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HIV Clinical Trials Volume 16, 2015 - Issue 2
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Original Articles

Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents

Juergen K. RockstrohDepartment of Medicine IUniversity of Bonn, Bonn, Germany
,
Vicente SorianoDepartment of Infectious Diseases and Internal MedicineHospital Carlos III-La Paz University Hospital, Madrid, Spain
,
Frank PlonskiGlobal Clinical DevelopmentPfizer Inc, Collegeville, PA, USA
,
Meena BansalDivision of Liver DiseasesIcahn School of Medicine at Mount Sinai, New York, NY,USA
,
Gerd FätkenheuerDepartment I of Internal MedicineUniversity Hospital Cologne, Cologne, Germany
,
Catherine B. SmallDepartment of MedicineDivision of Infectious Diseases, New York Medical College, Valhalla, NY, USA
,
David M. AsmuthDepartment of Internal MedicineUniversity of California Davis Medical Center, Sacramento, CA, USA
,
Gilles PialouxMaladies Infectieuses et TropicalesHôpital Tenon, Paris, France
,
Geoffrey MukwayaClinical Research and DevelopmentPfizer Inc, New York, NY, USA
,
Shyla JagannathaJanssen Research and Development, Janssen Pharmaceuticals, Inc., Titusville, NJ, USA
,
Jayvant HeeraClinical Sciences, Pfizer Inc, Groton, CT, USACorrespondence[email protected]
&
Juan A. PinedaUnit of Infectious Diseases, Hospital Universitario de Valme, Instituto de Investigación Biomédica de Sevilla (IBIS), Seville, Spain
 show all
Pages 72-80 | Published online: 29 Apr 2015

References

  • Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, et al. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis. 2001;32(3):492–497.
  • Weber R, Sabin CA, Friis-Møller N, Reiss P, El-Sadr WM, Kirk O, et al. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med. 2006;166(15):1632–1641.
  • Koziel MJ, Peters MG. Viral hepatitis in HIV infection. N Engl J Med. 2007;356(14):1445–1454.
  • Rockstroh JK. Management of hepatitis C/HIV coinfection. Curr Opin Infect Dis. 2006;19(1):8–13.
  • Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Muñoz A, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002;360(9349):1921–1926.
  • Food and Drug Administration. Selzentry: Highlights of Prescribing Information. 2007;. http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf. Accessed June 13, 2014.
  • European Medicines Agency. Celsentri (maraviroc), European Public Assessment Report. 2014;. http://www.ema.europa.eu/ema/index.jsp?curl = pages/medicines/human/medicines/000811/human_med_000689.jsp&murl = menus/medicines/medicines.jsp&mid = WC0b01ac058001d124. Accessed December 14, 2011..
  • Dragic T, Trkola A, Thompson DA, Cormier EG, Kajumo FA, Maxwell E, et al. A binding pocket for a small molecule inhibitor of HIV-1 entry within the transmembrane helices of CCR5. Proc Natl Acad Sci U S A. 2000;97(10):5639–5644.
  • Tsamis F, Gavrilov S, Kajumo F, Seibert C, Kuhmann S, Ketas T, et al. Analysis of the mechanism by which the small-molecule CCR5 antagonists SCH-351125 and SCH-350581 inhibit human immunodeficiency virus type 1 entry. J Virol. 2003;77(9):5201–5208.
  • Watson C, Jenkinson S, Kazmierski W, Kenakin T. The CCR5 receptor-based mechanism of action of 873140, a potent allosteric noncompetitive HIV entry inhibitor. Mol Pharmacol. 2005;67(4):1268–1282.
  • Seibert C, Ying W, Gavrilov S, Tsamis F, Kuhmann SE, Palani A, et al. Interaction of small molecule inhibitors of HIV-1 entry with CCR5. Virology. 2006;349(1):41–54.
  • Moreno C, Gustot T, Nicaise C, Quertinmont E, Nagy N, Parmentier M, et al. CCR5 deficiency exacerbates T-cell-mediated hepatitis in mice. Hepatology. 2005;42(4):854–862.
  • Marra F. Chemokines in liver inflammation and fibrosis. Front Biosci. 2002;7:d1899–d1914.
  • Schwabe RF, Bataller R, Brenner DA. Human hepatic stellate cells express CCR5 and RANTES to induce proliferation and migration. Am J Physiol Gastrointest Liver Physiol. 2003;285(5):G949–G958.
  • Nasta P, Gatti F, Borghi F, Chiari E, Paderni A, Carosi G. Liver stiffness (LS) change in HIV-hepatitis C (HCV) coinfected patients treated with CCR5 inhibitor based antiretroviral therapy. Abstract presented at: 51st Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17–20, 2011; Chicago, IL.
  • Mankhatitham W, Lueangniyomkul A, Manosuthi W. Hepatotoxicity in patients co-infected with tuberculosis and HIV-1 while receiving non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy and rifampicin-containing anti-tuberculosis regimen. Southeast Asian J Trop Med Public Health. 2011;42(3):651–658.
  • Macías J, Berenguer J, Japón MA, Girón JA, Rivero A, López-Cortés LF, et al. Fast fibrosis progression between repeated liver biopsies in patients coinfected with human immunodeficiency virus/hepatitis C virus. Hepatology. 2009;50(4):1056–1063.
  • Ayoub A, Alston S, Goodrich J, Heera J, Hoepelman AI, Lalezari J, et al. Hepatic safety and tolerability in the maraviroc clinical development program. AIDS. 2010;24(17):2743–2750.
  • Gulick RM, Su Z, Flexner C, Hughes MD, Skolnik PR, Wilkin TJ, 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(2):304–312.
  • Zingman BS, Suleiman J, DeJesus E, Slim J, McCarthy M, Lee M, et al. Vicriviroc, a next generation CCR5 antagonist, exhibits potent, sustained suppression of viral replication in treatment-experienced adults: VICTOR-E1 48-week results. Abstract presented at: 15th Conference on Retroviruses and Opportunistic Infections; February 3–6, 2008; Boston, MA.
  • Nichols WG, Steel HM, Bonny T, Adkison K, Curtis L, Millard J, et al. Hepatotoxicity observed in clinical trials of aplaviroc (GW873140). Antimicrob Agents Chemother. 2008;52(3):858–865.

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