Therapeutic efficacy of pyronaridine-artesunate (Pyramax) in treating Plasmodium vivax malaria in the central highlands of Vietnam.

Autor:	Manh ND; Vietnam People's Army Military Institute of Preventive Medicine, Hanoi, Vietnam., Thanh NV; Vietnam People's Army Military Institute of Preventive Medicine, Hanoi, Vietnam., Quang HH; Vietnam Ministry of Health Institute of Malariology, Parasitology and Entomology, Qui Nhon, Vietnam., Van NTT; Vietnam People's Army Military Institute of Preventive Medicine, Hanoi, Vietnam., San NN; Vietnam People's Army Military Institute of Preventive Medicine, Hanoi, Vietnam., Phong NC; Vietnam People's Army Military Institute of Preventive Medicine, Hanoi, Vietnam., Birrell GW; Australian Defense Force Malaria and Infectious Disease Institute, Brisbane, Australia., Edgel KA; U.S. Naval Medical Research Unit INDO PACIFIC, Singapore., Martin NJ; U.S. Naval Medical Research Unit INDO PACIFIC, Singapore., Edstein MD; Australian Defense Force Malaria and Infectious Disease Institute, Brisbane, Australia., Chavchich M; Australian Defense Force Malaria and Infectious Disease Institute, Brisbane, Australia.
Jazyk:	angličtina
Zdroj:	Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2024 Sep 04; Vol. 68 (9), pp. e0004424. Date of Electronic Publication: 2024 Jul 24.
DOI:	10.1128/aac.00044-24
Abstrakt:	The emergence and spread of chloroquine-resistant Plasmodium vivax have necessitated the assessment of alternative blood schizonticidal drugs. In Vietnam, chloroquine-resistant P. vivax malaria has been reported. In an open-label, single-arm trial, the safety, tolerability, and efficacy of pyronaridine-artesunate (Pyramax, PA) was evaluated in Dak Nong province, Vietnam. A 3-day course of PA was administered to adults and children (≥20 kg) infected with P. vivax . Patients also received primaquine (0.25 mg/kg daily for 14 days). PA was well tolerated with transient asymptomatic increases in liver transaminases. The per-protocol proportion of patients with day 42 PCR-unadjusted adequate clinical and parasitological response was 96.0% (95% CI, 84.9%-99.0%, n = 48/50). The median parasite clearance time was 12 h (range, 12-36 h), with a median fever clearance time of 24 h (range, 12-60 h). Single nucleotide polymorphisms (SNPs) as potential genetic markers of reduced drug susceptibility were analyzed in three putative drug resistance markers, Pvcrt-o , Pvmdr1 , and PvK12 . Insertion at position K10 of the Pvcrt-o gene was found in 74.6% (44/59) of isolates. Pvmdr1 SNPs at Y976F and F1076L were present in 61% (36/59) and 78% (46/59), respectively. Amplification of Pvmdr1 gene (two copies) was found in 5.1% (3/59) of parasite samples. Only 5.1% (3/59) of isolates had mutation 552I of the PvK12 gene. Overall, PA rapidly cleared P. vivax blood asexual stages and was highly efficacious in treating vivax malaria, with no evidence of artemisinin resistance found. PA provides an alternative to chloroquine treatment for vivax malaria in Vietnam. Clinical Trials: This study is registered with the Australian New Zealand Clinical Trials Registry as ACTRN12618001429246. Competing Interests: The authors declare no conflict of interest.
Databáze:	MEDLINE
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