Translational pharmacokinetic modelling and simulation for the assessment of duration of contraceptive use after treatment with miltefosine

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 8, 2012, Pages 1996-2004

  Dorlo, Thomas P C ^a,b   Balasegaram, Manica ^c   Lima, María Angeles ^d   De Vries, Peter J ^a   Beijnen, Jos H ^b   Huitema, Alwin D R ^b  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b NETHERLANDS CANCER INSTITUTE   (Netherlands)

^c Drugs for Neglected Diseases initiative DNDi   (Switzerland)

^d MÉDECINS SANS FRONTIÈRES   (Switzerland)

Author keywords

Anticonceptive; Contraception; Leishmaniasis; Monte Carlo simulation; Pharmacokinetics; Pharmacometrics; Population pharmacokinetics; Reproductive health; Reproductive toxicity; Teratogenicity; Translational research; Visceral leishmaniasis

Indexed keywords

CONTRACEPTIVE AGENT; MILTEFOSINE;

ADOLESCENT; ADULT; ANIMAL EXPERIMENT; ANIMAL REPRODUCTIVE PROCEDURES; ARTICLE; BODY WEIGHT; CONTRACEPTION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG ELIMINATION; DRUG EXPOSURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; NONHUMAN; PREGNANCY; PROBABILITY; PROCESS MODEL; RAT; TREATMENT DURATION;

ADOLESCENT; ADULT; ANIMALS; ANTIPROTOZOAL AGENTS; CONTRACEPTIVE AGENTS; FEMALE; HUMANS; INDIA; LEISHMANIASIS, VISCERAL; MODELS, STATISTICAL; PHOSPHORYLCHOLINE; TERATOGENS; TIME FACTORS; YOUNG ADULT;

EID: 84864498376     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks164     Document Type: Article

References (54)

