Therapeutic efficacies of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and chloroquine and dihydroartemisinin-piperaquine for uncomplicated Plasmodium vivax infection in Ethiopia
Creators: name: Sime, Heven
name: Tasew, Geremew
name: Solomon, Hiwot
name: Alemayehu, Bereket Hailegiorgis
name: Teka, Hiwot
name: Dilu, Dereje
name: Tadesse, Yehualashet
name: Girma, Samuel
name: Bekele, Worku
name: Etana, Kebede
name: Assefa, Ashenafi
name: Murphy, Matthew
name: Ezema, Bryan
name: Moriarty, Leah F.
name: Svigel, Samaly Souza
name: Zhou, Zhiyong
name: Haile, Mebrahtom
name: Minta, Anna A.
name: Tadesse, Mekonnen
name: Woyessa, Adugna
name: Mohammed, Hussein
name: Anand, Anjoli
name: Hwang, Jimee
name: Abera, Adugna
Publisher: name: Springer Nature
Year: 2022

description: <p>Background Routine monitoring of anti-malarial drugs is recommended for early detection of drug resistance and to inform national malaria treatment guidelines. In Ethiopia, the national treatment guidelines employ a species-specific approach. Artemether-lumefantrine (AL) and chloroquine (CQ) are the first-line schizonticidal treatments for Plasmodium falciparum and Plasmodium vivax, respectively. The National Malaria Control and Elimination Programme in Ethiopia is considering dihydroartemisinin-piperaquine (DHA/PPQ) as an alternative regimen for P. falciparum and P. vivax. Methods The study assessed the clinical and parasitological efficacy of AL, CQ, and DHA/PPQ in four arms. Patients over 6 months and less than 18 years of age with uncomplicated malaria mono-infection were recruited and allocated to AL against P. falciparum and CQ against P. vivax. Patients 18 years or older with uncomplicated malaria mono-infection were recruited and randomized to AL or dihydroartemisinin-piperaquine (DHA/PPQ) against P. falciparum and CQ or DHA/PPQ for P. vivax. Patients were followed up for 28 (for CQ and AL) or 42 days (for DHA/PPQ) according to the WHO recommendations. Polymerase chain reaction (PCR)-corrected and uncorrected estimates were analysed by Kaplan Meier survival analysis and per protocol methods. Results A total of 379 patients were enroled in four arms (n&thinsp;=&thinsp;106, AL-P. falciparum; n&thinsp;=&thinsp;75, DHA/PPQ- P. falciparum; n&thinsp;=&thinsp;142, CQ-P. vivax; n&thinsp;=&thinsp;56, DHA/PPQ-P. vivax). High PCR-corrected adequate clinical and parasitological response (ACPR) rates were observed at the primary end points of 28 days for AL and CQ and 42 days for DHA/PPQ. ACPR rates were 100% in AL-Pf (95% CI: 96&ndash;100), 98% in CQ-P. vivax (95% CI: 95&ndash;100) at 28 days, and 100% in the DHA/PPQ arms for both P. falciparum and P. vivax at 42 days. For secondary endpoints, by day three 99% of AL-P. falciparum patients (n&thinsp;=&thinsp;101) cleared parasites and 100% were afebrile. For all other arms, 100% of patients cleared parasites and were afebrile by day three. No serious adverse events were reported. Conclusion This study demonstrated high therapeutic efficacy for the anti-malarial drugs currently used by the malaria control programme in Ethiopia and provides information on the efficacy of DHA/PPQ for the treatment of P. falciparum and P. vivax as an alternative option.</p>