Drug safety evaluation of maraviroc for the treatment of HIV infection

Bibliography

• Saag M, Goodrich J, Fatkenheuer G, A double-blind, placebo-controlled trial of maraviroc in treatment-experienced patients infected with non-R5 HIV-1. J Infect Dis 2009;199:1638-47
   PubMed Web of Science ®Google Scholar
• Fatkenheuer G, Nelson M, Lazzarin A, Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med 2008;359:1442-55
   PubMed Web of Science ®Google Scholar
• Vandekerckhove L, Verhofstede C, Vogelaers D. Maraviroc: perspectives for use in antiretroviral-naive HIV-1-infected patients. J Antimicrob Chemother 2009;63:1087-96
   PubMed Web of Science ®Google Scholar
• Abel S, Russell D, Whitlock LA, Assessment of the absorption, metabolism and absolute bioavailability of maraviroc in healthy male subjects. Br J Clin Pharmacol 2008;65(Suppl 1):60-7
   PubMed Web of Science ®Google Scholar
• Abel S, van der Ryst E, Rosario MC, 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
   PubMedGoogle Scholar
• Abel S, Russell D, Taylor-Worth RJ, Effects of CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol 2008;65(Suppl 1):27-37
   PubMed Web of Science ®Google Scholar
• Abel S, Jenkins TM, Whitlock LA, 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
   PubMedGoogle Scholar
• Marviroc (Selzentry®). United States Prescribing Information. Pfizer Inc; New York: 2011
   Google Scholar
• Andrews E, Glue P, Fang J, Assessment of the pharmacokinetics of co-administered maraviroc and raltegravir. Br J Clin Pharmacol 2010;69:51-7
   PubMed Web of Science ®Google Scholar
• Nozza S, Galli L, Visco F, Raltegravir, maraviroc, etravirine: an effective protease inhibitor and nucleoside reverse transcriptase inhibitor-sparing regimen for salvage therapy in HIV-infected patients with triple-class experience. AIDS 2010;24:924-8
   PubMed Web of Science ®Google Scholar
• Melica G, Canestri A, Peytavin G, Maraviroc-containing regimen suppresses HIV replication in the cerebrospinal fluid of patients with neurological symptoms. AIDS 2010;24:2130-3
   PubMed Web of Science ®Google Scholar
• Tiraboschi JM, Niubo J, Curto J, Maraviroc Concentrations in Cerebrospinal Fluid in HIV-Infected Patients. J Acquir Immune Defic Syndr 2010; Available from: http://www.ncbi.nlm.nih.gov/pubmed/20706127 [Last accessed 25 May 2011]
   Web of Science ®Google Scholar
• Yilmaz A, Watson V, Else L, Cerebrospinal fluid maraviroc concentrations in HIV-1 infected patients. AIDS 2009;23:2537-40
   PubMed Web of Science ®Google Scholar
• Dumond JB, Patterson KB, Pecha AL, Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr 2009;51:546-53
   PubMed Web of Science ®Google Scholar
• Brown KC, Patterson KB, Malone SA, Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis 2011;203:1484-90
   PubMed Web of Science ®Google Scholar
• Mosier DE. How HIV changes its tropism: evolution and adaptation? Curr Opin HIV AIDS 2009;4:125-30
   PubMed Web of Science ®Google Scholar
• Irlbeck DM, Amrine-Madsen H, Kitrinos KM, Chemokine (C-C motif) receptor 5-using envelopes predominate in dual/mixed-tropic HIV from the plasma of drug-naive individuals. AIDS 2008;22:1425-31
   PubMed Web of Science ®Google Scholar
• Poveda E, Briz V, Quinones-Mateu M, HIV tropism: diagnostic tools and implications for disease progression and treatment with entry inhibitors. AIDS 2006;20:1359-67
   PubMed Web of Science ®Google Scholar
• Rose JD, Rhea AM, Weber J, Current tests to evaluate HIV-1 coreceptor tropism. Curr Opin HIV AIDS 2009;4:136-42
   PubMed Web of Science ®Google Scholar
• Whitcomb JM, Huang W, Fransen S, Development and characterization of a novel single-cycle recombinant-virus assay to determine human immunodeficiency virus type 1 coreceptor tropism. Antimicrob Agents Chemother 2007;51:566-75
