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J Infect Dis. A Randomized Comparison of Dihydroartemisinin-Piperaquine and Artesunate-Amodiaquine Combined with Primaquine for Radical Treatment of Vivax Malaria in Sumatera, Indonesia
[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]
A Randomized Comparison of Dihydroartemisinin-Piperaquine and Artesunate-Amodiaquine Combined with Primaquine for Radical Treatment of Vivax Malaria in Sumatera, Indonesia
Ayodhia Pitaloka Pasaribu 1,2, Watcharee Chokejindachai 1,5,*, Chukiat Sirivichayakul 1, Naowarat Tanomsing 1, Irwin Chavez 1, Emiliana Tjitra 3, Syahril Pasaribu 2, Mallika Imwong 1, Nicholas J. White 1,4 and Arjen M. Dondorp 1,4
Author Affiliations: <SUP>1</SUP>Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand <SUP>2</SUP>Medical Faculty, University of Sumatera Utara, Medan, North Sumatera, Indonesia <SUP>3</SUP>National Institute of Health Research and Development, Ministry of Health, Jakarta, Indonesia <SUP>4</SUP>Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7LE, U.K <SUP>5</SUP>Center for Emerging and Neglected Infectious Diseases, Mahidol University, Thailand
*Corresponding author: Dr Watcharee Chokejindachai. Address: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevi, Bangkok 10400, Thailand. E.mail: watcharee.cho@mahidol.ac.th
Abstract
Background.
High prevalence of chloroquine resistant P. vivax in Indonesia, has shifted first-line treatment to artemisinin-based combination therapies (ACTs), combined with primaquine for radical cure. Which combination is most effective and safe, needs to be established.
Methods.
We conducted a prospective open-label randomized comparison of 14 days primaquine (0.25 mg base/kg) plus either artesunate-amodiaquine (AAQ+PQ) or dihydroartemisinin-piperaquine (DHP+PQ) for the treatment of uncomplicated mono-infection P. vivax malaria in North Sumatera, Indonesia. Patients were randomized and treatments were given without prior testing for G6PD-status. The primary outcome was parasitological failure at day-42. Patients were followed up to one year.
Results.
Between December 2010 and April 2012, 331 patients were included. After AAQ+PQ, recurrent infection occurred in 0/167 patients within 42 days and in 15/130 (11.5%, 95%CI 6.6%-18.3%) within a year. With DHP+PQ this was 1/164 (0.6%, 95%CI 0.01%-3.4%) and 13/143 (9.1%, 95%CI 4.9%-15.0%), respectively (p>0.2). Intravascular hemolysis occurred in 5 patients, of which 3 males were hemizygous for G6PD-Mahidol. Minor adverse events were more frequent with AAQ+PQ.
Conclusions.
In North Sumatera, Indonesia, AAQ and DHP, both combined with primaquine, were effective for blood stage parasite clearance of uncomplicated P.vivax malaria. Both treatments were safe, but DHP+PQ was better tolerated. Registration: NCT01288820.
Received May 17, 2013. Revision received June 19, 2013. Accepted June 20, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/ ), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
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A Randomized Comparison of Dihydroartemisinin-Piperaquine and Artesunate-Amodiaquine Combined with Primaquine for Radical Treatment of Vivax Malaria in Sumatera, Indonesia
Ayodhia Pitaloka Pasaribu 1,2, Watcharee Chokejindachai 1,5,*, Chukiat Sirivichayakul 1, Naowarat Tanomsing 1, Irwin Chavez 1, Emiliana Tjitra 3, Syahril Pasaribu 2, Mallika Imwong 1, Nicholas J. White 1,4 and Arjen M. Dondorp 1,4
Author Affiliations: <SUP>1</SUP>Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand <SUP>2</SUP>Medical Faculty, University of Sumatera Utara, Medan, North Sumatera, Indonesia <SUP>3</SUP>National Institute of Health Research and Development, Ministry of Health, Jakarta, Indonesia <SUP>4</SUP>Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7LE, U.K <SUP>5</SUP>Center for Emerging and Neglected Infectious Diseases, Mahidol University, Thailand
*Corresponding author: Dr Watcharee Chokejindachai. Address: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevi, Bangkok 10400, Thailand. E.mail: watcharee.cho@mahidol.ac.th
Abstract
Background.
High prevalence of chloroquine resistant P. vivax in Indonesia, has shifted first-line treatment to artemisinin-based combination therapies (ACTs), combined with primaquine for radical cure. Which combination is most effective and safe, needs to be established.
Methods.
We conducted a prospective open-label randomized comparison of 14 days primaquine (0.25 mg base/kg) plus either artesunate-amodiaquine (AAQ+PQ) or dihydroartemisinin-piperaquine (DHP+PQ) for the treatment of uncomplicated mono-infection P. vivax malaria in North Sumatera, Indonesia. Patients were randomized and treatments were given without prior testing for G6PD-status. The primary outcome was parasitological failure at day-42. Patients were followed up to one year.
Results.
Between December 2010 and April 2012, 331 patients were included. After AAQ+PQ, recurrent infection occurred in 0/167 patients within 42 days and in 15/130 (11.5%, 95%CI 6.6%-18.3%) within a year. With DHP+PQ this was 1/164 (0.6%, 95%CI 0.01%-3.4%) and 13/143 (9.1%, 95%CI 4.9%-15.0%), respectively (p>0.2). Intravascular hemolysis occurred in 5 patients, of which 3 males were hemizygous for G6PD-Mahidol. Minor adverse events were more frequent with AAQ+PQ.
Conclusions.
In North Sumatera, Indonesia, AAQ and DHP, both combined with primaquine, were effective for blood stage parasite clearance of uncomplicated P.vivax malaria. Both treatments were safe, but DHP+PQ was better tolerated. Registration: NCT01288820.
Received May 17, 2013. Revision received June 19, 2013. Accepted June 20, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/ ), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
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