Therapeutic drug monitoring in the treatment of HIV-infection

Journal of Clinical Virology

Volumn 27, Issue 2, 2003, Pages 117-128

  Gerber, John G ^a   Acosta, Edward P ^b  

^a UNIVERSITY OF COLORADO   (United States)

^b University of Alabama at Birmingham   (United States)

Author keywords

Antiretroviral drugs; Nonnucleoside reverse transcriptase inhibitors; Pharmacodynamics; Pharmacokinetics; Protease inhibitors; Therapeutic drug monitoring

Indexed keywords

ANTIVIRUS AGENT; DELAVIRDINE; EFAVIRENZ; INDINAVIR; LAMIVUDINE; LOPINAVIR; NELFINAVIR; NEVIRAPINE; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; TELINAVIR; ZIDOVUDINE;

ANEMIA; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DRUG ACTIVITY; DRUG BINDING; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG MONITORING; EXPERIENCE; GASTROINTESTINAL SYMPTOM; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IC 50; NAUSEA; NEPHROLITHIASIS; NEUTROPENIA; NONHUMAN; PRIORITY JOURNAL; REVIEW;

EID: 0142258774     PISSN: 13866532     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1386-6532(03)00033-7     Document Type: Review

References (47)

1. Acosta E.P., Henry K., Baker L., et al. Indinavir concentrations and antiviral effects. Pharmacotherapy. 19:1999;708-712.
2. Acosta EP, Havlir DV, Richman DD, et al. Pharmacodynamics (PD) of indinavir (IDV) in protease-naive HIV-infected patients receiving ZDV and 3TC. Abstract 455. In: Program and Abstract of the 7th Conference on Retroviruses and Opportunistic Infections. San Francisco, California, 2000, January 30-February 2.
3. Back D.J., Khoo S.H., Gibbons S.E., Merry C. The role of therapeutic drug monitoring in treatment of HIV infections. Br. J. Clin. Pharmacol. 51:2001;301-308.
4. Back D., Gatti G., Fletcher C., et al. Therapeutic drug monitoring in HIV infection: current status and future directions. AIDS. 1:(Suppl. 16):2002;S5-S37.
5. Baede-van Dijk P.A., Hugen P.W.H., Verweij-vanWissen C.P.W.G.M., et al. Analysis of variation in plasma concentrations of nelfinavir and its active metabolite M8 in HIV-positive patients. AIDS. 15:2001;991-998.
6. Brodie M.J., McIntosh M.E., Hallworth M.J. Therapeutic drug monitoring - the need for audit. Scott. Med. J. 30:1985;75-82.
7. Burger D.M., Hugen P.W., Aarnoutse R.T., et al. A retrospective, cohort-based survey of patients using twice-daily indinavir+ritonavir combinations: pharmacokinetics, safety, and efficacy. J. Acquired Immune Deficiency Syndrome. 26:2001;218-224.
8. Burger D.M., Aarnoutse R.E., Hugen P.W.H. Pros and cons of therapeutic drug monitoring of antiretroviral agents. Curr. Opin. Infectious Diseases. 15:2002;17-22.
9. Burger DM, Hugen PWH, Droste J, Huitema ADR. Therapeutic drug monitoring of nelfinavir 1250 mg bid in treatment naive patients improves therapeutic outcome after 1 year: results from ATHENA. Abstract 6.26. In: 2nd International Workshop on Clinical Pharmacology of HIV Therapy. Noordwijk, the Netherlands, 2001b, April 2-4.
10. Clevenbergh P., Garraffo R., Durant J., Dellamonica P. PharmAdapt: a randomized prospective study to evaluate the benefit of therapeutic monitoring of protease inhibitors: 12 week results. AIDS. 16:2002;2311-2315.
11. Clevenbergh P, Garraffo R, Durant J, et al. Long term efficacy of protease inhibitor plasma drug level monitoring (PI TDM): PharmAdapt w 32 results. Abstract I-1730. In: Abstracts of the 41st ICAAC. Chicago, IL, 2001, December 16-19.
12. Condra J.H., Petropoulos C.J., Ziermann R., et al. Drug resistance and predicted virologic responses to human immunodeficiency virus type 1 protease inhibitor therapy. J. Infect. Dis. 182:2000;758-765.
