Pharmacokinetic predictors for recurrent malaria after dihydroartemisinin- piperaquine treatment of uncomplicated malaria in ugandan infants

Journal of Infectious Diseases

Volumn 207, Issue 11, 2013, Pages 1646-1654

  Creek, Darren J ^a,b   Bigira, Victor ^f   McCormack, Shelley ^b   Arinaitwe, Emmanuel ^f   Wanzira, Humphrey ^f   Kakuru, Abel ^f   Tappero, Jordan W ^c   Sandison, Taylor G ^d   Lindegardh, Niklas ^g   Nosten, Francois ^g,h,i   Aweeka, Francesca T ^b   Parikh, Sunil ^b,e  

^a UNIVERSITY OF MELBOURNE   (Australia)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f MAKERERE UNIVERSITY MEDICAL SCHOOL   (Uganda)

^g MAHIDOL UNIVERSITY   (Thailand)

^h SHOKLO MALARIA RESEARCH UNIT   (Thailand)

ⁱ UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

antimalarial; artemisinin combination therapy; malaria; pharmacokinetics; piperaquine

Indexed keywords

COTRIMOXAZOLE; DIHYDROARTEMISININ PLUS PIPERAQUINE;

ANTIBIOTIC PROPHYLAXIS; ARTICLE; BLOOD SAMPLING; CAPILLARY BLOOD; CHILD; CHILD CARE; DISEASE ASSOCIATION; DISEASE COURSE; DISEASE DURATION; DRUG BLOOD LEVEL; DRUG EXPOSURE; FOLLOW UP; HUMAN; INFANT; INFECTION RISK; MAJOR CLINICAL STUDY; MALARIA; PRESCHOOL CHILD; PRIORITY JOURNAL; PROSPECTIVE STUDY; RECURRENT DISEASE; RISK ASSESSMENT; UGANDA;

ANTIMALARIALS; ARTEMISININS; CHEMOPREVENTION; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; MALARIA; MALE; PLASMA; PROSPECTIVE STUDIES; QUINOLINES; RECURRENCE; TIME FACTORS; TREATMENT OUTCOME; TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION; UGANDA;

EID: 84877277245     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jit078     Document Type: Article

References (41)