1. Mondal D, Singh SP, Kumar N et al. Visceral leishmaniasis elimination programme in India, Bangladesh, and Nepal: reshaping the case finding/case management strategy. PLoS Negl Trop Dis 2009; 3: e355.
2. Sundar S, Mondal D, Rijal S et al. Implementation research to support the initiative on the elimination of kala azar from Bangladesh, India and Nepal-the challenges for diagnosis and treatment. Trop Med Int Health 2008; 13: 2-5.
3. Sindermann H, Engel J. Development of miltefosine as an oral treatment for leishmaniasis. Trans R Soc Trop Med Hyg 2006; 100: S17-20.
4. German Drug Registration Authorities. Impavido 10/50 mg Kapseln-Fachinformation. 2008. http://www.pharmnet-bund.de/dynamic/de/index.html (15 February 2010, date last accessed).
5. WHO. WHO Technical Report Series 949: Control of the leishmaniases. Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva 22-26 March 2010. 2011. http://whqlibdoc.who.int/trs/WHO_TRS_949_eng.pdf (16 January 2012, date last accessed).
6. Sundar S, Olliaro PL. Miltefosine in the treatment of leishmaniasis: Clinical evidence for informed clinical risk management. Ther Clin Risk Manag 2007; 3: 733-40.
7. Government of India: Dte. of National Vector Borne Disease Control Progamme. Guideline on Use of Miltefosine. http://nvbdcp.gov.in/Doc/Guidelines%20on%20miltefosine.pdf (12 December 2011, date last accessed).
8. Dorlo TP, van Thiel PP, Huitema AD et al. Pharmacokinetics of miltefosine in Old World cutaneous leishmaniasis patients. Antimicrob Agents Chemother 2008; 52: 2855-60.
9. Sundar S, Sinha PK, Verma DK et al. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg 2011; 105: 115-7.
10. Sundar S, Sinha PK, Rai M et al. Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. Lancet 2011; 377: 477-86.
11. Omollo R, Alexander N, Edwards T et al. Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials 2011; 12: 166.
12. ClinicalTrials.gov. Phase III, Study of Three Short Course Combination Regimens (Ambisomew, Miltefosine, Paromomycin) Compared With AmBisomew Alone for the Treatment of Visceral Leishmaniasis in Bangladesh. 2011. http://clinicaltrials.gov/ct2/show/NCT01122771 (16 January 2012, date last accessed).
13. Janmahasatian S, Duffull SB, Ash S et al. Quantification of lean bodyweight. Clin Pharmacokinet 2005; 44: 1051-65.
14. Beal SL, Boeckmann AJ, Sheiner LB. NONMEM Users Guides. Ellicott City, MD, USA: Icon Development Solutions, 2006.
15. R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing, 2011.
16. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 2004; 75: 85-94.
17. Keizer RJ, van Benten M, Beijnen JH et al. Piraña and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed 2011; 101: 72-9.
18. Holford NH. A size standard for pharmacokinetics. Clin Pharmacokinet 1996; 30: 329-32.
19. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008; 48: 303-32.
20. Anderson BJ, McKee AD, Holford NH. Size, myths and the clinical pharmacokinetics of analgesia in paediatric patients. Clin Pharmacokinet 1997; 33: 313-27.
21. West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science 1997; 276: 122-6.
22. FDA. Oncology Tools: Dose Calculator. http://www.accessdata.fda.gov/scripts/cder/onctools/animalquery.cfm (9 September 2011, date last accessed).
23. Freireich EJ, Gehan EA, Rall DP et al. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man. Cancer Chemother Rep 1966; 50: 219-44.
24. Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J 2008; 22: 659-61.
25. Boyd E. The Growth of the Surface Area of the Human Body. Minneapolis: University of Minnesota Press, 1935.
26. Dourson ML, Stara JF. Regulatory history and experimental support of uncertainty (safety) factors. Regul Toxicol Pharmacol 1983; 3: 224-38.
27. Dourson ML, Felter SP, Robinson D. Evolution of science-based uncertainty factors in noncancer risk assessment. Regul Toxicol Pharmacol 1996; 24: 108-20.
28. Rhomberg LR, Lewandowski TA. Methods for identifying a default cross-species scaling factor. Hum Ecol Risk Assess 2006; 12: 1094-127.
29. FDA. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. 2005. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078932.pdf (16 January 2012, date last accessed).
30. U.S. Environmental Protection Agency (EPA). Guidelines for Developmental Toxicity Risk Assessment. 1991. http://www.epa.gov/raf/publications/pdfs/DEVTOX.PDF (16 January 2012, date last accessed).
31. Dorlo TP, Hillebrand MJ, Rosing H et al. Development and validation of a quantitative assay for the measurement of miltefosine in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2008; 865: 55-62.
32. Berman J. Miltefosine to treat leishmaniasis. Expert Opin Pharmacother 2005; 6: 1381-8.
33. Paladin Labs Inc. Application for Inclusion of Miltefosine on WHO Model List of Essential Medicines. 2010. http://www.who.int/selection_medicines/committees/expert/18/applications/Miltefosine_application.pdf (13 December 2011, date last accessed).
34. Polifka JE, Friedman JM. Clinical teratology: identifying teratogenic risks in humans. Clin Genet 1999; 56: 409-20.
35. Schering-Plough Research Institute. Product Information: RebetronTM Combination Therapy containing Rebetolw (ribavirin, USP) Capsules and Intronw A (interferon alfa-2b, recombinant) Injection. 2001. http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf (9 December 2011, date last accessed).
36. Lertora JJ, Rege AB, Lacour JT et al. Pharmacokinetics and long-term tolerance to ribavirin in asymptomatic patients infected with human immunodeficiency virus. Clin Pharmacol Ther 1991; 50: 442-9.
37. European Medicines Agency (EMA) - Committee for Proprietary Medicinal Products (CPMP). Roaccutane - Article 30 referral - Annex I, II, III. 2003. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Roaccutane_30/WC500010806.pdf (12 December 2011, date last accessed).
38. Vahlquist A, Kuenzli S, Saurat J. Chapter 229. Retinoids. In: Wolff K, Goldsmith LA, Katz SI et al., eds. Fitzpatrick's Dermatology in General Medicine. 7th edn. New York: McGraw-Hill, 2008. http://www.accessmedicine.com/content.aspx?aID=2970300 (12 December 2011, date last accessed).
39. Wiegand UW, Chou RC. Pharmacokinetics of oral isotretinoin. J Am Acad Dermatol 1998; 39: S8-12.
40. Heinz N. Teratogenicity of isotretinoin revisited: Species variation and the role of all-trans-retinoic acid. J Am Acad Dematol 2001; 45: S183-7.
41. Rozman B. Clinical pharmacokinetics of leflunomide. Clin Pharmacokinet 2002; 41: 421-30.
42. European Medicines Agency (EMA). European Public Assessment Report (EPAR) for Arava (Leflunomide) - Product Information. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000235/WC500026289.pdf (9 December 2011, date last accessed).
43. Brent RL. Teratogen update: reproductive risks of leflunomide (Arava); a pyrimidine synthesis inhibitor: counseling women taking leflunomide before or during pregnancy and men taking leflunomide who are contemplating fathering a child. Teratology 2001; 63: 106-12.
44. Krishnan K. PBPK models in reproductive and developmental toxicology. In: Gupta RC, ed. Reproductive and Developmental Toxicology. London: Elsevier, 2011.
45. Fisher JW, Whittaker TA, Taylor DH et al. Physiologically based pharmacokinetic modeling of the pregnant rat: a multiroute exposure model for trichloroethylene and its metabolite, trichloroacetic acid. Toxicol Appl Pharmacol 1989; 99: 395-414.
46. Corley RA, Mast TJ, Carney EW et al. Evaluation of physiologically based models of pregnancy and lactation for their application in children's health risk assessments. Crit Rev Toxicol 2003; 33: 137-211.
47. Marschner N, Kötting J, Eibl H et al. Distribution of hexadecylphosphocholine and octadecyl-methyl-glycero-3-phosphocholine in rat tissues during steady-state treatment. Cancer Chemother Pharmacol 1992; 31: 18-22.
48. European Medicines Agency (EMA) - Committee for Medicinal Products for Human Use (CHMP). Note for Guidance on Toxicokinetics: A Guidance For Assessing Systemic Exposure in Toxicology Studies. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002770.pdf (12 December 2011, date last accessed).
49. Datta V, Chaturvedi P. Congenital malformations in rural Maharashtra. Indian Pediatr 2000; 37: 998-1001.
50. Swain S, Agrawal A, Bhatia BD. Congenital malformations at birth. Indian Pediatr 1994; 31: 1187-91.
51. EURO-PERISTAT Project in collaboration with SCPE, EUROCAT & EURONEOSTAT. European Perinatal Health Report. 2008. http://www.europeristat.com/bm.doc/european-perinatal-health-report.pdf (16 January 2012, date last accessed).
52. European Surveillance of Congenital Anomalies (EUROCAT). Special Report: A Review of Environmental Risk Factors for Congenital Anomalies. 2004. http://www.eurocat-network.eu/content/Special-Report-Env-Risk-I-and-II.pdf (17 January 2012, date last accessed).
53. van Thiel PP, Leenstra T, Kager PA et al. Miltefosine treatment of Leishmania major infection: an observational study involving Dutch military personnel returning from northern Afghanistan. Clin Infect Dis 2010; 50: 80-3.
54. Dorlo TP, Huitema BD, Beijnen JH et al. Optimal dosing of miltefosine in children and adults with visceral leishmaniasis. Antimicrob Agents Chemother 2012; in press.