Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients

J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

Abstract

Background: Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell chemokine coreceptor type-5 receptor. With its novel mechanism of action, we sought to describe the 5-year safety profile of maraviroc.

Methods: Two large phase 3 studies of maraviroc enrolled HIV-infected treatment-experienced patients and followed them up for 5 or more years. Survival and selected clinical end points were identified and assessed.

Results: A total of 938 enrolled patients received maraviroc-containing regimens. Rates of death and selected clinical events (eg, hepatic failure, malignancy, and myocardial infarction) were low during follow-up.

Conclusions: Maraviroc was generally safe in treatment-experienced participants for >5 years.

Trial registration: ClinicalTrials.gov NCT00098306 NCT00098722.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • CCR5 Receptor Antagonists
  • Cyclohexanes / adverse effects*
  • Cyclohexanes / therapeutic use
  • Double-Blind Method
  • HIV Fusion Inhibitors / adverse effects*
  • HIV Fusion Inhibitors / therapeutic use
  • HIV Infections / drug therapy*
  • HIV Infections / mortality
  • HIV-1 / drug effects
  • Humans
  • Maraviroc
  • Survival Analysis
  • Time Factors
  • Triazoles / adverse effects*
  • Triazoles / therapeutic use

Substances

  • CCR5 Receptor Antagonists
  • Cyclohexanes
  • HIV Fusion Inhibitors
  • Triazoles
  • Maraviroc

Associated data

  • ClinicalTrials.gov/NCT00098306
  • ClinicalTrials.gov/NCT00098722