Case Study of a Patient With Serious Hepatotoxicity in Maraviroc 2b/3 Trial Reported at Targeting HIV Entry -- 1st International WorkshopDecember 3, 2005 A note from TheBody.com: The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information! Bethesda, MD -- Howard Mayer, M.D. of Pfizer Global Research and Development presented today on a case of one patient with serious hepatotoxicity in the treatment naïve trial of the maraviroc phase 2b/3 program. Speaking at the "Targeting HIV Entry -- 1st International Workshop," Mayer said the single case was reported to Pfizer in early November through standard safety monitoring procedures. At the time, approximately 1300 patients with HIV had enrolled in this phase 2b/3 clinical program (~ 75% on maraviroc).
Pfizer recently reported that detailed reviews of safety and efficacy by the independent maraviroc Data Safety Monitoring Board (DSMB) conducted in July and September concluded that there were no safety concerns at that time, including no signal of significant liver dysfunction potentially associated with maraviroc. Upon learning of this case, Pfizer requested an ad-hoc DSMB review and informed all investigators, patients and regulatory authorities of this latest information. Key details of the case that Mayer reported today were:
Upon review, the DSMB concluded that the other medications administered during this episode appear more likely to be associated with the hepatotoxicity; however, they could not exclude that maraviroc had a role in this patient's illness.
The DSMB recommends no further changes to the maraviroc program at this time and will meet again as scheduled in January 2006. A note from TheBody.com: The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information! This article was provided by Pfizer, Inc..
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