Current advances in pharmacovigilance in the USA and Europe: Meeting the challenges of safety monitoring in HIV

Kendall A. Marcus, Alfred Sorbello, Melissa Truffa, Julie Williams, June M. Raine, William G. Powderly

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

Abstract

PURPOSE OF REVIEW: The success of antiretroviral therapy in HIV disease comes currently with the realization that patients are committed to life-long treatment, which raises the possibility of long-term toxicity. Such long-term side effects may not be identified in initial clinical trials requiring, therefore, a different approach to monitoring patients over time -a pharmacovigilance approaC.H. RECENT FINDINGS: Several key issues in long-term management of HIV infection have been addressed by a pharmacovigilance approach -including unusual and rare side effects and elucidation of emerging toxicities such as cardiovascular, bone and renal disease. Recent changes in legislation in the USA and Europe are aimed to strengthen pharmacovigilance in developed countries. SUMMARY: HIV infection and its treatment provide an important example of the role of pharmacovigilance. As clinical trials can rarely address the question of long-term tolerability, effective pharmacovigilance programs are and will remain essential.

Original languageEnglish
Pages (from-to)292-298
Number of pages7
JournalCurrent Opinion in HIV and AIDS
Volume7
Issue number4
DOIs
StatePublished - Jul 2012

Keywords

  • HIV
  • antiretroviral therapy
  • long-term toxicity
  • pharmacovigilance
  • treatment

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