Wenlock District Hospital
Down Town Hospital
Goa Medical College
National Institute of Malaria Research
National Institute of Malaria Research (Field Station) (ICMR)
National Institute of Malaria Research Field Unit
Keywords: Agricultural and Biological Sciences;Biochemistry, Genetics and Molecular Biology
Issue Date: 20-Aug-2010
Citation: PLoS ONE. Vol.5, No.7 (2010)
Abstract: Background: The artemisinin-based combination treatment (ACT) of dihydroartemisinin (DHA) and piperaquine (PQP) is a promising novel anti-malarial drug effective against multi-drug resistant falciparum malaria. The aim of this study was to show non-inferiority of DHA/PQP vs. artesunate-mefloquine (AS+MQ) in Asia. Methods and Findings: This was an open-label, randomised, non-inferiority, 63-day follow-up study conducted in Thailand, Laos and India. Patients aged 3 months to 65 years with Plasmodium falciparum mono-infection or mixed infection were randomised with an allocation ratio of 2:1 to a fixed-dose DHA/PQP combination tablet (adults: 40 mg/160 mg; children: 20 mg/320 mg; n = 769) or loose combination of AS+MQ (AS: 50 mg, MQ: 250 mg; n = 381). The cumulative doses of study treatment over the 3 days were of about 6.75 mg/kg of DHA and 54 mg/kg of PQP and about 12 mg/kg of AS and 25 mg/kg of MQ. Doses were rounded up to the nearest half tablet. The primary endpoint was day-63 polymerase chain reaction (PCR) genotype-corrected cure rate. Results were 87.9% for DHA/PQP and 86.6% for AS+MQ in the intention-to-treat (ITT;97.5% one sided confidence interval, CI: >-2.87%), and 98.7% and 97.0%, respectively, in the per protocol population (97.5% CI: >-0.39%). No country effect was observed. Kaplan-Meier estimates of proportions of patients with new infections on day 63 (secondary endpoint) were significantly lower for DHA/PQP than AS+MQ: 22.7% versus 30.3% (p = 0.0042; ITT). Overall gametocyte prevalence (days 7 to 63; secondary endpoint), measured as person-gametocyte-weeks, was significantly higher for DHA/PQP than AS+MQ (10.15% versus 4.88%; p = 0.003; ITT). Fifteen serious adverse events were reported, 12 (1.6%) in DHA/ PQP and three (0.8%) in AS+MQ, among which six (0.8%) were considered related to DHA/PQP and three (0.8%) to AS+MQ. Conclusions: DHA/PQP was a highly efficacious drug for P. falciparum malaria in areas where multi drug parasites are prevalent. The DHA/PQP combination can play an important role in the first-line treatment of uncomplicated falciparum malaria. Trial Registration: ISRCTN81306618. © 2010 Valecha et al.
ISSN: 19326203
Appears in Collections:Scopus 2006-2010

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