Therapeutic monitoring and variability of Atazanavir in HIV-infected patients, with and without HCV coinfection, receiving boosted or unboosted regimens

Therapeutic Drug Monitoring

Volumn 33, Issue 3, 2011, Pages 303-308

  Regazzi, Mario ^a   Villani, Paola ^a   Gulminetti, Roberto ^b   Cusato, Maria ^a   Brandolini, Michela ^b   Tinelli, Carmine ^a   Barassi, Alessandra ^c   Maserati, Renato ^a   Sighinolfi, Laura ^d   D'Arminio Monforte, Antonella ^c   Melzi D'Eril, Gian Vico ^c  

^a FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^b Infectious Diseases Department   (Italy)

^c UNIVERSITY OF MILAN   (Italy)

^d S ANNA HOSPITAL   (Italy)

Author keywords

Atazanavir; HCV coinfection; HIV; Therapeutic drug monitoring

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ATAZANAVIR; DIDANOSINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LAMIVUDINE PLUS TENOFOVIR DISOPROXIL; LAMIVUDINE PLUS ZIDOVUDINE; RITONAVIR; TENOFOVIR;

ADULT; ARTICLE; COMPARATIVE STUDY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG MONITORING; FEMALE; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; OUTPATIENT; PRIORITY JOURNAL; TROUGH PLASMA LEVEL;

ADULT; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DRUG MONITORING; FEMALE; FIBROSIS; HEPACIVIRUS; HEPATITIS C; HIV; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; MALE; MIDDLE AGED; OLIGOPEPTIDES; PYRIDINES; RETROSPECTIVE STUDIES; RITONAVIR;

EID: 80051788651     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31821c2772     Document Type: Article

References (30)

