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Aplaviroc phase II halted due to hepatic toxicity; Study continues in treatment-experienced
 
 
  2005-09-19 14:31:01 -0400 (Reuters Health)
 
By Ben Hirschler
 
LONDON (Reuters) - Two cases of serious liver problems have occurred in HIV-infected patients taking the experimental oral CCR5 inhibitor aplaviroc, also known as GSK 873140, GlaxoSmithKline Plc reported late last week.
 
As a result, the world's largest maker of HIV/AIDS drugs has terminated phase IIb tests of the drug on treatment-naive patients.
 
The discovery of severe liver toxicity is a blow for the drug but does not mean the end of development. Glaxo is offering treatment-experienced patients the option of continuing in a phase III study, but with additional monitoring for liver toxicity.
 
A Glaxo spokesman said on Monday the group still hopes aplaviroc, which was licensed from Japan's Ono Pharmaceuticals, would eventually get to market. It is too early to speculate whether the problem is aplaviroc-related (WSJ).
 
The news that 2 out of 250 treatment-naive patients given Glaxo's aplaviroc had liver problems is unexpected, since one of the main advantages of CCR inhibitors is supposed to be their low toxicity.
 
If successful, scientists believe CCR5 inhibitors could offer hope to patients whose virus has developed resistance to existing antiretroviral drugs.
 
 
 
 
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