Treatment of HIV infection with the CCR5 antagonist maraviroc

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 7, 2010, Pages 1215-1223

  Kromdijk, Wiete ^a   Huitema, Alwin D R ^a   Mulder, Jan Willem ^a  

^a SLOTERVAART HOSPITAL   (Netherlands)

Author keywords

Antiretroviral therapy; CCR5 antagonist; HIV; Maraviroc

Indexed keywords

ATAZANAVIR PLUS RITONAVIR; DARUNAVIR PLUS RITONAVIR; EFAVIRENZ; ELVITEGRAVIR; ETRAVIRINE; KETOCONAZOLE; LOPINAVIR PLUS RITONAVIR; MARAVIROC; NEVIRAPINE; RALTEGRAVIR; RIFAMPICIN; RITONAVIR PLUS SAQUINAVIR; RITONAVIR PLUS TIPRANAVIR; TENOFOVIR;

CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY CLEARANCE; MONOTHERAPY; PHARMACODYNAMICS; REVIEW; SCREENING;

CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CYCLOHEXANES; DRUG RESISTANCE, VIRAL; HIV FUSION INHIBITORS; HIV INFECTIONS; HUMANS; RECEPTORS, CCR5; TRIAZOLES; VIRAL TROPISM;

EID: 77951294261     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656561003801081     Document Type: Review

References (54)