   PubMed Web of Science ®Google Scholar
• Trofile® DNA (HIV Tropism Test). Available from: http://www.monogramvirology.com/hiv-tests/resistance-testing/tropism/trofile-dna/ [Last accessed 15 October 2011]
   Google Scholar
• Gonzalez N, Perez-Olmeda M, Mateos E, A sensitive phenotypic assay for the determination of human immunodeficiency virus type 1 tropism. J Antimicrob Chemother 2010;65:2493-501
   PubMed Web of Science ®Google Scholar
• Gonzalez-Serna A, Leal M, Genebat M, TROCAI (tropism coreceptor assay information): a new phenotypic tropism test and its correlation with Trofile enhanced sensitivity and genotypic approaches. J Clin Microbiol 2010;48:4453-8
   PubMed Web of Science ®Google Scholar
• Raymond S, Delobel P, Mavigner M, Development and performance of a new recombinant virus phenotypic entry assay to determine HIV-1 coreceptor usage. J Clin Virol 2010;47:126-30
   PubMed Web of Science ®Google Scholar
• Chan SY, Speck RF, Power C, V3 recombinants indicate a central role for CCR5 as a coreceptor in tissue infection by human immunodeficiency virus type 1. J Virol 1999;73:2350-8
   PubMed Web of Science ®Google Scholar
• Jensen MA, Li F-S, van 't Wout AB, Improved coreceptor usage prediction and genotypic monitoring of R5-to-X4 transition by motif analysis of human immunodeficiency virus type 1 env V3 loop sequences. J Virol 2003;77:13376-88
   PubMed Web of Science ®Google Scholar
• Low AJ, Dong W, Chan D, Current V3 genotyping algorithms are inadequate for predicting X4 co-receptor usage in clinical isolates. AIDS 2007;21:F17-24
   PubMedGoogle Scholar
• Harrigan PR, McGovern R, Dong W, Screening for HIV tropism using population-based V3 genotypic analysis: a retrospective virological outcome analysis using stored plasma screening samples from MOTIVATE-1. Antivir Ther 2008;13(Suppl 3):A106
   Google Scholar
• Reuter S, Braken P, Jensen B, Maraviroc in treatment-experienced patients with HIV-1 infection - experience from routine clinical practice. Eur J Med Res 2010;15:231-7
   PubMed Web of Science ®Google Scholar
• Daumer M, Kaiser R, Klein R, Inferring viral tropism from genotype with massively parallel sequencing: qualitative and quantitative analysis. Antivir Ther 2008;13(Suppl 3):A101
   PubMed Web of Science ®Google Scholar
• Saliou A, Delobel P, Dubois M, Concordance between two phenotypic assays and ultradeep pyrosequencing for determining HIV-1 tropism. Antimicrob Agents Chemother 2011;55:2831-6
   PubMed Web of Science ®Google Scholar
• Svicher V, Balestra E, Cento V, HIV-1 dual/mixed tropic isolates show different genetic and phenotypic characteristics and response to maraviroc in vitro. Antiviral Res 2011;90:42-53
   PubMed Web of Science ®Google Scholar
• Swenson L, Dong W, Mo T, Quantification of HIV Tropism by “deep” sequencing shows abroad distribution of prevalence of X4 variants in clinicalsamples that is associated with virological outcome [abstract 680]. 16th Conference on Retroviruses and Opportunistic Infections; 8 – 11 February 2009; Montreal, Canada
   Google Scholar
• Vandekerckhove L, Wensing A, Kaiser R, European guidelines on the clinical management of HIV-1 tropism testing. Lancet Infect Dis 2011;11:394-407
   PubMed Web of Science ®Google Scholar
• 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; Washington, D.C.: 2011. p. 1-166
   Google Scholar
• Gulick RM, Lalezari J, Goodrich J, Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med 2008;359:1429-41
   PubMed Web of Science ®Google Scholar
• Hardy WD, Gulick RM, Mayer H, Two-Year Safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-Tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr 2010;55:558-64
   PubMed Web of Science ®Google Scholar
