Characterization of virologic failure patients on darunavir/ritonavir in treatment-experienced patients

AIDS

Volumn 23, Issue 14, 2009, Pages 1829-1840

  De Meyer, Sandra ^a   Lathouwers, Erkki ^a   Dierynck, Inge ^a   De Paepe, Els ^a   Van Baelen, Ben ^a   Vangeneugden, Tony ^a   Spinosa Guzman, Sabrina ^a   Lefebvre, Eric ^b   Picchio, Gaston ^c   De Béthune, Marie Pierre ^a  

^a TIBOTEC BVBA   (Belgium)

^b Janssen Cilag BV   (Netherlands)

^c Tibotec Inc   (United States)

Author keywords

Darunavir; HIV drug resistance; HIV 1; Protease inhibitor; Resistance associated mutation; Ritonavir; Treatment experienced patients

Indexed keywords

DARUNAVIR PLUS RITONAVIR; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; VIRUS RNA;

ANTIVIRAL RESISTANCE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSS RESISTANCE; DRUG EFFICACY; DRUG SAFETY; DRUG SENSITIVITY; DRUG TREATMENT FAILURE; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; MAJOR CLINICAL STUDY; MUTATION; PHASE 3 CLINICAL TRIAL; PHENOTYPE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ANTI-HIV AGENTS; DRUG RESISTANCE, MULTIPLE, VIRAL; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MUTATION; PYRIMIDINONES; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; RNA, VIRAL; SULFONAMIDES; TREATMENT FAILURE; VIRAL LOAD;

EID: 70249141303     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e32832cbcec     Document Type: Article

References (35)

