title: Drug safety evaluation of  maraviroc  for the treatment of HIV infection.
abstract: BACKGROUND
  Maraviroc is the only C-chemokine receptor 5 (CCR5) antagonist approved for the treatment of infection with HIV. This article reviews the safety and efficacy of maraviroc in the treatment of HIV infection.
  
  
  METHODS
  The PubMed database was searched using the keywords 'maraviroc' and 'HIV'. In addition, conference proceedings from CROI, IAS and EACS meetings were searched for maraviroc clinical trials. The PubMed search revealed one Phase IIb - III clinical trial in treatment-naive HIV(+) patients (MERIT) and three Phase IIb - III randomized clinical trials (RCTs) in treatment-experienced patients (MOTIVATE 1 and 2, A4001029). All RCTs showed an excellent safety profile for maraviroc in the treatment of HIV-1 infection. However, long-term (> 3 years) safety data generated on maraviroc therapy are still scarce. Based on the findings from RCTs so far, no relevant toxicities and co-morbidities such as coronary heart disease or hepatotoxicity have been described. The overall CD4(+) cell count increase resulting from a maraviroc-containing regimen appears to be higher than those seen with other antiretroviral regimens. However, the significance remains controversial. To date, maraviroc has shown a potent and durable virological efficacy profile for the treatment of HIV-1 infection. The only use of maraviroc depends on pretreatment testing for CCR5 tropism.
  
  
  CONCLUSIONS
  Maraviroc is a generally safe and well-tolerated medication for the treatment of HIV-1 infection with a unique mechanism of action. Long-term (i.e., > 5 years) risks are not known and have to be carefully monitored.
authors: Universitätsklinikum Bonn, Medical Department I, Sigmund-Freud-Str. 25, 53105 Bonn, Germany.
authors: Jan-Christian
authors: JC
authors: Wasmuth
authors: Jürgen Kurt
authors: JK
authors: Rockstroh
authors: William David
authors: WD
authors: Hardy
mesh_terms: D000818:Animals; D065100:CCR5 Receptor Antagonists; D018791:CD4 Lymphocyte Count; D002986:Clinical Trials as Topic; D003510:Cyclohexanes / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D016903:Drug Monitoring; D023581:HIV Fusion Inhibitors / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D000077592:Maraviroc; D013997:Time Factors; D014230:Triazoles / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D065100:CCR5 Receptor Antagonists; D003510:Cyclohexanes; D023581:HIV Fusion Inhibitors; D014230:Triazoles; D000077592:Maraviroc