The management of treatment-experienced HIV-infected patients: New drugs and drug combinations

Clinical Infectious Diseases

Volumn 48, Issue 2, 2009, Pages 214-221

  Wilson, Lucy E ^a   Gallant, Joel E ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; CARBAMAZEPINE; CLARITHROMYCIN; DARUNAVIR; DARUNAVIR PLUS RITONAVIR; DELAVIRDINE; EFAVIRENZ; ELVITEGRAVIR; ENFUVIRTIDE; ETRAVIRINE; ITRACONAZOLE; KETOCONAZOLE; LOPINAVIR PLUS RITONAVIR; MARAVIROC; PHENOBARBITAL; PHENYTOIN; PLACEBO; RALTEGRAVIR; RIFAMPICIN; RITONAVIR; RITONAVIR PLUS SAQUINAVIR; RITONAVIR PLUS TIPRANAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; TIPRANAVIR; VIRUS RNA; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

CLINICAL TRIAL; DIARRHEA; DRUG HALF LIFE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLIPIDEMIA; INJECTION SITE REACTION; LABORATORY TEST; LIVER TOXICITY; NAUSEA; PATIENT CARE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RASH; REVIEW; METHODOLOGY; VIRUS LOAD;

ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; HIV INFECTIONS; HUMANS; PRACTICE GUIDELINES AS TOPIC; VIRAL LOAD;

EID: 58749089667     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/595701     Document Type: Review