13. Dieleman J.P., Gyssens I.C., van der Ende M.E., et al. Urological complaints in relations to indinavir plasma concentrations in HIV-infected patients. AIDS. 13:1999;473-478.
14. Fischl M.A., Richman D.D., Flexner C., et al. Phase I/II study of the toxicity, pharmacokinetics, and activity of the HIV protease inhibitor SC-52151. J. Acquired Immune Deficiency Syndrome-Human Retrovirol. 15:1997;28-34.
15. Fischl M, Castro J, Monrolg R, et al. Impact of directly observed therapy on long-term outcomes in HIV clinical trials. Abstract 528. In: Program and Abstracts of the 8th Conference on Retroviruses and Opportunistic Infections. Chicago, IL, 2001, February 4-8.
16. Fletcher C.V., Anderson P.L., Kakuda T.K., et al. Concentration- controlled compared with conventional antiretroviral therapy for human immunodeficiency-virus infection. AIDS. 16:2002;551-560.
17. Gatti G., DiBiagio A., Casazza R., et al. The relationship between ritonavir plasma levels and side effects: implications for therapeutic drug monitoring. AIDS. 13:1999;2083-2089.
18. Gerber JG, Acosta EP, Wu H, et al. Pharmacokinetic comparison of two indinavir/ritonavir regimens in salvage therapy. Abstracts of XIV International AIDS Conference, Barcelona, Spain, July 7-12, 2002. Abstract TuPeB4552.
19. Hallworth M.J. Audit of therapeutic drug monitoring. Ann. Clin. Biochem. 25:1988;121-128.
20. Havlir D., Cheeseman S.H., McLaughlin M., et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J. Infectious Diseases. 171:1995;537-545.
21. Hsu A., Granneman R., Guoliang C., et al. Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers. Antimicrob. Agents Chemother. 42:1998;2784-2791.
22. Hsyu PH, Flexner C, Chu A, Petersen C. Correlation of efficacy, nelfinavir pharmacokinetics and diarrhea in treatment-naïve HIV positive patients receiving nelfinavir, zidovudine, and lamivudine. Abstract I-1735. In: Abstracts of the 41st ICAAC. Chicago, IL, 2001, December 16-19.
23. Israili Z.H., Dayton P.G. Human alpha-1-glycoprotein and its interactions with drugs. Drug Metabolism Rev. 33:2001;161-235.
24. Kempf D, Hsu A, Isaacson J, et al. Evaluation of the inhibitory quotient a pharmacodynamic predictor of the virologic response to protease inhibitor therapy. Abstract 7.3. In abstracts of 2nd International Workshop on Clinical Pharmacology of HIV Therapy, April 2-4, 2001a, Noordwijk, the Netherlands.
25. Kempf D, Hsu A, Jiang P, et al. Response to ritonavir intensification in indinavir recipients is highly correlated with virtual inhibitory quotients. Abstract 523. Programs and Abstracts of the 8th Conference on Retrovirus and Opportunistic Infections, Chicago, IL, February 4-8, 2001b.
26. Kim R.B., Fromm M.F., Wandel C., et al. The drug transporter P-glycoprotein limits oral absorption and brain entry of HIV-1 protease inhibitors. J. Clin. Invest. 101:1998;289-294.
27. Kuritzkes D.R., Marschner I., Johnson V.A., et al. Lamuvidine in combination with zidovudine, stavudine, or didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group 306 Investigators. AIDS. 13:1999;685-694.
28. Lee C.G.L., Gottesman M.M., Cardarelli C.O., et al. HIV-1 protease inhibitors are substrates for the MDR1 multidrug transporter. Biochemistry. 37:1998;3594-3601.
29. Lillibridge JH, Lee CA, Pithavala YK, et al. The role of CYP2C19 in the formation of nelfinavir hydroxyl-t-butylamide (M8): in vitro/in vivo correlation. Abstract #109. In: 5th International ISSX Meeting, Cairns, Australia, 1998, October 25-29.
