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Abstract
The liver fluke Opisthorchis viverrini, highly prevalent in Southeast Asia, is an important public health burden, including a risk factor for developing an aggressive bile duct cancer, cholangiocarcinoma, in chronically infected patients. Praziquantel, administered at single 40 mg/kg in preventive chemotherapy programs and 3 x 25 mg/kg for individual treatment is the drug of choice, yet information on the nature of the dose-response relationship is lacking.We performed a randomized, parallel, single blind dose-ranging Phase 2 trial in Lao PDR in O. viverrini-infected adults. Patients were randomly assigned to 30, 40, 50, 3 x 25 mg/kg praziquantel or placebo. Adverse events were recorded at baseline, 3 and 24 hours post-treatment. Cure rates and egg reduction rates were estimated 3 weeks after drug administration using available case analysis. Dose-response curves were predicted using Emax models.Two-hundred and seventeen O. viverrini-infected patients were assigned to the five treatment arms. The majority (94.3%) of patients harbored light infections. The Emax model predicted a high efficacy among the observed dose range. We observed cure rates ranging from 92.7-93.3% and egg reduction rates above 99.5% for all praziquantel-treatment groups. Adverse events were mild but higher in the standard treatment group (3x25 mg/kg) than in the single dose treatment arms.Single dose praziquantel appear to be as efficacious as the standard 3x25 mg/kg regimen for the treatment of O. viverrini infections, while presenting fewer adverse events. Further studies are necessary in moderate and heavy O. viverrini infections.
View details for DOI 10.1093/cid/ciw785
View details for PubMedID 27927864