1. Aarnoutse RE, Shapiro JM, Bouchener CA, et al. Therapeutic drug monitoring. An aid to optimising response to antiretroviral drugs? Drugs. 2003;63:741-753. (Pubitemid 36428444)
2. Ray JE, Marriot D, Bloch MT, et al. Therapeutic drug monitoring of atazanavir: surveillance of pharmacotherapy in the clinic. Br J Clin Pharmacol. 2005;60:291-299. (Pubitemid 41224137)
3. Cleijsen RMM, van de Ende ME, Kroon FP, et al. Therapeutic drug monitoring of the HIV protease inhibitor atazanavir in clinical practice. J Antimicrob Chemother. 2007;60:897-900. (Pubitemid 47434275)
4. Rodriguez-Novoa S, Morello J, Barreiro P, et al. Switch from ritonavirboosted to unboosted atazanavir guided by therapeutic drug monitoring. AIDS Res Human Retrov. 2008;24:821-825. (Pubitemid 351871672)
5. Gazzard BG, on behalf of the BHIVA Treatment Guidelines Writing Group. British HIV Association guidelines on the treatment of HIV-1- infected adults with antiretroviral therapy 2008. HIV Med. 2008;9: 563-608.
6. Bonacini M. Liver injury during highly active antiretroviral therapy: the effect of hepatitis C coinfection. Clin Infect Dis. 2004;38(suppl 2):S104-S108. (Pubitemid 38328172)
7. Becker S. Liver toxicity in epidemiological cohorts. Clin Infect Dis. 2004; 38(suppl 2):S49-S55. (Pubitemid 38328165)
8. Gonzalez de Requena D, Bonora S, Cavechia I, et al. Atazanavir Ctrough is associated with efficacy and safety at 24 weeks: definition of therapeutic range (abstract no 60 plus oral presentation), 6th International Workshop on Clinical Pharmacology of HIV-1 Therapy; 2005 April 28-30; Quebec (QC).
9. Lescure FX, Poirier JM, Guiard-Schmid JB, et al. Atazanavir trough concentration is 150 ng/mL cut-off for efficacy? Definition of an optimal therapeutic range and analysis of factors of predictive failure (abstract no. P4.2/05). Madrid, Spain: 11th European AIDS Conference; 2007; 47-48.
10. Woon Geon Shin, Sang Hoon Park, Sun-Young Jun, et al. Simple tests to predict hepatic fibrosis in non-alcoholic chronic liver diseases. Gut Liver. 2007;1:145-150.
11. Moyer TP, Temesgen Z, Enger R, et al. Drug monitoring of antiretroviral therapy for HIV-1 infection: method validation and results of a pilot study. Clin Chem. 1999;45:1465-1476. (Pubitemid 29418999)
12. European Medicines Agency. REYATAZ: summary of product characteristics (online). Available at: URL:http://www.emea.europa.eu/humandocs/PDFs/EPAR/ reyataz/H-494-PI-en.pdf. Accessed July 19, 2010.
13. Bristol-Myers Squibb Company. Reyataz Prescribing Information (online). Available at: URL:http://packageinserts.bms.com/pi/pi-reyataz.pdf.Accessed June 11, 2009.
14. StohrW, Back D, Dunn D, et al. Factors influencing lopinavir and atazanavir plasma concentration. J Antimicrob Chemother. 2010;65:129-137.
15. Flexner C. Dual protease inhibitor therapy in HIV-infected patients: pharmacologic rationale and clinical benefits. Annu Rev Pharmacol Toxicol. 2000;40:649-674. (Pubitemid 30340696)
16. Moltò J, Santos RJ, Valle M, et al. Monitoring atazanavir concentrations with boosted or unboosted regimens in HIV-infected patients in routine clinical practice. Ther Drug Monit. 2007;29:648-651. (Pubitemid 47494066)
17. Solas C, Gagnieu MC, Ravaux I, et al. Population pharmacokinetics of atazanavir in human immunodeficiency virus-infected patients. Ther Drug Monit. 2008;30:670-673.
18. Winston A, Bloch M, Carr A, et al. Atazanavir trough plasma concentration monitoring in a cohort of HIV-1-positive individuals receiving highly active antiretroviral therapy. J Antimicrob Chemother. 2005;56:380-387. (Pubitemid 41158529)
19. Agarwala S, Russo R, Mumanneni V, et al. Steady-state pharmacokinetic (PK) interaction study of atazanavir (ATV) with ritonavir (RTV) in healthy subjects. In Abstracts of the Forty-Second Interscience Conference on Antimicrobial Agents and Chemotherapy. San Diego, CA: 2002. Abstr. H-1716, p. 274. American Society for Microbiology, Washington, DC.
20. George J, Murray M, Byth K. Differential alterations of cytochrome P450 proteins in livers from patients with severe chronic liver disease. Hepatology. 1995;21:120-128.
21. Frye R, Zgheib N, Matzke G, et al. Liver disease selectively modulates cytochrome p450-mediated metabolism. Clin Pharmacol Ther. 2006;80: 235-245. (Pubitemid 44313901)
22. Pineda JA, Santos J, Rivero A, et al. Liver toxicity of antiretroviral combinations including atazanavir/ritonavir in patients co-infected with HIV and hepatitis viruses: impact of pre-existing liver fibrosis. J Antimicrob Chemother. 2008;61:925-932. (Pubitemid 351426080)
23. Barreiro P, Rodriguez-Novoa S, Labarga P, et al. Influence of liver fibrosis stage on plasma levels of antiretroviral drugs in HIV-infected patients with chronic hepatitis C. J Infect Dis. 2007;195:973-938.
24. Peng JZ, Pulido F, Causemaker SJ, et al. Pharmacokinetics of lopinavir/ ritonavir in HIV/hepatitis C virus-coinfected subjects with hepatic impairment. J Clin Pharmacol. 2006;46:265-274. (Pubitemid 43260313)
25. Gatti F, Loregian A, Nasta P, et al. Pharmacokinetics of atazanavir in HIV-1- HCV coinfected patients with or without cirrhosis (abstract R2297).Munich, Germany: 17th European Congress of Clinical Microbiology and Infectious Diseases and the 25th International Congress of Chemotherapy, 2007.
26. Breilh D, Guinguene S, de Ledinghen V, et al. Pharmacokinetics of boosted protease inhibitors and non-nucleoside reverse transcriptase inhibitors in HCV-HIV-1-coinfected patients (abstract 946), Los Angeles, CA: 14th Conference on Retroviruses and Opportunistic Infections, 2008.
27. Micheli V, Regazzi M, Dickinson L, et al. Lopinavir/ritonavir pharmacokinetics in HIV/HCV-coinfected patients with or without cirrhosis. Ther Drug Monit. 2008;30:306-313.
28. Kaul S, Bassi K, Damie B, et al. Pharmacokinetic evaluation of the combination of atazanavir (ATV), enteric coated didanosine (ddI-EC) and tenofovir disoproxil fumarate (TDF) for a once-daily antiretroviral regimen. In: Abstracts of the Forty-Third Interscience Conference on Antimicrobial Agents and Chemotherapy. Chicago, IL, 2003, Abstract A-1616. American Society for Microbiology, Washington, DC.
29. Taburet AM, Piketty C, Chazallon C, et al. Interactions between atazanavir- ritonavir and tenofovir in heavily pretreated human immunodeficiency virus infected patients. Antimicrob Agents Chemother. 2004;48:2091-2096. (Pubitemid 38691603)
30. Von Hentig N, Dauer B, Haberl A, et al. Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir boosted atazanavir in HIV-1-infected adults. Eur J Clin Pharmacol. 2007;63: 935-940. (Pubitemid 47387910)