Five-Year Safety Evaluation of Maraviroc in HIV-1Infected 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

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

Author Information

*Weill Cornell Medical College, New York, NY;

University Hospital of Cologne, Cologne, Germany;

Pfizer, Inc, Groton, CT;

§David Geffen School of Medicine at UCLA, Los Angeles, CA;

Chelsea and Westminster Hospital, London, United Kingdom;

ViiV Healthcare, Research Triangle Park, NC;

#Pfizer, Inc, New York, NY; and

**Bristol-Myers Squibb, Wallingford, CT.

1Deceased.

Correspondence to: Roy M. Gulick, MD, MPH, Division of Infectious Diseases, Box 125, Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065 (e-mail: rgulick@med.cornell.edu).

Supported by Pfizer, Inc and National Institute of Allergy and Infectious Diseases Grants AI-51966 (K24 to R.M.G.) and AI055032 (K08 to W.D.H.).

Presented in part, in abstract form, at the 19th International AIDS Society Meeting, July 22–27, 2012, Washington, DC (Abstract TuPE029).

R.M.G. has served as an investigator on research grants from GlaxoSmithKline and ViiV to Weill Cornell Medical College. G.F. has served as an investigator on research grants from Pfizer to University Hospital of Cologne and has received travel grants and honoraria as a consultant from Pfizer. R.B., G.M., and J.R.H. are employees of Pfizer, Inc and hold stock/stock options in Pfizer, Inc. W.D.H. has served as an investigator on research grants from Bionor, Gilead, GlaxoSmithKline, Pfizer, Vertex, and ViiV to Cedars-Sinai Medical Center and as an ad-hoc consultant to Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, and ViiV. M.R.N. received research grants and consultancy fees and has acted as a speaker for Pfizer and ViiV. J.G. was an employee of Pfizer, Inc, and ViiV Healthcare at the time that this study was conducted and held stock in Pfizer, Inc. S.P. was an employee of Pfizer, Inc, at the time that this study was conducted and holds stock in Pfizer, Inc and is currently an employee of Bristol-Myers Squibb.

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Received May 21, 2013

Accepted July 29, 2013

© 2014 by Lippincott Williams & Wilkins