Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Wall Street Journal - September 19, 2005
Marilyn Chase, marilyn.chase@wsj.com
In a statement to the HIV patient community, Glaxo said data from safety and efficacy studies of the drug, aplaviroc, included reports of severe liver toxicity in a subgroup of volunteers known as "treatment-naive" because the drug was the first AIDS treatment they had received.
'In the Interests of Safety'
Two of the 250 treatment-naive patients taking the experimental drug experienced severe liver problems, Glaxo spokesman Rick Koenig said. "We don't know that this was drug-related, but in the interests of safety we took the actions," he said. The studies were being conducted in the U.S., Canada and the European Union. Glaxo said no patients died of the side effects, and none required liver transplants.
Aplaviroc is one of a next generation of experimental AIDS treatments, not yet on the market, known as entry-inhibitor drugs because they block CCR5, a co-receptor on cells that the virus uses as an entry portal. European AIDS activists previously criticized Pfizer Inc.'s tests of a rival CCR5 blocker, arguing that it was inappropriate to expose newly diagnosed patients to an experimental drug's risks when they could benefit from standard drugs.
In Glaxo's clinical trial, the patients were receiving aplaviroc in addition to standard therapy for treating HIV. Another 50 patients in a control group received standard therapy alone.
Increased Monitoring
Glaxo said it terminated the part of its trials involving treatment-naive patients after discussions of risks with the U.S. Food and Drug Administration. The company added in a statement to the HIV patient community that it also "has taken immediate steps to protect the welfare of patients in clinical studies of aplaviroc." That includes increased safety monitoring of the patients still receiving the drug, who aren't "treatment naive" and whose virus has developed resistance to some other AIDS treatments.
Glaxo said it is proceeding cautiously to continue studies of the drug in these 40 "treatment-experienced HIV patients" because they have fewer options for treatment because of viral resistance that has developed to older drugs. Half of the 40 are receiving aplaviroc; half are in the control group on a standard therapy.
The company also said it will freeze the second trial at 40 patients and forgo planned expansion until it knows more about the liver toxicity. Glaxo is also revising the informed-consent form to reflect the potential new side effects, and continuing volunteers must sign the updated document.
However, American activists say they worry that liver damage in the newly diagnosed may indicate broader risks endangering other patients.
"It may be the death knell for GSK's entry inhibitor," Martin Delaney, founder of the San Francisco AIDS activist group Project Inform, wrote in an email. "It may be a warning about the whole class of drugs. Right now GSK is saying the problem is only in the [treatment-] naive population. But there is virtually no medical logic for this to be the case."
Glaxo's Mr. Koenig disagreed in an interview, saying, "Right now, it's too early to speculate." He added the company isn't contending that side effects are limited only to the treatment-naive patients but is allowing the experienced patients to continue with caveats because they have fewer treatment alternatives.
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