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5-year Safety Evaluation of Maraviroc in HIV-1-Infected,
Treatment-Experienced Patients
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JAIDS Journal of Acquired Immune Deficiency Syndromes., POST ACCEPTANCE, 21 August 2013
Gulick, Roy M.; Fatkenheuer, Gerd; Burnside, Robert; Hardy, W. David; Nelson, Mark R.; Goodrich, James; Mukwaya, Geoffrey; Portsmouth, Simon; Heera, Jayvant R
Background: Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell CCR5 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 for 5 or more years. Survival and selected clinical endpoints were identified and assessed.
Results: A total of 938 enrolled patients received maraviroc-containing regimens. Rates of death and selected clinical events (e.g., hepatic failure, malignancy, myocardial infarction) were low during follow-up.
Conclusions: Maraviroc was generally safe in treatment-experienced participants over more than 5 years
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