1. Joint United Nations Programme on HIV/AIDS (UNAIDS) and World Health Organization (WHO). 2009. 09 AIDS epidemic update. Available from: http://www unaids org/en/ KnowledgeCentre/HIVData/EpiUpdate/ EpiUpdArchive/2009/default asp, 2010. [Last accessed 11 January 2010]
2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 1 December 2009;1-161. Available from: http://www aidsinfo nih gov/ContentFiles/ AdultandAdolescentGL pdf,9 A.D. [Last accessed 18 January 2010]
3. European AIDS Clinical Society (EACS). Guidelines: Clinical management and treatment of HIV infected adults in Europe. Version 5. November 2009. Available from: http://www europeanaidsclinicalsociety org/guidelines asp, 2009. [Last accessed 18 January 2010]
4. Sax PE. FDA approval: maraviroc. AIDS Clin Care 2007;19:75
5. Briz V, Poveda E, Soriano V. HIV entry inhibitors: mechanisms of action and resistance pathways. J Antimicrob Chemother 2006;57:619-627
6. Este JA, Telenti A. HIV entry inhibitors. Lancet 2007;370:81-88 (Pubitemid 47018315)
7. Chan SY, Speck RF, Power C, et al. V3 recombinants indicate a central role for CCR5 as a coreceptor in tissue infection by human immunodeficiency virus type 1. J Virol 1999;73:2350-2358 (Pubitemid 29098140)
8. Huang W, Toma J, Fransen S, et al. Coreceptor tropism can be influenced by amino acid substitutions in the gp41 transmembrane subunit of human immunodeficiency virus type 1 envelope protein. J Virol 2008;82:5584-5593 (Pubitemid 351705265)
9. Pastore C, Nedellec R, Ramos A, et al. Human immunodeficiency virus type 1 coreceptor switching: V1/V2 gain-of-fitness mutations compensate for V3 loss-of-fitness mutations. J Virol 2006;80:750-758 (Pubitemid 43062887)
10. Dean M, Carrington M, Winkler C, et al. Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study. Science 1996;273:1856-1862 (Pubitemid 26322495)
11. Eugen-Olsen J, Iversen AK, Garred P, et al. Heterozygosity for a deletion in the CKR-5 gene leads to prolonged AIDS-free survival and slower CD4 T-cell decline in a cohort of HIV-seropositive individuals. AIDS 1997;11:305-310 (Pubitemid 27086969)
12. Liu R, Paxton WA, Choe S, et al. Homozygous defect in HIV-1 coreceptor accounts for resistance of some multiply-exposed individuals to HIV-1 infection. Cell 1996;86:367-377 (Pubitemid 26272077)
13. Walli R, Reinhart B, Luckow B, et al. HIV-1-infected long-term slow progressors heterozygous for delta32-CCR5 show significantly lower plasma viral load than wild-type slow progressors. J Acquir Immune Defic Syndr Hum Retrovirol 1998;18:229-233 (Pubitemid 28308912)
14. Soriano V, Geretti AM, Perno CF, et al. Optimal use of maraviroc in clinical practice. AIDS 2008;22:2231-2240
15. Whitcomb JM, Huang W, Fransen S, et al. Development and characterization of a novel single-cycle recombinant-virus assay to determine human immunodeficiency virus type 1 coreceptor tropism. Antimicrob Agents Chemother 2007;51:566-575 (Pubitemid 46185274)
16. Saag M, Heera J, Goodrich J, et al. Reanalysis of the MERIT study with the enhanced TrofileTM assay (MERIT-ES) [abstract H-1232a]. Abstracts of the Forty-eighth Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America Forty-sixth Annual Meeting; 28 October 2008; Washington, DC, USA
17. Trinh L, Han D, Huang W, et al. Technical validation of an enhanced sensitivity Trofile HIV coreceptor tropism assay for selecting patients for therapy with entry inhibitors targeting CCR5. Anitivir Ther 2008;3(Suppl 3):A128
18. Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis 2010;201(6):803-813
19. Poveda E, Briz V, Quinones-Mateu M, Soriano V. HIV tropism: diagnostic tools and implications for disease progression and treatment with entry inhibitors. AIDS 2006;20:1359-1367 (Pubitemid 43948242)
20. Verhofstede C, Reynes J, Poveda E, et al. Correlation between population based-sequencing and viral tropism determination on PBMC DNA and plasma RNA in comparison with phenotypic methods. Abstracts of the Seventh European HIV Drug Resistance Workshop; 25-27 March 2009; Stockholm, Sweden
21. Dorr P, Westby M, Dobbs S, et al. Maraviroc (UK-427,857), a potent, orally bioavailable, and selective small-molecule inhibitor of chemokine receptor CCR5 with broad-spectrum anti-human immunodeficiency virus type 1 activity. Antimicrob Agents Chemother 2005;49:4721-4732 (Pubitemid 41552605)
22. Abel S, Russell D, Whitlock LA, et al. Assessment of the absorption, metabolism and absolute bioavailability of maraviroc in healthy male subjects. Br J Clin Pharmacol 2008;65(Suppl 1):60-67 (Pubitemid 351366540)
23. Abel S, van der Ryst E, Rosario MC, et al. Assessment of the pharmacokinetics, safety and tolerability of maraviroc, a novel CCR5 antagonist, in healthy volunteers. Br J Clin Pharmacol 2008;65(Suppl 1):5-18 (Pubitemid 351366533)
24. Walker DK, Abel S, Comby P, et al. Species differences in the disposition of the CCR5 antagonist, UK-427,857, a new potential treatment for HIV. Drug Metab Dispos 2005;33:587-595 (Pubitemid 40393203)
25. Chan PL, Weatherley B, McFadyen L. A population pharmacokinetic meta-analysis of maraviroc in healthy volunteers and asymptomatic HIV-infected subjects. Br J Clin Pharmacol 2008;65(Suppl 1):76-85 (Pubitemid 351366542)
26. Fatkenheuer G, Pozniak AL, Johnson MA, et al. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med 2005;11:1170-1172 (Pubitemid 43093663)
27. Abel S, Russell D, Taylor-Worth RJ, et al. Effects of CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol 2008;65(Suppl 1):27-37 (Pubitemid 351366536)
