12.07.2015 Views

The Potential Role of Therapeutic Drug Monitoring in the Treatment ...

The Potential Role of Therapeutic Drug Monitoring in the Treatment ...

The Potential Role of Therapeutic Drug Monitoring in the Treatment ...

SHOW MORE
SHOW LESS
  • No tags were found...

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

International AIDS Society–USA Topics <strong>in</strong> HIV Medic<strong>in</strong>eIn <strong>the</strong> treatment <strong>of</strong> drug-experienced subjects who havedrug-resistant virus, determ<strong>in</strong><strong>in</strong>g a prote<strong>in</strong>-corrected IC 50 maybe useful. Apply<strong>in</strong>g TDM to <strong>the</strong>n achieve a concentration several-foldabove that IC 50 would seem reasonable. Evaluation <strong>of</strong> <strong>the</strong><strong>in</strong>hibitory quotient (IQ), <strong>in</strong> which <strong>the</strong> phenotypic sensitivity <strong>of</strong><strong>the</strong> virus to <strong>the</strong> drug and <strong>the</strong> plasma concentration <strong>of</strong> <strong>the</strong> drugdeterm<strong>in</strong>e <strong>the</strong> IQ, is be<strong>in</strong>g studied <strong>in</strong> cl<strong>in</strong>ical trials. Welldesignedand adequately powered prospective studies need tobe performed before IQ can be generally recommended for cl<strong>in</strong>icalpractice.<strong>The</strong> important message about TDM is that it may ultimatelyprove useful, but at this time <strong>the</strong>re are not enough data to recommendits use outside <strong>of</strong> very specific circumstances. TDMshould currently be viewed as an <strong>in</strong>vestigational tool to exploremeans <strong>of</strong> improv<strong>in</strong>g <strong>the</strong>rapeutic outcome and reduc<strong>in</strong>g toxicities<strong>in</strong> <strong>the</strong> treatment <strong>of</strong> HIV <strong>in</strong>fection.F<strong>in</strong>ancial Disclosure: Dr Gerber has served as a consultant to Agouron, Merck, RocheDiagnostics, and Roche Pharma. Dr Acosta has served as a consultant to Bristol-MyersSquibb, Merck, and Roche.References1. Schumacher GE, Barr JT. Economic and outcome issues for <strong>the</strong>rapeuticdrug monitor<strong>in</strong>g <strong>in</strong> medic<strong>in</strong>e. <strong>The</strong>r <strong>Drug</strong> Monit. 1998;20:539-542.2. Spector R, Park GD, Johnson GF, Vesell ES. <strong>The</strong>rapeutic drug monitor<strong>in</strong>g.Cl<strong>in</strong> Pharmacol <strong>The</strong>r. 1988;43:345-353.3. Morse GD, Shelton MJ, O'Donnell AM. Comparative pharmacok<strong>in</strong>etics <strong>of</strong>antiviral nucleoside analogues. Cl<strong>in</strong> Pharmacok<strong>in</strong>et. 1993;24:101-123.4. Acosta EP, Henry K, Baken L, Page LM, Fletcher CV. Ind<strong>in</strong>avir concentrationsand antiviral effect. Pharmaco<strong>the</strong>rapy. 1999;19:708-712.5. Baede-van Dijk PA, Hugen PW, Verweij-van Wissen CP, Koopmans PP,Burger DM, Hekster YA. Analysis <strong>of</strong> variation <strong>in</strong> plasma concentrations <strong>of</strong>nelf<strong>in</strong>avir and its active metabolite M8 <strong>in</strong> HIV-positive patients. AIDS.2001;15:991-998.6. Zhou XJ, She<strong>in</strong>er LB, D'Aquila RT, et al. Population pharmacok<strong>in</strong>etics <strong>of</strong>nevirap<strong>in</strong>e, zidovud<strong>in</strong>e, and didanos<strong>in</strong>e <strong>in</strong> human immunodeficiency virus<strong>in</strong>fectedpatients. <strong>The</strong> National