• Steigbigel RT, Cooper DA, Kumar PN, Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med 2008;359:339-54
   PubMed Web of Science ®Google Scholar
• Clotet B, Bellos N, Molina J-M, 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;369:1169-78
   PubMed Web of Science ®Google Scholar
• Cooper DA, Heera J, Goodrich J, 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;201:803-13
   PubMed Web of Science ®Google Scholar
• Lanzafame M, Lattuada E, Vento S. Maraviroc and CD4+ cell count recovery in patients with virologic suppression and blunted CD4+ cell response. AIDS 2009;23:869
   PubMed Web of Science ®Google Scholar
• Stepanyuk O, Chiang TS, Dever LL, Impact of adding maraviroc to antiretroviral regimens in patients with full viral suppression but impaired CD4 recovery. AIDS 2009;23:1911-13
   PubMed Web of Science ®Google Scholar
• Wilkin T, Lalama C, Tenorio A, Maraviroc intensification for SUboptimal CD4+ cell response despite sustained virologic suppression: ACTG 5256 [abstract 285]. 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010); 16 – 19 February 2010; San Francisco, CA
   Google Scholar
• Hunt P, Shulman N, Hayes T, Immunomodulatory Effects of MVC intensification in HIV-infected individuals with incomplete CD4+ T cell recovery during suppressive ART [abstract 153LB]. 18th Conference on Retroviruses & Opportunistic Infections (CROI 2011); 27 February – 2 March 2011; Boston, MA
   Google Scholar
• Rusconi S, Vitiello P, Adorni F, Maraviroc intensification for HIV-1-positive immunological nonresponders(INRs) despite virological suppression during HAART [abstract O44]. 10th International Congress on Drug Therapy in HIV Infection; 7 November 2010; Glasgow, UK
   Google Scholar
• Funderburg N, Kalinowska M, Eason J, Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One 2010;5:e13188
   PubMed Web of Science ®Google Scholar
• Wilkin T, Lalama C, Tenorio A, Effect of Adding and Removing MVC on Immune Activation in HIV+ Patients on Suppressive ART: Results from ACTG A5256 [abstract 574]. 18th Conference on Retroviruses and Opportunistic Infections; 27 February – 2 March 2011; Boston, MA
   Google Scholar
• Hilldorfer B, Lalama C, McKinnon J, Effects of maraviroc (MVC) intensification on residual low-level viremia in patients on suppressive antiretroviral therapy (ART): results from ACTG 5256 [abstract MOPE275]. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 17 – 20 July 2011; Rome, Italy
   Google Scholar
• Fatkenheuer G, Pozniak AL, Johnson MA, Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med 2005;11:1170-2
   PubMed Web of Science ®Google Scholar
• Randell P, Jackson A, Taylor J, Maraviroc has a benign impact on glucose and lipidhomeostasis after 2 weeks in HIV-negative malevolunteers [abstract LBPE9.2/8]. 12th European AIDS Conference; 12 – 14 November 2009; Cologne, Germany
   Google Scholar
• Heera J, Ive P, Botes M, The MERIT study of maraviroc in antiretroviral-naive patients with R5 HIV-1: 96-week results [abstract TUAB103]. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 19 – 22 July 2009; Cape Town, South Africa
   Google Scholar
• Moreno C, Gustot T, Nicaise C, CCR5 deficiency exacerbates T-cell-mediated hepatitis in mice. Hepatology 2005;42:854-62
   PubMed Web of Science ®Google Scholar
• Nichols WG, Steel HM, Bonny T, Hepatotoxicity observed in clinical trials of aplaviroc (GW873140). Antimicrob Agents Chemother 2008;52:858-65
   PubMed Web of Science ®Google Scholar
• Abel S, Davis JD, Ridgway CE, Pharmacokinetics, safety and tolerability of a single oral dose of maraviroc in HIV-negative subjects with mild and moderate hepatic impairment. Antivir Ther (Lond) 2009;14:831-7
   PubMed Web of Science ®Google Scholar
