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Drug Evaluations

Clinical pharmacology, efficacy and safety of atazanavir: a review

, PhD, , MD, , PharmD, , PhD & , MD PhD
Pages 1455-1468 | Published online: 28 Oct 2009

Bibliography

  • Available from: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3950B1_01_BristolMyersSquibb-Atazanavir.pdf
  • Robinson BS, Riccardi KA, Gong YF, BMS-32632, a highly potent human immunodeficiency virus protease inhibitor that can be used in combination with other available antiretroviral agents. Antimicrob Agents Chemother 2000;44(8):2093-9
  • Yanchunas J Jr, Langley DR, Tao L, Molecular basis for increased susceptibility of isolates with atazanavir resistance-conferring substitution I50L to other protease inhibitors. Antimicrob Agents Chemother 2005;49(9):3825-32
  • Weinheimer S, Discotto L, Friborg J, Atazanavir signature I50L resistance substitution accounts for unique phenotype of increased susceptibility to other protease inhibitors in a variety of human immunodeficiency virus type 1 genetic backbones. Antimicrob Agents Chemother 2005;49(9):3816-24
  • Colonno RJ, Thiry A, Limoli K, Parkin N. Activities of atazanavir (BMS-232632) against a large panel of human immunodeficiency virus type 1 clinical isolates resistant to one or more approved protease inhibitors. Antimicrob Agents Chemother 2003;47(4):1324-33
  • Naeger LK, Struble KA. Effect of baseline protease genotype and phenotype on HIV response to atazanavir/ritonavir in treatment-experienced patients. AIDS 2006;20(6):847-53
  • Vora S, Marcelin AG, Gunthard HF, Clinical validation of atazanavir/ritonavir genotypic resistance score in protease inhibitor-experienced patients. AIDS 2006;20(1):35-40
  • Pellegrin I, Breilh D, Ragnaud JM, Virological responses to atazanavir-ritonavir-based regimens: resistance-substitutions score and pharmacokinetic parameters (Reyaphar study). Antivir Ther 2006;11(4):421-9
  • Santoro MM, Bertoli A, Lorenzini P, Two different patterns of mutations are involved in the genotypic resistance score for atazanavir boosted versus unboosted by ritonavir in multiple failing patients. Infection 2009;37(3):223-43
  • Solas C, Colson P, Ravaux I, The genotypic inhibitory quotient: a predictive factor of atazanavir response in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr 2008;48(2):177-80
  • Le Tiec C, Barrail A, Goujard C, Taburet AM. Clinical pharmacokinetics and summary of efficacy and tolerability of atazanavir. Clin Pharmacokinet 2005;44(10):1035-50
  • Dickinson L, Khoo S, Back D. Differences in the pharmacokinetics of protease inhibitors between healthy volunteers and HIV-infected persons. Curr Opin HIV AIDS 2008;3(3):296-305
  • Rodriguez-Novoa S, Morello J, Barreiro P, Switch from ritonavir-boosted to unboosted atazanavir guided by therapeutic drug monitoring. AIDS Res Hum Retroviruses 2008;24(6):821-5
  • Swainston Harrison T, Scott LJ. Atazanavir: a review of its use in the management of HIV infection. Drugs 2005;65(16):2309-36
  • Best BM, Letendre SL, Brigid E, Low atazanavir concentrations in cerebrospinal fluid. AIDS 2009;23(1):83-7
  • van Leeuwen E, Ter Heine R, van der Veen F, Penetration of atazanavir in seminal plasma of men infected with human immunodeficiency virus type 1. Antimicrob Agents Chemother 2007;51(1):335-7
  • Ter Heine R, Hillebrand M, Rosing H, Identification and profiling of circulating metabolites of atazanavir, a human immunodeficiency virus protease inhibitor. Drug Metab Dispos 2009;37(9):1826-40
