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Updated: Jun 8, 2026
07:06
Prediction of HIV-1 Coreceptor Usage (Tropism) by Sequence Analysis using a Genotypic Approach
Published on: December 1, 2011
Hepatic safety and tolerability in the maraviroc clinical development program
Ayman Ayoub1, Sam Alston, James Goodrich
1Pfizer Global Research and Development, Sandwich, UK.
AIDS (London, England)
|October 12, 2010
Summary
Maraviroc, a CCR5 antagonist for HIV-1, shows a good safety profile. Analysis of clinical trials indicates no significant hepatic risks at recommended doses.
Area of Science:
- Pharmacology
- Hepatology
- Virology
Background:
- Maraviroc is the first approved CCR5 antagonist for HIV-1 treatment.
- Hepatotoxicity is a potential concern with many HIV medications.
- Assessing maraviroc's hepatic safety is crucial for patient management.
Purpose of the Study:
- To evaluate the hepatic safety profile of maraviroc.
- To analyze liver enzyme abnormalities and hepatobiliary events in clinical trials.
- To determine the risk of severe hepatotoxicity associated with maraviroc.
Main Methods:
- Pooled analysis of safety data from Pfizer-sponsored maraviroc clinical trials.
- Inclusion of 2350 participants receiving maraviroc.
- Review of hepatic enzyme levels, bilirubin, and adverse events, including Hy's Law criteria.
Main Results:
- Sporadic hepatic enzyme abnormalities occurred in early studies without dose relationship.
- No significant imbalance in hepatic events observed in phase 2b/3 trials up to 96 weeks.
- No patients met Hy's Law criteria; two severe hepatotoxicity cases had uncertain maraviroc contribution.
Conclusions:
- Maraviroc demonstrates an acceptable hepatic safety profile at recommended doses.
- The drug does not appear to pose significant hepatic risks in the studied populations.
- Further monitoring is warranted for severe hepatotoxicity, though rare.
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