AUTHOR=Wang Qi , Zhang Zhenyan , Yu Weisheng , Lu Chenguang , Li Guoming , Pan Ziyi , Zhang Hongying , Wu Wanting , Oubou Tinah Atcha , Yuan Yueming , Guo Jiawen , Liang Yuan , Huang Xinan , Guo Wenfeng , Li Changqing , Julie `Nadia , Xu Qin , Sanwogou Logte , Song Jianping , Deng Changsheng 

TITLE=Surveillance of the Efficacy of Artemisinin–Piperaquine in the Treatment of Uncomplicated Plasmodium falciparum Malaria Among Children Under 5 Years of Age in Est-Mono District, Togo, in 2017

JOURNAL=Frontiers in Pharmacology

VOLUME=11

YEAR=2020

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00784

DOI=10.3389/fphar.2020.00784

ISSN=1663-9812

ABSTRACT=<sec><title>Background</title><p>Malaria is a major public health concern in Togo. The Est-Mono district of Togo has a population of 150,000. Accordingly, the Guangzhou University of Chinese Medicine, China and the Ministry of Health and Social Security, Togo launched a nationwide Mass Drug Administration Project with artemisinin–piperaquine (AP) in Est-Mono. Before launching this project, the sensitivity test of AP was conducted in a general clinic in Elawagnon, Togo. With this background, we evaluated the efficacy and safety of AP for the treatment of uncomplicated falciparum malaria in children under the age of 5 years.</p></sec><sec><title>Methods</title><p>Children aged 6–59 months with uncomplicated falciparum malaria were enrolled in this study. The selected patients were treated with a combination regime of artemisinin–piperaquine. The patients were followed up for 28 days, during which signs of the following were observed for: the duration for fever clearance, parasitemia density, gametophyte generation, cure rate, hemoglobin level, and <italic>merozoite surface protein-2</italic> (<italic>msp-2)</italic> polymorphism. The primary end point was a 28-day cure rate and polymerase chain reaction (PCR)-corrected reinfection and recrudescence. This research followed the standardized World Health Organization (WHO) protocol for the assessment of the efficacy of antimalarial drugs.</p></sec><sec><title>Results</title><p>A total of 91 children with uncomplicated falciparum malaria were enrolled in this study. Adequate clinical and parasitological responses (ACPRs) before and after PCR-correction were 66 (73%) and 90 (99%), respectively. The average hemoglobin level in the patient increased by 0.05 g/dl per day (p &lt; 0.0001) after the treatment. The gametophyte generation did not decline at the beginning of the treatment; however, after 14 days, it declined (day 21: p &lt; 0.05; day 28: p &lt; 0.01). In the <italic>msp-2</italic> polymorphism study of 24 children treated for parasite infection, one case of <italic>msp-2</italic> with <italic>3D7</italic> haplotype and <italic>FC27</italic> haplotype was noted, indicating its recrudescence, with a frequency of 4%. The remaining 23 cases could have been of reinfection, with a frequency of 96%. No serious adverse reactions occurred, and AP was well-tolerated by all patients.</p></sec><sec><title>Conclusion</title><p>Artemisinin–piperaquine was found to be an effective combination for treating uncomplicated falciparum malaria in children aged &lt;5 years in Togo, and the drugs were well-tolerated. In Togo, <italic>Plasmodium falciparum</italic> remains sensitive to artemisinin–piperaquine, necessitating its trial in this region.</p></sec><sec><title>Clinical Trial Registration</title><p>Trial registration: ECGPHCM No. B2017-054-01; MHSST AVIS N° 0001/2016/CBRS du 07 janvier 2016. Registered 17 March 2014, <uri xlink:href="http://www.chinadrugtrials.org.cn/eap/main" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.chinadrugtrials.org.cn/eap/main</uri>.</p></sec>