28. Abel S, Jenkins TM, Whitlock LA, et al. Effects of CYP3A4 inducers with and without CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol 2008;65(Suppl 1):38-46 (Pubitemid 351366537)
29. Pozniak AL, Boffito M, Russell D, et al. A novel probe drug interaction study to investigate the effect of selected antiretroviral combinations on the pharmacokinetics of a single oral dose of maraviroc in HIV-positive subjects. Br J Clin Pharmacol 2008;65(Suppl 1):54-59 (Pubitemid 351366539)
30. Abel S, Russell D, Whitlock LA, et al. The effects of cotrimoxazole or tenofovir co-administration on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol 2008;65(Suppl 1):47-53 (Pubitemid 351366538)
31. Heera J, Ive P, Botes M, et al. The MERIT study of maraviroc in anti-retroviral-naive patients with R5 HIV-1: 96-week results [abstract TUAB103]. Abstracts of the Fifth International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention; 19-22 July 2009; Cape Town, South Africa
32. Heera J, Saag M, Iversen AK, et al. Virological correlates associated with treatment failure at week 48 in the Phase 3 study of maraviroc in treatment-naive patients [abstract 40LB]. Abstracts of the Fiftheenth Conference on Retroviruses and Opportunistics infections; 3-6 February 2008; Boston, MA, USA
33. Gulick RM, Lalezari J, Goodrich J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med 2008;359:1429-1441
34. Fatkenheuer G, Nelson M, Lazzarin A, et al. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med 2008;359:1442-1455
35. Dolin R. A new class of anti-HIV therapy and new challenges. N Engl J Med 2008;359:1509-1511
36. Asmuth DM, Goodrich J, Cooper DA, et al. CD4+ T-Cell restoration after 48 weeks in the maraviroc treatment-experienced trials MOTIVATE 1 and 2. J Acquir Immune Defic Syndr 2009
37. Saag M, Goodrich J, Fatkenheuer G, et al. A double-blind, placebo-controlled trial of maraviroc in treatment-experienced patients infected with non-R5 HIV-1. J Infect Dis 2009;199:1638-1647
38. Saag M, Prudence I, Heera J, et al. A multicentre, 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 WESS 104]. Abstracts of the Fourth International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention; 22-25 July 2007; Sydney, Australia
39. Lazzarin A, Di Perri G, Sierra-Madero JG, et al. Fasted lipid changes after administration of maraviroc or efavirenz, both with zidovudine and lamivudine, to treatment-naive HIV-infected patients: 96-week results from MERIT. Abstracts of the Fortyninth Interscience Conference on Antimicrobial Agents and Chemotherapy; 12-14 September 2009; San Fransisco, CA, USA
40. DeJesus E, Walmsley S, Cohen C, et al. Fasted lipid changes after administration of maraviroc or efavirenz in combination with zidovudine and lamivudine for 48 weeks to treatment-naive HIV-infected patients. Abstracts of the Fiftheenth Conference on Retroviruses and Opportunistics infections; 3-6 February 2008; Boston, MA, USA
41. Nichols WG, Steel HM, Bonny T, et al. Hepatotoxicity observed in clinical trials of aplaviroc (GW873140). Antimicrob Agents Chemother 2008;52:858-865 (Pubitemid 351358363)
42. Abel S, Davis JD, Ridgway CE, et al. Pharmacokinetics, safety and tolerability of a single oral dose of maraviroc in HIV-negative subjects with mild and moderate hepatic impairment. Antivir Ther 2009;14:831-837
43. Thio CL, Astemborski J, Bashirova A, et al. Genetic protection against hepatitis B virus conferred by CCR5Delta32: evidence that CCR5 contributes to viral persistence. J Virol 2007;81:441-445 (Pubitemid 46067870)
44. Gulick RM, Su Z, Flexner C, et al. Phase 2 study of the safety and efficacy of vicriviroc, a CCR5 inhibitor, in HIV-1-Infected, treatment-experienced patients: AIDS clinical trials group 5211. J Infect Dis 2007;196:304-312 (Pubitemid 47047471)
45. Glass WG, McDermott DH, Lim JK, et al. CCR5 deficiency increases risk of symptomatic West Nile virus infection. J Exp Med 2006;203:35-40 (Pubitemid 43139642)
46. Armand-Ugon M, Moncunill G, Gonzalez E, et al. Different selection patterns of resistance and cross-resistance to HIV-1 agents targeting CCR5. J Antimicrob Chemother 2010;65(3):417-424
47. Available from: http://www accessdata fda gov/scripts/cder/drugsatfda/ index cfm?fuseaction=Search Label-ApprovalHistory#apphist Selzentry, 2009. [Last accessed 20 November 2009]
48. Verhofstede C, Vandekerckhove L, Eygen VV, et al. CXCR4-using HIV type 1 variants are more commonly found in peripheral blood mononuclear cell DNA than in plasma RNA. J Acquir Immune Defic Syndr 2009;50:126-136
49. Abrams D, Levy Y, Losso MH, et al. Interleukin-2 therapy in patients with HIV infection. N Engl J Med 2009;361:1548-1559
50. Poveda E, Rodes B, Labernardiere JL, et al. Evolution of genotypic and phenotypic resistance to Enfuvirtide in HIV-infected patients experiencing prolonged virologic failure. J Med Virol 2004;74:21-28 (Pubitemid 38988855)
51. Westby M, Lewis M, Whitcomb J, et al. Emergence of CXCR4-using human immunodeficiency virus type 1 (HIV-1) variants in a minority of HIV-1-infected patients following treatment with the CCR5 antagonist maraviroc is from a pretreatment CXCR4-using virus reservoir. J Virol 2006;80:4909-4920
52. Stepanyuk O, Chiang TS, Dever LL, et al. Impact of adding maraviroc to antiretroviral regimens in patients with full viral suppression but impaired CD4 recovery. AIDS 2009;23:1911-1913
53. Pope M, Haase AT. Transmission, acute HIV-1 infection and the quest for strategies to prevent infection. Nat Med 2003;9:847-852 (Pubitemid 36889925)
54. Dumond JB, Patterson KB, Pecha AL, et al. Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr 2009;51:546-553