A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults

Journal of Acquired Immune Deficiency Syndromes

Volumn 60, Issue 2, 2012, Pages 143-149

  Carey, Dianne ^a   Pett, Sarah L ^a   Bloch, Mark ^b   Wand, Handan ^a   MacRae, Karen ^c   Beileiter, Kate ^b   Ray, John E ^c   Boyd, Mark A ^a   Emery, Sean ^a   Cooper, David A ^a,c  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b Holdsworth House Medical Practice   (Australia)

^c ST VINCENT S HOSPITAL   (Australia)

Author keywords

Antiretroviral therapy; Atazanavir; HIV; Raltegravir

Indexed keywords

ATAZANAVIR; ATAZANAVIR PLUS RALTEGRAVIR; ATAZANAVIR PLUS RITONAVIR; RALTEGRAVIR; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MALE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DRUG TOXICITY; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; OLIGOPEPTIDES; PLASMA; PYRIDINES; PYRROLIDINONES; TREATMENT OUTCOME;

EID: 84862150332     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e318252f97e     Document Type: Article

References (40)

1. Shafran SD, Mashinter LD, Roberts SE. The effect of low-dose ritonavirmonotherapy on fasting serum lipid concentrations. HIV Med. 2005;6: 421-425. (Pubitemid 41723310)
2. Calza L, Manfredi R, Farneti B, et al. Incidence of hyperlipidaemia in a cohort of 212 HIV-infected patients receiving a protease inhibitorbased antiretroviral therapy. Int J Antimicrob Agents. 2003;22:54-59. (Pubitemid 36808718)
3. Fumaz CR, Munoz-Moreno JA, Molto J, et al. Long-term neuropsychiatric disorders on efavirenz-based approaches: quality of life, psychologic issues, and adherence. J Acquir Immune Defic Syndr. 2005;38:560-565. (Pubitemid 40524478)
4. Sanne I, Mommeja-Marin H, Hinkle J, et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis. 2005; 191:825-829. (Pubitemid 40349795)
5. Carr A, Miller J, Law M, et al. A syndrome of lipoatrophy, lactic acidaemia and liver dysfunction associated with HIV nucleoside analogue therapy: contribution to protease inhibitor-related lipodystrophy syndrome. AIDS. 2000;14:F25-F32. (Pubitemid 30132938)
6. Gallant JE, Parish MA, Keruly JC, et al. Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment. Clin Infect Dis. 2005;40:1194-1198. (Pubitemid 40490248)
7. Markowitz M, Nguyen B-Y, Gotuzzo E, et al. Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007;46:125-133. (Pubitemid 47482607)
8. Lennox JL, DeJesus E, Lazzarin A, et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009;374:796-806.
9. Steigbigel R, Cooper D, Kumar P, et al. Raltegravir with optimised background therapy for resistant HIV-1 infection. N Engl J Med. 2008; 359:339-354.
10. Cooper D, Speigbigel R, Gatell J, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008;359: 355-365.
11. Kassahun K, McIntosh I, Cui D, et al. Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the human immunodeficiency virus 1 integrase enzyme. Drug Metab Dispos. 2007;35:1657-1663. (Pubitemid 47296061)
12. Brainard DM, Wenning LA, Stone JA, et al. Clinical pharmacology profile of raltegravir, an HIV-1 integrase strand transfer inhibitor. J Clin Pharmacol. 2011;51:1376-1402.
13. Squires K, Lazzarin A, Gatell JM, et al. 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;36:1011-1019. (Pubitemid 38989366)
14. Malan DR, Krantz E, David N, et al. Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviraltherapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr. 2008;47:161-167. (Pubitemid 351172182)
15. Molina J-M, Andrade-Villanueva J, Echevarria J, et al. 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;372:646-655.
16. Johnson M, Grinsztejn B, Rodriguez C, et al. 96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS. 2006;20:711-718. (Pubitemid 43884298)
17. Bristol-Myers Squibb Company. Reyataz (atazanavir sulfate) capsules: prescribing information. Available at: http://packageinserts.bms.com/pi/-pi- reyataz.pdf. Accessed May 17, 2011.
18. Fontas E, van Leth F, Sabin CA, et al. Lipid profiles in HIV-infected patients receiving combination antiretroviral therapy: are different antiretroviral drugs associated with different lipid profiles? J Infect Dis. 2004;189:1056-1074. (Pubitemid 38373099)
19. Carey D, Amin J, Boyd M, et al. Lipid profiles in HIV-infected adults receiving atazanavir and atazanavir/ritonavir: systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother.2010;65: 1878-1888.
