HIV Digest	HIV Digest Archive

GlaxoSmithKline PLC announced that it had halted safety and efficacy trials of an HIV medication after two of the 250 treatment-naïve trial patients developed severe liver toxicity. However, studies of the drug aplaviroc-- GSK's candidate in a new class of drugs that will attempt to block HIV's infection of cells via the CCR5 co-receptor-- are continuing among 40 HIV patients whose virus is resistant to currently standard treatments.

In a statement to the HIV patient community, GSK said it halted the aplaviroc study in the treatment-naïve subgroup following discussions with the US Food and Drug Administration. No patients died from the liver problems or required liver transplants, said GSK. The aplaviroc studies were conducted in the United States, European Union, and Canada.

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A GSK spokesperson said the firm is not contending that severe liver toxicity was limited to treatment-naive subjects, and in fact it is too early to speculate whether the problem is aplaviroc-related.

"It may be the death knell for GSK's entry inhibitor," said Martin Delaney, founder of the San Francisco-based HIV/AIDS group Project Inform. "It may be a warning about the whole class of drugs. Right now, GSK is saying the problem is only in the [treatment-] naïve population. But there is no medical logic for this to be the case."

Editor's Note: from the Wall Street Journal