1. US Department of Health and Human Services (DHHS). Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents [online]. http://www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf; 2008. pp. 1-128. [Accessed 11 May 2008].
2. European AIDS Clinical Society (EACS). Guidelines for the clinical management and treatment of HIV-infected adults in Europe [online]. http://www.eacs.eu/guide/index.htm; 2007. [Accessed 11 May 2008].
3. Hammer SM, Saag MS, Schechter M,Montaner JS, Schooley RT, Jacobsen DM, et al. Treatment for adult HIV infection. 2006 recommendationsofthe International AIDS Society-USA Panel. JAMA 2006; 296:827-843.
4. Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, et al. The KLEAN study of fosamprenavir-ritonavir versus lo-pinavir-ritonavir, each in combination with abacavir-lamivu-dine, for initial treatment of HIV infection over 48 weeks: a randomised noninferiority trial. Lancet 2006; 368:476-482.
5. Marin-Niebla A, Lopez-Cortes LF, Ruiz-Valderas R, Viciana P, Mata R, Gutierrez A, et al. Clinical and pharmacokinetic data support once-daily low-dose boosted saquinavir (1200 milligrams saquinavir with 100 milligrams ritonavir) in treatment-naive or limited protease inhibitor-experienced human immunodeficiency virus-infected patients. Antimicrob Agents Che-mother 2007; 51:2035-2042.
6. Hicks C, King MS, Gulick RM, White AC Jr, Eron JJ Jr, Kessler HA, et al. Long-term safety and durable antiretroviral activity of lopinavir/ritonavir in treatment-naive patients: 4 year follow-up study. AIDS 2004; 18:775-779.
7. Johnson M, Grinsztejn B, Rodriguez C, Coco J, DeJesus E, Lazzarin A, et al. 96-week comparison of once-daily atazana-vir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS 2006; 20:711-718.
8. Markowitz M, Slater LN, Schwartz R, Kazanjian PH, Hathaway B, Wheeler D, et al. Long-term efficacy and safety of tipranavir boosted with ritonavir in HIV-1-infected patients failing multiple protease inhibitor regimens: 80-week data from a phase 2 study. J Acquir Immune Defic Syndr 2007; 45:401-410.
9. Sekar V, Guzman S, Stevens T, De Paepe E, Lefebvre E, Hoetel-mans R. Absolute bioavailability of TMC114, administered in the absence and presence of low-dose ritonavir [abstract #P86]. In: 7th International Workshop on Clinical Pharmacology of HIV Therapy; Lisbon, Portugal; 2006.
10. MacGregor TR, Sabo JP, Norris SH, Johnson P, Galitz L, McCallister S. Pharmacokinetic characterization of different dose combinations of coadministered tipranavir and ritonavir in healthy volunteers. HIV Clin Trials 2004; 5:371-382.
11. Ruane PJ, Luber AD, Wire MB, Lou Y, Shelton MJ, Lancaster CT, et al. Plasma amprenavir pharmacokinetics and tolerability following administration of 1400 milligrams of fosamprenavir once daily in combination with either 100 or 200 milligrams of ritonavir in healthy volunteers. Antimicrob Agents Chemother 2007; 51:560-565.
12. Kappelhoff BS, Huitema AD, Sankatsing SU, Meenhorst PL, Van Gorp EC, Mulder JW, et al. Population pharmacokinetics of indinavir alone and in combination with ritonavir in HIV-1-infected patients. Br J Clin Pharmacol 2005; 60:276-286.
13. Zeldin RK, Petruschke RA. Pharmacological and therapeutic properties of ritonavir-boosted protease inhibitor therapy in HIV-infected patients. J Antimicrob Chemother 2004; 53: 4-9.
14. Johnson VA, Brun-Vezinet F, Clotet B, Gunthard HF, Kuritzkes DR, Pillay D, et al. Update of the drug resistance mutations in HIV-1: 2007. Top HIV Med 2007; 15:119-125.
15. Walmsley S, Bernstein B, King M, Arribas J, Beall G, Ruane P, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med 2002; 346:2039-2046.
16. Becker SL. The role of pharmacological enhancement in protease inhibitor-based highly active antiretroviral therapy. Expert Opin Investig Drugs 2003; 12:401-412.
17. Lima VD, Gill VS, Yip B, Hogg RS, Montaner JS, Harrigan PR. Increased resilience to the development of drug resistance with modern boosted protease inhibitor-based highly active anti-retroviral therapy. J Infect Dis 2008; 198:51-58.
18. Youle M. Overview of boosted protease inhibitors in treatment-experienced HIV-infected patients. J Antimicrob Chemother 2007; 60:1195-1205.
19. De Meyer S, Azijn H, Surleraux D, Jochmans D, Tahri A, Pauwels R, et al. TMC114, a novel human immunodeficiency virus type 1 protease inhibitor active against protease inhibitor-resistant viruses, including a broad range of clinical isolates. Antimicrob Agents Chemother 2005; 49:2314-2321.
20. Ortiz R, DeJesus E, Khanlou H, Voronin E, Van Lunzen J, Andrade-Villanueva J, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-na-̈ive HIV-1-infected patients at week 48. AIDS 2008; 22:1389-1397.
21. Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, et al. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet 2007; 370: 49-58.
22. Clotet B, Bellos N, Molina JM, Cooper D, Goffard JC, Lazzarin A, et al. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet 2007; 369:1169-1178.
23. Zazzi M. Lack of major resistance mutations in HIV-1 protease at failure of boosted protease inhibitor-based first-line antire-troviral treatment. Rev Antiviral Ther 2007; 2:4-12.
24. Molina J-M, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antire-troviral-naïve HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008; 372:646-655.
25. Abbott Laboratories. Kaletra (lopinavir/ritonavir) prescribing information [online]. http://rxabbott.com/pdf/kaletrapi.pdf; 2005. [Accessed 21 July 2008].
26. Abbott Laboratories. Kaletra (lopinavir/ritonavir) prescribing information [online]. http://www.rxabbott.com/pdf/kaletratab-pi.pdf; 2007. [Accessed 21 July 2008].
27. Johnson VA, Brun-Vezinet F, Clotet B, Kuritzkes DR, Pillay D, Schapiro JM, et al. Update of the drug resistance mutations in HIV-1: Fall 2006. Top HIV Med 2006; 14:125-130.
28. De Meyer S, Vangeneugden T, Lefebvre E, Azijn H, De Baere I, Van Baelen B, et al. Phenotypic and genotypic determinants of resistance to TMC114: pooled analysis of POWER 1, 2 and 3 [abstract #73]. In: 15th International HIV Drug Resistance Workshop; Sitges, Spain; 2006.
29. Boehringer Ingelheim Pharmaceuticals Inc. Aptivus (tipranavir) prescribing information [online] http://www.aptivus.us/tipWeb/index.jsp 2007 Accessed 11 May 2008.
30. HIV French Resistance. HIV-1 genotypic drug resistance interpretation's algorithms [online]. http://www.hivfrenchresistance. org/2007/tab2.html; 2007. [Accessed 11 May 2008].
31. De Meyer S, Lathouwers E, Dierynck I, De Paepe E, Van Baelen B, Vangeneugden T, et al. Characterization of virologic failures on darunavir/ritonavir in the randomized, controlled, phase III TITAN trial in treatment-experienced patients [abstract #874]. In: 15th Conference on Retroviruses and Opportunistic Infections; Boston, Massachusetts, USA; 2008.
32. De Meyer S, Vangeneugden T, Van Baelen B, De Paepe, Van Marck H, Picchio G, et al. Resistance profile of darunavir: combined 24-week results from the POWER trials. AIDS Res Hum Retroviruses 2008; 24:379-388.
33. DeMeyerS,HillA,PicchioG,DeMasiR,DePaepeE,deBéthune MP. Influence of baseline protease inhibitor resistance on the efficacy of darunavir/ritonavir or lopinavir/ritonavir in the TITAN trial. J Acquir Immune Defic Syndr 2008; 49:563-564.
34. Parkin N, Stawiski E, Chappey C, Coakley E. Darunavir/am-prenavir cross-resistance in clinical samples submitted for phenotype/genotype combination resistance testing [abstract #607]. In: 14th Conference on Retroviruses and Opportunistic Infections; San Francisco, California, USA; 2007.
35. Descamps D, Lambert-Niclot S, Marcelin A-G, Peytavin G, Roquebert B, Katlama C, et al. Mutations associated with vir-ological response to darunavir/ritonavir in HIV-1-infected protease inhibitor-experienced patients. J Antimicrob Chemother 2009; 63:585-592.