20. Iwamoto M, Wenning L, Mistry G, et al. Atazanavir modestly increases plasma levels of raltegravir in healthy subjects. Clin Infect Dis. 2008;47: 137-140. (Pubitemid 351920602)
21. Zhu L, Butterton J, Persson A, et al. Pharmacokinetics and safety of twice-daily atazanavir 300 mg and raltegravir 400 mg in healthy individuals. Antivir Ther. 2010;15:1107-1114.
22. Ripamonti D, Maggiolo F, D'Avolio A, et al. Steady-state pharmacokinetics of atazanavir (200 mg BID) when combined with raltegravir (400 mg BID) in HIV-1 infected adults. Paper presented at: 10th International Workshop on Clinical Pharmacology of HIV Therapy; April 15-17, 2009; Amsterdam, the Netherlands.
23. Molto J, Valle M, Mothe B, et al. Pharmacokinetics and safety of oncedaily raltegravir (800 mg) plus atazanavir (400 mg) in HIV-infected patients. Paper presented at: 10th International Workshop on Clinical Pharmacology of HIV Therapy; April 15-17, 2009; Amsterdam, the Netherlands.
24. Cattaneo D, Ripamonti D, Baldelli S, et al. Exposure-related effects of atazanavir on the pharmacokinetics of raltegravir in HIV-1-infected patients. Ther Drug Monit. 2010;32:782-786.
25. Johnson VA, Brun-Vezinet F, Clotet B, et al. Update of the drug resistance mutations in HIV-1: December 2010. Top HIV Med. 2010;18:156-163.
26. Burger D, Teulen M, Eerland J, et al. The international interlaboratory quality control program for measurement of antiretroviral drugs in plasma: a global proficiency testing program. Ther Drug Monit. 2011;33:239-243.
27. Ray JE, Marriott 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)
28. Chan DJ, Ray JE, McNally L, et al. Correlation between HIV-1 RNA load in blood and seminal plasma depending on antiretroviral treatment status, regimen and penetration of semen by antiretroviral drugs. Curr HIV Res. 2008;6:477-484.
29. Australian Commonwealth Department of Health and Ageing Therapeutic Goods Administration. Note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98) April 2003.Available at: http://www.tga.gov.au/pdf/euguide/ewp140198rev1.pdf. Accessed June 28, 2011.
30. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at: http://www.aidsinfo.nih. gov/contentfiles/adultandadolescentgl.pdf. Accessed June 28, 2011.
31. Kozal MJ, Lupo S, DeJesus E, et al. The SPARTAN study: a pilot study to assess the safety and efficacy of an investigational NRTI- and RTV-sparing regimen of atazanavir (ATV) experimental dose of 300mg BID plus raltegravir (RAL) 400mg BID (ATV+RAL) in treatment naive HIV-infected subjects. Paper presented at: IAS Conference; July 18-23, 2010; Vienna, Austria.
32. Zhu L, Liao S, Child M, et al. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-1 infected, treatment-naive patients who participated in the CASTLE study. J Antimicrob Chemother. 2012;67:465-468.
33. Markowitz M, Morales-Ramirez JO, Nguyen B-Y, et al. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006;43:509-515. (Pubitemid 44885615)
34. Grinsztejn B, Nguyen B-Y, Katlama C, et al. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007;369:1261-1269. (Pubitemid 46553846)
35. Eron J, Rockstroh J, Reynes J, et al. QDMRK, a phase III study of the safety and efficacy of once daily vs twice daily RAL in combination therapy for treatment-naive HIV-infected patients. Paper presented at: 18th Conference on Retroviruses and Opportunistic Infections; February 27-March 2, 2011; Boston, M.A.
36. McSharry J, Weng Q, Kulaway R, et al. Dose range and dose fractionation studies for raltegravir pharmacodynamics in an in vitro hallow fibre infection model system. Paper presented at: 10th International Workshop on Clinical Pharmacology of HIV Therapy; April 15-17, 2009; Amsterdam, the Netherlands.
37. Best BM, Letendre SL, Brigid E, et al. Low atazanavir concentrations in cerebrospinal fluid. AIDS. 2009;23:83-87.
38. Drewe J, Gutmann H, Fricker G, et al. HIV protease inhibitor ritonavir: a more potent inhibitor of P-glycoprotein than the cyclosporine analog SDZ PSC 833. Biochem Pharmacol. 1999;57:1147-1152. (Pubitemid 29171690)
39. Clavel C, Peytavin G, Tubiana R, et al. Raltegravir concentrations in the genital tract of HIV-1-infected women treated with a raltegravir-containing regimen (DIVA 01 study). Antimicrob Agents Chemother. 2011;55: 3018-3021.
40. van Leeuwen E, Ter Heine R, van der Veen F, et al. Penetration of atazanavir in seminal plasma of men infected with human immunodeficiency virus type 1. Antimicrob Agents Chemother. 2007;51:335-337. (Pubitemid 46047724)