  • Guaraldi G, Cocchi S, Motta A, A pilot study on the efficacy, pharmacokinetics and safety of atazanavir in patients with end-stage liver disease. J Antimicrob Chemother 2008;62(6):1356-64
  • Colombo S, Buclin T, Cavassini M, Population pharmacokinetics of atazanavir in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother 2006;50(11):3801-8
  • Zhang D, Chando TJ, Everett DW, In vitro inhibition of UDP glucuronosyltransferases by atazanavir and other HIV protease inhibitors and the relationship of this property to in vivo bilirubin glucuronidation. Drug Metab Dispos 2005;33(11):1729-39
  • Burger DM, Huisman A, Van Ewijk N, The effect of atazanavir and atazanavir/ritonavir on UDP-glucuronosyltransferase using lamotrigine as a phenotypic probe. Clin Pharmacol Ther 2008;84(6):698-703
  • Beique L, Giguere P, la Porte C, Angel J. Interactions between protease inhibitors and acid-reducing agents: a systematic review. HIV Med 2007;8(6):335-45
  • Falcon RW, Kakuda TN. Drug interactions between HIV protease inhibitors and acid-reducing agents. Clin Pharmacokinet 2008;47(2):75-89
  • Tomilo DL, Smith PF, Ogundele AB, Inhibition of atazanavir oral absorption by lansoprazole gastric acid suppression in healthy volunteers. Pharmacotherapy 2006;26(3):341-6
  • Agarwala S, Gray K, Wang Y, Pharmacokinetic effect of omeprazole on atazanavir co-administered with ritonavir in healthy subjects [abstract 658]. 612th Conference on retroviruses and Opportunictic Infections, Boston; 2005
  • Agarwala S, Gray K, Eley T, Pharmacokinetic interaction between atazanavir and omeprazole in healthy subjects. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; 2005 July, 24-27th; Rio de Janeiro; 2005
  • Luber AD, Brower R, Kim D, Steady-state pharmacokinetics of once-daily fosamprenavir/ritonavir and atazanavir/ritonavir alone and in combination with 20 mg omeprazole in healthy volunteers. HIV Med 2007;8(7):457-64
  • Klein CE, Chiu YL, Cai Y, Effects of acid-reducing agents on the pharmacokinetics of lopinavir/ritonavir and ritonavir-boosted atazanavir. J Clin Pharmacol 2008;48(5):553-62
  • DiCenzo R, Peterson DR, Cruttenden K, Effects of minocycline and valproic acid coadministration on atazanavir plasma concentrations in human immunodeficiency virus-infected adults receiving atazanavir-ritonavir. Antimicrob Agents Chemother 2008;52(9):3035-9
  • Burger DM, Agarwala S, Child M, Effect of rifampin on steady-state pharmacokinetics of atazanavir with ritonavir in healthy volunteers. Antimicrob Agents Chemother 2006;50(10):3336-42
  • Acosta EP, Kendall MA, Gerber JG, Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily. Antimicrob Agents Chemother 2007;51(9):3104-10
  • Mallolas J, Sarasa M, Nomdedeu M, Pharmacokinetic interaction between rifampicin and ritonavir-boosted atazanavir in HIV-infected patients. HIV Med 2007;8(2):131-4
  • Haas DW, Koletar SL, Laughlin L, Hepatotoxicity and gastrointestinal intolerance when healthy volunteers taking rifampin add twice-daily atazanavir and ritonavir. J Acquir Immune Defic Syndr 2009;50(3):290-3
  • McCance-Katz EF, Moody DE, Morse GD, Interaction between buprenorphine and atazanavir or atazanavir/ritonavir. Drug Alcohol Depend 2007;91(2-3):269-78
  • Friedland G, Andrews L, Schreibman T, Lack of an effect of atazanavir on steady-state pharmacokinetics of methadone in patients chronically treated for opiate addiction. AIDS 2005;19(15):1635-41
  • Waters LJ, Moyle G, Bonora S, Abacavir plasma pharmacokinetics in the absence and presence of atazanavir/ritonavir or lopinavir/ritonavir and vice versa in HIV-infected patients. Antivir Ther 2007;12(5):825-30
