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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e3182a7a97a
Brief Report: Clinical Science

Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected Treatment-Experienced Patients

Gulick, Roy M. MD, MPH*; Fatkenheuer, Gerd MD; Burnside, Robert MPH; Hardy, W. David MD§; Nelson, Mark R. MA, MBBS, FRCP; Goodrich, James PhD, MD¶,1; Mukwaya, Geoffrey MD#; Portsmouth, Simon MBChB, MD**; Heera, Jayvant R. MD, MFPM

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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.

© 2014 by Lippincott Williams & Wilkins


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