Institute <strong>of</strong> Allergy and Infectious DiseasesAIDS Cl<strong>in</strong>ical Trials Group Protocol 241 Investigators. Antimicrob AgentsChemo<strong>the</strong>r. 1999;43:121-128.7. Marzol<strong>in</strong>i C, Telenti A, Decosterd LA, Greub G, Biollaz J, Bucl<strong>in</strong> T. Efavirenzplasma levels can predict treatment failure and central nervous system sideeffects <strong>in</strong> HIV-1-<strong>in</strong>fected patients. AIDS. 2001;15:71-75.8. Acosta EP, Gerber JG. Position paper on <strong>the</strong>rapeutic drug monitor<strong>in</strong>g <strong>of</strong>antiretroviral agents. AIDS Res Hum Retroviruses. In Press.9. Burger DM, Hugen PW, Aarnoutse RE, et al. A retrospective, cohort-basedsurvey <strong>of</strong> patients us<strong>in</strong>g twice-daily <strong>in</strong>d<strong>in</strong>avir + ritonavir comb<strong>in</strong>ations:pharmacok<strong>in</strong>etics, safety, and efficacy. J Acquir Immune Defic Syndr.2001;26:218-224.10. Havlir D, Cheeseman SH, McLaughl<strong>in</strong> M, et al. High-dose nevirap<strong>in</strong>e:safety, pharmacok<strong>in</strong>etics, and antiviral effect <strong>in</strong> patients with humanimmunodeficiency virus <strong>in</strong>fection. J Infect Dis. 1995;171:537-545.11. Zhang KE, Wu E, Patick AK, et al. Circulat<strong>in</strong>g metabolites <strong>of</strong> <strong>the</strong> humanimmunodeficiency virus protease <strong>in</strong>hibitor nelf<strong>in</strong>avir <strong>in</strong> humans: structuralidentification, levels <strong>in</strong> plasma, and antiviral activities. Antimicrob AgentsChemo<strong>the</strong>r. 2001;45:1086-1093.12. Lillibridge JH, Lee CA, Pithavala YK. <strong>The</strong> role <strong>of</strong> CYP2C19 <strong>in</strong> <strong>the</strong> formation<strong>of</strong> nelf<strong>in</strong>avir hydroxyl-t-butylamide (M8): <strong>in</strong> vitro/<strong>in</strong> vivo correlation.[Abstract 109.] 5th International ISSX Meet<strong>in</strong>g. October 25-29, 1998; Cairns,Australia.13. Fischl MA, Richman DD, Flexner C, et al. Phase I/II study <strong>of</strong> <strong>the</strong> toxicity,pharmacok<strong>in</strong>etics, and activity <strong>of</strong> <strong>the</strong> HIV protease <strong>in</strong>hibitor SC-52151. JAcquir Immune Defic Syndr Hum Retrovirol. 1997;15:28-34.14. Israili ZH, Dayton PG. Human alpha-1-glycoprote<strong>in</strong> and its <strong>in</strong>teractionswith drugs. <strong>Drug</strong> Metab Rev. 2001;33:161-235.15. Zhang XQ, Schooley RT, Gerber JG. <strong>The</strong> effect <strong>of</strong> <strong>in</strong>creas<strong>in</strong>g alpha1-acidglycoprote<strong>in</strong> concentration on <strong>the</strong> antiviral efficacy <strong>of</strong> human immunodeficiencyvirus protease <strong>in</strong>hibitors. J Infect Dis. 1999;180:1833-1837.16. Acosta EP, Havlir DV, Richman DD, et al. Pharmacodynamics (PD) <strong>of</strong><strong>in</strong>d<strong>in</strong>avir (IDV) <strong>in</strong> protease-naive HIV-<strong>in</strong>fected patients receiv<strong>in</strong>g ZDV and3TC. [Abstract 455.] 7th Conference on Retroviruses and OpportunisticInfections. January 30-February 2, 2000; San Francisco, Calif.17. Gatti G, Di Biagio A, Casazza R, et al. <strong>The</strong> relationship between ritonavirplasma levels and side-effects: implications for <strong>the</strong>rapeutic drug monitor<strong>in</strong>g.AIDS. 1999;13:2083-2089.18. Hsyu PH, Flexner C, Chu A, Petersen C. Correlation <strong>of</strong> efficacy, nelf<strong>in</strong>avirpharmacok<strong>in</strong>etics and diarrhea <strong>in</strong> treatment-naive HIV positive patientsreceiv<strong>in</strong>g nelf<strong>in</strong>avir, zidovud<strong>in</strong>e and lamivud<strong>in</strong>e. [Abstract 1735.] 