  • Seminari E, Guffanti M, Villani P, Steady-state pharmacokinetics of atazanavir given alone or in combination with saquinavir hard-gel capsules or amprenavir in HIV-1-infected patients. Eur J Clin Pharmacol 2005;61(7):545-9
  • Sekar VJ, Lefebvre E, De Marez T, Pharmacokinetics of darunavir (TMC114) and atazanavir during coadministration in HIV-negative, healthy volunteers. Drugs R D 2007;8(4):241-8
  • Dailly E, Tribut O, Tattevin P, Influence of tenofovir, nevirapine and efavirenz on ritonavir-boosted atazanavir pharmacokinetics in HIV-infected patients. Eur J Clin Pharmacol 2006;62(7):523-6
  • Ribera E, Azuaje C, Lopez RM, Atazanavir and lopinavir/ritonavir: pharmacokinetics, safety and efficacy of a promising double-boosted protease inhibitor regimen. AIDS 2006;20(8):1131-9
  • Pham PA, Flexner C, Parsons T, Beneficial pharmacokinetic interaction between atazanavir and lopinavir/ritonavir. J Acquir Immune Defic Syndr 2007;45(2):201-5
  • Di Giambenedetto S, De Luca A, Villani P, Atazanavir and lopinavir with ritonavir alone or in combination: analysis of pharmacokinetic interaction and predictors of drug exposure. HIV Med 2008;9(4):239-45
  • von Hentig N, Kaykhin P, Stephan C, Decrease of atazanavir and lopinavir plasma concentrations in a boosted double human immunodeficiency virus protease inhibitor salvage regimen. Antimicrob Agents Chemother 2008;52(6):2273-5
  • Iwamoto M, Wenning LA, Mistry GC, Atazanavir modestly increases plasma levels of raltegravir in healthy subjects. Clin Infect Dis 2008;47(1):137-40
  • Ford J, Boffito M, Maitland D, Influence of atazanavir 200 mg on the intracellular and plasma pharmacokinetics of saquinavir and ritonavir 1600/100 mg administered once daily in HIV-infected patients. J Antimicrob Chemother 2006;58(5):1009-16
  • Boffito M, Maitland D, Dickinson L, Pharmacokinetics of saquinavir hard-gel/ritonavir and atazanavir when combined once daily in HIV Type 1-infected individuals administered different atazanavir doses. AIDS Res Hum Retroviruses 2006;22(8):749-56
  • King JR, Kakuda TN, Paul S, Pharmacokinetics of saquinavir with atazanavir or low-dose ritonavir administered once daily (ASPIRE I) or twice daily (ASPIRE II) in seronegative volunteers. J Clin Pharmacol 2007;47(2):201-8
  • von Hentig N, Muller A, Rottmann C, Pharmacokinetics of saquinavir, atazanavir, and ritonavir in a twice-daily boosted double-protease inhibitor regimen. Antimicrob Agents Chemother 2007;51(4):1431-9
  • Taburet AM, Piketty C, Chazallon C, Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 2004;48(6):2091-6
  • von Hentig N, Dauer B, Haberl A, Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults. Eur J Clin Pharmacol 2007;63(10):935-40
  • Busti AJ, Bain AM, Hall RGII, Effects of atazanavir/ritonavir or fosamprenavir/ritonavir on the pharmacokinetics of rosuvastatin. J Cardiovasc Pharmacol 2008;51(6):605-10
  • Slish J, Ma Q, Zingman BS, Assessing the impact of substance use and hepatitis coinfection on atazanavir and lopinavir trough concentrations in HIV-infected patients during therapeutic drug monitoring. Ther Drug Monit 2007;29(5):560-5
  • von Hentig N. Atazanavir/ritonavir: a review of its use in HIV therapy. Drugs Today (Barc) 2008;44(2):103-32
  • Available from: http://www.hiv-druginteractions.org
  • Dickinson L, Boffito M, Back D, Population pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers. J Antimicrob Chemother 2009;63(6):1233-43
  • Molto J, Santos JR, Valle M, Monitoring atazanavir concentrations with boosted or unboosted regimens in HIV-infected patients in routine clinical practice. Ther Drug Monit 2007;29(5):648-51