30. Limoli KL, Trinh LH, Heilek-Snyder GM, et al. Effect of human serum on protease inhibitor activity in a phenotypic drug susceptibility assay (PhenoSense HIV) abstract 583-T. Programs and Abstracts of 9th Conference on Retroviruses and Opportunistic Infections, Seattle, WA, February 24-28, 2002a.
31. Limoli KL, Trinh LH, Heilek-Snyder GM, et al. Effects of human serum on protease inhibitor and non-nucleoside reverse transcriptase inhibitor activity in a phenotypic drug susceptibility assay (PhenoSense HIV) abstract 3.4. In: 3rd International Workshop on Clinical Pharmacology of HIV Therapy. Washington, DC, April 11-13, 2002b.
32. Marzolini C., Telenti A., Decosterd L.A., et al. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS. 15:2001;71-75.
33. Molla A., Vasavanonda S., Kumar G., et al. Human serum attenuates the activity of protease inhibitors toward wild-type and mutant human immunodeficiency virus. Virology. 250:1998;255-262.
34. Morse G.D., Shelton M.J., O'Donnell A.M. Comparative pharmacokinetics of antiviral nucleoside analogues. Clin. Pharmacokinetics. 24:1993;101-123.
35. Possi P, Peytavin G, Delaugerre C, et al. Genophar: an open prospective study of plasmatic drug measurements associated with genotypic resistance testing in patients failing antiretroviral therapy. Abstract WeOrB1264. Abstracts of XIV International AIDS Conference, Barcelona, Spain, July 7-12, 2002.
36. Saag M.S., Sonnerborg A., Torres R.A., et al. Antiretroviral effect and safety of abacavir and abacavir in combination with zidovudine in HIV-infected adults. AIDS. 12:1998;F202-F209.
37. Sadler B.M., Gillotin C., Stein D.S. Pharmacokinetic and pharmacodynamic study of the human immunodeficiency virus protease inhibitor amprenavir after multiple oral dosing. Antimicrob. Agents Chemother. 45:2001;30-37.
38. 4+ T-cell counts in HIV-infected patients. Ann. Internal Med. 124:1996;1039-1050.
39. Schumacher G.E., Barr J.T. Economic and outcome issues for therapeutic drug monitoring in medicine. Therap. Drug Monit. 20:1998;539-542.
40. Spector R., Park G.D., Johnson G.F., Vesell E.S. Therapeutic drug monitoring. Clin. Pharmacol. Ther. 43:1988;345-353.
41. Stein D.S., Fish D.G., Bilello J.A., et al. A 24-week open-label phase I/II evaluation of the HIV protease inhibitor MK-639 (indinavir). AIDS. 10:1996;485-492.
42. Stein D.S., Moore K.H. Phosphorylation of nucleoside analog antiretrovirals: a review for clinicians. Pharmacotherapy. 21:2001;11-34.
43. Veldkamp A.I., Weverling G.J., Lange J.M.A., et al. High exposure to nevirapine in plasma is associated with an improved virological response in HIV-1-infected individuals. AIDS. 15:2001;1089-1095.
44. Winters M.A., Schapiro J.M., Lawrence J., Merigan T.C. Human immunodeficiency virus type 1 protease genotypes and in vitro protease inhibitor susceptibilities of isolates from individuals who were switched to other protease inhibitors after long-term saquinavir treatment. J. Virol. 72:1998;5303-5306.
45. Zhang X.Q., Schooley R.T., Gerber J.G. The effect of increasing alpha-1-acid glycoprotein concentration on the antiviral efficacy of human immunodeficiency virus protease inhibitors. J. Infectious Diseases. 180:1999;1833-1837.
46. Zhang K.E., Wu E., Patick A.K., et al. Circulating metabolites of the human immunodeficiency virus protease inhibitor nelfinavir in humans: structural identification, levels in plasma, and antiviral activities. Antimicrob. Agents Chemother. 45:2001;1086-1093.
47. Zhou X.J., Sheiner L.B., D'Aquila R.T., et al. Population pharmackinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. Antimicrob. Agents Chemother. 43:1999;121-128.