References (45)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents, Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 3 November 2008; 1-128. Available at: http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed 8 December 2008.
2. Hammer SM, Eron JJ Jr, Reiss P, et al. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA Panel. JAMA 2008; 300:555-70.
3. Lazzarin A, Campbell T, Clotet B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet 2007; 370:39-48.
4. Johnson M, Campbell T, Clotet B, et al.; DUET-2 study group. DUET-2: week-48 results of a phase III randomized double-blind trial to evaluate the efficacy and safety of TMC125 vs. placebo in 591 treatment-experienced HIV-1-infected patients [abstract 791]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
5. Haubrich R, Cahn P, Grinsztejn B; DUET-1 study group. DUET-1: week-48 results of a phase III randomized double-blind trial to evaluate the efficacy and safety of TMC125 vs. placebo in 612 treatment-experienced HIV-1-infected patients [abstract 790]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
6. Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet 2007; 370:29-38.
7. Vingerhoets J, Peeters M, Azijn H, et al. An update of the list of NNRTI mutations associated with decreased virologic response to etravirine (ETR): multivariate analyses on the pooled DUET-1 and DUET-2 clinical trial data. In: Program and abstracts of the 17th International HIV Drug Resistance Workshop (Sitges, Spain). College Park, GA: Informed Horizons, 2008.
8. Benhamida J, Chappey C, Coakley E et al. HIV-1 genotype algorithms for prediction of etravirine susceptibility: novel mutations and weighting factors identified through correlations to phenotype. In: Program and abstracts of the 17th International HIV Drug Resistance Workshop (Sitges, Spain). College Park, GA: Informed Horizons, 2008.
9. Llibre J, Santos J, Puig T, et al. Prevalence of mutations with effect on virological response to etravirine in routine clinical samples [abstract 868]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
10. FDA. Intelence prescribing information. Available at: http://www.fda.gov/cder/foi/label/2008/022187lbl.pdf. Accessed 25 February 2008.
11. Pfizer. Selzentry product information. Available at: https://www. pfizerpro.com/brands/selzentry.jsp. Accessed 21 November 2008.
12. Cooper D, Gatell J, Rockstroh J, et al.; BENCHMRK-1 Study Group. 48-Week results from BENCHMRK-1, a phase III study of raltegravir in patients failing ART with triple-class resistant HIV-1 [abstract 788]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
13. Steigbigel R, Kumar P, Eron J, et al.; BENCHMRK-2 Study Group. 48-Week results from BENCHMRK-2, a phase III study of raltegravir in patients failing ART with triple-class resistant HIV. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
14. Markowitz M, Nguyen BY, 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; 46:125-33.
15. Grinsztejn B, Nguyen BY, 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; 369:1261-9.
16. Malet I, Delelis O, Valantin MA, et al. Mutations associated with failure of raltegravir treatment affect integrase sensitivity to the inhibitor in vitro. Antimicrob Agents Chemother 2008; 52:1351-8.
17. + cell depletion and progression to AIDS. Ann Intern Med 1993; 118:681-8.
18. Gallant JE. Approach to the treatment-experienced patient. Infect Dis Clin North Am 2007; 21:85-102.
19. Pfizer. Selzentry prescribing information. Available at: http://media.pfizer.com/files/products/uspi-maraviroc.pdf. Accessed 25 February 2008.
20. Hardy D, Reynes J, Konourina I, et al. Efficacy and safety of maraviroc plus optimized background therapy in treatment-experienced patients infected with CCR5-tropic HIV-1: 48-week combined analysis of the MOTIVATE studies [abstract 792]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
21. Coakley E, Benhamida J, Chappey C, et al. An evaluation of tropism profiles and other characteristics among 3988 individuals screened from A4001026, A4001027 (MOTIVATE 1) and A4001028 (MOTIVATE 2) studies for maraviroc [abstract 8]. In: Program and abstracts of the 2nd International Workshop on Targeting HIV Entry (Boston). Utrecht: Virology Education, 2006.
22. Monogram Biosciences. Trofile - Monogram's co-receptor tropism assay. Available at: http://www.monogrambio.com/414.aspx. Accessed 1 August 2008.
23. Reeves J, Han D, Wilkin T, et al. An enhanced version of the trofile HIV co-receptor tropism assay predicts emergence of CXCR4 use in ACTG5211 vicriviroc trial samples [abstract 869]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
24. Lewis M, Simpson P, Fransen S, et al. CXCR4-using virus detected in patients receiving maraviroc in the phase III studies MOTIVATE 1 and 2 originates from a pre-existing minority of CXCR4-using virus [abstract 56]. In: Program and abstracts of the 16th International HIV Drug Resistance Workshop (Barbados, West Indies). College Park, GA: Informed Horizons, 2007.
25. Heera J, Saag M, Ive P, et al. Virological correlates associated with treatment failure at week 48 in the phase 3 study of maraviroc in treatment-naive patients [abstract 40LB]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
26. Lewis M, Mori J, Simpson P, et al. Changes in V3 loop sequence associated with failure of maraviroc treatment in patients enrolled in the MOTIVATE 1 and 2 [abstract 871F]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
27. Saag M, Ive P, Heera J, et al. A multicenter, randomized, double-blind, comparative trial of a novel CCR5 antagonist, maraviroc versus efavirenz, both in combination with combivir (zidovudine [ZDV]/lamivudine [3TC]), for the treatment of antiretroviral naive patients infected with R5 HIV 1: week 48 results of the MERIT study [abstract WESS104]. In: Program and abstracts of the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (Sydney, Australia). Geneva: International AIDS Society, 2007.
28. Mayer H, van der Ryst, Saag M, et al. Safety and efficacy of maraviroc (MVC), a novel CCR5 antagonist, when used in combination with optimized background therapy (OBT) for the treatment of antiretroviral-experienced subjects infected with dual/mixed-tropic HIV-1: 24-week results of a phase 2b exploratory trial [abstract THLB0215]. In: Program and abstracts of the 16th AIDS Conference (Toronto, Canada). Geneva: International AIDS Society, 2006.
29. Wilkin T, Ribaudo H, Gulick R. The relationship of CCR5 inhibitors to CD4 cell count changes: a meta-analysis of recent clinical trials in treatment-experienced subjects [abstract 869]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
30. De Meyer S, Azijn H, Fransen E, et al. The pathway leading to TMC114 resistance is different for TMC114 compared with other protease inhibitors [abstract 19]. In: Program and abstracts of the 15th International HIV Drug Resistance Workshop (Sitges, Spain). College Park, GA: Informed Horizons, 2006.
31. Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavirritonavir 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; 369:1169-78.
32. Madruga JV, Berger D, McMurchie M, 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.
33. Prezista prescribing information. Available at: http://www.prezista.com/ prezista/. Accessed: 25 February 2008.
34. Tibotec Therapeutics. Important drug warnings. 2008. Available at: http://www.fda.gov/medwatch/safety/2008/prezista-DHCP.pdf. Accessed: 25 February 2008.
35. Hicks CB, Cahn P, Cooper DA, et al. Durable efficacy of tipranavirritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet 2006; 368:466-75.
36. Boehringer-Ingelheim. Aptivus prescribing information. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase= renetnt&folderPath=/Prescribing+Information/PIs/Aptivus/10003515+US+01.pdf. Accessed: 25 February 2008.
37. Reynes J, Arasteh K, Clotet B, et al. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care Stds 2007; 21:533-43.
38. Nelson M, Arasteh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr 2005; 40:404-12.
39. vircoTYPE. http://www.vircolab.com/index.jhtml?product=vircotype. Accessed 25 February 2008.
40. Hunt P, Deeks S, Huang W, et al. Detection of viral co-receptor tropism changes with a high-sensitivity phenotypic assay among HIV-infected patients with drug-resistant viremia [abstract 864]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
41. Reeves J, Han D, Liu Y, et al. Enhancements to the trofile HIV coreceptor tropism assay enable reliable detection of CXCR4 - using subpopulations at less than 1% [abstract H-1026]. In: Program and abstracts of the 47th International Conference on Antimicrobial Agents and Chemotherapy (Chicago). Washington, DC: American Society for Microbiology, 2007.
42. Tressler R, Valdez H, van der Ryst E, et al. Comparison of results from the SensiTrop vs. Trofile assays on 100 samples from the Maraviroc expanded access program [abstract 920a]. In: Program and abstracts of the 15th Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2008.
43. DeJesus E, Berger D, Markowitz M, et al. The HIV integrase inhibitor GS-9137 (JTK-303) exhibits potent antiviral activity in treatment-naïve and experienced patients [abstract 160LB]. In: Program and abstracts of the 13th Conference on Retroviruses and Opportunistic Infections (Denver). 2006.
44. Zolopa A, Mullen M, Berger D, et al. The HIV integrase inhibitor GS-9137 demonstrates potent antiviral activity in treatment-experienced patients [abstract 143LB]. In: Program and abstracts of the 14th Conference on Retroviruses and Opportunistic Infections (Los Angeles). 2007.
45. Jones G, Ledford R, Yu F, et al. In vitro resistance profile of HIV-1 mutants selected by the HIV-1 integrease inhibitor GS-9137 (JTK-303) [abstract 627]. In: Program and abstracts of the 14th Conference on Retroviruses and Opportunistic Infections (Los Angeles). 2007.