  • Macassa E, Delaugerre C, Teglas JP, Change to a once-daily combination including boosted atazanavir in HIV-1-infected children. Pediatr Infect Dis J 2006;25(9):809-14
  • Ripamonti D, Cattaneo D, Maggiolo F, Atazanavir plus low-dose ritonavir in pregnancy: pharmacokinetics and placental transfer. AIDS 2007;21(18):2409-15
  • O'Mara E, Randall D, Stolz R, BMS-232632: a prospective study of age and gender effects on the single-dose pharmacokinetics in healthy volunteers. 1st IAS Conference on HIV Pathogenesis and treatment; 2001 8-11 July; Buenos aeres, Argentina; 2001
  • Cameron DW, Heath-Chiozzi M, Danner S, Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease. The Advanced HIV Disease Ritonavir Study Group. Lancet 1998;351(9102):543-9
  • Gulick RM, Mellors JW, Havlir D, Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997;337(11):734-9
  • Murphy RL, Sanne I, Cahn P, Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects: 48-week results. AIDS 2003;17(18):2603-14
  • Sanne I, Piliero P, Squires K, Results of a phase 2 clinical trial at 48 weeks (AI424-007): a dose-ranging, safety, and efficacy comparative trial of atazanavir at three doses in combination with didanosine and stavudine in antiretroviral-naive subjects. J Acquir Immune Defic Syndr 2003;32(1):18-29
  • Squires K, Lazzarin A, Gatell JM, Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Immune Defic Syndr 2004;36(5):1011-9
  • Smith KY, Weinberg WG, Dejesus E, Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT. AIDS Res Ther 2008;5:5
  • Molina JM, Andrade-Villanueva J, Echevarria J, Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008;372(9639):646-55
  • Malan DR, Krantz E, David N, Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr 2008;47(2):161-7
  • Johnson M, Grinsztejn B, Rodriguez C, Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS 2005;19(2):153-62
  • Johnson M, Grinsztejn B, Rodriguez C, 96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS 2006;20(5):711-8
  • Goldsmith DR, Perry CM. Atazanavir. Drugs 2003;63(16):1679-93; discussion 94-5
  • Chan-Tack KM, Truffa MM, Struble KA, Birnkrant DB. Atazanavir-associated nephrolithiasis: cases from the US food and drug administration's adverse event reporting system. AIDS 2007;21(9):1215-8
  • Couzigou C, Daudon M, Meynard JL, Urolithiasis in HIV-positive patients treated with atazanavir. Clin Infect Dis 2007;45(8):e105-8
  • Rodriguez-Novoa S, Martin-Carbonero L, Barreiro P, Genetic factors influencing atazanavir plasma concentrations and the risk of severe hyperbilirubinemia. AIDS 2007;21(1):41-6
  • Rodriguez-Novoa S, Morello J, Gonzalez M, Increase in serum bilirubin in HIV/hepatitis-C virus-coinfected patients on atazanavir therapy following initiation of pegylated-interferon and ribavirin. AIDS 2008;22(18):2535-7
  • Ferreira C, Floch-Tudal C, Meir F, Atazanavir in pregnancy: influence on neonatal hyperbilirubinemia. XVth conference on retroviruses and opportunistic infections; 2008 February 3-6; Boston, USA; 2008
  • Soriano V, Garcia-Gasco P, Vispo E, Efficacy and safety of replacing lopinavir with atazanavir in HIV-infected patients with undetectable plasma viraemia: final results of the SLOAT trial. J Antimicrob Chemother 2008;61(1):200-5
  • Gatell J, Salmon-Ceron D, Lazzarin A, Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: the SWAN Study (AI424-097) 48-week results. Clin Infect Dis 2007;44(11):1484-92
  • Colafigli M, Di Giambenedetto S, Bracciale L, Cardiovascular risk score change in HIV-1-infected patients switched to an atazanavir-based combination antiretroviral regimen. HIV Med 2008;9(3):172-9