• Gulick RM, Su Z, Flexner C, 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;196:304-12
   PubMed Web of Science ®Google Scholar
• Tsibris AMN, Paredes R, Chadburn A, Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis 2009;48:642-9
   PubMed Web of Science ®Google Scholar
• Walmsley S, Campo R, Goodrich J, Low risk of malignancy with maraviroc in treatment-experienced (TE) and treatment-navie (TN) patients across the maraviroc clinical development program [abstract TUPE0157]. XVIII International AIDS Conference; 18 – 23 July 2010; Vienna, Austria
   Google Scholar
• Glass WG, McDermott DH, Lim JK, CCR5 deficiency increases risk of symptomatic West Nile virus infection. J Exp Med 2006;203:35-40
   PubMed Web of Science ®Google Scholar
• Lim JK, Louie CY, Glaser C, Genetic deficiency of chemokine receptor CCR5 is a strong risk factor for symptomatic West Nile virus infection: a meta-analysis of 4 cohorts in the US epidemic. J Infect Dis 2008;197:262-5
   PubMed Web of Science ®Google Scholar
• Pulendran B, Miller J, Querec TD, Case of yellow fever vaccine–associated viscerotropic disease with prolonged viremia, robust adaptive immune responses, and polymorphisms in CCR5 and RANTES genes. J Infect Dis 2008;198:500-7
   PubMed Web of Science ®Google Scholar
• Telenti A. Safety concerns about CCR5 as an antiviral target. Curr Opin HIV AIDS 2009;4:131-5
   PubMedGoogle Scholar
• Nozza S, Galli L, Bigoloni A, Durability and safety of a novel salvage therapy in R5-tropic HIV-infected patients: maraviroc, raltegravir, etravirine. J Acquir Immune Defic Syndr 2011;56:e113-15
   PubMed Web of Science ®Google Scholar
• Brumme ZL, Goodrich J, Mayer HB, Molecular and clinical epidemiology of CXCR4-using HIV-1 in a large population of antiretroviral-naive individuals. J Infect Dis 2005;192:466-74
   PubMed Web of Science ®Google Scholar
• Poveda E, Briz V, de Mendoza C, Prevalence of X4 tropic HIV-1 variants in patients with differences in disease stage and exposure to antiretroviral therapy. J Med Virol 2007;79:1040-6
   PubMed Web of Science ®Google Scholar
• Heera J, Saag M, Ive P, Virological correlates associated with treatment failure atweek 48 in the phase 3 study of Maraviroc in treatment-naı¨vepatients [abstract 40LB]. 15th Conference on Retroviruses and Opportunistic Infections; 3 - 5 February 2008; Boston, MA
   Google Scholar
• Nelson M, on behalf of the MERIT study team. 96-week resultsof the MERIT trial [abstract MOPEBO4O]. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 19 – 22 July 2009; Cape Town, South Africa
   Google Scholar
• Portsmouth S, Craig C, Mills A, 48-week results of a dual-therapy regimen of once-daily maraviroc (MVC) 150 mg in combination with ritonavir-boosted atazanavir (ATV/r) compared to emtricitabine/tenofovir (FTC/TDF) + ATV/r in treatment-naive (TN) patients infected with CCR5-tropic HIV [abstract TUAB0103]. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 17 – 20 July 2011; Rome, Italy
   Google Scholar
• Barbaro G, Iacobellis G. Metabolic syndrome associated with HIV and highly active antiretroviral therapy. Curr Diab Rep 2009;9:37-42
   PubMed Web of Science ®Google Scholar
• Sabin CA, Worm SW, Weber R, Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet 2008;371:1417-26
   PubMed Web of Science ®Google Scholar
• Giralt M, Domingo P, Guallar JP, HIV-1 infection alters gene expression in adipose tissue, which contributes to HIV- 1/HAART-associated lipodystrophy. Antivir Ther (Lond) 2006;11:729-40
   PubMed Web of Science ®Google Scholar
• Soriano V, Puoti M, Garcia-Gasco P, Antiretroviral drugs and liver injury. AIDS 2008;22:1-13
   PubMed Web of Science ®Google Scholar
• Hill A, Balkin A. Risk factors for gastrointestinal adverse events in HIV treated and untreated patients. AIDS Rev 2009;11:30-8