41stInterscience Conference on Antimicrobial Agents and Chemo<strong>the</strong>rapy.December 16-19, 2001; Chicago, Ill.19. Dieleman JP, Gyssens IC, van der Ende ME, de Marie S, Burger DM.Urological compla<strong>in</strong>ts <strong>in</strong> relation to <strong>in</strong>d<strong>in</strong>avir plasma concentrations <strong>in</strong> HIV<strong>in</strong>fectedpatients. AIDS. 1999;13:473-478.20. Hsu A, Granneman GR, Cao G, et al. Pharmacok<strong>in</strong>etic <strong>in</strong>teractionbetween ritonavir and <strong>in</strong>d<strong>in</strong>avir <strong>in</strong> healthy volunteers. Antimicrob AgentsChemo<strong>the</strong>r. 1998;42:2784-2791.21. Saag MS, Sonnerborg A, Torres RA, et al. Antiretroviral effect and safety<strong>of</strong> abacavir and abacavir <strong>in</strong> comb<strong>in</strong>ation with zidovud<strong>in</strong>e <strong>in</strong> HIV-<strong>in</strong>fectedadults. AIDS. 1998;12:F202-F209.22. Kuritzkes DR, Marschner I, Johnson VA, et al. Lamivud<strong>in</strong>e <strong>in</strong> comb<strong>in</strong>ationwith zidovud<strong>in</strong>e, stavud<strong>in</strong>e, or didanos<strong>in</strong>e <strong>in</strong> patients with HIV-1 <strong>in</strong>fection.A randomized, double-bl<strong>in</strong>d, placebo-controlled trial. National Institute <strong>of</strong>Allergy and Infectious Disease AIDS Cl<strong>in</strong>ical Trials Group Protocol 306Investigators. AIDS. 1999;13:685-694.23. Burger DM, Hugen PWH, Droste J, Huitema ADR. <strong>The</strong>rapeutic drug monitor<strong>in</strong>g<strong>of</strong> nelf<strong>in</strong>avir 1250 mg bid <strong>in</strong> treatment naive patients improves <strong>the</strong>rapeuticoutcome after 1 year: results from ATHENA. [Abstract 6.26.] 2ndInternational Workshop on Cl<strong>in</strong>ical Pharmacology <strong>of</strong> HIV <strong>The</strong>rapy. April 2-4,2001; Noordwijk, Ne<strong>the</strong>rlands.24. Clevenbergh P, Durant J, Garraffo R, et al. Usefulness <strong>of</strong> protease<strong>in</strong>hibitor <strong>the</strong>rapeutic drug monitor<strong>in</strong>g? PharmAdapt: a prospective multicentricrandomized controlled trial: 12 weeks results. [Abstract 260B.] 8thConference on Retroviruses and Opportunistic Infections. February 4-8,2001; Chicago, Ill.25. Clevenbergh P, Garraffo R, Durant J, et al. Long term efficacy <strong>of</strong> protease<strong>in</strong>hibitor plasma drug levels monitor<strong>in</strong>g (PI TDM): PharmAdapt W 32 results.[Abstract 1730.] 41st Interscience Conference on Antimicrobial Agents andChemo<strong>the</strong>rapy. December 16-19, 2001; Chicago, Ill.26. Fletcher CV, Anderson PL, Kakuda TN, et al. Concentration-controlledcompared with conventional antiretroviral <strong>the</strong>rapy for HIV <strong>in</strong>fection. AIDS.2002;16:551-560.27. Fischl M, Castro J, Monroig R, et al. Impact <strong>of</strong> directly observed <strong>the</strong>rapylong-term outcomes <strong>in</strong> HIV cl<strong>in</strong>ical trials. [Abstract 528.] 8th Conference onRetroviruses and Opportunistic Infections. February 4-8, 2001; Chicago, Ill.32

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!