  • Mallolas J, Podzamczer D, Milinkovic A, Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study. J Acquir Immune Defic Syndr 2009;51(1):29-36
  • Haerter G, Manfras BJ, Mueller M, Regression of lipodystrophy in HIV-infected patients under therapy with the new protease inhibitor atazanavir. AIDS 2004;18(6):952-5
  • McComsey G, Rightmire A, Wirtz V, Changes in body composition with ritonavir-boosted and unboosted atazanavir treatment in combination with Lamivudine and Stavudine: a 96-week randomized, controlled study. Clin Infect Dis 2009;48(9):1323-6
  • Noor MA, Flint OP, Maa JF, Parker RA. Effects of atazanavir/ritonavir and lopinavir/ritonavir on glucose uptake and insulin sensitivity: demonstrable differences in vitro and clinically. AIDS 2006;20(14):1813-21
  • Guffanti M, Caumo A, Galli L, Switching to unboosted atazanavir improves glucose tolerance in highly pretreated HIV-1 infected subjects. Eur J Endocrinol 2007;156(4):503-9
  • Stanley TL, Joy T, Hadigan CM, Effects of switching from lopinavir/ritonavir to atazanavir/ritonavir on muscle glucose uptake and visceral fat in HIV-infected patients. AIDS 2009;23(11):1349-57
  • Busti AJ, Tsikouris JP, Peeters MJ, A prospective evaluation of the effect of atazanavir on the QTc interval and QTc dispersion in HIV-positive patients. HIV Med 2006;7(5):317-22
  • Dubé MP, Shen C, Greenwald M, Mather KJ. No impairment of endothelial function or insulin sensitivity with 4 weeks of the HIV protease inhibitors atazanavir or lopinavir-ritonavir in healthy subjects without HIV infection: a placebo-controlled trial. Clin Infect Dis 2008;47(4):567-74
  • Parienti JJ, Bangsberg DR, Verdon R, Gardner EM. Better adherence with once-daily antiretroviral regimens: a meta-analysis. Clin Infect Dis 2009;48(4):484-8
  • Campbell T, Smeaton L, De Grutolla V, PEARLS (ACTG A5175): a multinational study of didanosine-EC, emtricitabine and atazanavir vs. co-formulated zidovudine/lamivudine and efavirenz for initial treatment of HIV-1 infection. XVIth International AIDS Conference; 2008 August 3-8; Mexico; 2008
  • Delfraissy JF, Moreno S, Sanz-Moreno J, Efficacy and safety of 48-week maintenance with QD ATV vs ATV/r (both + 2NRTIs) in patients with VL <50 c/mL after induction with ATV/r + 2NRTIs: study AI424136. 9th International Congress on Drug Therapy in HIV Infection; 2008 9-13 November; Glasgow, UK; 2008
  • Squires K, Young B, De Jesus E, Similar efficacy and tolerability of atazanavir (ATV) compared to ATV/ritonavir (RTV, r), each in combination with abacavir/lamivudine (ABC/3TC), after initial supression with ABC/3TC + ATV/r in HIV-1 infected patients: 84 week results of the ARIES trial 5th IAS Conference on AIDS pathogenesis, treatment and prevention; 2009 19-22 July; Cape Town, South Africa; 2009
  • Gulnik S, Eissenstat M, Afonina E, Preclinical and early clinical evaluation of SPI-452, a new pharmacokinetic enhancer XVIth conference on retroviruses and opportunistic infections; 2009 February 8-11th; Montreal, Canada; 2009
  • Rutstein R, Samson P, Kiser JJ, The PACTG 1020A protocol: atazanavir with or without ritonavir in HIV-infected infants, children, and adolescents. 14th Conference on Retroviruses and Opportunistic Infections; 2007 25-28 february; Los angeles, USA; 2007
  • Conradie F, Zorilla C, Josipovic D, The safety, efficacy, and steady state pharmacokinetics of atazanavir/ritonavir (ATV/r) once daily during pregnancy: results of study AI424182. 5th IAS Conference on AIDS pathogenesis, treatment and prevention; 2009 19-22 July; Cape Town, South Africa; 2009
  • Available at: http://www.aidsinfo.nih.gov

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