   PubMed Web of Science ®Google Scholar
• Cespedes MS, Aberg JA. Neuropsychiatric complications of antiretroviral therapy. Drug Saf 2006;29:865-74
   PubMed Web of Science ®Google Scholar
• Abrams D, Levy Y, Losso MH, Interleukin-2 therapy in patients with HIV infection. N Engl J Med 2009;361:1548-59
   PubMed Web of Science ®Google Scholar
• Wilkin TJ, Ribaudo HR, Tenorio AR, The relationship of CCR5 antagonists to CD4+ T-cell gain: a meta-regression of recent clinical trials in treatment-experienced HIV-infected patients. HIV Clin Trials 2010;11:351-8
   PubMed Web of Science ®Google Scholar
• Liu R, Paxton WA, Choe S, Homozygous defect in HIV-1 coreceptor accounts for resistance of some multiply-exposed individuals to HIV-1 infection. Cell 1996;86:367-77
   PubMed Web of Science ®Google Scholar
• Huang Y, Paxton WA, Wolinsky SM, The role of a mutant CCR5 allele in HIV-1 transmission and disease progression. Nat Med 1996;2:1240-3
   PubMed Web of Science ®Google Scholar
• Neff CP, Kurisu T, Ndolo T, A topical microbicide gel formulation of CCR5 antagonist maraviroc prevents HIV-1 vaginal transmission in humanized RAG-hu mice. PLoS ONE 2011;6:e20209
   PubMed Web of Science ®Google Scholar
• Maraviroc in Rheumatoid Arthritis - ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/NCT00427934 [Last accessed 13 October 2011]
   Google Scholar
• ClinicalStudyResults.org - Drug Details. Available from: http://www.clinicalstudyresults.org/drugdetails/?study_name=A4001056&sort=c.company_name&page=1&drug_id=9756 [Last accessed 13 October 2011]
   Google Scholar
• Hellier S, Frodsham AJ, Hennig BJW, Association of genetic variants of the chemokine receptor CCR5 and its ligands, RANTES and MCP-2, with outcome of HCV infection. Hepatology 2003;38:1468-76
   PubMed Web of Science ®Google Scholar
• Thio CL, Astemborski J, Bashirova A, Genetic protection against hepatitis B virus conferred by CCR5Delta32: Evidence that CCR5 contributes to viral persistence. J Virol 2007;81:441-5
   PubMed Web of Science ®Google Scholar
• Braunersreuther V, Steffens S, Arnaud C, A novel RANTES antagonist prevents progression of established atherosclerotic lesions in mice. Arterioscler Thromb Vasc Biol 2008;28:1090-6
   PubMed Web of Science ®Google Scholar
• Wheeler J, McHale M, Jackson V, Assessing theoretical risk and benefit suggested by genetic association studies of CCR5: experience in a drug development programme for maraviroc. Antivir Ther (Lond) 2007;12:233-45
   PubMed Web of Science ®Google Scholar
• Reale M, Iarlori C, Feliciani C, Peripheral chemokine receptors, their ligands, cytokines and Alzheimer's disease. J Alzheimers Dis 2008;14:147-59
   PubMed Web of Science ®Google Scholar
• Thio CL, Astemborski J, Thomas R, Interaction between RANTES promoter variant and CCR5Delta32 favors recovery from hepatitis B. J Immunol 2008;181:7944-7
   PubMed Web of Science ®Google Scholar
• Vincent T, Portales P, Baillat V, T-Cell surface CCR5 density is not correlated with hepatitis severity in hepatitis C virus/HIV-coinfected individuals: implications for the therapeutic use of CCR5 antagonists. J Acquir Immune Defic Syndr 2005;38:305-9
   PubMed Web of Science ®Google Scholar
• Westby M, Smith-Burchnell C, Mori J, Reduced maximal inhibition in phenotypic susceptibility assays indicates that viral strains resistant to the CCR5 antagonist maraviroc utilize inhibitor-bound receptor for entry. J Virol 2007;81:2359-71
   PubMed Web of Science ®Google Scholar
• Pugach P, Marozsan AJ, Ketas TJ, HIV-1 clones resistant to a small molecule CCR5 inhibitor use the inhibitor-bound form of CCR5 for entry. Virology 2007;361:212-28
   PubMed Web of Science ®Google Scholar