Thriemer Kamala, Hong Nguyen Van, Rosanas-Urgell Anna, Phuc Bui Quang, Ha Do Manh, Pockele Evi, Guetens Pieter, Van Nguyen Van, Duong Tran Thanh, Amambua-Ngwa Alfred, D'Alessandro Umberto, Erhart Annette
Institute of Tropical Medicine, Antwerp, Belgium
Institute of Tropical Medicine, Antwerp, Belgium National Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15.
Reduced susceptibility of Plasmodium falciparum toward artemisinin derivatives has been reported from the Thai-Cambodian and Thai-Myanmar borders. Following increasing reports from central Vietnam of delayed parasite clearance after treatment with dihydroartemisinin-piperaquine (DHA-PPQ), the current first-line treatment, we carried out a study on the efficacy of this treatment. Between September 2012 and February 2013, we conducted a 42-day in vivo and in vitro efficacy study in Quang Nam Province. Treatment was directly observed, and blood samples were collected twice daily until parasite clearance. In addition, genotyping, quantitative PCR (qPCR), and in vitro sensitivity testing of isolates was performed. The primary endpoints were parasite clearance rate and time. The secondary endpoints included PCR-corrected and uncorrected cure rates, qPCR clearance profiles, in vitro sensitivity results (for chloroquine, dihydroartemisinin, and piperaquine), and genotyping for mutations in the Kelch 13 propeller domain. Out of 672 screened patients, 95 were recruited and 89 available for primary endpoint analyses. The median parasite clearance time (PCT) was 61.7 h (interquartile range [IQR], 47.6 to 83.2 h), and the median parasite clearance rate had a slope half-life of 6.2 h (IQR, 4.4 to 7.5 h). The PCR-corrected efficacy rates were estimated at 100% at day 28 and 97.7% (95% confidence interval, 91.2% to 99.4%) at day 42. At day 3, the P. falciparum prevalence by qPCR was 2.5 times higher than that by microscopy. The 50% inhibitory concentrations (IC50s) of isolates with delayed clearance times (≥ 72 h) were significantly higher than those with normal clearance times for all three drugs. Delayed parasite clearance (PCT, ≥ 72 h) was significantly higher among day 0 samples carrying the 543 mutant allele (47.8%) than those carrying the wild-type allele (1.8%; P = 0.048). In central Vietnam, the efficacy of DHA-PPQ is still satisfactory, but the parasite clearance time and rate are indicative of emerging artemisinin resistance. (This study has been registered at ClinicalTrials.gov under registration no. NCT01775592.).
泰国与柬埔寨边境以及泰国与缅甸边境已报告恶性疟原虫对青蒿素衍生物的敏感性降低。随着越南中部关于目前一线治疗药物双氢青蒿素 - 哌喹(DHA - PPQ)治疗后寄生虫清除延迟的报告增多,我们开展了一项关于该治疗疗效的研究。2012年9月至2013年2月期间,我们在广南省进行了一项为期42天的体内和体外疗效研究。治疗过程直接观察,每天采集两次血样直至寄生虫清除。此外,还进行了分离株的基因分型、定量PCR(qPCR)以及体外敏感性测试。主要终点是寄生虫清除率和清除时间。次要终点包括PCR校正和未校正的治愈率、qPCR清除曲线、体外敏感性结果(针对氯喹、双氢青蒿素和哌喹)以及Kelch 13螺旋桨结构域突变的基因分型。在672名筛查患者中,95名被招募,89名可用于主要终点分析。中位寄生虫清除时间(PCT)为61.7小时(四分位间距[IQR],47.6至83.2小时),中位寄生虫清除率的斜率半衰期为6.2小时(IQR,4.4至7.5小时)。PCR校正的疗效率在第28天估计为100%,在第42天为97.7%(95%置信区间,91.2%至99.4%)。在第3天,通过qPCR检测的恶性疟原虫患病率比显微镜检测高2.5倍。清除时间延迟(≥72小时)的分离株对所有三种药物的50%抑制浓度(IC50)均显著高于清除时间正常的分离株。携带543突变等位基因的第0天样本中延迟寄生虫清除(PCT,≥72小时)的比例(47.8%)显著高于携带野生型等位基因的样本(1.8%;P = 0.048)。在越南中部,DHA - PPQ的疗效仍然令人满意,但寄生虫清除时间和清除率表明青蒿素耐药性正在出现。(本研究已在ClinicalTrials.gov注册,注册号为NCT01775592。)