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Background  Malaria is a major public health problem in India and accounts for about 88% of malaria burden in South-East Asia. India alone accounted for 2% of total malaria cases globally. Anti-malarial drug resistance is one of the major problems for malaria control and elimination programme. Artemether-lumefantrine (AL) is the first-line treatment of uncomplicated  Plasmodium falciparum  in north eastern states of India since 2013 after confirming the resistance against sulfadoxine-pyrimethamine. In the present study, therapeutic efficacy of artemether-lumefantrine and  k13  polymorphism was assessed in uncomplicated  P. falciparum  malaria.    Methods  This study was conducted at four community health centres located in Koraput district of Odisha, Bastar district of Chhattisgarh, Balaghat district of Madhya Pradesh and Gondia district of Maharashtra state. Patients with uncomplicated  P. falciparum  malaria were administered with fixed dose combination (6 doses) of artemether-lumefantrine for 3days and clinical and parasitological response was recorded up to 28days as per World Health Organization protocol. Nucleotide sequencing of  msp1  and  msp2  gene was performed to differentiate between recrudescence and reinfection. Amplification and sequencing of  k13  propeller gene region covering codon 450680 was also carried out to identify the polymorphism.    Results  A total 376 malaria patients who fulfilled the enrolment criteria as well as consented for the study were enrolled. Total 356 patients were followed up successfully up to 28days. Overall, the adequate clinical and parasitological response was 98.9% and 99.4% with and without PCR correction respectively. No case of early treatment failure was observed. However, four cases (1.1%) of late parasitological failure were found from the Bastar district of Chhattisgarh. Genotyping of  msp1  and  msp2  confirmed 2 cases each of recrudescence and reinfection, respectively. Mutation analysis of k13 propeller gene showed one non-synonymous mutation Q613H in one isolate from Bastar.    Conclusions  The study results showed that artemether-lumefantrine is highly effective in the treatment of uncomplicated  P. falciparum  malaria among all age groups. No functional mutation in  k13  was found in the study area. The data from this study will be helpful in implementation of artemether-lumefantrine in case of treatment failure by artesunate plus sulfadoxine-pyrimethamine.

malaria journal

Therapeutic efficacy of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in four malaria endemic states of India