PMID- 26486704 OWN - NLM STAT- MEDLINE DCOM- 20161013 LR - 20230303 IS - 1537-6591 (Electronic) IS - 1058-4838 (Linking) VI - 62 IP - 3 DP - 2016 Feb 1 TI - Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. PG - 334-341 LID - 10.1093/cid/civ882 [doi] AB - BACKGROUND: Available treatments for lymphatic filariasis (LF) are limited in their longterm clearance of microfilaria from the blood. The safety and efficacy of a single-dose triple-drug therapy of the antifilarial drugs diethylcarbamazine (DEC), ivermectin (IVM), and albendazole (ALB) for LF are unknown. METHODS: We performed a pilot study to test the efficacy, safety, and pharmacokinetics of single-dose DEC, IVM, and ALB in Wuchereria bancrofti-infected Papua New Guineans. Adults were randomized into 2 treatment arms, DEC 6 mg/kg + ALB 400 mg (N = 12) or DEC 6 mg/kg + ALB 400 mg + IVM 200 mug/kg (N = 12), and monitored for microfilaria, parasite antigenemia, adverse events (AEs), and serum drug levels. RESULTS: Triple-drug therapy induced >2-log reductions in microfilaria levels at 36 and 168 hours after treatment compared with approximately 1-log reduction with 2 drugs. All 12 individuals who received 3 drugs were microfilaria negative 1 year after treatment, whereas 11 of 12 individuals in the 2-drug regimen were microfilaria positive. In 6 participants followed 2 years after treatment, those who received 3 drugs remained microfilaria negative. AEs, particularly fever, myalgias, pruritus, and proteinuria/hematuria, occurred in 83% vs 50% of those receiving triple-drug compared to 2-drug treatment respectively (P = .021); all resolved within 7 days after treatment. No serious AEs were observed in either group. There was no significant effect of IVM on DEC or ALB drug levels. CONCLUSIONS: Triple-drug therapy is safe and more effective than DEC + ALB for Bancroftian filariasis and has the potential to accelerate elimination of lymphatic filariasis. CLINICAL TRIALS REGISTRATION: NCT01975441. CI - (c) The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com. FAU - Thomsen, Edward K AU - Thomsen EK AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. AD - Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio. FAU - Sanuku, Nelly AU - Sanuku N AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Baea, Manasseh AU - Baea M AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Satofan, Samson AU - Satofan S AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Maki, Elit AU - Maki E AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Lombore, Bart AU - Lombore B AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Schmidt, Mark S AU - Schmidt MS AD - Department of Pharmaceutical Sciences & Experimental Therapeutics, University of Iowa, Iowa City. FAU - Siba, Peter M AU - Siba PM AD - Papua New Guinea Institute of Medical Research, Papua New Guinea. FAU - Weil, Gary J AU - Weil GJ AD - Department of Medicine, Infectious Diseases Division, Washington University School of Medicine, St. Louis, Missouri. FAU - Kazura, James W AU - Kazura JW AD - Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio. FAU - Fleckenstein, Lawrence L AU - Fleckenstein LL AD - Department of Pharmaceutical Sciences & Experimental Therapeutics, University of Iowa, Iowa City. FAU - King, Christopher L AU - King CL AD - Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio. AD - Veterans Affairs Medical Center, Cleveland, Ohio. LA - eng SI - ClinicalTrials.gov/NCT01975441 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20151020 PL - United States TA - Clin Infect Dis JT - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JID - 9203213 RN - 0 (Filaricides) RN - 70288-86-7 (Ivermectin) RN - F4216019LN (Albendazole) RN - V867Q8X3ZD (Diethylcarbamazine) SB - IM MH - Adult MH - Albendazole/*administration & dosage/adverse effects/pharmacokinetics MH - Animals MH - Diethylcarbamazine/*administration & dosage/adverse effects/pharmacokinetics MH - Drug-Related Side Effects and Adverse Reactions/pathology MH - Elephantiasis, Filarial/*drug therapy MH - Female MH - Filaricides/*administration & dosage/adverse effects/pharmacokinetics MH - Humans MH - Ivermectin/*administration & dosage/adverse effects/pharmacokinetics MH - Male MH - Middle Aged MH - Papua New Guinea MH - Parasitemia/drug therapy MH - Pilot Projects MH - Serum/chemistry MH - Single-Blind Method MH - Treatment Outcome MH - Wuchereria bancrofti/isolation & purification MH - Young Adult OTO - NOTNLM OT - albendazole OT - chemotherapy OT - diethylcarbamazine OT - ivermectin OT - lymphatic filariasis EDAT- 2015/10/22 06:00 MHDA- 2016/10/14 06:00 CRDT- 2015/10/22 06:00 PHST- 2015/06/20 00:00 [received] PHST- 2015/10/07 00:00 [accepted] PHST- 2015/10/22 06:00 [entrez] PHST- 2015/10/22 06:00 [pubmed] PHST- 2016/10/14 06:00 [medline] AID - civ882 [pii] AID - 10.1093/cid/civ882 [doi] PST - ppublish SO - Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20.