1. World Health Organization (WHO). World malaria report. Geneva: WHO, 2009.
2. Smithuis F, Kyaw MK, Phe O, et al. Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison. Lancet 2006; 367:2075-85.
3. Yeka A, Dorsey G, Kamya MR, et al. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda. PLoS One 2008; 3:e2390.
4. Myint HY, Ashley EA, Day NPJ, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin-piperaquine. Trans R Soc Trop Med Hyg 2007; 101:858-66.
5. Ratcliff A, Siswantoro H, Kenangalem E, et al. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet 2007; 369:757-65.
6. Karema C, Fanello CI, Van Overmeir C, et al. Safety and efficacy of dihydroartemisinin/piperaquine (Artekin) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwandan children. Trans R Soc Trop Med Hyg 2006; 100:1105-11.
7. World Health Organization (WHO). Guidelines for the treatment of malaria. Geneva: WHO, 2010.
8. Nosten F, White NJ. Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 2007; 77:181-92.
9. Nguyen DV, Nguyen QP, Nguyen ND, et al. Pharmacokinetics and ex vivo pharmacodynamic antimalarial activity of dihydroartemisininpiperaquine in patients with uncomplicated falciparum malaria in Vietnam. Antimicrob Agents Chemother 2009; 53:3534-7.
10. White NJ, Stepniewska K, Barnes K, Price RN, Simpson J. Simplified antimalarial therapeutic monitoring: using the day-7 drug level? Trends Parasitol 2008; 24:159-63.
11. Barnes KI, Watkins WM, White NJ. Antimalarial dosing regimens and drug resistance. Trends Parasitol 2008; 24:127-34.
12. Tarning J, Ashley EA, Lindegardh N, et al. Population pharmacokinetics of piperaquine after two different treatment regimens with dihydroartemisinin- piperaquine in patients with Plasmodium falciparum malaria in Thailand. Antimicrob Agents Chemother 2008; 52:1052-61.
13. Roshammar D, Hai TN, Friberg Hietala S, Van Huong N, Ashton M. Pharmacokinetics of piperaquine after repeated oral administration of the antimalarial combination CV8 in 12 healthy male subjects. Eur J Clin Pharmacol 2006; 62:335-41.
14. Lwin KM, Phyo AP, Tarning J, et al. Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin- piperaquine chemoprevention in adults at high risk of malaria. Antimicrob Agents Chemother 2012; 56:1571-7.
15. Arinaitwe E, Sandison TG, Wanzira H, et al. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for falciparum malaria: a longitudinal, randomized trial in young Ugandan children. Clin Infect Dis 2009; 49:1629-37.
16. Bassat Q, Mulenga M, Tinto H, et al. Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial. PLoS One 2009; 4:e7871.
17. German PI, Aweeka FT. Clinical pharmacology of artemisinin-based combination therapies. Clin Pharmacokinet 2008; 47:91-102.
18. Davis TM, Hung TY, Sim IK, Karunajeewa HA, Ilett KF. Piperaquine: a resurgent antimalarial drug. Drugs 2005; 65:75-87.
19. Annerberg A, Lwin KM, Lindegardh N, et al. A small amount of fat does not affect piperaquine exposure in patients with malaria. Antimicrob Agents Chemother 2011; 55:3971-6.
20. Hai TN, Hietala SF, Van Huong N, Ashton M. The influence of food on the pharmacokinetics of piperaquine in healthy Vietnamese volunteers. Acta Trop 2008; 107:145-9.
21. Sim IK, Davis TM, Ilett KF. Effects of a high-fat meal on the relative oral bioavailability of piperaquine. Antimicrob Agents Chemother 2005; 49:2407-11.
22. Tarning J, Zongo I, Some FA, et al. Population pharmacokinetics and pharmacodynamics of piperaquine in children with uncomplicated falciparum malaria. Clin Pharmacol Ther 2012; 91:497-505.
23. Olliaro P,Wells TN. The global portfolio of new antimalarial medicines under development. Clin Pharmacol Ther 2009; 85:584-95.
24. Mwesigwa J, Parikh S, McGee B, et al. Pharmacokinetics of artemetherlumefantrine and artesunate-amodiaquine in children in Kampala, Uganda. Antimicrob Agents Chemother 2010; 54:52-9.
25. Barnes KI, Little F, Smith PJ, Evans A, Watkins WM, White NJ. Sulfadoxine-pyrimethamine pharmacokinetics in malaria: pediatric dosing implications. Clin Pharmacol Ther 2006; 80:582-96.
26. Karunajeewa HA, Mueller I, Senn M, et al. A trial of combination antimalarial therapies in children from Papua New Guinea. N Engl J Med 2008; 359:2545-57.
27. Price RN, Hasugian AR, Ratcliff A, et al. Clinical and pharmacological determinants of the therapeutic response to dihydroartemisininpiperaquine for drug-resistant malaria. Antimicrob Agents Chemother 2007; 51:4090-7.
28. Sandison TG, Homsy J, Arinaitwe E, et al. Protective efficacy of co-trimoxazole prophylaxis against malaria in HIV exposed children in rural Uganda: a randomised clinical trial. BMJ 2011; 342:d1617.
29. Okello PE, Van Bortel W, Byaruhanga AM, et al. Variation in malaria transmission intensity in seven sites throughout Uganda. Am J Trop Med Hyg 2006; 75:219-25.
30. Greenhouse B, Myrick A, Dokomajilar C, et al. Validation of microsatellite markers for use in genotyping polyclonal Plasmodium falciparum infections. Am J Trop Med Hyg 2006; 75:836-42.
31. Tarning J, Lindegardh N. Quantification of the antimalarial piperaquine in plasma. Trans R Soc Trop Med Hyg 2008; 102:409-11.
32. Vora N, Homsy J, Kakuru A, et al. Breastfeeding and the risk of malaria in children born to HIV-infected and uninfected mothers in rural Uganda. J Acquir Immune Defic Syndr 2010; 55:253-61.
33. German P, Parikh S, Lawrence J, et al. Lopinavir/ritonavir affects pharmacokinetic exposure of artemether/lumefantrine in HIV-uninfected healthy volunteers. J Acquir Immune Defic Syndr 2009; 51:424-9.
34. Fehintola FA, Scarsi KK, Ma Q, et al. Nevirapine-based antiretroviral therapy impacts artesunate and dihydroartemisinin disposition in HIV-infected Nigerian adults. AIDS Res Treat 2012; 2012:703604.
35. Bartelink IH, Rademaker CM, Schobben AF, van den Anker JN. Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations. Clin Pharmacokinet 2006; 45:1077-97.
36. Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol 2003; 17:281-99.
37. Zwang J, Ashley EA, Karema C, et al. Safety and efficacy of dihydroartemisinin-piperaquine in falciparum malaria: a prospective multi-centre individual patient data analysis. PLoS One 2009; 4:e6358.
38. Karunajeewa HA, Ilett KF, Mueller I, et al. Pharmacokinetics and efficacy of piperaquine and chloroquine in Melanesian children with uncomplicated malaria. Antimicrob Agents Chemother 2008; 52:237-43.
39. Tarning J, Lindegardh N, Sandberg S, Day NJ, White NJ, Ashton M. Pharmacokinetics and metabolism of the antimalarial piperaquine after intravenous and oral single doses to the rat. J Pharm Sci 2008; 97:3400-10.
40. Ashley EA, Stepniewska K, Lindegardh N, et al. Comparison of plasma, venous and capillary blood levels of piperaquine in patients with uncomplicated falciparum malaria. Eur J Clin Pharmacol 2010; 66:705-12.
41. Greenhouse B, Dokomajilar C, Hubbard A, Rosenthal PJ, Dorsey G. Impact of transmission intensity on the accuracy of genotyping to distinguish recrudescence from new infection in antimalarial clinical trials. Antimicrob Agents Chemother 2007; 51:3096-103.